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Note: This document contains side effect information about taliglucerase alfa. Some of the dosage forms listed on this page may not apply to the brand name Elelyso.
Common side effects of Elelyso include: arthralgia, back pain, and headache. Other side effects include: asthenia, chest discomfort, chest pain, fatigue, increased blood pressure, urticaria, erythema of skin, and flushing. See below for a comprehensive list of adverse effects.
Applies to taliglucerase alfa: intravenous powder for solution
Along with its needed effects, taliglucerase alfa (the active ingredient contained in Elelyso) 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 taliglucerase alfa:
Some side effects of taliglucerase 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:
Incidence not known
Applies to taliglucerase alfa: intravenous powder for injection
The most frequently reported side effects were headache, arthralgia, pain in extremity, fatigue, nausea, dizziness, pruritus, flushing, abdominal pain, vomiting, back pain, and rash.
Very common (10% or more): Vomiting, abdominal pain
Common (1% to 10%): Nausea, diarrhea
Frequency not reported: Gastrointestinal inflammation
In clinical trials, hypersensitivity reactions (including anaphylaxis) were reported in 29% of patients; these reactions occurred up to 3 hours after the start of infusion. Serious hypersensitivity reactions (including anaphylaxis) were reported in some patients. In clinical trials, 3% of patients had signs/symptoms consistent with anaphylaxis; these reactions occurred during the infusion.
Very common (10% or more): Hypersensitivity reactions (including anaphylaxis; 29%)
Frequency not reported: Type III immune-mediated fixed drug eruption
Postmarketing reports: Anaphylaxis
Very common (10% or more): Arthralgia (up to 13%), pain in extremity (up to 10%)
Common (1% to 10%): Back pain, bone pain
Frequency not reported: Muscle spasms
Very common (10% or more): Development of anti-drug antibodies (up to 53%), neutralizing antibodies detected (10.3%)
Very common (10% or more): Headache (up to 19%)
Common (1% to 10%): Dizziness, paresthesia
Frequency not reported: Tremor
Common (1% to 10%): Fatigue, flushing, peripheral edema, infusion reaction, weight increased
Frequency not reported: Chest discomfort, feeling hot
Infusion-related reactions occurred most often within 24 hours of the infusion and consisted of arthralgia, headache, vomiting, flushing, pruritus, pain in extremity, pulmonary hypertension, diarrhea, chest discomfort, feeling hot, muscle spasms, tremor, throat irritation, erythema, and rash.
Common (1% to 10%): Pruritus, erythema, rash, urticaria
Common (1% to 10%): Throat irritation, rhinorrhea, sneezing
Frequency not reported: Pulmonary hypertension
Common (1%to 10%): ALT increased
Common (1% to 10%): Infusion site pain
Common (1% to 10%): Eye pruritus, eye swelling, lacrimation increased