Pombiliti (Cipaglucosidase alfa-atga)
Pombiliti (Cipaglucosidase alfa-atga)
- Medicine Name: Pombiliti
- API: cipaglucosidase alfa-atga
- Dosage Form & Strength: For injection: 105 mg as a lyophilized powder in a single-dose vial for reconstitution
- Manufactured By: Amicus Therapeutics, Inc.
Pombiliti (cipaglucosidase alfa-atga) is a hydrolytic lysosomal glycogen-specific enzyme used, in combination with Opfolda, an enzyme stabilizer, for the treatment of adults with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their outgoing enzyme replacement therapy (ERT).
Recommended Dosage: The recommended dosage of Pombiliti is 20 mg/kg (of actual body weight) administered every other week as an IV infusion over approximately 4 hours. Start Pombiliti along with Opfolda 2 weeks after the last ERT dose. Start the infusion of Pombiliti approximately 1 hour after oral use of Opfolda. In case the Pombiliti infusion cannot be started within 3 hours of oral administration of Opfolda, reschedule Pombiliti along with Opfolda at least 24 hours after Opfolda was last taken. In case Pombiliti along with Opfolda are both missed, re-start treatment as quickly as possible.
- Patients with acute underlying respiratory illness or compromised cardiac or respiratory function may be at risk of critical exacerbation of their cardiac or respiratory compromise throughout the infusions. Appropriate medical support and monitoring measures need to be readily available during Pombiliti infusion.
- Immune complex-related reactions may occur with other ERTs in individuals who had high IgG antibody titers, including critical cutaneous reactions and nephrotic syndrome. A potential class effect cannot be excluded. Monitor patients for clinical signs and symptoms of systemic immune complex-related reactions while taking treatment with cipaglucosidase alfa along with miglustat.
- Reliable contraceptive measures must be used by women of childbearing age during treatment with cipaglucosidase alfa along with miglustat, and for 4 weeks after discontinuing therapy. This therapeutic drug is not recommended for women of childbearing age not using reliable contraception.
- Cipaglucosidase alfa has a minor influence on the potential to drive and use machines since hypotension, dizziness, and somnolence have been reported as side effects. Caution is needed when driving or using any machines or tools after receiving treatment with cipaglucosidase alfa.
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