Miplyffa

Adult Dosing .

Dosage forms:  CAP: 47 mg, 62 mg, 93 mg, 124 mg

Niemann-Pick disease, type C

[31-55 kg]

Dose: 93 mg PO tid; Info: give with miglustat

[>56 kg]

Dose: 124 mg PO tid; Info: give with miglustat

renal dosing

[31-55 kg]

eGFR 15-49: 93 mg bid; eGFR <15: not defined

HD/PD: not defined

[>56 kg]

eGFR 15-49: 124 mg bid; eGFR <15: not defined

HD/PD: not defined

hepatic dosing

[see below]

Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined

Peds Dosing .

Dosage forms:  CAP: 47 mg, 62 mg, 93 mg, 124 mg

Niemann-Pick disease, type C

[2 yo and older, 8-15 kg]

Dose: 47 mg PO tid; Info: give with miglustat

[2 yo and older, 16-30 kg]

Dose: 62 mg PO tid; Info: give with miglustat

[2 yo and older, 31-55 kg]

Dose: 93 mg PO tid; Info: give with miglustat

[2 yo and older, >56 kg]

Dose: 124 mg PO tid; Info: give with miglustat

renal dosing

[8-15 kg]

eGFR 15-49: 47 mg bid; eGFR <15: not defined

HD/PD: not defined

[16-30 kg]

eGFR 15-49: 62 mg bid; eGFR <15: not defined

HD/PD: not defined

[31-55 kg]

eGFR 15-49: 93 mg bid; eGFR <15: not defined

HD/PD: not defined

[>56 kg]

eGFR 15-49: 124 mg bid; eGFR <15: not defined

HD/PD: not defined

hepatic dosing

[see below]

Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined