09/03/2024
Please see full Prescribing Information, including 𝐁𝐎𝐗𝐄𝐃 𝐖𝐀𝐑𝐍𝐈𝐍𝐆, Medication Guide, and Instructions for Use for additional Important Safety Information for VIGAFYDE (VIGAFYDE.com/pi) and for VIGPODER (VIGPODER.com/pi)
𝐈𝐌𝐏𝐎𝐑𝐓𝐀𝐍𝐓 𝐒𝐀𝐅𝐄𝐓𝐘 𝐈𝐍𝐅𝐎𝐑𝐌𝐀𝐓𝐈𝐎𝐍 𝐟𝐨𝐫 𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄™ (𝐯𝐢𝐠𝐚𝐛𝐚𝐭𝐫𝐢𝐧) 𝐚𝐧𝐝 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑™ (𝐯𝐢𝐠𝐚𝐛𝐚𝐭𝐫𝐢𝐧)
𝐖𝐡𝐚𝐭 𝐢𝐬 𝐭𝐡𝐞 𝐦𝐨𝐬𝐭 𝐢𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐭 𝐢𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 𝐈 𝐬𝐡𝐨𝐮𝐥𝐝 𝐤𝐧𝐨𝐰 𝐚𝐛𝐨𝐮𝐭 𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑?
𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑 𝐜𝐚𝐧 𝐜𝐚𝐮𝐬𝐞 𝐬𝐞𝐫𝐢𝐨𝐮𝐬 𝐬𝐢𝐝𝐞 𝐞𝐟𝐟𝐞𝐜𝐭𝐬, 𝐢𝐧𝐜𝐥𝐮𝐝𝐢𝐧𝐠:
•𝐏𝐞𝐫𝐦𝐚𝐧𝐞𝐧𝐭 𝐯𝐢𝐬𝐢𝐨𝐧 𝐥𝐨𝐬𝐬: VIGAFYDE or 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 VIGAFYDE or VIGPODER or is acting differently than normal.
𝐕𝐢𝐬𝐢𝐨𝐧 𝐥𝐨𝐬𝐬 𝐢𝐧 𝐛𝐚𝐛𝐢𝐞𝐬: Because of the risk of vision loss, VIGAFYDE or VIGPODER is used in babies 1 month to 2 years of age with infantile spasms only when you and your healthcare provider decide that the possible benefits of VIGAFYDE or 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 VIGAFYDE or VIGPODER or within 4 weeks after starting VIGAFYDE or VIGPODER, and every 3 months after that until VIGAFYDE or VIGPODER is stopped. Your baby also should have a vision test about 3 to 6 months after VIGAFYDE or 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 VIGAFYDE or VIGPODER, but they will not be able to watch for any vision loss.
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 𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑:
•Are at risk for permanent vision loss with any amount of VIGAFYDE or VIGPODER.
•The risk of vision loss may increase with higher doses of VIGAFYDE or 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 VIGAFYDE or VIGPODER or any time during treatment. It may even happen after treatment has stopped.
Because VIGAFYDE or 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). 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.
• 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 VIGAFYDE or VIGPODER. It is not known if these changes are harmful.
𝐖𝐡𝐚𝐭 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐩𝐨𝐬𝐬𝐢𝐛𝐥𝐞 𝐬𝐢𝐝𝐞 𝐞𝐟𝐟𝐞𝐜𝐭𝐬 𝐨𝐟 𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑?
𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑 𝐜𝐚𝐧 𝐜𝐚𝐮𝐬𝐞 𝐬𝐞𝐫𝐢𝐨𝐮𝐬 𝐬𝐢𝐝𝐞 𝐞𝐟𝐟𝐞𝐜𝐭𝐬, 𝐢𝐧𝐜𝐥𝐮𝐝𝐢𝐧𝐠 𝐬𝐥𝐞𝐞𝐩𝐢𝐧𝐞𝐬𝐬 (sleepy babies may have a harder time suckling and feeding or may be irritable) and 𝐰𝐞𝐢𝐠𝐡𝐭 𝐠𝐚𝐢𝐧 𝐰𝐢𝐭𝐡𝐨𝐮𝐭 𝐬𝐰𝐞𝐥𝐥𝐢𝐧𝐠. Serious side effects that happen in 𝐚𝐝𝐮𝐥𝐭𝐬 𝐰𝐡𝐨 𝐭𝐚𝐤𝐞 𝐯𝐢𝐠𝐚𝐛𝐚𝐭𝐫𝐢𝐧 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 VIGAFYDE or VIGPODER 𝐢𝐧 𝐛𝐚𝐛𝐢𝐞𝐬 include sleepiness, ear infection, swelling of the bronchial tubes, and irritability.
Tell your healthcare provider if your baby has any side effect that bothers them or that does not go away. These are not all the possible side effects of VIGAFYDE or VIGPODER.
𝐃𝐨 𝐧𝐨𝐭 𝐬𝐭𝐨𝐩 𝐭𝐚𝐤𝐢𝐧𝐠 𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑 𝐬𝐮𝐝𝐝𝐞𝐧𝐥𝐲. 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 𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 𝐕𝐈𝐆𝐏𝐎𝐃𝐄𝐑?
𝐁𝐞𝐟𝐨𝐫𝐞 𝐠𝐢𝐯𝐢𝐧𝐠 𝐕𝐈𝐆𝐀𝐅𝐘𝐃𝐄 𝐨𝐫 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 VIGAFYDE or VIGPODER, such as hives, itching, or trouble breathing, as well as any history of vision problems, or kidney issues. 𝐓𝐞𝐥𝐥 𝐲𝐨𝐮𝐫 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐩𝐫𝐨𝐯𝐢𝐝𝐞𝐫 𝐚𝐛𝐨𝐮𝐭 𝐚𝐥𝐥 𝐭𝐡𝐞 𝐦𝐞𝐝𝐢𝐜𝐢𝐧𝐞𝐬 𝐲𝐨𝐮𝐫 𝐛𝐚𝐛𝐲 𝐭𝐚𝐤𝐞𝐬, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interactions between VIGAFYDE or 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, Medication Guide, and Instructions for Use for additional Important Safety Information for VIGAFYDE (VIGAFYDE.com/pi) and for VIGPODER (VIGPODER.com/pi)
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