To learn about Gold Medalist Kelly Clark’s ABSORICA journey, turn to page 14!
What you need to know about ABSORICA® A guide to the only isotretinoin therapy that is approved to be taken without regard to food1
Before ABSORICA treatment
5 months after ABSORICA treatment
Actual patient photographs courtesy of Mark Seraly, MD.
Save money on your ABSORICA prescription. Use your A-PLU$ discount card located in the back pocket of this brochure ABSORICA is a retinoid indicated for the treatment of severe recalcitrant nodular acne (SRNA) in patients 12 years of age and older.1 For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information.
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About ABSORICA (isotretinoin) capsules ABSORICA is used to treat the most severe form of acne, called severe recalcitrant nodular acne (SRNA) (in patients 12 years of age and older), that has not been helped by any other treatments, including antibiotics. SRNA is when many red, swollen, tender lumps form in the skin. They can be the size of pencil erasers or larger. If left untreated, SRNA can lead to permanent scars.2 ABSORICA medication is taken by mouth in two divided doses (follow your prescriber’s directions). ABSORICA capsules contain the active ingredient isotretinoin, and is the only oral medication with this ingredient that can be taken with or without food.1 ABSORICA is for both male and female patients. It is only for females who are not pregnant or are not planning to become pregnant, because it can cause severe birth defects. ABSORICA is only prescribed to patients registered in the iPLEDGE™ Program who can understand and agree to follow and carry out all the program instructions. Your prescriber will explain the program to you. You may also learn about the iPLEDGE™ Program online at www.ipledgeprogram.com.1,2 IMPORTANT SAFETY INFORMATION WARNING: CAUSES BIRTH DEFECTS Pregnancy Category X • ABSORICA must not be used by female patients who are or may become pregnant. • There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking ABSORICA in any amount, even for short periods of time. • Potentially any fetus exposed during pregnancy can be affected. • There are no accurate means of determining whether an exposed fetus has been affected.
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• Birth defects which have been documented following isotretinoin exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported. • Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain abnormalities previously noted. • If pregnancy does occur during the treatment of a female patient who is taking ABSORICA, ABSORICA must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements • Because of the risk of teratogenicity and to minimize fetal exposure, ABSORICA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGETM. Under iPLEDGETM, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program. For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information.
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About acne What causes acne? A combination of 3 factors occurs in the body, causing acne to form3:
• Too much of a skin oil called sebum is made • There are too many dead skin cells • There is a buildup of bacteria Hair Dead Skin Cells
Skin Surface
Oil (Sebum)
Oil-Producing Gland
Hair Follicle
During puberty, the body begins to make more hormones. Some of these hormones, called androgens, cause the oil glands in the skin to get bigger and make more sebum.3 Normally, sebum helps remove old skin cells and keeps your skin soft. The sebum flows up and out of the oil gland through a pore, or small opening to the skin surface.3,4 When you have acne, a pore has become blocked with too much sebum and too many dead skin cells. Once the pore clogs, bacteria start to build up. The bacteria can cause redness, swelling, and infection underneath the surface of the skin. This leads to acne lesions, which can be anywhere from mild to very severe.3,4 For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 4
When you have severe inflammatory acne, it is common to have nodules. These are large, painful lumps deep beneath the surface of the skin. Nodules can be the size of pencil erasers, or larger, and can be hard to treat.3,6
What makes some people more prone to having acne? Some people may think that dirt, greasy foods, and chocolate make you more likely to have acne. This is simply not true. Acne does tend to run in families. If any of your family members had acne, then you are more likely to have it. For women, the menstrual cycle and pregnancy can cause hormonal changes that make acne worse.3
How is acne treated? There are many ways to treat acne. Some medications are applied to the skin; others are taken by mouth. Different treatments work for different people, depending on how severe their acne is.5 ABSORICA capsules contain isotretinoin, which is used to treat people with SRNA that has not improved with other treatments, including antibiotics. This is why your prescriber has recommended ABSORICA for you.2
ABSORICA (isotretinoin) capsules are different from the other medications with isotretinoin It is a medication that does not need to be taken with food.1,2 (For more information on food and ABSORICA, please see the section, “Taking ABSORICA (isotretinoin) capsules with or without food” on page 8 of this brochure.) Be sure to visit the Web site at www.absorica.com for more information. W I T H
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How do ABSORICA (isotretinoin) capsules work? ABSORICA (isotretinoin) capsules reduce sebum in severe recalcitrant (difficult-to-treat) nodular acne1,3,5 Hair Skin Surface REDUCES Dead Skin Cells REDUCES Oil (Sebum)
SHRINKS Oil-Producing Gland
Hair Follicle
ABSORICA treats acne where it starts. It reduces the amount of sebum the skin produces by shrinking the oil glands. When less sebum is made, fewer bacteria grow. The pores have less chance of clogging and forming acne.
