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Indications and Usage for SABRIL® (vigabatrin) Tablets and Powder for Oral Solution

SABRIL is indicated as adjunctive therapy for patients 10 years of age and older with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. SABRIL is not indicated as a first line agent for CPS.

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

Important Safety Information

WARNING: VISION LOSS
See full Prescribing Information for complete boxed warning

  • SABRIL causes progressive and permanent bilateral concentric visual field constriction in a high percentage of patients. In some cases, SABRIL may also reduce visual acuity.
  • Risk increases with total dose and duration of use, but no exposure to SABRIL is known that is free of risk of vision loss
  • Risk of new and worsening vision loss continues as long as SABRIL is used, and possibly after discontinuing SABRIL
  • Unless a patient is formally exempted, periodic vision assessment is required for patients on SABRIL. However, this assessment cannot always prevent vision damage.
  • SABRIL can cause permanent vision loss. SABRIL is available only through a restricted program called the SHARE Program.
  • SABRIL causes permanent bilateral concentric visual field constriction. Because assessing vision may be difficult in infants and children, the frequency and extent of vision loss in pediatric patients are poorly characterized. In adults, 30% or more of patients can be affected, ranging in severity from mild to severe, including tunnel vision to within 10° of visual fixation, and can result in disability. SABRIL can also damage the central retina and may decrease visual acuity.
  • The onset of vision loss is unpredictable and can occur soon after starting treatment, at any time during treatment, even after months or years, or possibly after discontinuation. Symptoms of vision loss from SABRIL are unlikely to be recognized by patients or caregivers before it is severe. Vision loss of milder severity may still adversely affect function.
  • Unless a patient is formally exempted from periodic ophthalmologic assessment as documented in the SHARE Program, vision should be assessed at baseline (no later than 4 weeks after starting SABRIL), every 3 months during therapy, and at 3 to 6 months after discontinuing therapy. Once detected, vision loss is not reversible. Even with frequent monitoring, some patients will develop severe vision loss. Consider drug discontinuation, balancing benefit and risk, if vision loss is documented.
  • Because of the risk of permanent vision loss, withdraw SABRIL from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation, and from patients with infantile spasms who fail to show substantial clinical benefit within 2 to 4 weeks of initiation, or sooner, if treatment failure becomes obvious. Periodically reassess patient response and continued need for SABRIL.
  • Do not use SABRIL in patients with, or at high risk of, other types of irreversible vision loss, or, with other drugs associated with serious adverse ophthalmic effects, unless the benefits clearly outweigh the risks. The interaction in these situations has not been well characterized, but is likely adverse.
  • Use the lowest dose and shortest exposure to SABRIL that is consistent with clinical objectives. Adjust the dose in patients with renal impairment.
  • Abnormal magnetic resonance imaging (MRI) signal changes have been observed in some infants treated for IS with SABRIL. These changes generally resolved with discontinuation of treatment, and resolved in a few patients despite continued use.
  • Antiepileptic drugs (AEDs), including SABRIL, increase the risk of suicidal thoughts and behavior. Monitor appropriate patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • As with all AEDs, discontinue SABRIL gradually to avoid withdrawal seizures.
  • SABRIL can cause anemia, peripheral neuropathy, weight gain, and edema. SABRIL can cause somnolence and fatigue. Advise patients not to drive or operate machinery until they know how it will affect them.
  • Vigabatrin is excreted in human milk and may cause serious adverse events in nursing infants. Do not use SABRIL during pregnancy unless the potential benefit justifies the potential risk to the fetus. Pregnancy Registry: To provide information regarding the effects of in utero exposure to SABRIL, physicians should recommend that pregnant patients taking SABRIL enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Patients must call the toll-free number 1-888-233-2334 to enroll. Registry information can be found at http://www.aedpregnancyregistry.org/.
  • The most common adverse reactions in controlled studies (≥5% over placebo) include:
    • Adults >16 years of age: fatigue, somnolence, nystagmus, tremor, blurred vision, memory impairment, weight gain, arthralgia, abnormal coordination, and confusional state
    • Pediatrics 10 to 16 years of age: increased weight, upper respiratory tract infection, tremor, fatigue, aggression, and diplopia
  • In infants, the most common adverse reactions in a controlled clinical study (incidence >5%) were somnolence, bronchitis, ear infection, and acute otitis media.

Please see SABRIL full Prescribing Information including Boxed Warning, Medication Guide, and Instructions for Use; or call toll-free 1-888-45-SHARE (1-888-457-4273).

Para más información, vea por favor la información que prescribe completa incluyendo la advertencia encajonada, guía de la medicación y las instrucciones de uso.

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.