Select a medication above to begin.
Pombiliti (cipaglucosidase alfa-atga)
cipaglucosidase 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; D/C immediately 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 = cipaglucosidase alfa-atga
Pompe disease, late-onset
- [>40 kg]
- Dose: 20 mg/kg/dose IV q2wk; Start: 2wk after last enzyme replacement tx dose; Info: for patients not improving on current enzyme replacement tx; give 1h after Opfolda (miglustat) dose, no later than 3h after miglustat dose; do not administer if miglustat dose missed; consider premed with antihistamines, antipyretics, and/or corticosteroids
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.