Pharmacies McKesson Plasma and Biologics

2015 Product Catalog Winter Issue

877.MCK.BLOOD (877.625.2566)

Kogenate® FS, antihemophilic factor (recombinant), with Vial Adapter A needleless reconstitution system that contains a sterile vial adapter with a built-in 15-micrometer filter and a prefilled diluent syringe1

Available with a wide range of vial sizes, for flexibility in dose preparation1 ■ Kogenate FS is available in 250-IU, 500-IU, 1000-IU, 2000-IU, and 3000-IU vial sizes ■ Small diluent volumes* make reconstitution fast and easy *Diluent sizes are: 2.5 mL for 250-IU, 500-IU, and 1000-IU vial sizes; 5.0 mL for 2000-IU and 3000-IU vial sizes.

INDICATIONS Kogenate® FS antihemophilic factor (recombinant) is a recombinant factor VIII indicated for: ■ Control and prevention of bleeding episodes in adults and children with hemophilia A. ■ Surgical prophylaxis in adults and children with hemophilia A. ■ Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage. ■ Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. Kogenate FS is not indicated for the treatment of von Willebrand disease. SELECTED IMPORTANT SAFETY INFORMATION ■ Kogenate FS antihemophilic factor (recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product. ■ Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Kogenate FS if symptoms occur and seek immediate emergency treatment. Reference: 1. Kogenate® FS with Vial Adapter [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2014. Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. © 2014 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. Printed in USA

7/14

PP-575-US-0020

Kogenate FS can be stored at room temperature (up to 77°F) for up to 1 year1† Store Kogenate FS at 36°F to 46°F for up to 30 months from the date of manufacture. Within this period, Kogenate FS may be stored for a period of up to 12 months at temperatures up to 77°F. The starting date of room-temperature storage should be clearly recorded on the unopened product carton. Once stored at room temperature, the product must not be returned to the refrigerator. The shelf life then expires after the storage at room temperature (up to 12 months) or the expiration on the product vial, whichever is earlier.



To learn more about Kogenate FS, visit www.kogenatefs.com SELECTED IMPORTANT SAFETY INFORMATION (cont’d) ■ Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS predominately in previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration. ■ Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII. ■ Serious adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII. ■ The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) associated infections. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information, please see the brief summary of Prescribing Information on the next page.