ABSORICA capsules also reduce the number of dead skin cells7 If you recall, too many dead skin cells (caused by too much sebum) also cause pores to clog. ABSORICA helps your skin shed the dead cells.
ABSORICA capsules are different ABSORICA is different from other isotretinoin medications. Each ABSORICA (isotretinoin) capsule is created using Lidose™ Technology.8 With this technology, the body is able to absorb the medication without food. Once the medication is properly absorbed, it can then work to help clear up your acne.9
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 6
In helping to treat your acne, ABSORICA (isotretinoin) capsules may cause other side effects2
• Your acne may get worse when you first start taking ABSORICA. This should last only a short while. Talk with your prescriber if this is a problem for you
• Common, less serious side effects of ABSORICA
include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your prescriber if you have any side effects that bother you or that do not go away
• People who wear contact lenses may have trouble
wearing them while taking ABSORICA and for a while after therapy has stopped. Consider avoiding contact lenses during treatment
• ABSORICA may cause serious mental health problems
such as depression, psychosis (seeing or hearing things that are not real), and, rarely, suicidal thoughts and aggressive and/or violent behaviors. Call your prescriber right away if you notice any signs of these problems
• ABSORICA may cause serious brain problems, skin
problems, stomach area (abdomen) problems, bone and muscle problems, hearing problems, vision problems, blood sugar problems, and decreased red and white blood cells. These are not all of the possible side effects with ABSORICA. Your prescriber or pharmacist can give you more detailed information or see the full prescribing information
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Taking ABSORICA (isotretinoin) capsules with or without food How does food affect other isotretinoin medications? Food is a very important part of other isotretinoin acne treatments. Food affects how these medications are taken up by the body. Without food, other isotretinoin pills and capsules may not be absorbed well by your body.10 Most of these medications are absorbed best when they are taken with a high-fat meal.10
How does food affect how you take your ABSORICA medication?1 You may take ABSORICA with a meal or without a meal. ABSORICA capsules are specially designed so that they do not need to be taken with a high-fat meal to be effective. Therefore, it’s important to make sure your pharmacist does not substitute ABSORICA capsules for any other brand. ABSORICA is not interchangeable with generic products of Accutane® (isotretinoin) capsules.
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 8
Why are ABSORICA (isotretinoin) capsules different? Typical isotretinoin treatments need to be taken with a high-fat meal to be effective.1,9 Only a very small percentage of people take them with a highfat meal; most people either forget or don’t normally eat high-fat meals. This could prevent the medication from working as well as it should.11 This is not a problem with ABSORICA. ABSORICA is an isotretinoin medication made with a special capsule technology called Lidose™. Scientists designed Lidose™ so that the body can absorb some medicines without a high-fat meal.8 Tests with ABSORICA show that a person’s body will absorb this medicine well, even in the fasting state. Skipping meals is not recommended, but it is good to know that you can be flexible with your eating habits, if necessary, with ABSORICA.1 With ABSORICA, you don’t have to change your usual eating habits and you don’t have to schedule your meals so that they match the time you take your medication. ABSORICA capsules now come in 25- and 35-mg strengths. These strengths allow your doctor to more accurately tailor your dose based on your weight. ABSORICA capsules are the only isotretinoin acne treatment to offer 6 dosage strengths. ABSORICA fits your lifestyle while helping to clear up your severe acne.
