Discussing Restless Legs Syndrome (RLS) with your doctor is an important step in getting the right treatment

THE HORIZANT DOCTOR DISCUSSION GUIDE Discussing Restless Legs Syndrome (RLS) with your doctor is an important step in getting the right treatment. TE...
Author: Martha Boone
0 downloads 0 Views 533KB Size
THE HORIZANT DOCTOR DISCUSSION GUIDE

Discussing Restless Legs Syndrome (RLS) with your doctor is an important step in getting the right treatment. TELL YOUR DOCTOR EXACTLY WHAT YOU ARE EXPERIENCING Read the list below and check off the statements that are true for you. Be sure to share this information with your doctor.

What does your RLS feel like? It feels like there is a tingling, creeping, crawling feeling in my legs The weird feeling in my legs gets better if I get up and move around

Are your RLS symptoms disrupting your night and affecting your day? My symptoms are worst in the evening when I’m trying to relax and wind down My RLS symptoms wake me up at night Because of my RLS symptoms, I am having trouble getting to sleep and staying asleep My RLS symptoms don’t seem to ever end I’m really struggling to get through my day

Are you currently taking medication for RLS? I’m on medication but it doesn’t seem to be working as well as it used to I’m on medication but I stopped taking it because I thought it made my symptoms worse I’m interested in finding out more about my medication options

HORIZANT is specifically designed to treat the symptoms of moderate-to-severe primary RLS in adults. Ask your doctor if once-daily HORIZANT is right for you. IMPORTANT SAFETY INFORMATION • Do not drive after taking your dose of HORIZANT until you know how it affects you, including the morning after you take it. Do not operate heavy machinery or do other dangerous activities until you know how HORIZANT affects you. HORIZANT can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it is okay to do these activities. • Do not take other medicines that make you sleepy or dizzy while taking HORIZANT without talking to your healthcare provider. Taking HORIZANT with these other medicines may make your sleepiness or dizziness worse. Please see additional Important Safety Information on page 3 and attached full Prescribing Information and Medication Guide.

Assess the Severity of Restless Legs Syndrome HOW BAD IS YOUR RLS? RATE IT AND SHARE IT. Ask your doctor if once-daily HORIZANT® (gabapentin enacarbil) is right for you. Doctors use the IRLS Rating Scale to evaluate whether you have RLS and how severe your RLS might be.1 Rate the questions below from 0-4, and then add up your scores at the end. Overall scores can range from 0-40. Be sure to share your total score with your doctor. This scale is for informational purposes only and should not be used for self-diagnosis. Always consult a doctor or other health care professional for diagnosis and treatment of medical conditions.

In the past week:

Score

Overall, how would you rate the RLS discomfort in your legs or arms?

4 Very severe

3 Severe

2 Moderate

1 Mild

0 None

Overall, how would you rate the need to move around because of your RLS symptoms?

4 Very severe

3 Severe

2 Moderate

1 Mild

0 None

Overall, how much relief of your RLS arm or leg discomfort did you get from moving around?

4 No relief

3 Mild relief

2 Moderate relief

Either complete

No RLS

1 or almost

0 symptoms to

1 Mild

0 None

complete relief

be relieved

How severe was your sleep disturbance from your RLS symptoms?

4 Very severe

3 Severe

2 Moderate

How severe was your tiredness or sleepiness during the day due to your RLS symptoms?

4 Very severe

3 Severe

2 Moderate

1 Mild

0 None

2 Moderate

1 Mild

0 None

2 Sometimes (2–3

1 Occasionally

0 Never

1 Mild (less than

0 None

How severe was your RLS as a whole?

4 Very severe

3 Severe

How often did you get RLS symptoms?

4 Very often (6–7 days in 1 week)

3 Often (4–5

days in 1 week)

days in 1 week)

(1 day in 1 week)

When you had RLS symptoms, how severe were they on average?

