Infantile spasms treatment VIGAFYDE™ | Promise of Support (original) (raw)

WHAT IS VIGAFYDETM (vigabatrin)?

VIGAFYDE™ (vigabatrin) Oral Solution is a prescription medicine used to treat:

• Infantile Spasms (IS) in babies 1 month to 2 years of age, if you and your baby’s healthcare provider decide the possible benefits of taking VIGAFYDE are more important than the possible risk of vision loss.

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

All caregivers of babies who take VIGAFYDE:

• Your baby is at risk for permanent vision loss with any amount of VIGAFYDE.

• Your baby’s risk of vision loss may be higher the more VIGAFYDE is taken daily and the longer it is taken.

• It is not possible for your baby’s healthcare provider to know when vision loss will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped.

• Because VIGAFYDE 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 baby’s healthcare provider will explain the details of this Program to you.

• VIGAFYDE 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, your baby may only be able to see things straight in front of them (sometimes called "tunnel vision"). Your baby may also have blurry vision. If this happens, it will not get better.

• Tell your healthcare provider right away if your baby might not be seeing as well as before starting VIGAFYDE or is acting differently than normal. These changes can mean that vision damage has occurred.

• Regular vision testing is recommended. It is recommended that your healthcare provider test your baby’s vision before or within 4 weeks after starting VIGAFYDE, and at least every 3 months during treatment until VIGAFYDE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGAFYDE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your baby’s 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 VIGAFYDE, but they do allow VIGAFYDE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.

• If you do not have these vision tests regularly, your baby’s healthcare provider may stop prescribing VIGAFYDE. Your baby may not be able to complete vision testing. If vision testing cannot be done, the healthcare provider may continue prescribing VIGAFYDE but will not be able to watch for any vision loss.

• Magnetic resonance imaging (MRI) changes in patients with infantile spasms (IS). Brain pictures taken by MRI show changes in some patients after they are given VIGAFYDE. It is not known if these changes are harmful.

• A type of swelling in the brain called intramyelinic edema (IME) has been seen in postmortem examination of infants treated with vigabatrin.

• Risk of suicidal thoughts or actions. VIGAFYDE is approved for use in patients 1 month to 2 years of age [see WHAT IS VIGAFYDE?]. VIGAFYDE is not approved for use in adolescents or adults. Like other antiepileptic drugs, vigabatrin may cause suicidal thoughts and actions in some adolescents and adults (about 1 in 500 people). A healthcare provider should be called right away if a patient taking vigabatrin experiences any symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worrying.

• Do not stop VIGAFYDE without first talking to a healthcare provider. Stopping VIGAFYDE suddenly can cause seizures that will not stop.

VIGAFYDE is more concentrated than vigabatrin solutions prepared from powder. The volume of VIGAFYDE solution prescribed by your baby’s healthcare provider may be less than the volume prescribed for other vigabatrin solutions prepared from powder. Always double check the volume (mL) that you are to give your baby when you get a new prescription filled.

VIGAFYDE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, and weight gain.

VIGAFYDE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.

Before starting VIGAFYDE, tell your baby’s doctor about all of their medical conditions including any allergic reaction to vigabatrin, vision problems, kidney problems, or low red blood cell counts (anemia). Tell your doctor about all the medicines your baby is receiving.

The most common side effects of VIGAFYDE 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 your baby has any side effect that bothers them or that does not go away.

This is the most important information to know about VIGAFYDE, but not all of the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGAFYDE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit VIGAFYDE.com, upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.