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NEXVIAZYME (avalglucosidase alfa-ngpt)

Patients 1 year of age and older with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency).

Consider administering antihistamines, antipyretics, and/or corticosteroids prior to NEXVIAZYME administration to reduce the risk of Infusion-Associated Reactions (IARs).

Must be reconstituted and diluted prior to use.

 NEXVIAZYME is administered as intravenous infusion. For patients weighing:

  •   ≥30 kg, the recommended dosage is 20 mg/kg (of actual body weight) every two weeks.
  • <30 kg, the recommended dosage is 40 mg/kg (of actual body weight) every two weeks.(198)

For injection: 100 mg of avalglucosidase alfa-ngpt as a lyophilized powder in a single-dose vial for reconstitution.

IV

Headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia and urticaria. 

1b

198. Jordi Diaz-Manera, Priya S Kishnani, Hani Kushlaf, Shafeeq Ladha, Tahseen Mozaffar, Volker Straub et al., Safety and efficacy of avalglucosidase alfa versus alglucosidase alfa in patients with late-onset Pompe disease (COMET): a phase 3, randomised, multicentre trial. Randomized Controlled Trial Lancet Neurol . 2021 Dec;20(12):1012-1026. doi: 10.1016/S1474-4422(21)00241-6.

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