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
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:More common
- chest pain or discomfort
- facial swelling
- fever or chills
- hives or welts
- nausea or vomiting
- redness of the skin
- shortness of breath
- skin rash
- 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
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
- Back pain
- bladder pain
- bloody or cloudy urine
- body aches or pain
- difficult, burning, or painful urination
- dryness or soreness of the throat
- frequent urge to urinate
- lack or loss of strength
- runny nose
- voice changes
- Abdominal or stomach pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bone pain
- muscle spasms
- tingling of the hands or feet
- trouble with sleeping
- unusual weight gain or loss
- 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
The most common side effects requiring interventions were infusion reactions.
Other side effects have included infusion reaction (up to 46%), back pain (up to 11%), and extremity pain (up to 11%). Fatigue, pain, flushing, peripheral edema, asthenia, and chest discomfort have been reported in greater than 2% of patients.
Hypersensitivity side effects have included anaphylaxis and allergic reactions. At least one patient experienced a type III immune-mediated skin reaction.
Immunologic side effects have included development of IgG anti-drug antibodies to taliglucerase alfa (the active ingredient contained in Elelyso)
Respiratory side effects have included upper respiratory tract infection/nasopharyngitis (up to 22%), pharyngitis/throat infection (up to 19%), and influenza/flu (up to 13%). Pharyngolaryngeal pain, dyspnea, and throat irritation have been reported in greater than 2% of patients.
Nervous system side effects have included headache (up to 19%). Dizziness, paresthesia, and insomnia have been reported in greater than 2% of patients.
Musculoskeletal side effects have included arthralgia (up to 13%). Bone pain, muscle spasms, musculoskeletal discomfort, and musculoskeletal pain have been reported in greater than 2% of patients.
Genitourinary side effects have included urinary tract infection/pyelonephritis (up to 11%).
Gastrointestinal side effects have included diarrhea, nausea, and abdominal pain in greater than 2% of patients.
Dermatologic side effects have included pruritus, erythema, rash, and skin irritation in greater than 2% of patients.
Local side effects have included infusion site pain (greater than 2%).
Hepatic side effects have included increased alanine aminotransferase (greater than 2%).
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