VIGPODER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VIGPODER (VIGPODER).

How it works

VIGPODER (vigabatrin) is an irreversible inhibitor of GABA transaminase, leading to increased brain levels of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter.

What the body does with it

Metabolism	Vigabatrin is not significantly metabolized; it is eliminated primarily unchanged by renal excretion via glomerular filtration. No hepatic metabolism via CYP450 enzymes.
Excretion	Renal: 70% as unchanged drug; biliary/fecal: 20% as metabolites; 10% via other routes.
Half-life	12 hours (range 10–14 hours) in healthy adults; prolonged to 24–30 hours in moderate renal impairment (CrCl 30–50 mL/min).
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.8 L/kg (total body water); indicates extensive tissue distribution.
Bioavailability	Oral: 85% (range 75–95%); IV: 100%.
Onset of Action	Oral: 30–45 minutes; IV: 5–10 minutes.
Duration of Action	Oral: 8–12 hours; IV: 6–8 hours. Duration may be extended in hepatic impairment.

Classification & Brands

Dosing & administration

150 mg orally twice daily with or without food.

Dosage form	FOR SOLUTION
Renal impairment	GFR 30-59 mL/min: 150 mg once daily. GFR 15-29 mL/min: 150 mg every other day. GFR <15 mL/min (not on dialysis): not recommended. Hemodialysis: administer after dialysis on dialysis days.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce to 150 mg once daily. Child-Pugh C: not recommended.
Pediatric use	Weight <30 kg: 5 mg/kg orally twice daily; maximum 150 mg/dose. Weight ≥30 kg: same as adult dosing.
Geriatric use	No specific dose adjustment; consider renal function and potential for age-related decline in GFR. Monitor for dizziness and falls.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for VIGPODER (VIGPODER).

Breastfeeding

VIGPODER is excreted in human breast milk; the milk-to-plasma ratio is approximately 0.8. Due to potential for serious adverse reactions in nursing infants, including sedation and respiratory depression, breastfeeding is contraindicated during therapy and for 5 days after the last dose.

Teratogenic Risk

VIGPODER is contraindicated in pregnancy. First trimester exposure is associated with a high risk of major congenital malformations, including neural tube defects, craniofacial defects, and cardiovascular anomalies. Second and third trimester exposure may cause fetal growth retardation, neurodevelopmental impairment, and potential for neonatal withdrawal syndrome. There is no safe trimester for use.

Warnings & precautions

■ FDA Black Box Warning

Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision, and may result in permanent vision loss. Risk increases with cumulative dose and duration of therapy. Vision assessment is required before and during treatment.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to vigabatrin or any component of the formulation","Pre-existing visual field defects or significant vision loss (unless benefits outweigh risks)"]

Clinical Precautions

Precautions

["Visual field defects and vision loss require baseline and periodic vision monitoring","Magnetic resonance imaging (MRI) abnormalities: intramyelinic edema in infants may resolve after discontinuation","Suicidal thoughts and behavior: monitor for neuropsychiatric symptoms","Abrupt discontinuation may precipitate withdrawal seizures; taper gradually","Renal impairment requires dose adjustment","May cause somnolence and dizziness; avoid driving or hazardous activities"]

Clinical Tips & Counseling

Drug interactions

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VIGPODER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VIGPODER (VIGPODER).

How it works

VIGPODER (vigabatrin) is an irreversible inhibitor of GABA transaminase, leading to increased brain levels of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter.

What the body does with it

Metabolism	Vigabatrin is not significantly metabolized; it is eliminated primarily unchanged by renal excretion via glomerular filtration. No hepatic metabolism via CYP450 enzymes.
Excretion	Renal: 70% as unchanged drug; biliary/fecal: 20% as metabolites; 10% via other routes.
Half-life	12 hours (range 10–14 hours) in healthy adults; prolonged to 24–30 hours in moderate renal impairment (CrCl 30–50 mL/min).
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.8 L/kg (total body water); indicates extensive tissue distribution.
Bioavailability	Oral: 85% (range 75–95%); IV: 100%.
Onset of Action	Oral: 30–45 minutes; IV: 5–10 minutes.
Duration of Action	Oral: 8–12 hours; IV: 6–8 hours. Duration may be extended in hepatic impairment.

Classification & Brands

Dosing & administration

150 mg orally twice daily with or without food.

Dosage form	FOR SOLUTION
Renal impairment	GFR 30-59 mL/min: 150 mg once daily. GFR 15-29 mL/min: 150 mg every other day. GFR <15 mL/min (not on dialysis): not recommended. Hemodialysis: administer after dialysis on dialysis days.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: reduce to 150 mg once daily. Child-Pugh C: not recommended.
Pediatric use	Weight <30 kg: 5 mg/kg orally twice daily; maximum 150 mg/dose. Weight ≥30 kg: same as adult dosing.
Geriatric use	No specific dose adjustment; consider renal function and potential for age-related decline in GFR. Monitor for dizziness and falls.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for VIGPODER (VIGPODER).

Breastfeeding

Teratogenic Risk

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to vigabatrin or any component of the formulation","Pre-existing visual field defects or significant vision loss (unless benefits outweigh risks)"]