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Avalglucosidase alfa Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 12, 2024.

Applies to avalglucosidase alfa: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Warning: Severe hypersensitivity reactions, infusion-associated reactions, and risk of acute cardiorespiratory failure in susceptible patientsHypersensitivity Reactions including AnaphylaxisPatients treated with avalglucosidase alfa-ngpt have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during avalglucosidase alfa-ngpt administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue avalglucosidase alfa-ngpt immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to avalglucosidase alfa-ngpt may be considered.Infusion-Associated Reactions (IARs)Patients treated with avalglucosidase alfa-ngpt have experienced severe IARs. If severe IARs occur, consider immediate discontinuation of avalglucosidase alfa-ngpt, initiation of appropriate medical treatment, and the benefits and risks of readministering avalglucosidase alfa-ngpt following severe IARs. Patients with an acute underlying illness at the time of avalglucosidase alfa-ngpt infusion may be at greater risk for IARs. Patients with advanced Pompe disease may have compromised cardiac and respiratory function, which may predispose them to a higher risk of severe complications from IARs.Risk of Acute Cardiorespiratory Failure in Susceptible PatientsPatients susceptible to fluid volume overload, or those with acute underlying respiratory illness or compromised cardiac or respiratory function for whom fluid restriction is indicated may be at risk of serious exacerbation of their cardiac or respiratory status during avalglucosidase alfa-ngpt infusion. More frequent monitoring of vitals should be performed during avalglucosidase alfa-ngpt infusion in such patients.

Serious side effects

Along with its needed effects, avalglucosidase alfa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking avalglucosidase alfa:

More common

Other side effects

Some side effects of avalglucosidase alfa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to avalglucosidase alfa: intravenous injection.

General

The most common adverse reactions were headache, fatigue, diarrhea, nausea, arthralgia, dizziness, myalgia, pruritus, vomiting, dyspnea, erythema, paresthesia, rash, urticaria, and chills.[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension, increased blood pressure

Uncommon (0.1% to 1%): Tachycardia, ventricular extrasystoles, flushing, increased heart rate[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, erythema, urticaria, palmar erythema, contusion

Uncommon (0.1% to 1%): Angioedema, hyperhidrosis, skin discoloration[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 12%), nausea (up to 12%)

Common (1% to 10%): Vomiting, abdominal pain, upper abdominal pain, lip swelling, swollen tongue, dyspepsia

Uncommon (0.1% to 1%): Oral hypoesthesia, oral paresthesia, dysphagia[Ref]

Genitourinary

Common (1% to 10%): Cystitis[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity reactions (up to 48%)

Common (1% to 10%): Anaphylaxis[Ref]

Life-threatening hypersensitivity reactions (including anaphylaxis) have been reported in patients treated with this drug. In clinical studies, 67 (48%) patients treated with this drug reported hypersensitivity reactions, including severe hypersensitivity reactions in 6 (4%) patients and anaphylaxis in 3 (2%) patients.[Ref]

Immunologic

Very common (10% or more): Antidrug antibodies positive (up to 95.1%), neutralizing antibodies positive (up to 39%)

Uncommon (0.1% to 1%): Complement factor increased, immune complex level increased[Ref]

In therapy-naive patients, the incidence of antidrug antibodies (ADA) at baseline was 3.3% and the incidence of ADA after treatment was 95.1%. In therapy-experienced patients, the incidence of ADA at baseline was up to 74% and the incidence of ADA after treatment was up to 55%. The median time to seroconversion was 8 weeks. ADA cross-reactivity studies showed that antibodies to this drug were cross-reactive to alglucosidase alfa.

In therapy-naive patients, the incidences of both neutralizing antibody (NAb) types, inhibition of enzyme activity only, and inhibition of enzyme cellular uptake only were 21.1%, 28%, and 39%, respectively. In therapy-experienced patients, the incidences of both NAb types, inhibition of enzyme activity only, and inhibition of enzyme cellular uptake only were up to 5%, up to 18%, and up to 21%, respectively.[Ref]

Local

Common (1% to 10%): Infusion site pain

Uncommon (0.1% to 1%): Infusion site extravasation, infusion site joint pain, infusion site rash, infusion site reaction, infusion site urticaria[Ref]

Metabolic

Common (1% to 10%): Decreased oxygen saturation[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 23.5%), pain in extremity (up to 15.7%)

Common (1% to 10%): Arthralgia, myalgia, muscle spasms[Ref]

Nervous system

Very common (10% or more): Headache (up to 22%)

Common (1% to 10%): Dizziness, paresthesia, tremor

Uncommon (0.1% to 1%): Somnolence[Ref]

Ocular

Common (1% to 10%): Ocular hyperemia

Uncommon (0.1% to 1%): Conjunctivitis, conjunctival hyperemia, eye pruritus, increased lacrimation

Frequency not reported: Eye irritation[Ref]

Other

In clinical studies, infusion-associated reactions (IARs) occurred at any time during and/or within a few hours after infusion of this drug. IARs were reported in 48 (34%) patients treated with this drug, with 5 (4%) patients reporting severe IARs.[Ref]

Very common (10% or more): Infusion-associated reactions (included chills, cough, diarrhea, erythema, fatigue, headache, influenza-like illness, nausea, ocular hyperemia, pain in extremity, pruritus, rash, erythematous rash, tachycardia, urticaria, vomiting, chest discomfort, dizziness, dyspnea, feeling hot, hyperhidrosis, lip swelling, oxygen saturation decreased, pain, palmar erythema, swollen tongue, upper abdominal pain, burning sensation, eyelid edema, feeling cold, flushing, respiratory distress, throat irritation, tremor; up to 34%), fatigue (up to 18%), fall (13.7%)

Common (1% to 10%): Pyrexia, chills, chest discomfort, pain, influenza-like illness, asthenia, noncardiac chest pain, peripheral edema

Uncommon (0.1% to 1%): Facial pain, hyperthermia, localized edema, peripheral swelling, increased body temperature

Frequency not reported: Middle ear effusion[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 23.5%), influenza (up to 17.6%)

Common (1% to 10%): Cough, dyspnea, upper respiratory tract infection

Uncommon (0.1% to 1%): Tachypnea, laryngeal edema, respiratory distress, throat irritation, abnormal breath sounds

Frequency not reported: Rhinorrhea[Ref]

References

1. (2021) "Product Information. Nexviazyme (avalglucosidase alfa)." Genzyme Corporation

2. (2022) "Product Information. Nexviazyme (avalglucosidase alfa)." Sanofi-Aventis Australia Pty Ltd

3. (2023) "Product Information. Nexviadyme (avalglucosidase alfa)." Sanofi Genzyme

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.