Galsulfase Side Effects

Please note - some side effects for Galsulfase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Galsulfase - for the Consumer

Galsulfase

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Galsulfase:

Cough; diarrhea; ear pain; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills; decreased reflexes; difficulty swallowing; eye redness or irritation; fever; hoarseness; joint pain; nausea; pain, swelling, or redness at the injection site; shortness of breath; sore throat; stomach pain; sudden, severe headache or dizziness; swelling of hands or legs; vision problems; vomiting.

Side Effects by Body System

Hypersensitivity

Hypersensitivity side effects including infusion reactions have been reported despite routine pretreatment with antihistamines. Some of the infusion reactions have been severe.

Severe symptoms have included angioneurotic edema, hypotension, dyspnea, bronchospasm, respiratory distress, apnea, and urticaria. Common symptoms of infusion reactions have included fever, chills/rigors, headache, rash, and mild to moderate urticaria. Nausea, vomiting, elevated blood pressure, retrosternal pain, abdominal pain, malaise, and joint pain have also been reported. Initial reactions have been reported as late as the fifty fifth week of treatment.

Symptoms generally abated with slowing of the infusion or the temporary interruption of the infusion along with additional antihistamines, antipyretics, and occasionally corticosteroids. Most patients were able to complete their infusions. Subsequent infusions were managed with a slower rate of galsulfase administration and treatment with additional prophylactic antihistamines. In patients who had more severe reactions, treatment included prophylactic corticosteroids. Even with these additional precautions, 13 out of 30 patients still had additional infusion reactions.

Other

Other side effects have included abdominal pain (53%), ear pain (42%), chest pain 16%), facial edema (11%), and umbilical hernia (11%).

General

General side effects have included pain (26%), rigors (21%), and malaise (11%).

Ocular

Ocular side effects have included conjunctivitis (21%) and increased corneal opacification (11%).

Respiratory

Respiratory side effects including dyspnea (21%) and nasal congestion (11%) have been reported.

Gastrointestinal

Gastrointestinal side effects have included pharyngitis (16%) and gastroenteritis (11%).

Nervous system

Nervous system side effects including areflexia (11%) have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (11%) have been reported.

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