4 Very severe (8 h

or more per 24 h)

3 Severe (3–8 h per 24 h)

2 Moderate

(1–3 h per 24 h)

1 h per 24 h)

Overall, how severe was the impact of your RLS symptoms, on your ability to carry out your daily affairs, for example, carrying out a satisfactory family, home, social, school, or work life?

4 Very severe

3 Severe

2 Moderate

1 Mild

0 None

How severe was your mood disturbance from your RLS symptoms–for example angry, depressed, sad, anxious, or irritable?

4 Very severe

3 Severe

2 Moderate

1 Mild

0 None

Add the scores from above and share the total with your patient. Mild 0 to 10

Moderate 11 to 20

Severe 21 to 30

Total Score

Very Severe 31 to 40

Distributed by Arbor Pharmaceuticals, LLC with permission from the International Restless Legs Syndrome Study Group. This scale is copyrighted by the International Restless Legs Syndrome Study Group. ©IRLS Study Group 2013. All rights reserved. For information about approved uses of this scale and about RLS, visit www.IRLSSG.org. IRLS contact information and permission to use: MAPI Research Trust, Lyon, France. Email: [email protected] Reference: 1. The International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group Rating Scale for restless legs syndrome. Sleep Med. 2003;4(2):121-132. HORIZANT is a registered trademark of Arbor Pharmaceuticals, LLC. © 2016 Arbor Pharmaceuticals, LLC. All rights reserved. Printed in USA. December 2016. PP-HOR-US-0100

Important Safety Information for HORIZANT® (gabapentin enacarbil) Extended-Release Tablets INDICATIONS HORIZANT® (gabapentin enacarbil) is a prescription medicine used to: • treat adults with moderate to severe primary Restless Legs Syndrome (RLS). HORIZANT is not for people who need to sleep during the daytime and stay awake at night. • manage pain from damaged nerves (postherpetic neuralgia) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults. IMPORTANT SAFETY INFORMATION • Do not drive after taking your dose of HORIZANT until you know how it affects you, including the morning after you take it. Do not operate heavy machinery or do other dangerous activities until you know how HORIZANT affects you. HORIZANT can cause sleepiness, dizziness, slow thinking, and can affect your coordination. Ask your healthcare provider when it is okay to do these activities. • Do not take other medicines that make you sleepy or dizzy while taking HORIZANT without talking to your healthcare provider. Taking HORIZANT with these other medicines may make your sleepiness or dizziness worse. • HORIZANT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: or actions about suicide, self-harm, or dying; attempt ˚ thoughts to commit suicide or worsening depression or anxiety; or feeling agitated ˚ new new or worse restlessness or panic attacks ˚ new or worse trouble sleeping (insomnia); or irritability ˚ acting aggressive, being angry, or violent; acting on ˚ dangerous impulses extreme increase in activity or talking (mania); other unusual ˚ anchanges in mood or behavior • Do not stop taking HORIZANT without first talking to your healthcare provider. Suicidal thoughts or actions can be caused by things other than medicines. If you have these thoughts or actions, your healthcare provider may check for other causes. • HORIZANT may cause a serious or life-threatening allergic reaction that may affect your skin or other parts of your body such as your liver or blood cells. You may or may not have a rash with these types of reactions. Call a healthcare provider right away if you have any of the following symptoms: skin rash, hives, fever, swollen glands that do not go away, swelling of your lips or tongue, yellowing of your skin or eyes, unusual bruising or

bleeding, severe fatigue or weakness, unexpected severe muscle pain, or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine you to decide if you should continue taking HORIZANT. • HORIZANT is not the same medicine as gabapentin [for example, NEURONTIN® (gabapentin) and GRALISE® (gabapentin)]. HORIZANT should not be used in their place. Do not take these or other gabapentin products while taking HORIZANT. • Before taking HORIZANT, tell your healthcare provider if you: or have had kidney problems or are on hemodialysis ˚ have or have had depression, mood problems, or suicidal ˚ have thoughts or behavior or have had seizures ˚ have have a history of drug abuse ˚ have any other medical conditions ˚ are pregnant or plan to become pregnant. It is not known if ˚ HORIZANT will harm your unborn baby. Talk to your healthcare

provider if you are pregnant or plan to become pregnant while taking HORIZANT. You and your healthcare provider will decide if you should take HORIZANT while you are pregnant

breastfeeding or plan to breastfeed. Your body turns ˚ are HORIZANT into another drug (gabapentin) that passes into

your milk. It is not known if this can harm your baby. You and your healthcare provider should decide if you will take HORIZANT or breastfeed