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Taking ABSORICA (isotretinoin) capsules Your ABSORICA prescription You will receive no more than a 30-day supply of ABSORICA (isotretinoin) capsules at a time. This is because of the iPLEDGE™ Program requirements. The dose of ABSORICA that you will take has been specifically chosen for you by your prescriber. The amount of medicine you need is based on your weight and other factors. It is recommended that ABSORICA be taken twice a day.1,2
How to take your ABSORICA medication Take ABSORICA in two divided doses. Be sure to swallow your ABSORICA capsules whole with a full glass of liquid. Do not chew or suck on the capsules. ABSORICA can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.2 IF YOU MISS A DOSE, JUST SKIP THAT DOSE. Do not take 2 doses at the same time. If you take too much ABSORICA, or overdose, call your prescriber or the Poison Control Center (1-800-222-1222) right away.2
Actual patient photographs courtesy of Dr Scott A. Smith, FAOCD, FASMS.
Before ABSORICA treatment
5 months after ABSORICA treatment
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 10
With ABSORICA (isotretinoin) capsules, what you eat and when you eat is up to you You do not have to change your usual eating style with ABSORICA. You can eat healthy foods, such as foods with little or no fat, while taking this medication.1 With ABSORICA, you are not limited to only eating a high-fat meal with each dose. You can continue to enjoy whatever diet you decide is best for you, whether it involves high-fat, low-fat, or no-fat foods.
Getting your ABSORICA capsules is easy Ask your health care provider about PARTNERx SHIP™. This program offers the convenience of fast, easy, and free delivery of ABSORICA right to your door.
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What factors can affect the success of ABSORICA treatment? Isotretinoin, the active ingredient in ABSORICA (isotretinoin) capsules, has successfully helped to clear up severe cases of nodular (inflamed) acne after other treatments have failed.6,12,13 Patients often have no recurrence of their acne after using ABSORICA.7 Factors that affect the success of treatment with ABSORICA (isotretinoin) capsules include:
• Appropriate patient selection
ABSORICA is for patients with severe recalcitrant (difficult-to-treat) nodular acne that has not been helped by other treatments, including antibiotics.2
• Age
ABSORICA is for patients who are 12 years of age and older. ABSORICA has not been studied in younger patients.1
• Dosage of ABSORICA capsules
Your prescriber will determine the best dose of ABSORICA for you based on your weight and how you respond to treatment. Your prescriber may change your dose during treatment. Regardless of the dose, you should take ABSORICA twice a day, and your ABSORICA treatment may last 15 to 20 weeks.1,2 Actual patient photographs courtesy of Dr Scott A. Smith, FAOCD, FASMS.
Before ABSORICA treatment
5 months after ABSORICA treatment
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 12
• Food Remember, you may take ABSORICA without regard to meals. You may choose foods based on your usual eating habits.1,2 The foods need not be high fat.
• Staying on track with your therapy
It’s important to follow all of your prescriber’s instructions for your treatment to be most successful. Take ABSORICA medication regularly twice a day, don’t miss doses, and continue taking ABSORICA for 15 to 20 weeks. You must also follow all requirements of the iPLEDGE™ Program.1,2
• Family support
Having support from your family is important. You will need support, both as you begin therapy and as you continue it for the full course of 15 to 20 weeks of your prescription.2 Your family and friends can help you keep a positive attitude. Actual patient photographs courtesy of Melissa L.F. Knuckles, MD.
Before ABSORICA treatment
5 months after ABSORICA treatment
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Kelly Clark— A champion’s ABSORICA journey Kelly Clark is widely regarded as one of the most accomplished and respected snowboarders in the world. She is the most successful female snowboarder in the history of the sport and, with over 70 career wins, she has the most snowboarding wins among women and men. At 32 years of age, she remains at the top of her field and shows no signs of slowing down. Kelly is a true champion.