15 REFERENCES Description (11)]. Patients treated with this product may develop hypersensitivity to these † Denominator for de novo inhibitors is N = 60, since one patient had a pre-existing inhibitor. 1. White GC, Rosendaal F, Aledort LM, Lusher JM, Rothschild C, Ingerslev J, for the Factor VIII and Factor non-human mammalian proteins. IX Subcommittee of the Scientific and Standardization Committee of the International Society on ® – Dysgeusia KOGENATE FS [Antihemophilic (Recombinant), Formulated with Sucrose] Sensory System Table 3 Adverse Reactions in Previously Patients with Frequency of ≥ 4% Minimally Treated(AR) Patients (MTPs) inTreated the Joint Outcome Study Discontinue KogenateFactor FS if symptoms occur and seek immediate emergency treatment. Thrombosis and Haemostasis. Definitions in hemophilia. Thromb Haemost 85:560-75, 2001. (Age Range years) In 12–59 the Joint Outcome Study with pediatric MTPs treated with routine prophylaxis or episodic enhanced Additionally, available registries have reported inhibitor rates for PUPs with severe hemophilia A in the range For Intravenous LyophilizedAntibodies Powder for Reconstitution with BIO-SET, a 5.2 Use, Neutralizing 5. Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, et al. Prophylaxis versus treatment for 5.5 years, 46 of the 65 randomized patients experienced adverse events over the study duration. of 28% to 38% for factor VIII products. needle-less Neutralizing self-contained reconstitution system MedDRA Primary SOC Preferred Term N = 73 antibodies (inhibitors) have been reported following administration of Kogenate FS predominantly in episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med previously untreated Powder patients.forCarefully monitorwith patients for the development of factor VIII inhibitors, using Table 5 Adverse Reactions in Minimally Treated Patients in the Joint Outcome Study AR (%) 2007;357(6):535-44. 8 USE IN SPECIFIC POPULATIONS For Intravenous Use, Lyophilized Reconstitution Vial Adapter (Age Range 0–6 years) appropriate clinical observations and laboratory tests.6 If expected plasma factor VIII activity levels are not attained, 6. Kasper CK: Complications of hemophilia A treatment: factor VIII inhibitors. Ann NY Acad Sci 614:97-105, 8.1 Pregnancy Skin and Subcutaneous Rash, pruritus 6 (8.2%) Initial U.S. or Approval: 1993 if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor 1991. C. Tissue Disorders MedDRA Primary SOC Preferred Prophylaxis Enhanced Pregnancy Category concentration [See Warnings and Precautions (5.3)]. BRIEF SUMMARY Term Arm Episodic ArmAnimal reproduction 7. Barnes C,studies Lillicrap D, Pazmino-Canizares et al: Pharmacokinetics recombinant factorKogenate VIII (Kogenatehave not been conductedJ,with Kogenate FS. It is alsoofnot known whether General Disorders and Infusion site reactions 3 (4.1%) ® 5.3 Cardiovascular Risk Factors CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION N = 32 N = 33 FS can cause FSfetal ) in harm children andadministered causes of inter-patient pharmacokinetic variability. Haemophilia 12 (Suppl. 4): 40-49, when to a pregnant woman or affect reproductive capacity. Kogenate Administration Site Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop AR (%) AR (%) FS should be2006. given to a pregnant woman only if clearly needed. Conditions cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Surgical and Central venous 19 (59%) 18 (55%)‡ 1 INDICATIONS AND USAGE 17 PATIENT COUNSELING INFORMATION 8.2 Labor and Delivery factor SOC = System Organ Class Medical Procedures catheterization, Kogenate® FS is a VIII. recombinant antihemophilic factor indicated for: There is no information available on the effect of factor VIII replacement therapy on labor and delivery. Kogenate Catheter removal 5.4 Monitoring Laboratory Tests • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). • Control and prevention of bleeding episodes in adults and children with hemophilia A. FS should be used only if clinically needed. Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) • Monitor plasma factor activity levels by the one-stage clotting assay to confirm the adequate factor VIII Infections and Central line 6 (19%) 6 (18%) • Advise patients to report any adverse reactions or problems following Kogenate FS administration to their physician • Surgical prophylaxis in adults and VIII children with hemophilia A. clinical studies with pediatric PUPs and MTPs, there were 29 adverse reactions reported in the course of 8.3 Nursing Mothers levels have been achieved and maintained, when clinically indicated [See Dosage and AdministrationIn(2)]. Infestations infection or healthcare provider. • Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in children with 9,389 infusions. whether this drug is excreted into human milk.reported Becausewith many drugs are into human • AMonitor development VIII inhibitors. Perform assay pre-existing to determine joint if factor VIII inhibitor is present. If General Disorders Pyrexia 1 (3%) 4 (12%) It is not known • Allergic-type hypersensitivity reactions have been Kogenate FS.excreted Warn patients of the early hemophilia and tofor reduce the risk of of factor joint damage in children without damage. Adverse reported by ≥ 4% of the patients are listed in Table 4 below. milk, caution should be exercised if reactions Kogenate[including FS is administered to with a nursing woman. expected factor VIII activity plasma levels are not attained or if bleeding is not controlled with the expected dose reactions and Administration signs of hypersensitivity hives (rash itching), generalized urticaria, tightness of • Routine prophylactic to prevent reduce theinhibitors. frequency of bleeding episodes in adults with of Kogenatetreatment FS, use Bethesda Unitsor(BU) to titer Site Conditions the chest, Table 4 Adverse Reactions (AR) in Previously Untreated Patients and Minimally Treated Patients with 8.4 Pediatric Use wheezing, hypotension] and anaphylaxis. Advise patients to discontinue use of the product if these hemophilia A. occur have and seek treatment with measures such as the Frequency of ≥ 4% (Age Range � • If the inhibitor is less than 10 BU per mL, the administration of additional Kogenate FS concentrate SOC = System Organ2–27 Classmonths) Safety and symptoms efficacy studies been immediate performed emergency in previously untreated andresuscitative minimally treated pediatric Kogenate FS is not forthe theinhibitor treatment of may von Willebrand disease. hemostatic response. administration of epinephrine and oxygen. mayindicated neutralize and permit an appropriate patients. Children, in comparison to adults, present higher factor VIII clearance values and, thus, lower halfThree patients arm had catheter MedDRA‡Primary SOC from the enhanced episodic Preferred Term removal. N = 61 7 4 CONTRAINDICATIONS • Inhibitor may occur anydue timetoindifferences the treatment a patient with hemophilia A. Advise � • If inhibitor titers are above 10 BU per mL, adequate hemostasis may not be achieved. The inhibitor titer may life and recovery of formation factor VIII. This mayatbe in of body composition. Account for thispatients AR (%) Immunogenicity their physician treatment further and/or assessment, if theyClinical experience a rise followinginKogenate FS infusion as a result ofhypersensitivity an anamnesticreactions, responseincluding to factor anaphylaxis VIII. The treatment or Kogenate FS is contraindicated patients who have life-threatening difference to in contact clearance when dosingoror followingcenter factorforVIII levelstreatment in the pediatric population [See Skin and Subcutaneous Rash, pruritus, urticaria 10 (16%) lack of clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor. prevention of bleeding in such patients requires the use of alternative therapeutic approaches and agents. In clinical studies with 73 PTPs (defined as having more than 100 exposure days), one patient had a pre-existing to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium Pharmacology (12.3)]. Tissue Disorders inhibitor. In the other 72 patients, followed over 4 years, no de novo inhibitors were observed. chloride, polysorbate 80, sucrose, imidazole, tri-n-butyl phosphate, and copper). • Advise patients to consult with their healthcare provider prior to travel. While traveling advise patients to Routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown 6 ADVERSE REACTIONS bring an adequate supply of Kogenate based on theirThis current of treatment.to ages >2.5– Blood and Factor VIIIinhibitor inhibition 9 (15%) In Lymphatic clinical studies with pediatric PUPs and MTPs, development was observed in 9 †out of 60 patients to reduce spontaneous joint bleeding and the risk FS of joint damage. dataregimen can be extrapolated Serious AND adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions, including bronchospastic 5 WARNINGS PRECAUTIONS 1 System Disorders antibodies) 3 were low-titer inhibitors. Inhibitors were detected at a median (15%), 6 were high titer (> 5 BU) and(neutralizing 16 years for children who have no existing joint damage [See Clinical Studies (14)]. reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative 5.1 Hypersensitivity Reactions number of 7 exposure days (range 2 to 16 exposure days). treatments to factor VIII. anaphylaxis have been reported with Kogenate FS. Reported symptoms General Disorders and Infusion site reactions 4 (7%) 8.5 Geriatric Use Hypersensitivity reactions, including 5 In the Joint Administration SiteOutcome Study with Kogenate FS, de novo inhibitor development was observed in 8 of 64 patients Theswelling, most common adverse in nausea, clinical trials inhibitor formation included facial flushing, hives,reactions decrease(≥ in 4%) bloodobserved pressure, rash,were restlessness, shortness in of previously Clinical studies with Kogenate FS did not include patients aged 65 and over. Dose selection for an elderly with negative baseline values (12.5%), 2 patients developed high titer1 (> 5 BU) and were withdrawn from the Conditions untreatedtightness patients (PUPs) and minimally treated patients (MTPs), skin-related hypersensitivity reactions (e.g., breath, tachycardia, of the chest, tingling, urticaria, and vomiting. patient should be individualized. study. Six patients developed low-titer inhibitors. Inhibitors were detected at a median number of 44 exposure rash, pruritus), infusion site reactions (e.g., inflammation, pain), and central venous access device (CVAD) SOC = System Organ5Class Kogenate FS contains trace amounts of mouse immunoglobulin G (MuIgG) and hamster (BHK) proteins [See days (range to 151 exposure days). 15 REFERENCES infections.treated with this product may develop hypersensitivity to these Description associated (11)]. Patients † Denominator for de novo N = 60, since one patient pre-existing The detection ofinhibitors antibody is formation is dependent onhad the asensitivity andinhibitor. specificity of the assay. Additionally, 1. White GC, Rosendaal F, Aledort LM, Lusher JM, Rothschild C, Ingerslev J, for the Factor VIII and Factor non-human 6.1 mammalian proteins. Clinical Trials Experience the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced byIX Subcommittee of the Scientific and Standardization Committee of the International Society on Bayer HealthCare LLC Treated Patients (MTPs) in methodology, the Joint Outcome Because clinical trials areoccur conducted under widely varying conditions, adverse reaction rates observedMinimally in the Discontinue Kogenate FS if symptoms and seek immediate emergency treatment. assay sample Study handling, timing of sample collection, concomitant medications,Thrombosis several factors including andNJ Haemostasis. Whippany, 07981 USA Definitions in hemophilia. Thromb Haemost 85:560-75, 2001. clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not Joint In the Study withFor pediatric MTPs treated with ofroutine prophylaxis or episodic enhanced andOutcome underlying disease. these reasons, comparison the incidence of antibodies to Kogenate FS with5.theManco-Johnson 5.2 Neutralizing Antibodies TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, et al. Prophylaxis versus reflect the rates observed in clinical practice. U.S. LicenseMJ, No. Abshire 8 treatment for 5.5 years, 46 of theto65other randomized patients experienced adverse events over the study duration. incidence of antibodies products may be misleading. Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS predominantly in episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med (License Holder: Bayer Corporation) Previously Treated Patients (PTPs) Table 5 Adverse Reactions in Minimally Treated Patients in the Joint Outcome Study previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using 6.2 Postmarketing Experience 2007;357(6):535-44. During the open-label clinical studies conducted in 73 PTPs, there wereFrequency 24 adverse reported http://www.kogenatefs.com/ (Age Range years) adverse Table 3 Adverse Reactions (AR) in 6Previously Patients with of reactions ≥attained, 4% appropriate clinical observations and laboratory tests. Sensory System reaction – Dysgeusia If expected Treated plasma factor VIII activity levels are not The0–6 following has been identified during post approval use of Kogenate FS. Because adverse 6. Kasper CK: Complications of hemophilia A treatment: factor VIII inhibitors. Ann NY Acad Sci 614:97-105, in is the course of12–59 24,936 infusions. or if bleeding not controlled withyears) an expected dose, perform an assay that measures factor VIII inhibitor (Age Range reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their Additionally, available registries have reported inhibitor rates for PUPs with severe hemophilia A in the range 1991. MedDRA Primary SOC Preferred Prophylaxis Enhanced Adverse reactionsand reported by ≥ 4% of the patients are listed in Table 3 below. 