Galsulfase Side Effects

Brand Names: Naglazyme

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.

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

During a double-blind, placebo-controlled trial, 19 patients received galsulfase and 20 patients received placebo. Serious side effects included apnea, pyrexia, and respiratory distress. Severe side effects included chest pain, dyspnea, laryngeal edema, and conjunctivitis.

During 4 open-label clinical trials, common side effects included pruritus, urticaria, pyrexia, headache, nausea, and vomiting. Serious side effects included laryngeal edema, urticaria, angioedema, and other allergic reactions. Severe side effects included urticaria, rash, and abdominal pain.

During each trial, the most common side effects requiring interventions were infusion reactions.

Other

Other side effects have included abdominal pain (47%), ear pain (42%), pain (32%), chills/rigors (21%), chest pain (16%), malaise (11%), umbilical hernia (11%), pyrexia, and facial edema. Infusion reactions (some severe) have been reported in 56% of patients despite routine pretreatment with antihistamines. Serious symptoms reported during infusion have included angioedema, laryngeal edema, pyrexia, anaphylactoid reaction, respiratory distress, apnea, and urticaria. Severe symptoms of infusion reactions have included chest pain, dyspnea, apnea, laryngeal edema, conjunctivitis, rash, and urticaria. The most common infusion reaction symptoms have included pyrexia, chills, rash, urticaria, dyspnea, nausea, vomiting, pruritus, erythema, hypertension, abdominal pain, and headache. Symptoms of infusion reactions have also included respiratory distress, chest pain, hypotension, angioedema, conjunctivitis, tremor, cough, retrosternal pain, and joint pain. Recurrent infusion reactions have been reported in 70% of patients during multiple infusions, but not always in consecutive weeks. Serious reactions occurring during galsulfase infusion (including anaphylaxis, shock, hypotension, bronchospasm, and respiratory failure) have been reported during postmarketing experience. Additional infusion reactions (including pyrexia, erythema, pallor, bradycardia, tachycardia, hypoxia, cyanosis, tachypnea, and paresthesia) have been reported during postmarketing experience.

Infusion reactions have been reported as early as the first week and as late as the 146th week of galsulfase therapy.

Infusion reaction symptoms generally abated with slowing or temporary interruption of the infusion along with administration of 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.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis and severe allergic reactions. Some reactions have been life-threatening and have included anaphylaxis, shock, respiratory distress, dyspnea, bronchospasm, laryngeal edema, and hypotension. Angioedema and other allergic reactions (unspecified) have been reported.

Respiratory

Respiratory side effects have included dyspnea (21%), pharyngitis (11%), nasal congestion (11%), apnea, respiratory distress, and laryngeal edema. Acute respiratory complications associated with administration have been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (42%).

Dermatologic

Dermatologic side effects have included rash (21%), pruritus, and urticaria.

Ocular

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

Gastrointestinal

Gastrointestinal side effects have included gastroenteritis (11%), nausea, and vomiting.

Nervous system

Nervous system side effects have included areflexia (11%), hearing impairment (11%), and headache.

Cardiovascular

Cardiovascular side effects have included hypertension (11%). A risk of acute cardiorespiratory failure and the possible development of congestive heart failure have been reported.

Immunologic

Immunologic side effects have included type III immune complex-mediated reactions (including membranous glomerulonephritis). The development of anti-galsulfase IgG antibodies have been reported in 98% of patients within 4 to 8 weeks of therapy.

Renal

Renal side effects have included at least once case of membranous nephropathy during postmarketing experience. Renal biopsy revealed galsulfase-immunoglobulin complexes in the glomeruli.

A patient with membranous nephropathy was successfully rechallenged and continued to receive galsulfase.

Hematologic

Patients with thrombocytopenia have been successfully rechallenged and have continued to receive galsulfase.

Hematologic side effects have included rare cases of thrombocytopenia during postmarketing experience.

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