Medication Guide

Vigabatrin REMS for Prescribers
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Prescribing Sabril^® (vigabatrin)

Vigabatrin REMS Program

Healthcare providers must be certified in the Vigabatrin REMS Program in order to prescribe branded Sabril or generic vigabatrin.

The US Food and Drug Administration (FDA) has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products, called the Vigabatrin REMS Program. The Vigabatrin REMS Program is required by the FDA to ensure informed risk-benefit decisions before initiating treatment, and to ensure appropriate use of vigabatrin while patients are treated. Clicking on the link below will take prescribers to the website that manages the process and contains the required vigabatrin REMS forms.

Vigabatrin REMS Program Enrollment and Treatment Initiation: Step by Step

Note: Prescribers who have been enrolled in the Sabril REMS Program will be transitioned into the new Vigabatrin REMS Program without being required to recertify. New patients will need to be enrolled in the Vigabatrin REMS Program.

Step 1: REVIEW

Review the Prescribing Information for vigabatrin
FOR NEW PRESCRIBERS ONLY: Complete and submit the Prescriber Enrollment and Agreement Form online or print the form and fax or mail it to the Vigabatrin REMS Program. An e-mail will be sent to confirm your enrollment

Step 2: COUNSEL

Counsel the patient/parent/legal guardian on the benefits and risks associated with vigabatrin and provide a copy of What You Need to Know About Vigabatrin Treatment: A Patient Guide
FOR NEW PATIENTS ONLY: Complete the Patient/Parent/Legal Guardian–Physician Agreement Form. Please note that the patient/parent/legal guardian will need to sign this form online or you will need to print this form, have the patient/parent/legal guardian sign it, and fax or e-mail it to the Vigabatrin REMS Program. Patients already enrolled in the Sabril REMS program do not need to complete the form again

Step 3: DECIDE

Decide whether to prescribe branded Sabril or generic vigabatrin
- If you decide that branded Sabril is clinically appropriate for your patient, download, print, and complete a Sabril Prescription Form. When completing the Sabril Prescription Form, indicate “Dispense as written (DAW)” or follow your state's instructions for indicating branded vs. generic product. Fax the completed form to SHAREPlus at
- If you choose to prescribe a generic vigabatrin, look up a certified pharmacy on the vigabatrin REMS website (www.vigabatrinREMS.com) and fax the prescription directly to the pharmacy. A prescription for branded Sabril can also be submitted this way, by indicating “DAW” or following your state's instructions for indicating branded vs. generic product

Vigabatrin REMS program and the FDA-Mandated REMS Forms

www.vigabatrinREMS.com

Phone:

Fax:

Mail: Vigabatrin REMS Program

200 Pinecrest Plaza

Morgantown, WV 26505-8065

Click the links below for access to the Sabril Prescription Form or access to the Complete Terms and Conditions for the Sabril patient support programs that may be available for eligible, commercially insured patients.

www.Sabril.net

Phone:

Fax:

Download the Complete Terms and Conditions

SABRIL^® (vigabatrin) tablets, for oral use

SABRIL^® (vigabatrin) for oral solution

Approved Use

SABRIL (vigabatrin) is a prescription medicine used with other treatments in adults and children 2 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments and if the possible benefits outweigh the risk of vision loss. SABRIL should not be the first medicine used to treat CPS.

SABRIL (vigabatrin) is a prescription medicine used in babies, 1 month to 2 years old, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.

IMPORTANT
SAFETY INFORMATION

EXPAND

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

All people who take SABRIL:

You are at risk for vision loss with any amount of SABRIL.
Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it.
It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting SABRIL or any time during treatment. It may even happen after treatment has stopped.

IMPORTANT
SAFETY INFORMATION

COLLAPSE

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

All people who take SABRIL:

You are at risk for vision loss with any amount of SABRIL.
Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it.
It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting SABRIL or any time during treatment. It may even happen after treatment has stopped.

Because SABRIL might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this program to you.
SABRIL can damage the vision of anyone who takes it. Some people can have severe loss particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.
Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting SABRIL; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting SABRIL and at least every 3 months during treatment until SABRIL is stopped. It is also recommended that vision be tested about 3 to 6 months after SABRIL is stopped. Your vision loss may get worse after you stop taking SABRIL. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
Vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow SABRIL to be stopped if vision has gotten worse. Even these regular vision tests may not show vision damage before it is severe and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
If vision tests are not done regularly, your healthcare provider may stop prescribing SABRIL for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing SABRIL, but will not be able to watch for any vision loss.
Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given SABRIL. It is not known if these changes are harmful.
A type of swelling in the brain called intramyelinic edema (IME) has been seen in autopsy examination of babies treated with vigabatrin.
Like other antiepileptic drugs, SABRIL may cause suicidal thoughts and actions in some people. Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, get worse, or worry you.
Do not stop SABRIL without first talking to a healthcare provider. Stopping SABRIL suddenly can cause seizures that will not stop.
SABRIL can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because SABRIL causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task unless it is decided that these things can be done safely. SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
Before starting SABRIL, tell your doctor about all of your (or your child’s) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to SABRIL, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illness. Tell your doctor about all the medicines you (or your child) take.
If you are breastfeeding or plan to breastfeed, SABRIL can pass into breast milk and may harm your baby. Breastfeeding is not recommended. If you decide to breastfeed, watch your baby for signs of vision loss, sleepiness, and poor sucking.
If you are pregnant or plan to become pregnant, SABRIL can cause harm to your unborn baby. Tell your healthcare provider if you are pregnant or intend to get pregnant. You and your healthcare provider will have to decide if you should take SABRIL while you are pregnant.
If you become pregnant while taking SABRIL, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
The most common side effects of SABRIL in adults include: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor), and tiredness. The most common side effect of SABRIL in children 3 to 16 years is weight gain. Also expect side effects like those seen in adults.
The most common side effects of SABRIL in babies include: sleepiness—sleepy babies may have a harder time suckling and feeding or may be irritable—swelling in the bronchial tubes (bronchitis), ear infection, and irritability.
Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. These are not all of the possible side effects of SABRIL. 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, please see SABRIL Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use.

The product information provided in this site is intended only for residents of the U.S. The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. Sabril may not be a fit for everyone. You and your doctor should decide if the possible benefits of taking Sabril are more important than the risk of permanent vision loss.

Sabril is a registered trademark of Lundbeck.

Prescribing Sabril® (vigabatrin)

Vigabatrin REMS Program

Vigabatrin REMS Program Enrollment and Treatment Initiation: Step by Step

Vigabatrin REMS program and the FDA-Mandated REMS Forms

Click the links below for access to the Sabril Prescription Form or access to the Complete Terms and Conditions for the Sabril patient support programs that may be available for eligible, commercially insured patients.

IMPORTANT SAFETY INFORMATION

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

IMPORTANT SAFETY INFORMATION

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

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, please see SABRIL Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use.

Prescribing Sabril^® (vigabatrin)

IMPORTANT
SAFETY INFORMATION

IMPORTANT
SAFETY INFORMATION