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Xenpozyme (olipudase alfa-rpcp)
olipudase alfa
Black Box Warnings .
Severe Hypersensitivity Reaction
severe reactions including anaphylaxis have occurred; administer where appropriate medical support including cardiopulmonary resuscitation equipment available; D/C immediately and start appropriate tx if severe reaction occurs; may consider desensitization procedure in patients with severe reaction
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = olipudase alfa-rpcp
acid sphingomyelinase deficiency
- [dose escalation phase]
- Dose: 0.1 mg/kg/dose IV x1 on wk 0, then 0.3 mg/kg/dose IV x1 on wk 2, 4, then 0.6 mg/kg/dose IV x1 on wk 6, 8, then 1 mg/kg/dose IV x1 on wk 10, then 2 mg/kg/dose IV x1 on wk 12, then 3 mg/kg/dose IV x1 on wk 14; Info: for non-CNS manifestations; consider premed with antipyretic, antihistamine, corticosteroids; use adjusted wt of [30 kg/m^2 x (height in meters)^2] if BMI >30 kg/m^2; see pkg insert for toxicity-related dose adjustments and missed dose recommendations
- [maintenance phase]
- Dose: 3 mg/kg/dose IV q2wk; Start: 2 wk after dose escalation phase complete; Info: for non-CNS manifestations; consider premed with antipyretic, antihistamine, corticosteroids; use adjusted wt of [30 kg/m^2 x (height in meters)^2] if BMI >30 kg/m^2; see pkg insert for toxicity-related dose adjustments and missed dose recommendations
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = olipudase alfa-rpcp
acid sphingomyelinase deficiency
- [dose escalation phase]
- Dose: 0.1 mg/kg/dose IV x1 on wk 0, then 0.3 mg/kg/dose IV x1 on wk 2, 4, then 0.6 mg/kg/dose IV x1 on wk 6, 8, then 1 mg/kg/dose IV x1 on wk 10, then 2 mg/kg/dose IV x1 on wk 12, then 3 mg/kg/dose IV x1 on wk 14; Info: for non-CNS manifestations; consider premed with antipyretic, antihistamine, corticosteroids; use adjusted wt of [30 kg/m^2 x (height in meters)^2] if BMI >30 kg/m^2; see pkg insert for toxicity-related dose adjustments and missed dose recommendations
- [maintenance phase]
- Dose: 3 mg/kg/dose IV q2wk; Start: 2 wk after dose escalation phase complete; Info: for non-CNS manifestations; consider premed with antipyretic, antihistamine, corticosteroids; use adjusted wt of [30 kg/m^2 x (height in meters)^2] if BMI >30 kg/m^2; see pkg insert for toxicity-related dose adjustments and missed dose recommendations
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]