REMS restricted

Vigabatrin

SABRIL

Open Vigabatrin in the interactive console ↗

Pronunciation: vye-GA-ba-trin (SAY-bril)

Vigabatrin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Vigabatrin ballicule

Vigabatrin SABRIL mascot mnemonic cartoon — Visual mnemonic: Vigabatrin mascot
**“Violent GABA Sabre!”**
Viga → “Vision Gone” - concentric peripheral visual field deficits
GABA transaminase inhibitor with GABA in its name
¡Viva GABA!

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.

Vigabatrin molecular structure (skeletal formula) — Molecular structure: Vigabatrin

FDA-approved for

infantile spasms (2009)
refractory complex partial seizures (2009)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Permanent bilateral concentric visual field constriction (including tunnel vision, can cause disability); may reduce visual acuity

FDA dosing	Population	Start	Target	Max
Refractory complex partial seizures	adult (≥17y)	1000 mg/day (500 mg BID)	3000 mg/day (1500 mg BID)	3000 mg/day
Refractory complex partial seizures	pediatric 2-16y	weight-based, divided BID	weight-based (adult dosing if >60 kg)	weight-based
Infantile spasms	pediatric	50 mg/kg/day (25 mg/kg BID)	titrate per response	150 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

Give orally with or without food
Taper gradually on discontinuation to avoid withdrawal seizures

Available strengths

tab 500 mg
sol 100 mg/mL
sol 500 mg/packet

Cautions

Permanent vision loss
MRI abnormalities / intramyelinic edema in infants
Suicidal behavior and ideation
Withdrawal seizures (taper)
Anemia
Somnolence and fatigue
Peripheral neuropathy
Weight gain
Edema

Adverse reactions

Vision loss
Somnolence
Fatigue
Weight gain
Edema
Peripheral neuropathy
Anemia

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

Lactation Vigabatrin is excreted in human milk

Cost

Vigabatrin (SABRIL)

Strength		#/mo	CostPlus
500 mg	tab	60 BID	not offered
100 mg/mL	sol	per unit	not offered
500 mg/packet	sol	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Vigabatrin is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2017

⚠ BOXED WARNING

Permanent vision loss

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.

Open Vigabatrin in the interactive console ↗

Memory aids: interaction avatars

no kinetic interactions

Open Vigabatrin in the interactive console ↗