• Permanent vision loss
• Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS)

• Vision loss in babies: Because of the risk of vision loss, VIGAFYDE is used in babies 1 month to 2 years of age with IS only when you and your healthcare provider decide that the possible benefits of VIGAFYDE are more important than the risks.
• Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe.
• It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting VIGAFYDE or within 4 weeks after starting VIGAFYDE, and every 3 months after that until VIGAFYDE is stopped. Your baby should also have a vision test about 3 to 6 months after VIGAFYDE is stopped.
• Your baby may not be able to be tested. Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGAFYDE, but your healthcare provider will not be able to watch for any vision loss.

• not seeing as well as before taking VIGAFYDE
• acting differently than normal
• Even if your baby’s vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby’s vision before it is severe and permanent.

• 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). VIGAFYDE can only be prescribed to people who are enrolled in this program. As part of the Vigabatrin REMS, it is recommended that your healthcare provider test your (or your child’s) vision from time to time (periodically) while you (or your child) are being treated with VIGAFYDE, and even after you (or your child) stop treatment. Your healthcare provider will explain the details of the Vigabatrin REMS to you. For more information, go to www.vigabatrinREMS.com or call 1-866-244-8175.

• VIGAFYDE is a prescription medicine used to treat babies 1 month to 2 years of age who have infantile spasms (IS) 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.

What should I tell my baby's healthcare provider before starting VIGAFYDE?

• an allergic reaction to VIGAFYDE, such as hives, itching, or trouble breathing
• any vision problems
• any kidney problems

• VIGAFYDE comes as an oral solution.
• Important: 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.
• Your baby will receive VIGAFYDE from a specialty pharmacy.
• Give VIGAFYDE exactly as your baby's healthcare provider tells you to. VIGAFYDE is usually taken 2 times each day.
• VIGAFYDE may be taken with or without food.
• Before starting to give VIGAFYDE, talk to your baby’s healthcare provider about what you should do if a VIGAFYDE dose is missed.
• If your baby is taking VIGAFYDE for IS and the seizures do not improve within 2 to 4 weeks, your baby’s healthcare provider will stop prescribing VIGAFYDE.
• Do not stop taking VIGAFYDE suddenly. This can cause serious problems. Stopping VIGAFYDE or any seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures. You should follow your baby's healthcare provider’s instructions on how to stop taking VIGAFYDE.
• Tell your baby’s healthcare provider right away about any increase in seizures when VIGAFYDE treatment is being stopped. Before your baby starts taking VIGAFYDE, speak to your baby’s healthcare provider about what to do if your baby misses a dose, vomits, spits up, or only takes part of the dose of VIGAFYDE.
• Do not stop taking VIGAFYDE without talking to your healthcare provider. If VIGAFYDE improves your baby’s seizures, you and your baby's healthcare provider should talk about whether the benefit of taking VIGAFYDE is more important than the risk of vision loss, and decide if your baby will continue to take VIGAFYDE.
• VIGAFYDE can be given to your baby at the same time as their meal.
• Measure the dose of VIGAFYDE using the syringe given to you by the pharmacy. A household teaspoon is not an accurate measuring device.
• Do not add water or other liquids to VIGAFYDE (do not dilute) when measuring the dose.
• See “Instructions for Use” for detailed information about how to give VIGAFYDE to your baby the right way.

• See “What is the most important information I should know about VIGAFYDE?”
• VIGAFYDE may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding or may be irritable.
• weight gain that happens without swelling

• low red blood cell counts (anemia)
• nerve problems. Symptoms of a nerve problem can include numbness and tingling in your toes or feet. It is not known if nerve problems will go away after treatment with VIGAFYDE is stopped.
• swelling
• suicidal thoughts and ideation.

VIGAFYDE may make certain types of seizures worse. You should tell your baby’s healthcare provider right away if your baby’s seizures get worse. Tell your baby’s healthcare provider if you see any changes in your baby’s behavior.

The most common side effects of VIGAFYDE in babies include:

• sleepiness – VIGAFYDE may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding or may be irritable.
• ear infection
• swelling in the bronchial tubes (bronchitis)
• 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 the possible side effects of VIGAFYDE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Store unopened bottles at room temperature between 68°F to 77°F (20°C to 25°C). Once opened, store bottle in a refrigerator or at room temperature between 36°F to 86°F (2°C to 30°C).
• Throw away (discard) any opened bottle of VIGAFYDE 90 days after first opening, even if there is still medicine in the bottle.