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REMS restricted

Vigabatrin

SABRIL

What it isIrreversible GABA transaminase inhibitor; infantile spasms and refractory focal seizures.

Why this oneIt is uniquely effective in the infantile spasms of tuberous sclerosis.

What limits it⚑ Permanent bilateral visual field loss in a third of patients, under a REMS with periodic perimetry. The benefit must be weighed against certain vision monitoring.

FDA-approved for

FDA label

BOXED WARNING Permanent bilateral concentric visual field constriction (including tunnel vision, can cause disability); may reduce visual acuity
FDA dosingPopulationStartTargetMax
Refractory complex partial seizuresadult (≥17y)1000 mg/day (500 mg BID)3000 mg/day (1500 mg BID)3000 mg/day
Refractory complex partial seizurespediatric 2-16yweight-based, divided BIDweight-based (adult dosing if >60 kg)weight-based
Infantile spasmspediatric50 mg/kg/day (25 mg/kg BID)titrate per response150 mg/kg/day (75 mg/kg BID)

Titration CPS adults: increase weekly in 500 mg/day increments; infantile spasms: increase every 3 days

Renal Reduce dose: mild (CLcr >50-80) −25%, moderate (>30-50) −50%, severe (>10-30) −75%

Hepatic Undefined

Instructions

Cautions

Adverse reactions

Pregnancy May cause fetal harm (animal data); enroll in NAAED pregnancy registry

Lactation Vigabatrin is excreted in human milk

⚠ BOXED WARNING

Cost, est. cash$10–$500/month

Generic entry2017

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4
Overdose danger2 / 4
Weight-gain liability2 / 4
Sedation liability1 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilityPermanent concentric visual-field loss requires structured ophthalmic monitoring.

Mechanism of action: Vigabatrin ballicule

Vigabatrin ballicule: receptor binding, kinetics and half-life diagram

Open Vigabatrin in the interactive console ↗

Memory aids: mascots and interaction avatars

Vigabatrin SABRIL mascot mnemonic cartoon
“Violent GABA Sabre!”
Viga → “Vision Gone” - concentric peripheral visual field deficits
GABA transaminase inhibitor with GABA in its name
¡Viva GABA!
Vigabatrin no kinetic interactions avatar
no kinetic interactions

Open Vigabatrin in the interactive console ↗