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SABRIL

VIGABATRIN

Manufacturer: Lundbeck Pharmaceuticals LLC

Score: 144.0

Quick Summary

Vigabatrin is an oral antiepileptic drug used for the treatment of refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older, and as monotherapy for infantile spasms in pediatric patients 1 month to 2 years of age. The drug works by irreversibly inhibiting the enzyme gamma-aminobutyric acid transaminase (GABA-T), leading to increased levels of the inhibitory neurotransmitter GABA in the central nervous system. However, vigabatrin can cause permanent vision loss, and its use requires careful consideration of the benefits and risks. The recommended dosage varies based on age, weight, and indication, and dose adjustments are necessary for patients with renal impairment.

Key Clinical Findings and Indications

  • Refractory complex partial seizures as adjunctive therapy in patients 2 years of age and older
  • Infantile spasms as monotherapy in pediatric patients 1 month to 2 years of age

Important Safety Information

Warning

Vigabatrin can cause permanent vision loss, including bilateral concentric visual field constriction and decreased visual acuity

Contraindications

Adverse Reactions

  • Somnolence
  • Fatigue
  • Dizziness
  • Abnormal coordination
  • Tremor
  • Nystagmus
  • Blurred vision
  • Diplopia
  • Weight gain

Dosing Recommendations

General Guidance

Dose adjustments are necessary for patients with renal impairment, with decreases of 25% for mild impairment, 50% for moderate impairment, and 75% for severe impairment

Refractory complex partial seizures

Adult Dose

1000 mg/day (500 mg twice daily), increased weekly by 500 mg increments to a maximum of 3000 mg/day (1500 mg twice daily)

Pediatric Dose

Based on body weight, administered as two divided doses

Infantile spasms

Adult Dose

Not applicable

Pediatric Dose

50 mg/kg/day (25 mg/kg twice daily), increased every 3 days by 25 mg/kg/day to 50 mg/kg/day increments to a maximum of 150 mg/kg/day (75 mg/kg twice daily)

Special Population Considerations

Pregnancy

  • Vigabatrin can cause fetal harm, and its use during pregnancy should be carefully considered

Nursing Mothers

  • Vigabatrin is excreted in human milk, and breastfeeding is not recommended due to the potential for serious adverse reactions in nursing infants

Pediatric Use

  • The safety and effectiveness of vigabatrin have been established in pediatric patients 2 years of age and older with refractory complex partial seizures, and in pediatric patients 1 month to 2 years of age with infantile spasms

Geriatric Use

  • Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they responded differently from younger patients, and dose adjustments may be necessary due to decreased renal function