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Elosulfase alfa Side Effects

In 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 symptoms, hypotension, retching, skin rash, urticaria, erythema, and flushing. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to elosulfase alfa: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by elosulfase alfa. 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 elosulfase alfa, check with your doctor or nurse immediately:

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

Minor Side Effects

Some of the side effects that can occur with elosulfase 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:
  • Abdominal or stomach pain
  • headache
  • vomiting

For Healthcare Professionals

Applies to elosulfase alfa: intravenous solution

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]

Hypersensitivity

Very common (10% or more): Hypersensitivity reactions (including anaphylaxis; 18.7%)
Common (1% to 10%): Anaphylaxis[Ref]

References

1. "Product Information. Vimizim (elosulfase alfa)." BioMarin Pharmaceutical Inc, Novato, CA.

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

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