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    INDICATION

    VIGPODER™ (vigabatrin) is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

    Please refer to the full Prescribing Information to view other approved indications.

    IMPORTANT SAFETY INFORMATION FOR VIGPODER™ (vigabatrin)
    WARNING: PERMANENT VISION LOSS
    • VIGPODER can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGPODER also can damage the central retina and may decrease visual acuity.
    • The onset of vision loss from VIGPODER is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years.
    • Symptoms of vision loss from VIGPODER are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function.
    • The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.
    • Vision assessment is recommended at baseline (no later than 4 weeks after starting VIGPODER), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy.
    • Once detected, vision loss due to VIGPODER is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.
    • Consider drug discontinuation, balancing benefit and risk, if vision loss is documented.
    • Risk of new or worsening vision loss continues as long as VIGPODER is used. It is possible that vision loss can worsen despite discontinuation of VIGPODER.
    • Because of the risk of vision loss, VIGPODER should be withdrawn from patients with infantile spasms who fail to show a substantial clinical benefit within 2-4 weeks of initiation or sooner if treatment failure becomes obvious. Patients’ response to and continued need for VIGPODER should be periodically reassessed.
    • VIGPODER should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks.
    • VIGPODER should not be used with other drugs associated with serious ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.
    • Use the lowest dosage and shortest exposure to VIGPODER consistent with clinical objectives.

    Because of the risk of permanent vision loss, VIGPODER is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.

    WARNINGS AND PRECAUTIONS
    • Permanent Vision Loss: VIGPODER can cause permanent vision loss. Because of this risk and because, when it is effective, VIGPODER provides an observable symptomatic benefit, patient response and continued need for treatment should be periodically assessed.
      Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is recommended. Because vision testing in infants is difficult, vision loss may not be detected until it is severe.
    • VIGPODER is available only through a restricted program called the Vigabatrin REMS Program.
    • Magnetic Resonance Imaging (MRI) Abnormalities in Infants: Abnormal MRI signal changes characterized by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with vigabatrin.
    • Neurotoxicity: Intramyelinic edema (IME) has been reported in postmortem examination of infants being treated for IS with vigabatrin.
    • Withdrawal of Antiepileptic Drugs (AEDs) As with all AEDs, VIGPODER should be withdrawn gradually. However, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. Patients and caregivers should be told not to suddenly discontinue VIGPODER therapy.
    • Anemia: Monitor for symptoms of anemia.
    • Somnolence and Fatigue: VIGPODER causes somnolence and fatigue.
    • Peripheral Neuropathy and Edema: Vigabatrin causes symptoms of peripheral neuropathy and edema in adults. In pediatric clinical trials (pooled data), the incidence of peripheral neuropathy and edema observed in pediatric patients was similar on vigabatrin and placebo.
    ADVERSE REACTIONS

    The most common (>5%) adverse reactions that occurred more frequently than in placebo patients were somnolence, bronchitis, ear infection, and acute otitis media.

    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 or Pyros at 1-855-406-1010.

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