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 14
Kelly’s experience with SRNA Kelly first developed acne as a teenager, as do many people, but as her peers’ skin began to clear, Kelly saw no relief and she actually found her acne becoming more inflamed, red, and painful. When her acne persisted into her adult years, Kelly feared “severe acne was just something I would have to live with.”
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Kelly’s treatment with ABSORICA After discussing the challenges of living with severe acne and past treatment attempts, Kelly and her dermatologist decided that isotretinoin would be an appropriate therapy. Given her lifestyle as a professional athlete, Kelly was concerned about the dietary requirements of standard isotretinoins. Not only could she not commit to routinely scheduled meals, but the necessary high-fat foods were not feasible in light of her training diet. Her doctor explained that ABSORICA capsules were different because their effectiveness was not dependent on food intake.1 Together, Kelly and her dermatologist decided that ABSORICA was the right isotretinoin treatment for her.
Kelly also found the PARTNERx SHIP program to be a good fit for her busy schedule because it offers express delivery of the medication and worked with her travel schedule. For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 16
Kelly’s ABSORICA success story Kelly began to see a noticeable improvement in her skin within weeks of starting ABSORICA. Her skin was clearer and her pain from her lesions was reduced. During her 5-month treatment regimen, she remained committed to close monitoring and regular screening. After completing treatment, the results spoke for themselves.
“My friends and teammates kept telling me how great my skin looked, which I’d never heard before.” IMPORTANT SAFETY INFORMATION ABSORICA may cause serious mental health problems. See pages 18-22 for more information. W I T H
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Safety information for ABSORICA (isotretinoin) capsules Isotretinoin medication causes birth defects2 There is a very high risk of birth defects (deformed babies) if a pregnant woman takes medication that contains isotretinoin. There are additional risks to pregnant women taking isotretinoin, including premature (early) birth, miscarriage (loss of the baby), and stillbirth (death of the baby). Female patients must not get pregnant:
• For 1 month before starting ABSORICA treatment • While taking ABSORICA treatment • For 1 month after stopping ABSORICA treatment For female patients, stop using ABSORICA (isotretinoin) capsules and call your prescriber right away if you2:
• Have sex at any time without using 2 forms of the
iPLEDGE™ Program accepted birth control methods
• Get pregnant • Miss your expected period
Do not drive at night until you know if ABSORICA (isotretinoin) capsules have affected your vision ABSORICA may decrease your ability to see in the dark, so night driving may be more difficult.2
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 18
What are the possible side effects of ABSORICA (isotretinoin) capsules? Serious mental health problems2 ABSORICA may cause depression, psychosis (seeing or hearing things that are not real), and suicide. Some patients taking ABSORICA have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives, and some people have ended their own lives. Stop ABSORICA treatment and call your prescriber right away if you or a family member notices that you have any of the following signs and symptoms of depression or psychosis:
• Start to feel sad or have crying spells • Lose interest in activities you once enjoyed • Sleep too much or have trouble sleeping • Become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
• Have a change in your appetite or body weight • Have trouble concentrating • Withdraw from your friends or family • Feel like you have no energy • Have feelings of worthlessness or guilt • Start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
• Start acting on dangerous impulses • Start seeing or hearing things that are not real After stopping ABSORICA capsules, you may need to see a mental health care professional if you experienced any of these symptoms. 19
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Safety information for ABSORICA (isotretinoin) capsules Serious brain problems2 ABSORICA (isotretinoin) capsules can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking ABSORICA and call your prescriber right away if you have any of these signs of increased brain pressure:
• Bad headache • Blurred vision • Dizziness • Nausea or vomiting • Seizures (convulsions) • Stroke Skin problems2
Skin rash can occur in patients taking ABSORICA. In some patients, a rash can be serious. Stop using ABSORICA and call your prescriber right away if you develop conjunctivitis (red or inflamed eyes, like “pink eye”); a rash with a fever; blisters on your legs, arms, or face, and/or sores in your mouth, throat, nose, or eyes; or if your skin begins to peel.