˚ drink alcohol

• Do not drink alcohol while taking HORIZANT because it may increase the risk of side effects. • Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking HORIZANT with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. • Do not stop taking HORIZANT without talking to your healthcare provider first. If you stop taking HORIZANT suddenly, you may develop side effects. • The most common side effects of HORIZANT include dizziness, sleepiness, and headache. Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of HORIZANT. For more information, ask your healthcare provider or pharmacist. 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 more information, ask your healthcare provider or pharmacist, or consult the full Prescribing Information and Medication Guide on the following pages and at www.horizant.com.

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HORIZANT safely and effectively. See full prescribing information for HORIZANT.

--------------------- DOSAGE FORMS AND STRENGTHS -------------Extended-Release Tablets: 300 mg and 600 mg. (3) ------------------------------- CONTRAINDICATIONS -----------------------None. (4)

HORIZANT (gabapentin enacarbil) Extended-Release Tablets for oral use Initial U.S. Approval: 2011

----------------------- WARNINGS AND PRECAUTIONS --------------- Driving impairment: Warn patients not to drive until they have gained sufficient experience with HORIZANT to assess whether it will impair their ability to drive. (5.1)  Somnolence/sedation and dizziness: May impair the patient’s ability to operate complex machinery. (5.2)  HORIZANT is not interchangeable with other gabapentin products. (5.3)  Suicidal thoughts or behaviors: HORIZANT is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behaviors. Monitor for suicidal thoughts or behaviors. (5.4)

--------------------------- RECENT MAJOR CHANGES -------------------Warnings and Precautions, Effects on Driving (5.1) 03/2013 ----------------------------INDICATIONS AND USAGE --------------------HORIZANT is indicated for:  treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. (1.1)  management of postherpetic neuralgia (PHN) in adults. (1.2) ----------------------- DOSAGE AND ADMINISTRATION ---------------Instruct patients to swallow tablets whole and not to cut, crush, or chew tablets. Take with food. (2) RLS: 600 mg once daily taken at about 5 PM. (2.1)  A dose of 1,200 mg once daily provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions. (2.1)  If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed. (2.1) PHN: The starting dose is 600 mg in the morning for 3 days, then increase to 600 mg twice daily beginning on day 4. (2.2)  A daily dose greater than 1,200 mg provided no additional benefit. (2.2)  If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of next scheduled dose. (2.2) Patients with renal impairment: Doses of HORIZANT must be adjusted in accordance with renal function. (2.3)

------------------------------ ADVERSE REACTIONS ---------------------- RLS: Most common adverse reactions (10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness. (6.1)  PHN: Most common adverse reactions (10% and greater than placebo) were dizziness, somnolence, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact XenoPort at 1-877-XENOPRT (1-877-936-6778) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ----------------------- USE IN SPECIFIC POPULATIONS ---------------Pregnancy: Based on animal data, may cause fetal harm. (8.1) See 17 for PATIENT COUNSELING INFORMATION and MEDICATION GUIDE. Revised: 07/2013