6709902BS concentration [See Warnings Precautions (5.3)]. frequency or establish afor causal relationship to drug exposure. of 28% to 38% factor VIII products. Term Arm Episodic Arm 7. Barnes C, Lillicrap D, Pazmino-Canizares J, et al: Pharmacokinetics of recombinant factor VIII (KogenateMedDRA Primary SOC Preferred Term N = 73 5.3 Cardiovascular Risk Factors (AR) in Previously Treated Patients with Frequency of ≥ 4% N = 32 N = 33 FS ®) in children and causes of inter-patient pharmacokinetic variability. Haemophilia 12 (Suppl. 4): 40-49, Table 3 Adverse Reactions Sensory – Dysgeusia AR (%) 8 System USE IN SPECIFIC POPULATIONS Hemophilic with cardiovascular risk factors or diseases may be at the same risk to develop (%) 2006. (Agepatients Range 12–59 years) Additionally, available registries have reported inhibitor ratesAR for(%) PUPs with severe AR hemophilia A in the range 8.1 Pregnancy Skin and Rash, cardiovascular events as Subcutaneous non-hemophilic patients when clotting haspruritus been normalized by treatment with6 (8.2%) Surgicalofand venous 19 (59%) 18 (55%)‡ 28% to 38% for factor VIII products. Tissue Disorders Pregnancy Category C.Central Primary SOC Preferred Term N = 73 17 PATIENT COUNSELING INFORMATION factor VIII.MedDRA Medical Procedures catheterization, AR (%) Animal studies haveremoval not been conducted with Kogenate FS. It is also not known whether Kogenate General Disorders Infusion site reactions 3 (4.1%) 8 USE INreproduction SPECIFIC POPULATIONS Catheter 5.4 Monitoring Laboratory Testsand • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). N can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Kogenate 8.1andFSPregnancy and Subcutaneous pruritus 6 (8.2%) Administration Site levels by the one-stageRash, • MonitorSkin plasma factor VIII activity clotting assay to confirm the adequate factor VIII Infections Central line 6 (19%) 6 (18%) • Advise patients to report any adverse reactions or problems following Kogenate FS administration to their physician FS should be given to a pregnant woman only if clearly needed. Tissue Disorders Conditions Pregnancy Category C. levels have been achieved and maintained, when clinically indicated [See Dosage and Administration (2)]. Infestations infection or healthcare provider. 8.2 Labor and Delivery reproduction studies have not been conducted with Kogenate Disorders and Infusion site reactions 3 (4.1%) SOC = System Organ • MonitorGeneral for development of factor VIIIClass inhibitors. Perform assay to determine if factor VIII inhibitor is present. If General Animal Disorders Pyrexia 1 (3%) FS. It is also not4 known (12%) whether Kogenate • Allergic-type hypersensitivity reactions have been reported with Kogenate FS. Warn patients of the early There is no information available on the effect factor VIII replacement on laborcapacity. and delivery. Kogenate FS can cause fetal harm when administered to a of pregnant woman or affecttherapy reproductive Kogenate expected factor VIII activity plasma levels are not attained or if bleeding is not controlled with the expected dose and Administration signs of hypersensitivity reactions [including hives (rash with itching), generalized urticaria, tightness of Administration Site FS should be used if clinically Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) FS should be given to a only pregnant womanneeded. only if clearly needed. of Kogenate FS, use Bethesda Units (BU) to titer inhibitors. Site Conditions the chest, wheezing, hypotension] and anaphylaxis. Advise patients to discontinue use of the product if these Conditions In clinical studies with pediatric PUPs and MTPs, there were 29 adverse reactions reported in the course of symptoms occur and seek immediate emergency treatment with resuscitative measures such as the � • If theSOC inhibitor is less than Class 10 BU per mL, the administration of additional Kogenate FS concentrate SOC = System OrganNursing Class Mothers 8.2 8.3 Labor and Delivery = System Organ des in children with 9,389 infusions. administration of epinephrine and oxygen. may neutralize the inhibitor and may permit an appropriate hemostatic response. isno not known whether thison drug excreted into human milk. Because drugs aredelivery. excreted into human ThereItisfrom information available the is effect of factor VIII replacement therapymany on labor and Kogenate ‡ Three patients the enhanced episodic arm had catheter removal. nt damage. Adverse reported byadequate ≥ 4% the patients are listed Table 4 below. • Inhibitor formation may occur at any time in the treatment of a patient with hemophilia A. Advise patients � • If inhibitor titersUntreated arereactions above 10 BU per (PUPs) mL, hemostasis may notPatients beinachieved. The inhibitor titer may milk, be caution be exercised if Kogenate FS is administered to a nursing woman. FS should used should only if clinically needed. Previously Patients andofMinimally Treated (MTPs) odes in adults with Immunogenicity to contact their physician or treatment center for further treatment and/or assessment, if they experience a rise following Kogenate FS infusion asPUPs a(AR) result an anamnestic response to factor VIII. The treatment or course Table 4 Adverse Reactions inofMTPs, Previously Patients and Minimally Treated Patients In clinical studies with pediatric and thereUntreated were 29 adverse reactions reported in the of with 8.4 Pediatric Use Mothers lack of clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor. of bleedingof in ≥such requires themonths) use of alternative therapeutic approaches and agents. In clinical 8.3 studiesNursing with 73 PTPs (defined as having more than 100 exposure days), one patient had a pre-existing children with prevention Frequency 4% patients (Age Range 2–27 9,389 infusions. Safety and efficacy studies have beennoperformed inmilk. previously untreated andare minimally pediatric It the is not known whether this drug is4excreted into human Because many drugs excretedtreated into•human inhibitor. In other 72 patients, followed over years, de novo inhibitors were observed. Advise patients to consult with their healthcare provider prior to travel. While traveling advise patients to mage. 6 ADVERSE REACTIONS AdverseMedDRA reactions reportedSOC by ≥ 4% of the patients are listedPreferred in Table 4Term below. Children, in comparison to adults, present higher factor VIII clearance halfmilk, patients. caution should be exercised if Kogenate FS is administered to a nursing woman.values and, thus, lower Primary N = 61 bring an adequate supply of Kogenate FS based on their current regimen of treatment. In clinical studies with pediatric PUPs and MTPs, inhibitor development was observed in 9 out of 60 patients 7 n adults Serious with adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions, including bronchospasticAR (%) life and recovery of factor VIII. This may be due to differences in body composition. Account for this 1 Table 4 Adverse Reactions (AR) in Previously Untreated Patients and Minimally Treated Patients(15%), with 6 8.4 Pediatric Use (> 5 BU) and 3 were low-titer inhibitors. Inhibitors were detected at a median were high titer ncluding anaphylaxis reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative difference in clearance when dosing or following factor VIII levels in the pediatric population [See Clinical Frequency ofand ≥ 4% (Age Range 2–27 months) Skin Subcutaneous Rash, pruritus, urticaria 10 (16%) number ofSafety 7 exposure days (range 2 tohave 16 exposure days). in previously untreated and minimally treated pediatric and efficacy studies been performed e, sodium, calciumto factor treatments VIII. Pharmacology (12.3)]. 5 adults, present higher factor VIII clearance values and, thus, lower halfTissue Disorders patients. Children, in comparison In the Joint Outcome Study with Kogenate FS,to de novo inhibitor development wasnoobserved in 8 joint of 64damage patientshas been shown MedDRA Primary SOC Preferred Term N = 61 The most common adverse reactions (≥ 4%) observed in clinical trials were inhibitor formation in previously Routine prophylactic treatment in children ages 0–2.5 years with pre-existing 7 1 † negative life baseline and recovery of(12.5%), factor VIII. This may be the duehigh to of differences body composition. Account this with values 2 patients developed titer (>damage. 5 BU)inand were withdrawn from the tofor (%) Blood andand Lymphatic VIII inhibition 9 (15%) untreated patients (PUPs) minimally treated patients (MTPs),Factor skin-related hypersensitivity reactionsAR(e.g., to reduce spontaneous joint bleeding and risk joint This data can be extrapolated ages >2.5– g anaphylaxis difference in clearance when dosing or following factor VIII levels in the pediatric population [See Clinical study. Six patients developed low-titer inhibitors. Inhibitors were detected at a median number of 44 exposure System Disorders antibodies) rash, pruritus), infusion site reactions (e.g., inflammation,Rash, pain),(neutralizing and central venous access device 10 (CVAD) 16 years for children who have no existing joint damage [See Clinical Studies (14)]. Skin and Subcutaneous pruritus, urticaria (16%) um, calcium days (range 5 to 151 exposure days). Pharmacology (12.3)]. associated infections. Disorders Disorders and Infusion site reactions 4 (7%) Geriatric Use is dependent on the sensitivity and specificity of the assay. Additionally, eported symptomsTissueGeneral The detection of8.5 antibody formation Routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown Administration 6.1 Clinical ExperienceSite sness, shortness ofBloodTrials Clinical studies with Kogenate FS include and over. Dose selection for an elderly and Lymphatic Factor VIII inhibition 9 (15%)† the observed incidence of antibody (including neutralizing antibody) positivity in an 65 assay may influenced by to reduce spontaneous joint bleeding anddid thenot risk of jointpatients damage.aged This data can bebe extrapolated to ages >2.5– Bayer HealthCare LLC patient should be individualized. Because clinical trials are conducted under widely varying conditions, reaction rates observed in the SystemConditions Disorders (neutralizingadverse antibodies) several factors including assay methodology, sample handling, of sample collection, concomitant 16 years for children who have no existing joint timing damage [See Clinical Studies (14)]. medications, Whippany, NJ 07981 USA clinical[See trials of SOC a drug cannot be directly compared to rates in clinical trials of another drug and may not = System Organ Class BHK) proteins disease.REFERENCES For these reasons, comparison of the incidence of antibodies to Kogenate FS with the Disorders and practice. Infusion site reactions 4 (7%) and underlying 8.5 15Geriatric Use d symptoms reflect theGeneral rates observed in clinical U.S. License No. 8 nsitivity to these incidence of antibodies to other products may be misleading. † Denominator for de novo inhibitors is N = 60, since one patient had a pre-existing inhibitor. Administration Site 1. studies White GC, Aledort LM, Lusherpatients JM, Rothschild J, for the Factor and Factor shortness of Clinical withRosendaal KogenateF,FS did not include aged 65 C, andIngerslev over. Dose selection for VIII an elderly Bayer Corporation) PreviouslyConditions Treated Patients (PTPs) 6.2 Postmarketing Experience IX Subcommittee of the Scientific and Standardization Committee of the International (License Society Holder: on patient should be individualized. Minimally Treated Patients (MTPs) in the Joint Outcome Study During the open-label clinical studies conducted 73 PTPs, there were 24 adverse reactions reported http://www.kogenatefs.com/ The following adverse reaction has been identified during post approval use of Kogenate FS. Because adverse Thrombosis and Haemostasis. Definitions in hemophilia. Thromb Haemost 85:560-75, 2001. SOC of = System Organ ClassStudy with pediatric MTPs treated with routine prophylaxis or episodic enhanced proteins [See In the Joint Outcome in the course 24,936 infusions. 15 REFERENCES reactions are reported voluntarily fromMJ, a population is not always possible reliably estimate 5. Manco-Johnson Abshire of TC,uncertain Shapirosize, AD,itRiske B, Hacker MR,toKilcoyne R, et al.their Prophylaxis versus y to these † Denominator treatment 5.5 the randomized experienced adverse events over the study duration. forforde novo is N65 = 60, patient3 had a pre-existing inhibitor. Adverse reactions reported by ≥years, 4%inhibitors of46 theofpatients aresince listedone inpatients Table below. 