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 20
Additional possible side effects of ABSORICA (isotretinoin) capsules Stomach area (abdomen) problems2 Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking ABSORICA. Stop taking ABSORICA and call your prescriber if you have
• Severe stomach, chest, or bowel pain • Trouble swallowing or painful swallowing • New or worsening heartburn • Diarrhea • Bleeding from the rectum • Yellowing of your skin or eyes • Dark urine Bone and muscle problems2
ABSORICA may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your prescriber if you plan to engage in hard physical activity, including sports, during treatment with ABSORICA. Tell your prescriber if you have back pain, joint pain, or a broken bone. Tell your prescriber, or any other health care providers, that you take ABSORICA if you break a bone. Stop ABSORICA treatment and call your prescriber right away if you have muscle weakness. Muscle weakness, with or without pain, can be a sign of serious muscle damage. ABSORICA may stop long bone growth in teenagers who are still growing.
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Safety information for ABSORICA (isotretinoin) capsules Hearing problems2 Stop ABSORICA treatment and call your prescriber if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent. Vision problems2 ABSORICA may affect your ability to see in the dark. This condition usually clears up after you stop taking ABSORICA, but it may be permanent. Other serious eye effects can occur. Stop taking ABSORICA and call your prescriber right away if you have any problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them during and after ABSORICA treatment. Lipid (fats and cholesterol in blood) problems2 ABSORICA can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to your prescriber for blood tests to check your lipid levels and to get any needed treatment. These problems associated with fats or cholesterol while taking ABSORICA usually go away when ABSORICA treatment is finished. Blood sugar problems2 ABSORICA may cause blood sugar problems, including diabetes. Tell your prescriber if you are very thirsty or urinate a lot. Decreased red and white blood cells2 Call your prescriber if you have trouble breathing, if you faint, or feel weak. These are not all of the possible side effects with ABSORICA (isotretinoin) capsules. Please see the enclosed Package Insert in pocket for more information.
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 22
What should I tell my prescriber before taking ABSORICA (isotretinoin) capsules? Tell your prescriber if you or a family member has any of the following health conditions2:
• Mental problems, asthma, liver disease, diabetes, heart disease, bone loss (osteoporosis) or weak bones, an eating problem called anorexia nervosa (where people eat too little), and food or medicine allergies
Tell your prescriber if you are pregnant or breastfeeding. ABSORICA (isotretinoin) capsules must not be used by women who are pregnant or breastfeeding.2 Tell your prescriber about all of the medications you take, including prescription and nonprescription medications, vitamins, and herbal supplements.2 ABSORICA (isotretinoin) capsules and certain other medications can interact with each other, sometimes causing serious side effects. Especially tell your prescriber if you take2:
• Vitamin A supplements • Tetracycline antibiotics • Progestin-only birth control pills (minipills) • Dilantin (phenytoin) • Corticosteroid medicines • St. John’s wort
These medications should not be used with ABSORICA (isotretinoin) capsules, unless your prescriber tells you it is okay.2 Know the medications you take. Keep a list of them to show to your prescriber and pharmacist. Do not take any new medication without talking with your prescriber.2 W I T H
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What should I avoid while taking ABSORICA (isotretinoin) capsules?2
• Do not get pregnant while taking ABSORICA and for 1 month after stopping treatment
• Do not breastfeed while taking ABSORICA and for •
•
1 month after stopping treatment — It is not known if ABSORICA can pass through breast milk and harm a baby Do not donate blood while taking ABSORICA and for 1 month after stopping treatment — If a pregnant woman gets your donated blood, her baby may be exposed to ABSORICA and may be born with birth defects Do not take other medications or herbal supplements while taking ABSORICA, unless allowed by your prescriber
• Do not drive at night until you know if ABSORICA • •
