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Vigafyde
vigabatrin
Black Box Warnings .
Appropriate Use
restricted distribution program due to risk of permanent vision loss; patients, prescribers, and pharmacies must enroll at 1-866-244-8175 or www.vigabatrinREMS.com
Permanent Vision Loss
progressive and permanent bilateral concentric visual field constriction may occur, including tunnel vision resulting in disability; central retina damage may occur and lead to decr. visual acuity; due to difficulty with vision assessment in peds patients, extent of vision loss is poorly characterized in these patients; unknown if vision loss in peds patients is more common or severe than in adult patients; onset unpredictable, risk continues after vigabatrin D/C; patients and caregivers unlikely to notice symptoms until severe; risk incr. with total dose, duration of use but no risk-free dose or exposure level known; vision testing recommended at baseline (within 4wk of tx start), at least q3mo during tx, and 3-6mo after D/C tx, though severe vision loss may still occur even with frequent monitoring; vision loss is irreversible and can worsen despite D/C tx; D/C if no clinical response within 3 mo of tx start in partial seizure patients or within 2-4wk of tx start in infantile spasm patients; periodically reassess patient response and need for tx; avoid use in patients with vision loss or risk factors unless benefits outweigh risks; avoid use with other drugs associated with serious ophthalmic adverse effects including retinopathy or glaucoma unless benefits outweigh risks; use lowest effective dose, shortest effective tx duration
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: SOLUTION: 100 mg per mL
Restricted Distribution in US
- [1-866-244-8175 or www.vigabatrinREMS.com for more info]
infantile spasms
- [1 mo-2 yo]
- Dose: 50-150 mg/kg/day PO/GT/GJ divided bid; Start: 50 mg/kg/day PO/GT/GJ divided bid, may incr. by 25-50 mg/kg/day q3 days; Max: 150 mg/kg/day; Info: periodically reassess need for tx; D/C if no response within 2-4wk; taper dose by 25-50 mg/kg/day q3-4 days to D/C
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]