Elelyso Side Effects

Generic Name: taliglucerase alfa

Note: This page contains information about the side effects of taliglucerase alfa. Some of the dosage forms included on this document may not apply to the brand name Elelyso.

Not all side effects for Elelyso may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to taliglucerase alfa: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by taliglucerase alfa (the active ingredient contained in Elelyso). In the event that any of these side effects do occur, they may 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 pain or discomfort
  • dizziness
  • facial swelling
  • fever or chills
  • headache
  • hives or welts
  • itching
  • nausea or vomiting
  • redness of the skin
  • shortness of breath
  • skin rash
  • weakness
Incidence not known
  • difficult or labored breathing
  • difficulty with swallowing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing

Some of the side effects that can occur with taliglucerase alfa may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Back pain
  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • congestion
  • difficult, burning, or painful urination
  • dryness or soreness of the throat
  • frequent urge to urinate
  • lack or loss of strength
  • runny nose
  • sneezing
  • voice changes
Less common
  • Abdominal or stomach pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bone pain
  • diarrhea
  • muscle spasms
  • tingling of the hands or feet
  • trouble with sleeping
  • unusual weight gain or loss
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

In clinical trials, the most common side effects were headache, arthralgia, extremity pain, fatigue, nausea, dizziness, pruritus, flushing, abdominal pain, vomiting, back pain, and rash.[Ref]

Immunologic

Very common (10% or more): Development of anti-drug antibodies (up to 53%), neutralizing antibodies detected (10.3%)[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, 2.8% 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 skin reaction
Postmarketing reports: Anaphylaxis[Ref]

Nervous system

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

Musculoskeletal

Very common (10% or more): Arthralgia (13%)
Common (1% to 10%): Back pain
Frequency not reported: Bone pain, muscle spasms, musculoskeletal discomfort, musculoskeletal pain[Ref]

Other

Common (1% to 10%): Extremity pain, fatigue, flushing
Frequency not reported: Infusion reaction, pain, peripheral edema, asthenia, chest discomfort[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain, vomiting
Frequency not reported: Diarrhea[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, urticaria
Frequency not reported: Erythema, skin irritation[Ref]

Respiratory

Frequency not reported: Upper respiratory tract infection/nasopharyngitis, pharyngitis/throat infection, influenza/flu, pharyngolaryngeal pain, dyspnea, throat irritation[Ref]

Hepatic

Frequency not reported: Increased ALT[Ref]

Psychiatric

Frequency not reported: Insomnia[Ref]

Genitourinary

Frequency not reported: Urinary tract infection/pyelonephritis[Ref]

Local

Frequency not reported: Infusion site pain[Ref]

References

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

2. "In brief: Taliglucerase (Elelyso) for Gaucher disease." Med Lett Drugs Ther 54 (2012): 56

3. Traynor K "Taliglucerase alfa approved for Gaucher disease." Am J Health Syst Pharm 69 (2012): 1009

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.

Hide
(web3)