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Xenpozyme Side Effects

Generic name: olipudase alfa

Medically reviewed by Drugs.com. Last updated on Feb 18, 2023.

Note: This document contains side effect information about olipudase alfa. Some dosage forms listed on this page may not apply to the brand name Xenpozyme.

Applies to olipudase alfa: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Hypersensitivity Reactions Including AnaphylaxisPatients treated with olipudase alfa-rpcp have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during olipudase alfa-rpcp administration. If a severe hypersensitivity reaction (eg, anaphylaxis) occurs, olipudase alfa-rpcp should be discontinued immediately and appropriate medical treatment should be initiated. In patients with severe hypersensitivity reaction, a desensitization procedure to olipudase alfa-rpcp may be considered.

Serious side effects of Xenpozyme

Along with its needed effects, olipudase alfa (the active ingredient contained in Xenpozyme) 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 olipudase alfa:

More common

Incidence not known

Other side effects of Xenpozyme

Some side effects of olipudase 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 olipudase alfa: intravenous powder for injection.

General

Most frequently reported adverse drug reactions were hypotension, ocular hyperemia, pyrexia, cough, diarrhea, rhinitis, abdominal pain, vomiting, headache, urticaria, nausea, rash, arthralgia, pruritus, fatigue, myalgia, increased C-reactive protein, and pharyngitis.[Ref]

Cardiovascular

Very common (10% or more): Hypotension (15%), tachycardia (13%)

Common (1% to 10%): Palpitation, hot flush, flushing[Ref]

Dermatologic

Very common (10% or more): Urticaria (50%), rash (38%), pruritus (25%)

Common (1% to 10%): Erythema, papule, angioedema, fixed eruption, papular rash, macular rash, maculopapular rash, erythematous rash, pruritic rash, morbilliform rash, macule, erythema[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (75%), abdominal pain (63%), vomiting (50%), nausea (38%)

Common (1% to 10%): Upper abdominal pain, abdominal discomfort, gastrointestinal pain[Ref]

Hepatic

Common (1% to 10%): Hepatic pain, increased alanine aminotransferase, increased aspartate aminotransferase

Immunologic

Patients treated with this drug who developed IgG antidrug antibodies had a higher percentage of hypersensitivity reactions than those who did not develop IgG antidrug antibodies.[Ref]

Very common (10% or more): Anaphylactic reaction (13%), hypersensitivity (13%)[Ref]

Local

Very common (10% or more): Infusion site swelling (13%)

Common (1% to 10%): Asthenia, pain, catheter site pain, catheter site related reaction, catheter site pruritus, catheter site swelling[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (38%), myalgia (11.7%)

Common (1% to 10%): Bone pain, back pain[Ref]

Nervous system

Very common (10% or more): Headache (54%)[Ref]

Ocular

Very common (10% or more): Ocular hyperemia (15%), ocular discomfort, eye pruritus[Ref]

Other

Very common (10% or more): Pyrexia (100%), fatigue (25%), increased C-reactive protein (13%), elevated transaminase levels (13%)

Common (1% to 10%): C-reactive protein abnormal, chills, increased serum ferritin, increased body temperature[Ref]

Respiratory

Very common (10% or more): Cough (75%), rhinitis (75%), pharyngitis (25%), pharyngeal swelling (13%)

Common (1% to 10%): Dyspnea, throat irritation, pharyngeal edema, throat tightness, wheezing, larynx irritation[Ref]

Frequently asked questions

References

1. Product Information. Xenpozyme (olipudase alfa). Genzyme Corporation. 2022.

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.