1. establish Whiteepisodic GC, Rosendaal F, Aledort LM, Lusher Rothschild C, Ingerslev J, for hemophilia. the Factor VIIINand Factor 6709902BS frequency or a causal relationship totodrug exposure. FS predominantly in treatment prevent joint JM, disease in boys with severe Engl J Med IX Subcommittee of the Scientific and Standardization Committee of the International Society on Table 5 Adverse Reactions in Minimally Treated Patients in the Joint Outcome Study III inhibitors, using 2007;357(6):535-44. Minimally Treated Patients (MTPs) in the Joint Outcome Study Thrombosis and Haemostasis. Definitions in hemophilia. Thromb Haemost 85:560-75, 2001. Sensory System – Dysgeusia Table 3 Adverse Reactions (AR)years) in Previously Treated Patients with Frequency of ≥ 4% (Age Range 0–6 vels are not attained, 6. Kasper CK: Complications of hemophilia A treatment: factor VIII inhibitors. Ann NY Acad Sci 614:97-105, In the Jointyears) Outcome Study with pediatric MTPs treated with routine prophylaxis or episodic enhanced (Age Range 12–59 5. available Manco-Johnson Shapirorates AD,for Riske B, with Hacker MR,hemophilia Kilcoyne R,A et versus Additionally, registries MJ, haveAbshire reportedTC, inhibitor PUPs severe in al. theProphylaxis range factor VIII inhibitor 1991. treatment for 5.5 years, 46SOC of the 65 randomized patients experienced adverse events over the studyEnhanced duration. MedDRA Primary Preferred Prophylaxis dominantlyMedDRA in of 28% to 38%episodic for factortreatment VIII products. to prevent joint disease in boys with severe hemophilia. N Engl J Med Primary SOC Preferred Term N = 73 Term Arm Episodic Arm 7. Barnes C, Lillicrap D, Pazmino-Canizares J, et al: Pharmacokinetics of recombinant factor VIII (Kogenatebitors, using Table 5 Adverse Reactions in Minimally Treated Patients in the Joint Outcome StudyAR (%) 2007;357(6):535-44. The high cost of blood factor products makes stocking them cost-prohibitive for many N = 32 N =8 33 USE IN SPECIFIC FS®) POPULATIONS in children and causes of inter-patient pharmacokinetic variability. Haemophilia 12 (Suppl. 4): 40-49, (Age Range 0–6 years) not attained, 6. Kasper CK: Complications of hemophilia A treatment: factor VIII inhibitors. Ann NY Acad Sci 614:97-105, me risk toSkin develop AR (%) AR8.1 (%) Pregnancy 2006. and Subcutaneous Rash, pruritus 6 (8.2%) providers. With McKesson’s Plasma and Biologics Consignment Program, you have VIII inhibitor 1991. by treatment with MedDRA Primary Preferred Prophylaxis Enhanced Surgical andSOC Central venous 19 (59%) 18 (55%)‡ Tissue Disorders Pregnancy Category C. 17 PATIENT COUNSELING INFORMATION Term Arm Episodic Arm 7. Barnes C, Lillicrap D, Pazmino-Canizares J, et al: Pharmacokinetics of recombinant factor VIII (Kogenatethe convenience of purchasing only what you need, when you need it, for a minimal Medical catheterization, have been conducted with Kogenate FS. It is also not known whether Kogenate General Disorders and Procedures Infusion site reactions 3 (4.1%) N = 33 Animal reproduction N = 32 FS•®)Advise instudies children andnot causes inter-patient pharmacokinetic variability. Haemophilia 12 (Suppl. 4): Catheter removal the patient to readof the FDA-approved patientorlabeling (Patient Information andKogenate Instructions for40-49, Use). FS can cause fetal harm when administered to a pregnant woman affect reproductive capacity. convenience fee. Once products are purchased, they are replenished upon use and Administration Site kadequate to develop AR (%) AR (%) 2006. factor VIII Infections and Central line 6 (19%) 6 (18%) FS should be given to a pregnant woman if clearly needed.or problems following Kogenate FS administration to their physician • Advise patients to report only any adverse reactions Conditions atment with and Centralinfection venous 19 (59%) 18 (55%)‡ Administration (2)].Surgical Infestations or healthcare provider. guaranteed never to expire. 17 and PATIENT COUNSELING INFORMATION 8.2 Labor Delivery SOC = System Organ Class Procedures catheterization, nhibitor is present. IfMedical General Disorders Pyrexia 1 (3%) 4 (12%) • Allergic-type hypersensitivity reactions have been therapy reportedonwith FS. Warn patients of the early There is no•information available on thethe effect of factor VIIIpatient replacement laborKogenate and delivery. Kogenate Catheter removal Advise the patient to read FDA-approved labeling (Patient Information and Instructions for Use). h the expected dose and Administration hypersensitivity used signs only ifofclinically needed. reactions [including hives (rash with itching), generalized urticaria, tightness of Untreated Patients (PUPs) and Minimally Patients (MTPs)6 (19%) te factorPreviously VIII Infections Central Treated line 6 (18%) FS should be • Advisethe patients report any adverse reactions problems following Kogenate administration their physician Site and Conditions chest,towheezing, hypotension] andor anaphylaxis. Advise patients to FS discontinue use oftothe product if these More convenience for you. With on-demand factor products, you In clinical Infestations studies with pediatric PUPs and MTPs, there were 29 adverse reactions reported in the course of 8.3 Nursing Mothers stration (2)]. infection or healthcare provider. symptoms occur and seek immediate emergency treatment with resuscitative measures such as the ate withFS concentrate 9,389 infusions. SOC = System Organ Class whether thishypersensitivity drugof isepinephrine excretedreactions into human milk. Because many drugs are excreted intopatients human of the early is present. If General Disorders Pyrexia 1 (3%) 4 (12%) It is not known administration and oxygen. The McKesson Plasma and Biologics have peace of mind that products are: • Allergic-type have been reported with Kogenate FS. Warn ‡ Three patients thethe enhanced had catheter Adverse reactions reported by ≥from 4% of patients episodic are listedarm in Table 4 below.removal. milk, caution signs should exercised if Kogenate FS [including isatadministered to atreatment nursing woman. xpected dose ofbe hypersensitivity reactions hives (rash with itching), generalized urticaria,A.tightness of • Inhibitor formation may occur any time in the of a patient with hemophilia Advise patients he inhibitor titer mayand Administration with Consignment Program is customized to • There when you need them Table 4 Adverse Reactions (AR) in Previously Untreated Patients and Minimally Treated Patients with the Use chest, wheezing, hypotension] and anaphylaxis. Advise patients to discontinue use of the product if these a Immunogenicity 8.4 Pediatric to contact their physician or treatment center for further treatment and/or assessment, if they experience II. The treatment orSite Conditions Frequency of ≥In (Agestudies Range Class 2–2773months) symptoms and seek immediate emergency treatment with resuscitative measures the concentrate =4% System Organ lack ofoccur clinical response to factorinVIII replacement therapy, asminimally this may be a manifestation of anasinhibitor. oaches and agents.SOC clinical with PTPs (defined as having more than 100 exposure days), one patient had aSafety pre-existing and efficacy studies have been performed previously untreated and treated pediatricsuch deliver convenience. Not only are products • Billed when you use them administration of epinephrine and oxygen. inhibitor. the other 72 patients, followedPreferred overhad 4 years, novo inhibitors were patients. Children, in comparison to present higher factor VIII clearance and,While thus, lower half-advise patients to • Advise patients to adults, consult with their healthcare provider priorvalues to travel. traveling MedDRA Primary SOCInfrom Termno de N =observed. 61 ‡ Three patients the enhanced episodic arm catheter removal. recovery of factor This may to differences in Account forA.this • Inhibitor formation maysupply occurbeof atdue any time inFSthe treatment ofcomposition. a patient with7 hemophilia Advise patients available on demand; products and billing itor titer may bring an VIII. adequate Kogenate based onbody their current regimen of treatment. In clinical studies with pediatric PUPs and MTPs, inhibitor development was AR observed 60 and patients (%) in 9 out oflife ding bronchospastic ylaxis • Guaranteed fresh difference whenphysician dosing ororfollowing VIII in treatment the pediatric population [See Clinical Immunogenicity contact their treatmentfactor center forlevels further and/or assessment, if they experience a treatmentalternative or and pruritus, 3 were low-titer were detected at a medianintoclearance (15%), 6 were high titer 1 (> 5 BU) essitating Skin and Subcutaneous Rash, urticaria inhibitors. Inhibitors 10 (16%) are tailored to meet your needs. cium Pharmacologylack (12.3)]. of clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor. and agents. clinical studies 73 PTPsdays (defined as 2having than days). 100 exposure days), one patient had a pre-existing number of with 7 exposure (range to 16 more exposure TissueInDisorders • Competitively priced inhibitor. In the other 72 patients, over 4 years, de novo inhibitors were observed. prophylactic treatmenttoinconsult childrenwith agestheir 0–2.5 years withprovider no pre-existing damage been shown • Advise patients healthcare prior tojoint travel. Whilehas traveling advise patients to inhibitor development was observed in 8 ofRoutine 64 patients In the Joint Outcome Studyfollowed with Kogenate FS,5 denonovo † mation in previously Blood and Lymphatic Factor VIIIinhibitor inhibition 9 (15%) 1 to reduce spontaneous joint bleeding andofthe risk of joint damage. can regimen be extrapolated to ages >2.5– bring an adequate supply Kogenate FS based on This their data current of treatment. In clinical with pediatric PUPs and MTPs, development was observed in 9were out withdrawn of 60 patients (> 5 BU) and from the withstudies negative baseline values (12.5%), 2 patients developed high titer onchospastic vity reactions (e.g., System Disorders (neutralizing antibodies) 1 16 years for children who have no existing joint damage [See Clinical Studies (14)]. study. Six patients developed low-titer inhibitors. Inhibitors were detected at a median number of 44 exposure (15%), 6 were high titer (> 5 BU) and 3 were low-titer inhibitors. Inhibitors were detected at a median ng essalternative device (CVAD) days 5 to 151 number of 7(range exposure daysexposure (range 2days). to Infusion 16 exposure days). General Disorders and site reactions 4 (7%) 8.5 Geriatric Use oms Administration ss of TheSite detection antibody formationFS, is 5dependent on the sensitivity andwas specificity assay. Additionally, Clinical studies with Kogenate FS did not include patients aged 65 and over. Dose selection for an elderly In the Joint Outcome of Study with Kogenate de novo inhibitor development observedofinthe 8 of 64 patients n previously 1 Conditions the observed incidence antibody neutralizing antibody) an assay may befrom influenced by be individualized. patient with negative baseline values of (12.5%), 2 (including patients developed high titer (> positivity 5 BU) andinwere withdrawn the should actions (e.g., in the Bayer HealthCare LLC tes observed several factors includinglow-titer assay methodology, handling, timing of sample collection, concomitant medications, SixOrgan patients developed inhibitors. sample Inhibitors were detected at a median number of 44 exposure [See SOC = study. System Class vice (CVAD) Whippany, NJ 07981 USA 15 REFERENCES drug and may not and underlying disease. For these reasons, comparison of the incidence of antibodies to Kogenate FS with the days (range 5 to 151 exposure days). hese † Denominator incidence for de novo inhibitors is N = 60, since one patient had a pre-existing inhibitor. 1. White GC, Rosendaal F, Aledort U.S. License No. 8 LM, Lusher JM, Rothschild C, Ingerslev J, for the Factor VIII and Factor antibodies to other products may be The detection ofofantibody formation is dependent onmisleading. the sensitivity and specificity of the assay. Additionally, IX Subcommittee of Holder: the Scientific and Standardization Committee of the International Society on (License Bayer Corporation) theTreated observed incidence of antibody (including neutralizing Minimally (MTPs) in the Joint Outcome Study antibody) positivity in an assay may be influenced by 6.2 Patients Postmarketing Experience Thrombosis and Haemostasis. Definitions in hemophilia. Thromb Haemost 85:560-75, 2001. Bayer HealthCare LLC served in the reactionsInreported assay methodology, sample handling, timingpost of sample collection, concomitant several factors including http://www.kogenatefs.com/ the Joint Outcome Studyadverse with pediatric MTPs treated with routine prophylaxis oruse episodic enhanced The following reaction has been identified during approval of Kogenate FS.medications, Because adverse Whippany,MJ, NJ Abshire 07981 USA 5. the Manco-Johnson TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, et al. Prophylaxis versus and maytreatment not and disease. these reasons, ofuncertain theadverse incidence antibodies to Kogenate FS with forunderlying 5.5 years, 46 theFor 65 voluntarily randomized patients experienced events over the study duration. reactions areof reported from acomparison population of size, itof is not always possible to reliably estimate their

