Prescribing Sabril for Your Patients

Sabril (vigabatrin) causes permanent vision loss in infants, children, and adults. Because assessing vision may be difficult in infants and children, the frequency and extent of vision loss in pediatric patients are poorly characterized. For this reason, the data described below are primarily based on the adult experience.

In adults, Sabril causes permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability. In some cases, Sabril can also damage the central retina and may decrease visual acuity.

Because of the risk of permanent vision loss, Sabril is available only through SHARE (Support, Help, And Resources for Epilepsy), a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS). Physicians must be certified with SHARE to begin prescribing Sabril for their patients. Learn more about how SHARE supports the Sabril prescribing process below:

  • Attestation and Registration

    Review the full Prescribing Information and Medication Guide

    Review and sign Prescriber Enrollment and Agreement Form

    • Nurse practitioners and physician assistants check the "Other" box under Prescriber Degree
    • Fax to SHARE Call Center at 1-877-742-1002

    By faxing the form to the SHARE Call Center, you will be registered to prescribe Sabril

    • A confirmation will be sent from the SHARE Call Center, at which time you can begin prescribing Sabril

    A Sabril patient Starter Kit will be sent to you from the SHARE Call Center. Additional kits will be provided by your Sabril Account Manager or can be requested from the SHARE Call Center at 1-888-45-SHARE

    GOOD TO KNOW
    • To begin prescribing Sabril (vigabatrin), you must review and sign the Prescriber Enrollment and Agreement Form and fax it to the SHARE Call Center at 1-877-742-1002
    • A confirmation will be sent from the SHARE Call Center, at which time you can begin prescribing Sabril
  • Education and Prescription Initiation

    Review the Medication Guide with patients/parents/legal guardians

    • Discuss potential benefits of seizure reduction and serious risks associated with Sabril, including permanent vision loss
    • For patients receiving Sabril Powder for Oral Solution, review the Instructions for Use and confirm that patient/caregiver understands how to reconstitute Sabril Powder for Oral Solution and administer the correct dosage

    You and the patient, parent, or legal guardian review and sign the agreement form

    • Fax the form to the SHARE Call Center at 1-877-742-1002
    • Place the original form in the patient’s medical record and provide a copy to the patient, parent, or legal guardian

    Complete Treatment Initiation Form and fax all three pages to the SHARE Call Center at 1-877-742-1002

    • This serves as the prescription for Sabril

    For the Spanish translation of the patient/parent/legal guardian treatment authorization paragraph located on the first page of the Treatment Initiation Form, please click here

    GOOD TO KNOW
  • Visual Assessment

    The prescriber or consulting ophthalmic professional* must complete an Ophthalmologic Assessment Form following the baseline visual assessment. The prescriber must sign the form.

    • Fax the form to the SHARE Call Center at 1-877-742-1002
    Assessment Schedule for All Patients
    Baseline Obtained at treatment initiation – no more than 4 weeks after starting Sabril
    Maintenance At least every 3 months while on therapy
    Discontinuation About 3 to 6 months after discontinuation of therapy

    The SHARE Call Center will remind patients to obtain visual assessments.

    Unless a patient is formally exempted from periodic ophthalmologic assessment as documented in the SHARE program, vision assessment is required at baseline (no later than 4 weeks after starting Sabril), at least every 3 months while on therapy and about 3-6 months after the discontinuation of Sabril therapy. Once detected, vision loss is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Drug discontinuation should be considered, balancing benefit and risk, if visual loss is documented.

    The diagnostic approach should be individualized according to each patient and/or clinical situation.

    Although attempts should be made to assess visual acuity and visual fields, no specific tests are required.

    In infants and children, vision loss may not be detected until it is severe.

    For patients formally exempted from visual assessment due to blindness or an irreversible neurological condition, subsequent forms are not required to be submitted.

    * With expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina.

    GOOD TO KNOW
    • An Ophthalmologic Assessment Form must be completed no more than 4 weeks after starting Sabril (vigabatrin)
    • Fax the completed form to the SHARE Call Center at 1-877-742-1002
  • Evaluation Phase and Benefit-risk Assessment

    Because of the risk of permanent vision loss, Sabril should be withdrawn from patients who fail to show substantial clinical benefit. Therefore, an evaluation of the potential benefits and risk of permanent vision loss associated with Sabril treatment is to be done for:

    • Patients 10 years of age and older: within 3 months or sooner
    • Pediatric patients 1 month to 2 years of age: within 2 to 4 weeks or sooner

    If therapy is continued:

    1. You sign the Treatment Maintenance Form and fax it to the SHARE Call Center at 1-877-742-1002
      • This form is only completed once after the initial evaluation
    2. You must complete an Ophthalmologic Assessment Form following every assessment and fax it to the SHARE Call Center at 1-877-742-1002
      • Refer patients for visual assessments at appropriate intervals
      • Complete and fax an Ophthalmologic Assessment Form following every assessment
      • Conduct ongoing benefit-risk assessments
    GOOD TO KNOW

    Following evaluation, to continue treatment with Sabril:

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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.

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.