Avalglucosidase Alfa-Ngpt: uses, dosing, side effects & brands
Avalglucosidase Alfa-Ngpt is a medicine sold in the U.S. under one brand, for glycogen storage disease type ii. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Glycogen Storage Disease Type II
- Available as
- Injectable
- Sold as
- Nexviazyme
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How avalglucosidase alfa-ngpt is dosed
From the FDA label for Nexviazyme (application BLA761194). Other avalglucosidase alfa-ngpt products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Consider administering antihistamines, antipyretics, and/or corticosteroids prior to NEXVIAZYME administration to reduce the risk of IARs. ( 2.1 ) NEXVIAZYME is administered as intravenous infusion. For patients weighing ( 2.2 ): ≥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. See the full prescribing information for dosage modifications due to hypersensitivity reactions or IARs. ( 2.3 ) Must be reconstituted and diluted prior to use. ( 2.4 ) For instructions on storage and administration, see full prescribing information. ( 2.5 , 2.6 ) 2.1 Recommendations Prior to NEXVIAZYME Treatment Prior to NEXVIAZYME administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids [see Warnings and Precautions (5.1 , 5.2) ] . NEXVIAZYME must be reconstituted and diluted prior to use [see Dosage and Administration (2.4) ] . Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during NEXVIAZYME administration. 2.2 Recommended Dosage and Administration NEXVIAZYME is administered as intravenous infusion. For patients weighing: 30 kg or more- the recommended dosage is 20 mg/kg (of actual body weight) every two weeks [see Dosage and Administration (2.6) ] Less than 30…
Avalglucosidase Alfa-Ngpt side effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions (IARs) [see Warnings and Precautions (5.2) ] The most common adverse reactions (>5%) were headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia and urticaria. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme at 1-800-633-1610, option 1 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials in the Pompe Disease Population The pooled safety analysis from 4 clinical trials in the Pompe disease population (including Study 1) with a mean exposure of 26 months and up to 85 months of treatment included a total of 141 NEXVIAZYME-treated patients (118 adult and 23 pediatric patients [see Clinical Studies (14.1) ] . Adverse reactions were similar across both adult and pediatric populations. Serious adverse reactions reported in 2 or more NEXVIAZYME-treated patients…
Who shouldn’t take avalglucosidase alfa-ngpt
None. None. ( 4 )
Every avalglucosidase alfa-ngpt product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Nexviazyme.
What people report to the FDA about avalglucosidase alfa-ngpt
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 58 reports naming avalglucosidase alfa-ngpt, and the FDA flagged 45% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- drug specific antibody present8 reports
- chest pain4 reports
- covid-194 reports
- dyspnoea4 reports
- fall4 reports
- headache4 reports
- pneumonia4 reports
- chest discomfort3 reports
Read these as a signal, not a rate. A report does not mean avalglucosidase alfa-ngpt caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is avalglucosidase alfa-ngpt?
Nexviazyme (Avalglucosidase Alfa-Ngpt) is a medication used to treat Glycogen Storage Disease Type II.
Can you take avalglucosidase alfa-ngpt with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run avalglucosidase alfa-ngpt against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does avalglucosidase alfa-ngpt come in?
Across the brands we track, avalglucosidase alfa-ngpt is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic avalglucosidase alfa-ngpt?
We do not currently list a generic-labelled avalglucosidase alfa-ngpt product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Avalglucosidase Alfa-Ngpt: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/avalglucosidase-alfa-ngpt
- MLA
- “Avalglucosidase Alfa-Ngpt: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/avalglucosidase-alfa-ngpt.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for avalglucosidase alfa-ngpt on DailyMed (NIH) ↗ — including its boxed warning in full.