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Taliglucerase alfa Side Effects

For the Consumer

Applies to taliglucerase alfa: intravenous powder for solution

Along with its needed effects, taliglucerase 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 taliglucerase alfa:

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

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:

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

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.

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