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Fintepla
fenfluramine
Black Box Warnings .
Appropriate Use
avail. only through restricted program (Fintepla REMS) due to risk of valvular heart dz and pulmonary arterial HTN; prescribers, pts, and pharmacies must enroll at 1-877-964-3649 or www.FinteplaREMS.com
Valvular Heart Dz and Pulmonary Arterial HTN
association between serotonergic drugs w/ 5-HT2B receptor agonist activity, incl. fenfluramine, and valvular heart dz and pulmonary arterial HTN; echocardiogram required before, during, and after tx; weigh risk vs. benefit of initiating or continuing tx based on echocardiogram
Adult Dosing .
Dosage forms: SOL: 2.2 mg per mL
Restricted Distribution in US
- [1-877-964-3649 or www.FinteplaREMS.com for more info]
seizures, Dravet syndrome
- [w/o stiripentol]
- Dose: 0.1-0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.2 mg/kg/dose PO bid x7 days, then may incr. to 0.35 mg/kg/dose PO bid; Max: 0.35 mg/kg/dose, 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam]
- Dose: 0.1-0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.15 mg/kg/dose PO bid x7 days, then may incr. to 0.2 mg/kg/dose PO bid; Max: 0.2 mg/kg/dose, 17 mg/day; Info: taper dose gradually to D/C
seizures, Lennox-Gastaut syndrome
- [w/o stiripentol]
- Dose: 0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.2 mg/kg/dose PO bid x7 days, then incr. to 0.35 mg/kg/dose PO bid; Max: 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam]
- Dose: 0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.15 mg/kg/dose PO bid x7 days, then incr. to 0.2 mg/kg/dose PO bid; Max: 17 mg/day; Info: taper dose gradually to D/C
renal dosing
- [w/o stiripentol]
- eGFR 15-29: max 20 mg/day; eGFR <15: not defined
- HD/PD: not defined
- [w/ stiripentol and clobazam]
- eGFR 15-29: max 17 mg/day; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [w/o stiripentol]
- Child-Pugh Class A or B: max 20 mg/day; Child-Pugh Class C: max 17 mg/day
- [w/ stiripentol and clobazam]
- Child-Pugh Class A: max 13 mg/day; Child-Pugh Class B or C: avoid use
Peds Dosing .
- Dosage forms: SOL: 2.2 mg per mL
Restricted Distribution in US
- [1-877-964-3649 or www.FinteplaREMS.com for more info]
seizures, Dravet syndrome
- [w/o stiripentol, 2 yo and older]
- Dose: 0.1-0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.2 mg/kg/dose PO bid x7 days, then may incr. to 0.35 mg/kg/dose PO bid; Max: 0.35 mg/kg/dose, 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam, 2 yo and older]
- Dose: 0.1-0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then may incr. to 0.15 mg/kg/dose PO bid x7 days, then may incr. to 0.2 mg/kg/dose PO bid; Max: 0.2 mg/kg/dose, 17 mg/day; Info: taper dose gradually to D/C
seizures, Lennox-Gastaut syndrome
- [w/o stiripentol, 2 yo and older]
- Dose: 0.35 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.2 mg/kg/dose PO bid x7 days, then incr. to 0.35 mg/kg/dose PO bid; Max: 26 mg/day; Info: may incr. dose q4 days if more rapid titration needed; taper dose gradually to D/C
- [w/ stiripentol and clobazam, 2 yo and older]
- Dose: 0.2 mg/kg/dose PO bid; Start: 0.1 mg/kg/dose PO bid x6 days, then incr. to 0.15 mg/kg/dose PO bid x7 days, then incr. to 0.2 mg/kg/dose PO bid; Max: 17 mg/day; Info: taper dose gradually to D/C
renal dosing
- [w/o stiripentol]
- eGFR 15-29: max 20 mg/day; eGFR <15: not defined
- HD/PD: not defined
- [w/ stiripentol and clobazam]
- eGFR 15-29: max 17 mg/day; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [w/o stiripentol]
- Child-Pugh Class A or B: max 20 mg/day; Child-Pugh Class C: max 17 mg/day
- [w/ stiripentol and clobazam]
- Child-Pugh Class A: max 13 mg/day; Child-Pugh Class B or C: avoid use