Summary
Commonly reported side effects of elosulfase alfa include: anaphylaxis, abdominal pain, fever, hypersensitivity reaction, nausea, and vomiting. Other side effects include: cyanosis, chest discomfort, constriction of the pharynx, cough, dyspnea, gastrointestinal signs and symptoms, hypotension, retching, skin rash, urticaria, erythema of skin, and flushing. Continue reading for a comprehensive list of adverse effects.
Applies to elosulfase alfa: intravenous solution.
Warning
Intravenous route (Solution)
Life-threatening anaphylactic reactions have occurred in some patients during elosulfase alfa infusions. Anaphylaxis, presenting as cough, erythema, throat tightness, urticaria, flushing, cyanosis, hypotension, rash, dyspnea, chest discomfort, and gastrointestinal symptoms in conjunction with urticaria, have been reported to occur during infusions, regardless of duration of the course of treatment. Closely observe patients during and after elosulfase alfa administration and be prepared to manage anaphylaxis Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with acute respiratory illness may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring.
Serious side effects of Elosulfase alfa
Along with its needed effects, elosulfase 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 elosulfase alfa:
More common
- Chills
- cough
- difficulty with swallowing
- dizziness
- fast heartbeat
- fever
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash, hives, or itching
- tightness in the chest
- unusual tiredness or weakness
Other side effects of Elosulfase alfa
Some side effects of elosulfase 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
- headache
- vomiting
For Healthcare Professionals
Applies to elosulfase alfa: intravenous solution.
General
The more commonly reported adverse reactions include pyrexia, vomiting, headache, nausea, abdominal pain, chills, and fatigue.
Hypersensitivity
During clinical trials, 7.5% of patients (n=18/235) experienced signs and symptoms of anaphylaxis. These 18 patients experienced 26 anaphylactic reactions. These cases occurred 30 to 180 minutes after the start of the infusion. Anaphylaxis occurred as late into treatment as the 47th infusion. Hypersensitivity reactions (including anaphylaxis) occurred in 18.7% (n=44/235) of patients.[Ref]
Very common (10% or more): Hypersensitivity reactions (including anaphylaxis; 18.7%)
Common (1% to 10%): Anaphylaxis[Ref]
Local
Very Common (10% or more): Infusion reaction (up to 96%)
In clinical trials, 96% of patients experienced infusion reactions (IRs). IRs may include allergic reactions. Thirty-five patients (15.2%) discontinued at least one infusion due to an IR. Sixty (0.66%) of the 9,126 infusions administered in the clinical trials were discontinued due to an IR. 17.3% of patients had an infusion reaction requiring medical intervention. In 13 out of 231 patients and less than 1% of the total infusions, the infusion was discontinued, and medical intervention was required.
Immunologic
All patients tested positive at least once during the trial for neutralizing antibodies capable of inhibiting the drug from binding to the mannose-6-phosphate receptor; this receptor binding is needed for drug intake into cells.[Ref]
Very common (10% or more): Development of anti-drug antibodies (100%), tested positive for neutralizing antibodies (100%)[Ref]
Other
Very common (10% or more): Pyrexia (33%), chills (10.3%), fatigue (10.3%)[Ref]
Gastrointestinal
Very common (10% or more): Vomiting (31%), nausea (24%), abdominal pain (21%)[Ref]
Nervous system
Very common (10% or more): Headache (26%)[Ref]