Consignment Program

Peace of mind. Factor products on-site, on-hand, ready when you are. Let us help ensure you have the products you need in the safest and most cost-effective way. Call a Plasma Service Representative today at 877.MCK.BLOOD (877.625.2566) to design your customized Consignment Program.

nEw

nOw intRODUCinG nOw intRODUCinG

CONVENIENCE CONVENIENCE with FEwER vials

with FEwER vials

nEw

40 g 40 vialg vial

>

avoid potential iG waste—with the widest range of vial sizes, dispense iG according to prescription avoid potential iG waste—with the of vial sizes, iG according to prescription 2.5 g range 5 g 10 g 20 g 40dispense g 1 gwidest Important Safety Information

Important Safety Information ®

1 g 2.5 g 5 g 10 g 20 g 40 g

Visit gamunex-c.com to learn more.

Visit gamunex-c.com to learn more.

GAMUNEX -C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral GAMUNEX®-Cdisease (immune(PIDD), globulin injection thrombocytopenic [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency idiopathic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). immunodeficiency disease (PIDD), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, Thrombosis may occur with immune globulin including GAMUNEX-C. Risk factors may include: advanced prolonged immobilization, hypercoagulable conditions, history of venous orproducts, arterial thrombosis, use of estrogens, indwelling central vascularage, catheters, hyperviscosity, and hypercoagulable conditions, history of venous thrombosis, use risk of estrogens, indwelling central catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occurorinarterial the absence of known factors. For patients at riskvascular of thrombosis, administer GAMUNEX-C risk factors. Thrombosis may occur in the adequate absence ofhydration known risk patients at risk of thrombosis, administer GAMUNEX-C at thecardiovascular minimum dose and infusion rate practicable. Ensure infactors. patientsFor before administration. Monitor for signs and symptoms of at the minimum dose and viscosity infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood in patients at risk for hyperviscosity. thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, depletion, sepsis, paraproteinemia, oror patients receiving Renaldysfunction dysfunctionand andacute acute renal failure thanvolume 65, volume depletion, sepsis, paraproteinemia, patients receivingknown knownnephrotoxic nephrotoxic drugs. drugs. Renal renal failure occuroccur moremore commonly in patients receiving IVIG products containing sucrose. GAMUNEX-C does not contain sucrose. For patients at risk of renal commonly in patients receiving IVIG products containing sucrose. GAMUNEX-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration minimuminfusion infusionrate ratepracticable. practicable. dysfunction or failure, administer GAMUNEX-C at the minimum concentrationavailable available and and the the minimum GAMUNEX-C is contraindicated in patients who have had anan anaphylactic to the theadministration administrationofofhuman human immune globulin. GAMUNEX-C is contraindicated in patients who have had anaphylacticororsevere severesystemic systemic reaction reaction to immune globulin. It is contraindicated in IgA-deficient patients with antibodies against It is contraindicated in IgA-deficient patients with antibodies againstIgA IgAand andhistory historyof ofhypersensitivity. hypersensitivity. Severe hypersensitivity reactions maymay occur with IVIG products, including hypersensitivity,discontinue discontinueGAMUNEX-C GAMUNEX-C infusion Severe hypersensitivity reactions occur with IVIG products, includingGAMUNEX-C. GAMUNEX-C.In In case case of hypersensitivity, infusion immediately and institute appropriate treatment. immediately and institute appropriate treatment. Monitor function, including blood urea nitrogen (BUN), serum creatinine,and andurine urineoutput output in patients renal failure. Monitor renalrenal function, including blood urea nitrogen (BUN), serum creatinine, patientsat atrisk riskofofdeveloping developingacute acute renal failure. Hyperproteinemia, increased serum viscosity, hyponatremia mayoccur occurininpatients patientsreceiving receiving IVIG treatment, Hyperproteinemia, increased serum viscosity, andand hyponatremia may treatment,including includingGAMUNEX-C. GAMUNEX-C. reports of noncardiogenic pulmonary edema (transfusion-relatedacute acutelung lung injury injury [TRALI]), and aseptic meningitis ThereThere have have beenbeen reports of noncardiogenic pulmonary edema (transfusion-related [TRALI]),hemolytic hemolyticanemia, anemia, and aseptic meningitis in patients administered including GAMUNEX-C. in patients administered withwith IVIG,IVIG, including GAMUNEX-C. The high-dose regimen (1g/kg x 1-2 days) is not recommended individualswith withexpanded expanded fluid fluid volumes may bebe a concern. The high-dose regimen (1g/kg x 1-2 days) is not recommended forforindividuals volumesor orwhere wherefluid fluidvolume volume may a concern. Because GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the CreutzfeldtBecause GAMUNEX-C is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldtdisease agent. JakobJakob disease (CJD)(CJD) agent. Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation. Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation. Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Periodic monitoring of renal functionmeasurement and urine output is particularly importantbefore in patients judged to beofatGAMUNEX-C increased risk renal failure. Assess renal function, including of BUN and serum creatinine, the initial infusion andof atdeveloping appropriateacute intervals thereafter. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly Consider assessment of bloodorviscosity in patients at risk forbecause hyperviscosity, includingincreased those with cryoglobulins, fasting chylomicronemia/markedly highbaseline triacylglycerols (triglycerides), monoclonal gammopathies, of the potentially risk of thrombosis. high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis. If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation. If signs and/or of hemolysis are present an infusion of GAMUNEX-C, perform laboratory testing for confirmation. If TRALI is symptoms suspected, perform appropriate tests forafter the presence of antineutrophil antibodies andappropriate anti-HLA antibodies in both the product and patient’s serum. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient’s serum. After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, the potential fortransitory misleadingrise interpretation. After with infusion of IgG, the of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection-site pharyngitis, and urticaria with intravenous usechills, (in PIDD) and infusion-site reactions, headache, In clinical studies, the most commonreaction, adversenausea, reactions with GAMUNEX-C were headache, fever, hypertension, rash, nausea, and astheniafatigue, (in CIDP); arthralgia andinjection-site pyrexia with subcutaneous use (in PIDD); andand headache, vomiting, fever, nausea, pain, and (in ITP). reactions, headache, fatigue, headache, cough, reaction, nausea, pharyngitis, urticaria with intravenous useback (in PIDD) andrash infusion-site arthralgia and pyrexia with subcutaneous use (in PIDD); back pain, and rash The most serious adverse reactions in clinical studies and wereheadache, pulmonaryvomiting, embolismfever, (PE) nausea, in 1 subject with a history of PE(in(inITP). CIDP), an exacerbation of autoimmune pure red reactions cell aplasiaininclinical 1 subject (in PIDD), myocarditis in 1 subject 50 days post-study infusion was not of The most serious adverse studies wereand pulmonary embolism (PE)that in 1occurred subject with a history of PEdrug (in CIDP), anand exacerbation considered drug (in ITP). autoimmune pure redrelated cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP). Please see brief summary of GaMUnEX-C full Prescribing information on adjacent page. © 2014 Grifols All rights reserved. XXXXX 2014 XXXXX-XX14 © 2014 Grifols

All rights reserved.

XXXXX 2014

XXXXX-XX14

Please see brief summary of GaMUnEX-C full Prescribing information on adjacent page.

GAMUNEX®-C

• Hyperproteinemia, with resultant changes in serum viscosity an electrolyte imbalances may occur in patients receiving IG therapy. with resultant changes in serum viscosity and Immune Globulin Injection (Human) 10% • Hyperproteinemia, electrolyte imbalanceshasmayoccurred occur inin patients Caprylate/Chromatography Purified • Thrombosis patients receiving receiving IGIV IGIV therap therapy. Monitor patients with known risk factors for thrombosis; consid Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified HIGHLIGHTS OF PRESCRIBING INFORMATION • Thrombosis has assessment occurred inofpatients receivingforIGIV therapy. baseline blood viscosity those at risk of hype Monitor patients with known risk factors for thrombosis; consider viscosity. These highlights do not include all the information needed to use HIGHLIGHTS OF PRESCRIBING INFORMATION baseline assessment of blood viscosity for those at risk of hyperGAMUNEX®-C safely and effectively. See full prescribing • Aseptic Meningitis Syndrome (AMS) has been reported wi viscosity. These highlights do not include all the information needed to use information for GAMUNEX-C. GAMUNEX-C and other IGIV treatments, especially with high dos GAMUNEX®-C safely and effectively. See full prescribing • Aseptic Meningitis Syndrome (AMS) has been reported with or rapid infusion. GAMUNEX-C, [Immune Globulin Injection (Human) 10% information for GAMUNEX-C. GAMUNEX-C and other IGIV treatments, especially with high doses Caprylate/Chromatography Purified] • Hemolytic or rapid infusion. anemia can develop subsequent to IGIV therapy due GAMUNEX-C, [Immune Globulin Injection (Human) 10% enhanced RBC sequestration. Monitor patients for hemolysis an Initial U.S. Approval: 2003 Caprylate/Chromatography Purified] • Hemolytic anemia can develop subsequent to IGIV therapy due to hemolytic anemia. enhanced RBC sequestration. Monitor patients for hemolysis and Initial U.S. Approval: 2003 WARNING: THROMBOSIS, RENAL DYSFUNCTION • Monitor hemolytic anemia.patients for pulmonary adverse reactions (transfusio and ACUTERENAL RENALDYSFUNCTION FAILURE WARNING: THROMBOSIS, related lung injury adverse [TRALI]).reactions (transfusion• Monitor patientsacute for pulmonary and ACUTE RENAL FAILURE See full prescribing information for complete boxed warning.related• acute lungoverload. injury [TRALI]). Volume

GAMUNEX®-C

See• full prescribingmay information complete boxed warning. Thrombosis occur for with immune globulin products, • Volume • overload. GAMUNEX-C is made from human plasma and may conta includingmay GAMUNEX-C. factorsglobulin may include: advanced • Thrombosis occur withRisk immune products, infectious agents, viruses and, theoretically, the Creutzfeld • GAMUNEX-C is made frome.g., human plasma and may contain age, prolonged immobilization, hypercoagulable conditions, including GAMUNEX-C. Risk factors may include: advanced disease infectiousJakob agents, e.g., agent. viruses and, theoretically, the Creutzfeldtage,history prolonged immobilization, hypercoagulable conditions, of venous or arterial thrombosis, use of estrogens, Jakob•disease agent. is not approved for subcutaneous use in ITP patient GAMUNEX-C history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardio• GAMUNEX-C is not approvedrisk for subcutaneous in ITP patients. Due to a potential of hematoma use formation, do not administ indwelling catheters, hyperviscosity, and cardiovascularvascular risk factors. Due to a potential risk of hematoma formation, do not administer GAMUNEX-C subcutaneously in patients with ITP. vascular risk factors. • For patients at risk of thrombosis, administer GAMUNEX-C at GAMUNEX-C subcutaneously in patients with ITP. • Passive transfer of antibodies may confound serologic testing. • For patients at risk ofdose thrombosis, administer the minimum and infusion rateGAMUNEX-C practicable.at Ensure • Passive transfer of antibodies may confound serologic testing. the adequate minimum hydration dose andininfusion practicable. EnsureMonitor patients rate before administration. ----------------------------ADVERSE REACTIONS -------------------------adequate hydration patients before administration. ----------------------------ADVERSE REACTIONS ---------------------------for signs and insymptoms of thrombosis and Monitor assess blood Serious adverse reactions which occurred in the clinical trials we for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Serious adverse reactions which occurred in the clinical trials were an exacerbation of autoimmune pure red cell aplasia in one subje viscosity in patients at risk for hyperviscosity. an exacerbation of autoimmune pure red cell aplasia in one subject • Renal dysfunction, acute renal failure, osmotic nephrosis, and and pulmonary embolism in one subject with a history of PE. T • Renal dysfunction, acute renal failure, osmotic nephrosis, and and pulmonary embolism in one subject with a history of PE. The death may occur with immune globulin intravenous (IGIV) most common adverse reactions observed in  5% patients were death may occur with immune globulin intravenous (IGIV) most common adverse reactions observed in  5% patients were: products in predisposed patients. products in predisposed patients. PI: Intravenous: Headache, cough,site injection sitenausea, reaction, nausea, PI: Intravenous: Headache, cough, injection reaction, • Renal dysfunction and acute renal failure occur more pharyngitis and urticaria. • Renal dysfunction and acute renal failure occur more pharyngitis and urticaria. commonly in patients receiving IGIV products containing Subcutaneous: Subcutaneous: Infusion site reactions, fatigue, commonly in patients receiving IGIV products containing Infusion site reactions, headache, headache, fatigue, sucrose. GAMUNEX-C does not contain sucrose. arthralgia and pyrexia. sucrose. GAMUNEX-C does not contain sucrose. arthralgia and pyrexia.

