VIGABATRIN
Vigabatrin is an anti-epileptic agent indicated for the treatment of refractory complex partial seizures and infantile spasms. It is used as an adjunctive therapy for patients two years of age and older with complex partial seizures who have responded inadequately to several alternative treatments. For pediatric patients aged one month to two years, the drug is indicated as monotherapy for the treatment of infantile spasms. Because of the potential risk of vision loss, vigabatrin is not indicated as a first-line agent for complex partial seizures.
How VIGABATRIN Works
Vigabatrin acts as an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for metabolizing the inhibitory neurotransmitter GABA. By blocking this enzyme, the drug increases the levels of GABA within the central nervous system to produce anti-seizure effects. The duration of the drug's clinical effect depends on the rate of enzyme re-synthesis rather than the rate at which the drug is eliminated from the body.
Details
- Status
- Prescription
- First Approved
- 2017-04-27
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION, TABLET
Companies
VIGABATRIN Approval History
What VIGABATRIN Treats
2 indicationsVIGABATRIN is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complex Partial Seizures
- Infantile Spasms
VIGABATRIN Boxed Warning
PERMANENT VISION LOSS Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity [see Warnings and Precautions (5.1) ] . The onset of vision loss from vigabatrin 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 ...
WARNING: PERMANENT VISION LOSS Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity [see Warnings and Precautions (5.1) ] . The onset of vision loss from vigabatrin 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 vigabatrin 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 vigabatrin), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to vigabatrin 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 vigabatrin is used. It is possible that vision loss can worsen despite discontinuation of vigabatrin. Because of the risk of vision loss, vigabatrin should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2 to 4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious. Patient response to and continued need for vigabatrin should be periodically reassessed. Vigabatrin should not be used in patients with, or at high risk of, other types of irreversib
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VIGABATRIN FDA Label Details
ProIndications & Usage
Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; vigabatrin tablets are not indicated as a first line agent Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory compl...
WARNING: PERMANENT VISION LOSS Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity [see Warnings and Precautions (5.1) ] . The...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.