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Sabril
vigabatrin
Black Box Warnings .
Appropriate Use
restricted distribution program due to risk of permanent vision loss; pts, 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, incl. tunnel vision resulting in disability; central retina damage may occur and lead to decr. visual acuity; due to difficulty w/ vision assessment in peds pts, extent of vision loss is poorly characterized in these pts; unknown if vision loss in peds pts is more common or severe than in adult pts; onset unpredictable, risk continues after vigabatrin D/C; pts and caregivers unlikely to notice sx until severe; risk incr. w/ total dose, duration of use but no risk-free dose or exposure level known; vision testing recommended at baseline (w/in 4wk of tx start), at least q3mo during tx, and 3-6mo after D/C tx, though severe vision loss may still occur even w/ frequent monitoring; vision loss is irreversible and can worsen despite D/C tx; D/C if no clinical response w/in 3 mo of tx start in partial seizure pts or w/in 2-4wk of tx start in infantile spasm pts; periodically reassess pt response and need for tx; avoid use in pts w/ vision loss or risk factors unless benefits outweigh risks; avoid use w/ other drugs assoc. w/ serious ophthalmic adverse effects incl. retinopathy or glaucoma unless benefits outweigh risks; use lowest effective dose, shortest effective tx duration
Adult Dosing .
Dosage forms: TAB: 500 mg; PWDR: 500 mg per pkt
Restricted Distribution in US
- [1-866-244-8175 or www.vigabatrinREMS.com for more info]
refractory complex partial seizures, adjunct tx
- [1500 mg PO bid]
- Start: 500 mg PO bid, may incr. by 500 mg/day qwk; Info: consider decr. dose or frequency in elderly pts; periodically reassess need for tx; D/C if no response w/in 3mo; taper dose by 1000 mg/day qwk to D/C
renal dosing
- [adjust dose amount]
- CrCl 51-80: decr. usual dose by 25%; CrCl 31-50: decr. usual dose by 50%; CrCl 11-30: decr. usual dose by 75%; CrCl <11: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: TAB: 500 mg; PWDR: 500 mg per pkt
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 divided bid; Start: 50 mg/kg/day PO 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 w/in 2-4wk; taper dose by 25-50 mg/kg/day q3-4 days to D/C
refractory complex partial seizures, adjunct tx
- [2-16 yo, 10-15 kg]
- Dose: 525 mg PO bid; Start: 175 mg PO bid, may incr. dose qwk; Info: periodically reassess need for tx; D/C if no response w/in 3mo; taper daily dose by 1/3 qwk to D/C
- [2-16 yo, 15.1-20 kg]
- Dose: 650 mg PO bid; Start: 225 mg PO bid, may incr. dose qwk; Info: periodically reassess need for tx; D/C if no response w/in 3mo; taper daily dose by 1/3 qwk to D/C
- [2-16 yo, 20.1-25 kg]
- Dose: 750 mg PO bid; Start: 250 mg PO bid, may incr. dose qwk; Info: periodically reassess need for tx; D/C if no response w/in 3mo; taper daily dose by 1/3 qwk to D/C
- [2-16 yo, 25.1-60 kg]
- Dose: 1000 mg PO bid; Start: 250 mg PO bid, may incr. dose qwk; Info: periodically reassess need for tx; D/C if no response w/in 3mo; taper daily dose by 1/3 qwk to D/C
- [2-16 yo, >61 kg]
- Dose: 1500 mg PO bid; Start: 500 mg PO bid, may incr. by 500 mg/day qwk; Info: periodically reassess need for tx; D/C if no response w/in 3mo; taper dose by 1000 mg/day qwk to D/C
- [17 yo and older]
- Dose: 1500 mg PO bid; Start: 500 mg PO bid, may incr. by 500 mg/day qwk; Info: periodically reassess need for tx; D/C if no response w/in 3mo; taper dose by 1000 mg/day qwk to D/C
renal dosing
- [<2 yo]
- renal impairment: not defined
- HD/PD: not defined
- [2 yo and older]
- CrCl 51-80: decr. usual dose by 25%; CrCl 31-50: decr. usual dose by 50%; CrCl 11-30: decr. usual dose by 75%; CrCl <11: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]