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Sabril®
(vigabatrin) Tablets

For Oral Administration Only.

WARNING: VISION LOSS

  • SABRIL (vigabatrin oral solution) 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 (vigabatrin oral solution) also can damage the central retina and may decrease visual acuity.
  • The onset of vision loss from SABRIL (vigabatrin oral solution) is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years
  • 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 testing at baseline (no later than 4 weeks after starting SABRIL (vigabatrin oral solution) ) and at least every 3 months during therapy is required for adults on SABRIL (vigabatrin oral solution) . Vision testing is also required about 3 to 6 months after the discontinuation of SABRIL (vigabatrin oral solution) therapy. Once detected, vision loss due to SABRIL (vigabatrin oral solution) is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.
  • It is possible that vision loss can worsen despite discontinuation of SABRIL (vigabatrin oral solution)
  • Because of the risk of vision loss, SABRIL (vigabatrin oral solution) should be withdrawn from patients who fail to show substantial clinical benefit within 3 months of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for SABRIL (vigabatrin oral solution) should be periodically reassessed.
  • Symptoms of vision loss from SABRIL (vigabatrin oral solution) 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, can still adversely affect function.
  • SABRIL (vigabatrin oral solution) 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. The interaction of other types of irreversible vision damage with vision damage from SABRIL (vigabatrin oral solution) has not been well-characterized, but is likely adverse.
  • SABRIL (vigabatrin oral solution) should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks
  • The lowest dose and shortest exposure to SABRIL (vigabatrin oral solution) should be used that is consistent with clinical objectives

Because of the risk of permanent vision loss, SABRIL (vigabatrin oral solution) is available only through a special restricted distribution program called SHARE, by calling 1-888-45-SHARE. Only prescribers and pharmacies registered with SHARE may prescribe and distribute SABRIL (vigabatrin oral solution) . In addition, SABRIL (vigabatrin oral solution) may be dispensed only to patients who are enrolled in and meet all conditions of SHARE [see WARNINGS AND PRECAUTIONS, Distribution Program for SABRIL (vigabatrin oral solution) ].

DRUG DESCRIPTION

Table 3. Description

Proprietary Name: SABRIL®
Established Name: Vigabatrin Tablet
Dosage Form: White, film-coated tablet
Route of Administration: Oral
Pharmacologic Class of Drug: Antiepileptic
Chemical Name: (±) 4-amino-5-hexenoic acid

Structural Formula:

Sabril®
  (vigabatrin) Structural Formula Illustration

SABRIL (vigabatrin) is available as a white, film-coated tablet for oral administration. Each tablet contains 500 mg vigabatrin. Tablets also contain as inactive ingredients: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide. Vigabatrin is an oral antiepileptic drug with the chemical name (±) 4-amino-5-hexenoic acid. It is a racemate consisting of two enantiomers. The molecular formula is C6H11NO2 and the molecular weight is 129.16.

Vigabatrin is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log P=-1.96) at physiologic pH. Vigabatrin melts with decomposition in a 3-degree range within the temperature interval of 171°C to 176°C. The dissociation constants (pKa) of vigabatrin are 4 and 9.7 at room temperature (25°C).

What are the possible side effects of vigabatrin (Sabril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • any change in your vision, no matter how mild;
  • back and forth eye movements you cannot control;
  • tremors;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • worsening seizures; or
  • confusion, mood or behavior changes, depression, thoughts about suicide or hurting...

Read All Potential Side Effects and See Pictures of Sabril »

Last reviewed on RxList: 3/7/2011
This monograph has been modified to include the generic and brand name in many instances.