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Taliglucerase alfa Side Effects

In Summary

Commonly reported side effects of taliglucerase alfa include: arthralgia, back pain, and headache. Other side effects include: chest discomfort, chest pain, fatigue, increased blood pressure, urticaria, weakness, erythema, and flushing. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to taliglucerase alfa: intravenous powder for solution

As well as its needed effects, taliglucerase alfa may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking taliglucerase alfa, check with your doctor or nurse immediately:

More common:
  • Chest tightness
  • dizziness
  • feeling of warmth
  • hives or welts, itching, or skin rash
  • irritation in the throat
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea or vomiting
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
Less common:
  • Blurred vision
  • confusion
  • cough
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast heartbeat
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • sweating
  • unusual tiredness or weakness

Minor Side Effects

Some taliglucerase alfa side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Abdominal or stomach pain
  • difficulty with moving
  • feeling of warmth
  • headache
  • muscle pain or stiffness
  • pain in the joints
Incidence not known:
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to taliglucerase alfa: intravenous powder for injection

General

The most frequently reported side effects were headache, arthralgia, pain in extremity, fatigue, nausea, dizziness, pruritus, flushing, abdominal pain, vomiting, back pain, and rash.[Ref]

Gastrointestinal

Very common (10% or more): Vomiting, abdominal pain
Common (1% to 10%): Nausea, diarrhea
Frequency not reported: Gastrointestinal inflammation[Ref]

Hypersensitivity

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.[Ref]

Very common (10% or more): Hypersensitivity reactions (including anaphylaxis; 29%)
Frequency not reported: Type III immune-mediated fixed drug eruption
Postmarketing reports: Anaphylaxis[Ref]

Musculoskeletal

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[Ref]

Immunologic

Very common (10% or more): Development of anti-drug antibodies (up to 53%), neutralizing antibodies detected (10.3%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%)
Common (1% to 10%): Dizziness, paresthesia
Frequency not reported: Tremor[Ref]

Other

Common (1% to 10%): Fatigue, flushing, peripheral edema, infusion reaction, weight increased
Frequency not reported: Chest discomfort, feeling hot[Ref]

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.[Ref]

Dermatologic

Common (1% to 10%): Pruritus, erythema, rash, urticaria[Ref]

Respiratory

Common (1% to 10%): Throat irritation, rhinorrhea, sneezing
Frequency not reported: Pulmonary hypertension[Ref]

Hepatic

Common (1%to 10%): ALT increased[Ref]

Local

Common (1% to 10%): Infusion site pain[Ref]

Ocular

Common (1% to 10%): Eye pruritus, eye swelling, lacrimation increased[Ref]

References

1. "Product Information. Elelyso (taliglucerase alfa)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

2. Cerner Multum, Inc. "Australian Product Information." O 0

It is possible that some side effects of taliglucerase alfa may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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