has affected your vision — ABSORICA may decrease your ability to see in the dark Avoid sunlight and ultraviolet lights as much as possible — Tanning machines use ultraviolet lights. ABSORICA may make your skin more sensitive to light Do not share ABSORICA with other people — It can cause birth defects and other serious health problems — Each treatment is individualized for each patient, as determined by a licensed prescriber
During treatment with ABSORICA (isotretinoin) capsules and for 6 months after treatment2
• Do not have cosmetic procedures to smooth your skin
— This includes waxing, dermabrasion, and laser procedures — ABSORICA can increase your chance of scarring from these procedures. Check with your prescriber for advice about when you can have cosmetic procedures For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 24
Instructions for taking ABSORICA (isotretinoin) capsules You must take ABSORICA (isotretinoin) capsules exactly as directed by your prescriber. You must also follow all the instructions of the iPLEDGE™ Program. Before prescribing ABSORICA to you, your prescriber will2
• Explain the iPLEDGE™ Program to you • Have you sign the Patient Information/Informed
Consent form (for all patients). Female patients who can get pregnant must also sign another consent form
Your prescriber will not prescribe ABSORICA if you cannot agree to or follow all the instructions of the iPLEDGE™ Program.2 Your prescriber will have you return to the office monthly to make sure you don’t have any signs of serious side effects, and may prescribe blood tests. Female patients who can get pregnant will also be given a monthly pregnancy test. At each visit, you should talk with your prescriber about any side effects you may have.1,2 Store ABSORICA at 68° to 77°F (20° to 25°C) and protect from light. Keep ABSORICA and all medicines out of the reach of children.2
For male patients taking ABSORICA (isotretinoin) capsules who are in a sexual relationship with a woman who may get pregnant Use 2 methods of iPLEDGE™ Program accepted birth control during treatment with ABSORICA and for 1 month after stopping treatment. ABSORICA is found in semen of male patients in very small quantities. The relationship between isotretinoin in semen and birth defects is unknown.2
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Additional instructions for females taking ABSORICA (isotretinoin) capsules who can get pregnant This information applies to patients who are able to get pregnant. This includes
• Women who have menstrual periods • Young women who have not started having menstrual periods
• Women who have had a tubal sterilization (women
who have had their tubes tied can still get pregnant)
This information does not apply to the following patients:
• Males • Women who have stopped having periods for
12 months in a row (menopause) and are confirmed by a prescriber as being in menopause
• Women who have had their ovaries or uterus removed by surgery
Because ABSORICA (isotretinoin) capsules cause birth defects1,2 It is critical for female patients not to get pregnant while taking ABSORICA. Abstinence means that you will not have sex or sexual contact with any male for 24 hours a day, 7 days a week. This may be difficult to do, especially if you are used to having sex. If you cannot commit to continuous abstinence from sex with a male, you should use 2 forms of effective birth control while you are taking ABSORICA and for 1 month after finishing your therapy.
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 26
Getting started
• You must choose 2 separate forms of effective birth
control because any single form (including sterilization and birth control pills) can fail. You may either discuss effective forms of birth control with your prescriber or discuss birth control with another prescriber or family planning expert at a free visit. Your prescriber can arrange this free visit, which will be paid for by the makers of ABSORICA (isotretinoin) capsules1,2
• Get a pregnancy test administered by your prescriber. Results from this test must be negative1
• Start using 2 methods of iPLEDGE™ Program accepted birth control together for 30 days before your next appointment with your prescriber1
• Get a second pregnancy test at a CLIA (Clinical
Laboratory Improvement Amendments)–certified laboratory, which your prescriber can recommend. The results from this test must be negative1
• Sign 2 consent forms for treatment • Get a prescription from your prescriber for your first 2
30-day supply of ABSORICA2
• Before you fill the prescription, answer questions to show that you understand the iPLEDGE™ Program and pregnancy prevention. Your prescriber will explain the iPLEDGE™ Program requirements. You may also learn about iPLEDGE™ online at www.ipledgeprogram.com2
