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What is VIGPODER?

VIGPODER is a prescription medicine used to treat babies aged 1 month to 2 years who have infantile spasms (IS). The use of
VIGPODER should be based on a decision by you and your healthcare provider, weighing the potential benefits against the possible risk of vision loss.

IMPORTANT SAFETY INFORMATION FOR VIGPODER™ (vigabatrin)
What is the most important information I should know about VIGPODER?

VIGPODER can cause serious side effects, including:

Permanent vision loss: VIGPODER can damage the vision of anyone who takes it. Some babies can have severe loss, particularly to their ability to see to the side when they look 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 also may 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 VIGPODER. Changes in your baby's ability to see could be recognized if your baby begins tripping or bumping into things, becomes more clumsy than usual, or is surprised by people or things coming in front of them that seem to come out of nowhere; these changes can mean your baby has vision loss.

Vision loss in babies: Because of the risk of vision loss, VIGPODER is used in babies aged 1 month to 2 years who are diagnosed with infantile spasms only when you and your healthcare provider decide that the possible benefits of VIGPODER 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 VIGPODER or within 4 weeks after starting VIGPODER, and every 3 months after that until VIGPODER is stopped. Your baby also should have a vision test about 3 to 6 months after VIGPODER is stopped.
  • Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGPODER, but they will not be able to watch for any vision loss.
  • Tell your healthcare provider right away if you think that your baby is not seeing as well as before taking VIGPODER or is 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.

All babies who take VIGPODER

  • Are at risk for permanent vision loss with any amount of VIGPODER.
  • The risk of vision loss may increase with higher doses of VIGPODER, and the longer it is taken.
  • It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGPODER or any time during treatment. It may even happen after treatment has stopped.

Because VIGPODER might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of the Vigabatrin REMS Program to you. For more information, go to www.vigabatrinREMS.com or call 1-866-244-8175.

Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS): brain pictures taken by MRI show changes in some babies after they are given VIGPODER. It is not known if these changes are harmful.

What are the possible side effects of VIGPODER?

VIGPODER can cause serious side effects, including sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable). Serious side effects that happen in adults and are not known if they will happen in babies are low red blood cell counts, nerve problems, and swelling.

Tell your baby's healthcare provider right away if your baby's seizures get worse. The most common side effects of VIGPODER are sleepiness, ear infection, swelling of the bronchial tubes, and irritability.

Tell your healthcare provider if your baby has any side effect that worries you or that does not go away. These are not all the possible side effects of VIGPODER.

Do not suddenly stop giving VIGPODER to your baby. This can cause serious problems. Talk to your healthcare provider for directions on how to stop treatment.

What should I tell my healthcare provider before starting VIGPODER?

Before giving VIGPODER to your baby for IS, inform your healthcare provider about all your baby's medical conditions. This includes whether your baby has ever had an allergic reaction to VIGPODER, such as hives, itching, or trouble breathing; as well as any history of vision problems, kidney issues, or low red blood cell counts. Tell your healthcare provider about all the medicines your baby takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interactions between VIGPODER and other medicines could lead to side effects.

You may report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088 or Pyros at 1-855-406-1010.

Please see full Prescribing Information including BOXED WARNING, for additional Important Safety Information.