9  DRUG ABUSE AND DEPENDENCE  9.1  Controlled Substance  9.2  Abuse  9.3  Dependence  10  OVERDOSAGE  10.1  Human Overdose Experience  10.2  Overdosage Management  11  DESCRIPTION  12  CLINICAL PHARMACOLOGY  12.1  Mechanism of Action  12.3  Pharmacokinetics 12.6  Cardiac Electrophysiology  13  NONCLINICAL TOXICOLOGY  13.1  Carcinogenesis, Mutagenesis, Impairment of Fertility  14  CLINICAL STUDIES  14.1  Restless Legs Syndrome (RLS) 12-Week Pivotal Studies  14.2  Postherpetic Neuralgia (PHN) 12-Week Study  14.3  Effects on Driving  16  HOW SUPPLIED/STORAGE AND HANDLING  17  PATIENT COUNSELING INFORMATION  17.1  Effects on Driving  17.2  Somnolence/Sedation and Dizziness  17.3  Suicidal Behavior and Ideation  17.4  Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity  17.5  Lack of Interchangeability With Gabapentin  17.6  Dosing Instructions  17.7  Alcohol  *Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION: CONTENTS* 1  INDICATIONS AND USAGE  1.1  Treatment of Restless Legs Syndrome  1.2  Management of Postherpetic Neuralgia  2  DOSAGE AND ADMINISTRATION  2.1  Restless Legs Syndrome  2.2  Postherpetic Neuralgia  2.3  Renal Impairment  3  DOSAGE FORMS AND STRENGTHS  4  CONTRAINDICATIONS  5  WARNINGS AND PRECAUTIONS  5.1  Effects on Driving  5.2  Somnolence/Sedation and Dizziness  5.3  Lack of Interchangeability With Gabapentin  5.4  Suicidal Behavior and Ideation  5.5  Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity  5.6  Discontinuation of HORIZANT  5.7  Tumorigenic Potential  6  ADVERSE REACTIONS  6.1  Clinical Trials Experience  6.2  Adverse Events Associated With Gabapentin  7  DRUG INTERACTIONS  8  USE IN SPECIFIC POPULATIONS  8.1  Pregnancy  8.2  Labor and Delivery  8.3  Nursing Mothers  8.4  Pediatric Use  8.5  Geriatric Use  8.6  Renal Impairment 

1

______________________________________________________________________ FULL PRESCRIBING INFORMATION 1 1.1

INDICATIONS AND USAGE Treatment of Restless Legs Syndrome HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night. 1.2 Management of Postherpetic Neuralgia HORIZANT (gabapentin enacarbil) Extended-Release Tablets are indicated for the management of postherpetic neuralgia (PHN) in adults. 2

DOSAGE AND ADMINISTRATION Tablets should be swallowed whole and should not be cut, crushed, or chewed. Tablets should be taken with food. HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles [see Warnings and Precautions (5.3)]. 2.1 Restless Legs Syndrome The recommended dosage for HORIZANT is 600 mg once daily at about 5 PM. A daily dose of 1,200 mg provided no additional benefit compared with the 600-mg dose, but caused an increase in adverse reactions [see Adverse Reactions (6.1)]. If the dose is not taken at the recommended time, the next dose should be taken the following day as prescribed. 2.2 Postherpetic Neuralgia The recommended dosage of HORIZANT is 600 mg twice daily. HORIZANT should be initiated at a dose of 600 mg in the morning for 3 days of therapy, then increased to 600 mg twice daily (1,200 mg/day) on day four. In the 12-week principal efficacy study, additional benefit of using doses greater than 1,200 mg a day was not demonstrated, and these higher doses resulted in an increase in adverse reactions [see Adverse Reactions (6.1)]. If the dose is not taken at the recommended time, skip this dose, and the next dose should be taken at the time of the next scheduled dose. 2.3 Renal Impairment Dosing of HORIZANT is adjusted in accordance with renal function, as represented by creatinine clearance [see Clinical Pharmacology (12.3)]. Target dose regimens are listed in Table 1 and Table 2.

2

Table 1. Dosage of HORIZANT for Patients With Restless Legs Syndrome in Accordance With Creatinine Clearance Creatinine Clearance (mL/min) Target Dose Regimen ≥60 600 mg per day 30 – 59 Start at 300 mg per day and increase to 600 mg as needed 15 – 29 300 mg per day

Suggest Documents