• patients For patients at of risk of renal dysfunction or failure, administer ITP: Headache, fever,back nausea, pain and rash. • For at risk renal dysfunction or failure, administer ITP: Headache, vomiting,vomiting, fever, nausea, pain back and rash. GAMUNEX-C the minimum concentration available the Headache, GAMUNEX-C at theatminimum concentration available and theand CIDP: CIDP: Headache, fever, chills, hypertension, rash, fever, chills, hypertension, rash, nausea andnausea and minimum infusion rate practicable. minimum infusion rate practicable. asthenia.asthenia.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols --------------------------INDICATIONS AND USAGE --------------------------------------------------INDICATIONS AND USAGE ------------------------- To report SUSPECTED ADVERSE REACTIONS, contact Grifo Therapeutics Inc. at 1-800-520-2807 or FDA at or 1-800-FDA-1088 or Therapeutics Inc. at 1-800-520-2807 FDA at 1-800-FDA-1088 GAMUNEX-C is anis immune globulin injection (human) 10% liquid GAMUNEX-C an immune globulin injection (human) 10% www.fda.gov/medwatch. liquid www.fda.gov/medwatch. indicated for treatment of: of: indicated for treatment ----------------------------DRUG INTERACTIONS -------------------------------------------------------DRUG INTERACTIONS -------------------------• Primary Humoral Immunodeficiency (PI) (PI) • Primary Humoral Immunodeficiency • The passive transfer of antibodies may transiently interfere • The passive transfer of antibodies may transientlywith interfere wi • Idiopathic Thrombocytopenic Purpura (ITP) • Idiopathic Thrombocytopenic Purpura (ITP) the response to live viral vaccines, such as measles, mumps and the response to live viral vaccines, such as measles, mumps an • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) rubella. • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ----------------------------CONTRAINDICATIONS ----------------------------

rubella.

---------------------USE IN SPECIFIC POPULATIONS ---------------------

----------------------------CONTRAINDICATIONS ----------------------------

• Anaphylactic or • Anaphylactic immunoglobulin

severe

or

systemic

severe

reactions

systemic

to

reactions

---------------------USE IN SPECIFIC POPULATIONS -------------------

human • Pregnancy: no human or animal data. Use only if clearly needed.

to

human • Pregnancy: no human or animal data. Use only if clearly neede

• Geriatric: In patients over 65 years of age do not exceed the • Geriatric: In and patients 65 years of age minimum do not exceed t • IgA deficient patients with antibodies against IgA and a history of recommended dose, infuseover GAMUNEX-C at the • IgA deficient patients with antibodies against IgA and a historyinfusion of recommended hypersensitivity rate practicable. dose, and infuse GAMUNEX-C at the minimu

immunoglobulin

hypersensitivity

----------------------WARNINGS AND PRECAUTIONS----------------------

----------------------WARNINGS ANDagainst PRECAUTIONS---------------------• IgA deficient patients with antibodies IgA are at greater risk of• developing severe hypersensitivity and against anaphylactic reactions. IgA deficient patients with antibodies IgA are at greater risk Haveofepinephrine immediately to treat acute severe developingavailable severe hypersensitivity and any anaphylactic reactions. hypersensitivity reactions. Have epinephrine available immediately to treat any acute severe

infusion rate practicable.

hypersensitivity reactions. • Monitor renal function, including blood urea nitrogen, serum Grifols Therapeutics Inc. creatinine, and urine output in patients of developing acute serum Research Triangle Park, NC 27709 USA 3036427/3036428-BS • Monitor renal function, includingat risk blood urea nitrogen, Grifols Therapeutics Inc. renalcreatinine, failure. and urine output in patients at risk of developing acute U.S. License No. 1871 Revised: 9/2013 Research Triangle Park, NC 27709 USA 3036427/3036428-B renal failure. U.S. License No. 1871 Revised: 9/201

McKesson Plasma and Biologics is dedicated to bringing a wide selection of plasma-derivative products to your pharmacy.

Welcome to the McKesson Plasma and Biologics (MPB) Winter 2015 Catalog Happy New Year and welcome to the first MPB catalog of 2015! With the closing of any calendar year, it’s tradition to look back at the past 12 months as well as commit to future resolutions for the upcoming year. This was a year for growth at MPB for products and people! We launched 39 new Plasma NDCs that included new vial sizes of some of the classic plasma items as well as introduced a few newer ones to the market such as Octapharma’s 10% Octagam and Bivigam by Biotest. In addition, 53 Specialty items got added to the MPB product portfolio, including the recently FDA-approved Rapivab by Biocryst, Bristol-Myers Squibb’s Opdivo, and Onyx’s Blincyto. Our internal team

Three simple steps to get started:

Inside: Consignment Program

3

How to Order

6

Product Guide

8–14

Return Goods Policy

19

Plasma and Biologics Team 25

also experienced a large increase in headcount. The MPB Team added nine additional members in 2014: Seven teammates were added to our Inside Sales

1

Call 877.MCK.BLOOD. You will be connected to a dedicated Plasma Service Representative.

2

Activate your McKesson account for plasma purchases. Your Plasma Service Representative will ask you to confirm which account number(s) you would like to use, or help you establish a new account for your plasma purchases. You will also be asked for an email address to receive plasma order acknowledgments.

Team, Steve Bidwell was brought on as the new Senior Director of Operations, and

3

Dan Bush was hired as MPB’s first Director of Product Management to assist with

If applicable, share your current GPO or manufacturer allocations. McKesson will work directly with your GPO and/or plasma manufacturers to shift your allocations to McKesson within a target of 30 days. Your GPO must validate that transfer. Non-contract purchases can be ordered immediately.

the many drug launches and recent channel shifts. Any additions made to the product catalog and MPB Team are done with our customers as the top priority. We commit to learning from the challenges associated with drug launches with their various idiosyncrasies and to continue perfecting the process as well as striving to meet your needs by adding headcount when considered necessary. The past year was also a year of operational enhancements for MPB. From additional improvements made to our Returns and Credit/Rebill processes, to putting more systematic controls in place surrounding contract pricing and manufacturer price updates, MPB has focused on making improvements to areas customers deal with daily. We have also centered our attention on improving communication to our partners with phone messaging now available through our new phone system and more effective messaging in McKesson ConnectSM. Another main focal point of 2014 was implementing more efficient ways for manufacturers to capture crucial order information at the time of sale to better improve their visibility of the transaction and help improve the overall patient outcome. These are just a few of the advancements made to our division — and we have big plans for 2015! In the upcoming year, we are launching a CRM (Customer Relationship Manager)

Multiple Ordering Options

system with our Inside Sales Team that will positively affect the overall customer experience. Macro-Helix for 340B management is scheduled to be available for MPB purchases by mid-year. Plus, many enhancements to McKesson Connect are in the pipeline including EDI price files, the ability to purchase MPB drop-ship items directly through McKesson Connect, and an integrated catalog that includes both MPB and Pharma items. In conclusion, I would like to say thank you for another milestone MPB recognized in March of this past year when we celebrated our 5th-year anniversary as a

Online: connect.mckesson.com

Call: 877.MCK.BLOOD (877.625.2566)

Email: [email protected]

Fax: 888.752.7626

division of McKesson. This wouldn’t have been possible without our strong partnerships with our customers, manufacturers and our internal team. Thank

Holly Alley Director of Inside Sales McKesson Plasma and Biologics [email protected]

you for a successful 2014, and together we plan on making 2015 even better!

7

McKesson Plasma and Biologics

McKesson Plasma and Biologics

Call: 877.625.2566 | Email: [email protected] | Fax: 888.752.7626

Call: 877.625.2566 | Email: [email protected] | Fax: 888.752.7626 Product Description

Item

Manufacturer

NDC

Size/Form

Code

Albumin Albuked 25% 50 mL Albuked® 25% 100 mL Albuked® 5% 250 mL Albumin 25% 50 mL Albumin 25% 100 mL Albumin 5% 250 mL Albumin 5% 500 mL Albumin 25% 50 mL Albumin 25% 100 mL Albumin 5% 250 mL Albumin 5% 500 mL Albumin Admin IV Set Albuminar® 25% 50 mL Albuminar® 25% 100 mL Albuminar® 5% 250 mL Albuminar® 5% 500 mL Alburx® 25% 50 mL Alburx® 25% 100 mL Alburx® 5% 250 mL Alburx® 5% 500 mL Albutein® 25% 50 mL Albutein® 25% 100 mL Albutein® 5% 250 mL Albutein® 5% 500 mL Buminate 25% 20 mL Buminate 5% 250 mL Buminate 5% 500 mL Buminate Admin IV Set Buminate Admin IV Set Codan Albumin IV Set Flexbumin 25% 50 mL Flexbumin 25% 100 mL Flexbumin 50 mL Admin IV Set Flexbumin 50 mL Admin IV Set Flexbumin 100 mL Admin IV Set Flexbumin 100 mL Admin IV Set Kedbumin 25% 50 mL Kedbumin 25% 100 mL Plasbumin® 25% 20 mL Plasbumin® 25% 50 mL Plasbumin® 25% 100 mL Plasbumin® 5% 50 mL Plasbumin® 5% 250 mL Plasbumin® Low Aluminum 5% 50 mL Plasbumin® Low Aluminum 5% 250 mL Plasbumin® Low Aluminum 25% 20 mL Plasbumin® Low Aluminum 25% 50 mL Plasbumin® Low Aluminum 25% 100 mL Factors Advate® 200-400 IU* Advate® 401-800 IU* Advate® 801-1200 IU* Advate® 1201-1800 IU* Advate® 1801-2400 IU* Advate®+Baxject 200-400 IU* Advate®+Baxject 401-800 IU* Advate®+Baxject 801-1200 IU* Advate®+Baxject 1201-1800 IU* Advate®+Baxject 1801-2400 IU* Advate®+Baxject 2401-3600 IU* Advate®+Baxject 2401-3600 IU* Advate®+Baxject 3601-4800 IU* ®

8

Product Description

Item

Manufacturer

NDC

Size/Form

Code

Baxter Baxter Baxter Baxter Baxter Baxter Grifols Grifols Grifols Grifols Grifols Grifols Grifols Biogen Idec Biogen Idec Biogen Idec Biogen Idec Baxter Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc. Spectrum Spectrum Spectrum Spectrum Spectrum Spectrum Spectrum Baxter Baxter Baxter CSL Behring CSL Behring CSL Behring CSL Behring CSL Behring Baxter Baxter Baxter Baxter CSL Behring CSL Behring CSL Behring CSL Behring CSL Behring Kedrion Kedrion Kedrion Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer Bayer CSL Behring Novo Nordisk