• Continue using 2 forms of effective birth control
together throughout your ABSORICA treatment2
• Begin your first 30-day prescription of ABSORICA and
make sure to schedule your next appointment with your prescriber. Take ABSORICA exactly as prescribed. IF YOU MISS A DOSE, SKIP IT. DO NOT TAKE W I T H LI D O S E T E CH N O LO G Y 2 DOSES TOGETHER2 ™
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Additional instructions for taking ABSORICA (isotretinoin) capsules if you can get pregnant Each month of your therapy with ABSORICA (isotretinoin) capsules
• Continue using 2 methods of iPLEDGE™ Program accepted birth control together2
• Get a pregnancy test performed at a CLIA-certified laboratory. The test results must be negative2
• Get a prescription from your prescriber for your next 30-day supply of ABSORICA2
• Answer questions to show that you understand the iPLEDGE™ Program requirements and pregnancy prevention2
• Begin your next 30-day prescription of ABSORICA and
make sure to schedule your next appointment. Take ABSORICA exactly as prescribed. IF YOU MISS A DOSE, SKIP IT. DO NOT TAKE 2 DOSES TOGETHER2
After your final prescription is finished
• Get a pregnancy test administered by your prescriber • Answer questions to show that you understand
1
the iPLEDGE™ Program requirements and pregnancy prevention2
• Continue using 2 methods of iPLEDGE™ Program
accepted birth control together for 30 more days2
• Get a final pregnancy test administered by your
prescriber 30 days after your last dose of ABSORICA1
• DO NOT donate blood for 1 month after your last dose of ABSORICA2
For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. 28
References 1. ABSORICA [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories Inc.; September 2015. 2. ABSORICA Medication Guide. Jacksonville, FL: Ranbaxy Laboratories Inc.; September 2015. 3. Acne Mayo Clinic Web site: http://www.mayoclinic.org/diseases-conditions/acne/ basics/causes/con-20020580. Accessed December 10, 2015. 4. Acne. MedlinePlus Medical Encyclopedia Web site. http://www.nlm.nih.gov/ medlineplus/ency/article/000873.htm. Accessed September 24, 2014. 5. Questions and answers about acne. National Institute of Arthritis and Musculoskeletal and Skin Diseases Web site. http://www.niams.nih.gov/ health_info/acne/. Accessed September 24, 2014. 6. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol. 1980;3(6):602-611. 7. Del Rosso JQ. Face to face with oral isotretinoin: a closer look at the spectrum of therapeutic outcomes and why some patients need repeated courses. J Clin Aesthet Dermatol. 2012;5(11):17-24. 8. Vanderbist F, Servais C, Baudier P, (2008). U.S. Patent No. 7,435,427. Washington, DC: U.S. Patent and Trademark Office. 9. Del Rosso JQ. Status report on oral isotretinoin in the management of acne vulgaris: why all the discussion about drug absorption and relapse rates? Curr Derm Rep. 2013;2(3):177-180. 10. Sotret [prescribing information]. Jacksonville, FL: Ranbaxy Laboratories Inc.; February 2010. 11. Zeichner J. On dosage and diet: isotretinoin 101. Pract Dermatol. January 2014:4647. 12. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with13-cis-retinoic acid. N Engl J Med. 1979;300(7):329-333. 13. Jones H, Blanc D, Cunliffe WJ. 13-cis retinoic acid and acne. Lancet. 1980;2(8203):1048-1049. ABSORICA and PARTNER x SHIP are trademarks of Ranbaxy Laboratories Inc. All other trademarks are property of their respective owners.
W I T H
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L I D O S E™ T E C H N O L O G Y
Visit absorica.com
IMPORTANT SAFETY INFORMATION
• ABSORICA is used to treat a type of severe recalcitrant nodular acne
that has not been helped by other treatments, including antibiotics.
• Because ABSORICA can cause birth defects, ABSORICA is only for patients who can understand and agree to carry out all of the requirements of the iPLEDGETM Program.
• ABSORICA may cause serious mental health problems. For more information, please see PATIENT COUNSELING INFORMATION (Section 17) at the end of the full Prescribing Information. For more product information, please visit www.absorica.com.
W I TH
L I D O S E™ T E C H N O L O G Y
If you experience any Adverse Events you are encouraged to report them to the Drug Safety Department at 1-800-406-7984 or email
[email protected]. You can also report to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Ranbaxy Laboratories Inc. Jacksonville, FL 32257 Copyright © 2015 Ranbaxy Laboratories Inc, a SUN PHARMA company. Printed in USA ABS0004Ae 11/15
