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
- 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 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
- 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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