Nexviazyme Generic Name & Formulations
Legal Class
Rx
General Description
Avalglucosidase alfa-ngpt 100mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Pharmacological Class
Hydrolytic lysosomal glycogen-specific enzyme.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Nexviazyme Indications
Indications
Late-onset Pompe disease (GAA deficiency).
Nexviazyme Dosage and Administration
Adults and Children
<1yr: not established. Consider premedication with antihistamines, antipyretics, and/or corticosteroids prior to initiation. ≥1yr (<30kg): 40mg/kg every 2 weeks; (≥30kg): 20mg/kg every 2 weeks. Give by IV infusion incrementally, based on response. Duration: between 4–7hrs. Initial infusion rate: 1mg/kg/hr; may gradually increase every 30mins as tolerated; see full labeling. Dosage and administration modifications: see full labeling.
Nexviazyme Contraindications
Not Applicable
Nexviazyme Boxed Warnings
Boxed Warning
Severe hypersensitivity reactions or infusion-associated reactions. Risk of acute cardiorespiratory failure in susceptible patients.
Nexviazyme Warnings/Precautions
Warnings/Precautions
Risk of severe hypersensitivity reactions (including anaphylaxis); discontinue immediately if occurs. Have appropriate medical support and resuscitative equipment readily available. Monitor for severe infusion-associated reactions (IARs); consider immediate discontinuation if occurs. Withhold temporarily or slow the infusion rate if mild or moderate hypersensitivity reactions or moderate IARs occur. Increased risk of severe complications from IARs in those with advanced Pompe disease. Fluid volume overload, acute underlying respiratory illness, or compromised cardiac/respiratory function (with fluid restriction): risk of acute cardiorespiratory failure; monitor vitals frequently. Pregnancy. Nursing mothers.
Nexviazyme Pharmacokinetics
See Literature
Nexviazyme Interactions
Not Applicable
Nexviazyme Adverse Reactions
Adverse Reactions
Headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, urticaria; hypersensitivity reactions, IARs.
Nexviazyme Clinical Trials
See Literature
Nexviazyme Note
Not Applicable
Nexviazyme Patient Counseling
See Literature
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