00944-3051-02 00944-3052-02 00944-3053-02 00944-3054-02 00944-3045-10 00944-3046-10 68516-4601-01 68516-4602-01 68516-4603-02 68516-4604-02 68516-3601-02 68516-3602-02 68516-3603-02 64406-0911-01 64406-0922-01 64406-0933-01 64406-0944-01 64193-0445-02 58394-0633-03 58394-0634-03 58394-0635-03 58394-0636-03 58394-0637-03 64406-0801-01 64406-0802-01 64406-0803-01 64406-0804-01 64406-0805-01 64406-0806-01 64406-0807-01 64193-0423-02 64193-0424-02 64193-0425-02 00053-8131-02 00053-8132-02 00053-8133-02 00053-8134-02 00053-8135-02 00944-3940-02 00944-3942-02 00944-3944-02 00944-3946-02 63833-0615-02 63833-0616-02 63833-0617-02 63833-0386-02 63833-0387-02 76125-0250-20 76125-0667-30 76125-0667-50 00026-3792-20 00026-3793-30 00026-3795-50 00026-3796-60 00026-3797-70 00026-3782-25 00026-3783-35 00026-3785-55 00026-3786-65 00026-3787-75 00053-6233-02 00169-7201-01

Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial

J7192 J7192 J7192 J7192 J7192 J7192 J7186 J7186 J7186 J7186 J7193 J7193 J7193 J7199 J7199 J7199 J7199 J7194

Factors (continued) 1356385 1356526 1355791 1250679 1251057 1250547 1250646 1731439 1731470 2116424 1725845 1222116 2286318 2286763 2536233 2536241 2291540 2291664 2292530 2292746 1248376 1248392 1248137 1248285 1325950 1328277 1329747 1722701 1725837 1870930 1332253 1332709 1722586 1725688 1722669 1725704 3915998 2043206 3221405 3221454 3221397 3221470 3221496 3224797 3224813 3224839 3224854 3224870

Kedrion Kedrion Kedrion Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma CSL Behring CSL Behring CSL Behring CSL Behring CSL Behring CSL Behring CSL Behring CSL Behring CSL Behring Grifols Grifols Grifols Grifols Baxter Baxter Baxter Baxter Baxter Grifols Baxter Baxter Baxter Baxter Baxter Baxter Kedrion Kedrion Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols

76125-0784-25 76125-0784-10 76125-0785-25 67467-0643-01 67467-0643-02 67467-0623-02 67467-0623-03 68209-0643-01 68209-0643-02 68209-0623-02 68209-0623-03 00053-7970-04 00053-7680-32 00053-7680-33 00053-7670-31 00053-7670-32 44206-0251-05 44206-0251-10 44206-0310-25 44206-0310-50 68516-5216-01 68516-5216-02 68516-5214-01 68516-5214-02 00944-0490-01 00944-0491-01 00944-0491-02

76179-0025-01 76179-0025-04 13533-0684-16 13533-0684-20 13533-0684-71 13533-0685-20 13533-0685-25 13533-0690-20 13533-0690-25 13533-0692-16 13533-0692-20 13533-0692-71

Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Each Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial 10/CS 6/CS 6/CS Each 6/CS Each 24/CS 12/CS Each 24/CS Each 12/CS Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial

3920642 3920659 3920667 3920675 1290535 1216639 1216670 1216993 1217025 1217033 1217058 1290543 1290527

Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter

00944-2921-02 00944-2922-02 00944-2923-02 00944-2924-02 00944-2964-10 00944-2941-10 00944-2942-10 00944-2943-10 00944-2944-10 00944-2945-10 00944-2946-10 00944-2965-10 00944-2948-10

Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial

Note: Order quantities are based on the size/form indicated per item

* Refrigerated

** Frozen

00944-0493-01 00944-0493-02

† Available only for in-patient hospital pharmacies

P9047 P9047 P9045 P9047 P9047 P9045 P9045 P9047 P9047 P9045 P9045 Q0157 Q0157 P9047 P9047 Q0157 Q0157 P9041 P9041 Q0157 Q0157 P9041 P9041 Q0157 P9045 P9041

P9046 P9046

Q0157 Q0157 Q0157 P9041 P9041

J7192 J7192 J7192 J7192 J7192 J7192 J7192 J7192 J7192 J7192 J7192 J7192 J7192 ‡ Drop ship

Advate®+Baxject III 200-400 IU* 3290038 Advate®+Baxject III 401-800 IU* 3290046 Advate®+Baxject III 801-1200 IU* 3290053 Advate®+Baxject III 1201-1800 IU* 3290061 Advate®+Baxject III 1801-2400 IU* 3283801 Advate®+Baxject III 2401-3600 IU* 3289758 Alphanate® 250-499 IU* 1182914 Alphanate® 500-999 IU* 1179670 Alphanate® 1000-1299 IU* 1186469 Alphanate® 1300+ IU* 1101872 Alphanine® 500-1500 IU* 2115871 Alphanine® 1000-1499 IU* 2115897 Alphanine® 1500+ IU* 2115939 2586097 Alprolix® 500-999 IU* Alprolix® 1000-1999 IU* 2586113 Alprolix® 2000-2999 IU* 2586261 Alprolix® 3000+ IU* 2586329 BEBULIN 500-700 IU* 2124691 3915824 BeneFix® RT 250-499 IU* BeneFix® RT 500-999 IU* 3915089 3915105 BeneFix® RT 1000-1999 IU* BeneFix® RT 2000+ IU* 3915113 BeneFix® RT 3000+ IU* 1125905 Eloctate® 200-324 IU* 3210986 Eloctate® 325-649 IU* 3209988 3210093 Eloctate® 650-849 IU* Eloctate® 850-1249 IU* 3210903 Eloctate® 1250-1799 IU* 3210911 Eloctate® 1800-2299 IU* 3210929 Eloctate® 2300-3500 IU* 3210937 2042828 FEIBA® NF+Baxject 400-650 IU* FEIBA® NF+Baxject 651-1200 IU* 2042836 FEIBA® NF+Baxject 1750-3250 IU* 2042844 Helixate® FS 200-399 IU* 1236686 Helixate® FS 400-799 IU* 1237254 1237296 Helixate® FS 800-1999 IU* Helixate® FS 2000+ IU* 1237304 Helixate® FS 3000+ IU* 1237841 Hemofil® M 220-400 IU* 2068260 Hemofil® M 401-800 IU* 2068252 Hemofil® M 801-1700 IU* 2068245 Hemofil® M 1701-2000 IU* 2068237 Humate-P 500-999 IU* 2117034 Humate-P 1000-1600 IU* 2117042 Humate-P 1600-3000 IU* 2117109 Kcentra 400-620 IU* 2042950 Kcentra 800-1240 IU* 1190719 Koate® DVI 250-399 IU* 3914710 Koate® DVI 400-799 IU* 2043305 3914736 Koate® DVI 800-1250 IU* Kogenate® FS with BIO-SET 250-499 IU* 1754894 Kogenate® FS with BIO-SET 500-999 IU* 1754928 Kogenate® FS with BIO-SET 1000-1999 IU* 1755057 Kogenate® FS with BIO-SET 2000 IU* 1755305 1723618 Kogenate® FS with BIO-SET 3000 IU* Kogenate® FS with Vial Adapter 250-499 IU*    2050813 Kogenate® FS with Vial Adapter 500-999 IU*    2050821 Kogenate® FS with Vial Adapter 1000-1999 IU* 2050839 Kogenate® FS with Vial Adapter 2000-2999 IU*   2050847 2050854 Kogenate® FS with Vial Adapter 3000+ IU*      Mononine® 720-1300 IU* 3915022 Novoseven® MixPro 1 mg* 2042299 Note: Order quantities are based on the size/form indicated per item

* Refrigerated

** Frozen

† Available only for in-patient hospital pharmacies

J7195 J7195 J7195 C9399 C9399 C9399 C9399 C9399 C9399 C9399 J7198 J7198 J7198 J7192 J7192 J7192 J7192 J7192 J7190 J7190 J7190 J7190 J7187 J7187 J7187 J3490 J3490 J7190 J7190 J7190 J7192 J7192 J7192 J7192 J7192 J7195 J7197 J7193 J7194 J7196 J7193 J7189 ‡ Drop ship

9

McKesson Plasma and Biologics

McKesson Plasma and Biologics

Call: 877.625.2566 | Email: [email protected] | Fax: 888.752.7626

Call: 877.625.2566 | Email: [email protected] | Fax: 888.752.7626 Product Description

Item

Manufacturer

NDC

Size/Form

Code

Factors (continued) Novoseven MixPro 2 mg* Novoseven® MixPro 5 mg* Novoseven® MixPro 8 mg* Novoseven® RT Infusion Kit* Profilnine® 450-999 IU* Profilnine® 1000-1499 IU* Profilnine® 1500-2000 IU* Recombinate® RAHF 220-400 IU* Recombinate® RAHF 401-800 IU* Recombinate® RAHF 801-1240 IU* Recombinate® RAHF 1241-1800 IU* Recombinate® RAHF 1801-2400 IU* Riastap® 900-1300 IU* RIXUBIS KIT 175-325 IU* RIXUBIS KIT 350-650 IU* RIXUBIS KIT 700-1300 IU* RIXUBIS KIT 1400-2600 IU* RIXUBIS KIT 2700-3900 IU* Wilate® 500-999 IU* Wilate® 1000+ IU* Xyntha® 250-499 IU* Xyntha® 500-999 IU* Xyntha® 1000-1999 IU* Xyntha® 2000+ IU* Xyntha® SOLOFUSE® 3000 IU+* Xyntha® SOLOFUSE® 250-499 IU* Xyntha® SOLOFUSE® 500-999 IU* Xyntha® SOLOFUSE® 1000-1999 IU* Xyntha® SOLOFUSE® 2000-2999 IU* Hyperimmunes GamaSTAN® S/D 2 mL* GamaSTAN® S/D 10 mL* Hepagam B® SDV 1 mL* Hepagam B® SDV 5 mL* HyperHEP B® S/D 0.5 mL Pre-filled Syringe* HyperHEP B® S/D 1 mL Pre-filled Syringe* HyperHEP B® S/D 5 mL* HyperRAB® S/D 2 mL* HyperRAB® S/D 10 mL* HyperRHO® S/D 50 mcg Syringe* HyperRHO® S/D 250 mL Syringe* HyperTET® 250 mL Syringe* RhoGAM® MICRH 50 mcg 1 mL Syringe* RhoGAM® MICRH 50 mcg 1 mL Syringe* RhoGAM® MICRH 50 mcg 1 mL Syringe* RhoGAM® Ultra-Filtered PLUS Syringe* RhoGAM® Ultra-Filtered PLUS Syringe* RhoGAM® Ultra-Filtered PLUS Syringe* Rhophylac® RHO Pre-filled Syringe* Rhophylac® RHO Pre-filled Syringe* WinRho® SDV 2500 IU 2.2 mL* WinRho® SDV 1500 IU 1.3 mL* WinRho® SDV 5000 IU 4.4 mL* WinRho® SDV 15000 IU 13 mL* IVIG Bivigam 10% 5 gm* Bivigam 10% 10 gm* Carimune® NF 6 gm Carimune® NF 12 gm Flebogamma® DIF 5% 2.5 gm Flebogamma® DIF 5% 5 gm Flebogamma® DIF 5% 10 gm ®

