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Nexviazyme (avalglucosidase alfa-ngpt)
avalglucosidase alfa
Black Box Warnings .
Hypersensitivity Reaction
life-threatening reactions including anaphylaxis have occurred; administer where appropriate medical support including cardiopulmonary resuscitation equip. available; D/C immediately and start appropriate tx if severe reaction occurs; may consider desensitization procedure in patients with severe reaction
Infusion Reactions
severe reactions have occurred; consider immediate D/C and start appropriate tx if severe reaction occurs; weigh risk vs. benefit of readministration; acute underlying illness at time of infusion may incr. risk; compromised cardiac and respiratory function in advanced Pompe disease may incr. risk of severe complications from infusion reactions
Acute Cardiorespiratory Failure Risk in Susceptible Patients
patients with compromised cardiac/respiratory function on fluid restriction, acute underlying respiratory illness, or patients susceptible to volume overload may be at risk of serious exacerbation of cardiac/respiratory function; monitor vital signs more frequently during infusion in these patients
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = avalglucosidase alfa-ngpt
Pompe disease, late-onset
- [20 mg/kg/dose IV q2wk]
- Info: consider premed with antipyretic, antihistamine, corticosteroids
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 = avalglucosidase alfa-ngpt
Pompe disease, late-onset
- [1 yo and older, <30 kg]
- Dose: 40 mg/kg/dose IV q2wk; Info: consider premed with antipyretic, antihistamine, corticosteroids
- [1 yo and older, >30 kg]
- Dose: 20 mg/kg/dose IV q2wk; Info: consider premed with antipyretic, antihistamine, corticosteroids
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]