10

Product Description

Item

Manufacturer

NDC

Size/Form

Code

1141357 1281872 1245380 1243575 1215581 1215599 1215607 1215615 1215631 3913993 1975903 1976901 2144558 1356567 1356971 1357649 3914694 3914702 3919206 3919214 2790988 1245398 1247055 1248020 1250810 1254986 3400348 1731702 1731728 1731744 2209724 3298718 3298726 3298734 3298783 3298825 1251131 1251206 1251271 1251537 1251636 1251644 1251685 1251776 3295730 3295748 3295755 3295763 2293470 2293488 2293538 2042513

Grifols Grifols Grifols Grifols Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter Baxter Kedrion Kedrion Kedrion Kedrion Kedrion BPL BPL BPL Grifols Grifols Grifols Grifols Grifols Grifols CSL Behring CSL Behring CSL Behring CSL Behring Baxter Baxter Baxter Baxter Baxter Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma Octapharma CSL Behring CSL Behring CSL Behring CSL Behring

61953-0004-05 61953-0005-01 61953-0005-03 61953-0005-02 00944-2700-02 00944-2700-03 00944-2700-04 00944-2700-05 00944-2700-06 00944-2700-07 00944-2656-03 00944-2658-04

J1567 J1572 J1572 J1572 J1569 J1569 J1569 J1569 J1569

76125-0900-01 76125-0900-25 76125-0900-50 76125-0900-10 76125-0900-20 64208-8234-02 64208-8234-03 64208-8234-04 13533-0800-12 13533-0800-15 13533-0800-20 13533-0800-71 13533-0800-24 13533-0800-40 44206-0451-01 44206-0451-02 44206-0454-04 44206-0455-10 00944-2510-02 00944-2511-02 00944-2512-02 00944-2513-02 00944-2514-02 67467-0843-01 67467-0843-02 67467-0843-03 67467-0843-04 68209-0843-01 68209-0843-02 68209-0843-03 68209-0843-04 68982-0850-01 68982-0850-02 68982-0850-03 68982-0850-04 44206-0436-05 44206-0437-10 44206-0438-20 44206-0439-40

Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Each Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial

2117018

CSL Behring

00053-6871-00

Each

3224524 3224565

Grifols Grifols

13533-0613-20 13533-0613-25

Single Vial Single Vial

P9043 P9043

3237880

Novartis

63851-0501-02

Single Vial

90675

2046654 2058428

Genentech Teva

50242-0138-01 57844-0510-55

Each 5/CS

J3262 J3490

IVIG (continued) 2042323 2042356 2042380 1728765 2115863 2115764 2115798 3913233 3913241 3913258 3913266 3913274 2115509 2190254 2190247 2190239 2190437 2190445 1690114 1690122 1249309 1249838 1250042 1250075 3915626 3915956 3915980 3915642 3915634

Novo Nordisk Novo Nordisk Novo Nordisk Novo Nordisk Grifols Grifols Grifols Baxter Baxter Baxter Baxter Baxter CSL Behring Baxter Baxter Baxter Baxter Baxter Octapharma Octapharma Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc. Pfizer Inc.

00169-7202-01 00169-7205-01 00169-7208-01 00169-7080-06 68516-3201-01 68516-3202-02 68516-3203-02 00944-2841-10 00944-2842-10 00944-2843-10 00944-2844-10 00944-2845-10 63833-8915-10 00944-3026-02 00944-3028-02 00944-3030-02 00944-3032-02 00944-3034-02 67467-0182-01 67467-0182-02 58394-0012-01 58394-0013-01 58394-0014-01 58394-0015-01 58394-0016-03 58394-0022-03 58394-0023-03 58394-0024-03 58394-0025-03

Single Vial Single Vial Single Vial Each Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial

3224664 3224672 3411444 3411469 3224763 3224730 3224771 3224573 3221280 2784239 3224581 3224649 1186113 1245299 1249937 1266493 1273333 1280494 2291870 2292423 2118024 2118008 2118040 2118057

Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols Grifols JOM JOM JOM JOM JOM JOM CSL Behring CSL Behring Cangene Cangene Cangene Cangene

13533-0635-04 13533-0635-12 53270-0052-01 53270-0051-01 13533-0636-03 13533-0636-02 13533-0636-05 13533-0618-02 13533-0618-10 13533-0661-06 13533-0631-02 13533-0634-02 00562-7806-01 00562-7806-05 00562-7806-25 00562-7805-01 00562-7805-05 00562-7805-25 44206-0300-01 44206-0300-10 53270-3500-01 53270-3300-01 53270-3100-01 53270-3000-01

Single Vial Single Vial Single Vial Single Vial Each Each Single Vial Single Vial Single Vial 10/CS Each Single Vial Each 5/CS 25/CS Each 5/CS 25/CS Each 10/CS Single Vial Single Vial Single Vial Single Vial

2058063 2058071 2293181 2293421 1135540 1137280 1139138

Biotest Biotest CSL Behring CSL Behring Grifols Grifols Grifols

59730-6502-01 59730-6503-01 44206-0417-06 44206-0418-12 61953-0004-02 61953-0004-03 61953-0004-04

Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial Single Vial

Note: Order quantities are based on the size/form indicated per item

* Refrigerated

** Frozen

† Available only for in-patient hospital pharmacies

J7189 J7189 J7189 J7194 J7194 J7194 J7192 J7192 J7192 J7192 J7192 J1680 J3490 J3490 J3490 J3490 J3490 J3590 J7185 J7185 J7185 J7185 J7185 J7185 J7185 J7185 J7185 J1470 J1550

90371 90371 CPT-90371 CPT-90375 CPT-90375 J2790 J2790 J1670

J2790 J2790 J2790 J2790 J2790 J2792 J2792 J2792 J2792

J1566 J1566 J1567 J1567 J1567 ‡ Drop ship

Flebogamma® DIF 5% 20 gm Flebogamma® DIF 10% 5 gm Flebogamma® DIF 10% 20 gm Flebogamma® DIF 10% 10 gm Gammagard 1 gm Liquid* Gammagard 2.5 gm Liquid* Gammagard 5 gm Liquid* Gammagard 10 gm Liquid* Gammagard 20 gm Liquid* Gammagard 30 gm Liquid* Gammagard SD Low IgA 5 gm* Gammagard SD 10 gm IgA1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received Halaven. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications

Peripheral Neuropathy Patients should be monitored closely for signs of peripheral motor and sensory neuropathy

Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received Halaven. Delay administration of Halaven until resolution to Grade 2 or less Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days) Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation

Pregnancy Category D Halaven is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks

QT Prolongation In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias;

HALAVEN ® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2013 Eisai Inc. All rights reserved. Printed in USA/November 2013 HALA0478

concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities Correct hypokalemia or hypomagnesemia prior to initiating Halaven and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome

Hepatic and Renal Impairment For patients with mild (Child-Pugh A) or moderate (ChildPugh B) hepatic and/or moderate (CrCl 30-50 mL/min) renal impairment, a reduction in starting dose is recommended

Most Common Adverse Reactions Most common adverse reactions (≥25%) reported in patients receiving Halaven were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%) The most common serious adverse reactions reported in patients receiving Halaven were febrile neutropenia (4%) and neutropenia (2%)

References: 1. Dufresne A, et al. Breast Cancer Res Treat. 2008;107(2):275-279. 2. Planchat E, et al. Breast. 2011;20(6):574-578. 3. Ray S, et al. In: J Clin Oncol. San Francisco, CA: ASCO Breast Cancer Symposium; 2012. Abstract 116. 4. Cardoso F, et al. Ann Oncol. 2002;13(2):197-207. 5. Seah DS, et al. Poster presented at: 2012 ASCO Annual Meeting; June 1–5, 2012; Chicago, IL. Abstract 6089. 6. Lin NU, et al. Lancet. 2011;377(9769):878-880. 7. Halaven [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2013. 8. Saad ED, et al. J Clin Oncol. 2010;28(11):1958-1962. 9. Slamon DJ, et al. N Engl J Med. 2001;344(11):783-792. 10. Geyer CE, et al. N Engl J Med. 2006;355(26): 2733-2743. 11. von Minckwitz G, et al. J Clin Oncol. 2009;27(12):1999-2006. 12. Miller K, et al. N Engl J Med. 2007;357(26):2666-2676. 13. Robert NJ, et al. J Clin Oncol. 2011;29(10):1252-1260. 14. Sparano JA, et al. J Clin Oncol. 2010;28(20): 3256-3263. 15. Cortes J, et al. Lancet. 2011;377(9769):914-923.

Please see accompanying brief summary of Halaven full Prescribing Information.

Visit www.halaven.com/hcp.aspx

T:7.875" S:7"

Return Goods Policy

Table 2 (cont'd) MedDRA ver 10.0

1. I tems Eligible for Return

• Refrigerated product that is received in damaged condition must be reported within two business days of receipt. Ambient (room temperature) product that is received in damaged condition must be reported within five business days of receipt. • Product that is purchased on a non-returnable basis, including refrigerated product, is not eligible for credit. • Due to the unique manufacturing process of certain products and limitations on usage, McKesson follows all manufacturer policies regarding acceptance of returns. McKesson sells products as non-returnable only when the manufacturer policy does not allow returns. McKesson allows returns on products when the manufacturer policy deems the product fit.

2. Return Authorization (RA)

• All customers must obtain an RA number from a Plasma Service Representative prior to returning a product. • An RA provides the right to return product; it does not guarantee credit. Credit will be provided when product is received and all return requirements have been met. • RA request must be made within 30 days of product delivery. • An RA is valid for 30 days from the date of RA approval. • Any returned product without an RA will not be provided credit.

T:11”

B:11.25”

S:10”

S:10"

HALAVEN (n=503) Control Group (n=247) All Grades ≥ Grade 3 All Grades ≥ Grade 3 Infections and Infestations Urinary Tract Infection 10% 1% 5% 0 a Based upon laboratory data. b Includes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. c Not applicable; (grading system does not specify > Grade 2 for alopecia). Cytopenias: Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia. Dose reduction due to neutropenia was required in 12% (62/503) of patients and discontinuation was required in