Naglazyme Side Effects

Generic name: galsulfase

Note: This document contains side effect information about galsulfase. Some of the dosage forms listed on this page may not apply to the brand name Naglazyme.

Some side effects of Naglazyme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to galsulfase: intravenous solution

Some people receiving a galsulfase (the active ingredient contained in Naglazyme) injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected.

Get emergency medical help if you have any of these signs of an allergic reaction while taking galsulfase: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects of galsulfase may include:

• headache;

• joint pain;

• eye redness;

• nausea, vomiting, stomach pain, diarrhea;

• runny or stuffy nose, sore throat, cough, ear pain; or

• pain, redness, swelling, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to galsulfase: intravenous solution

General

During a double-blind, placebo-controlled trial, 19 patients received galsulfase (the active ingredient contained in Naglazyme) 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 (the active ingredient contained in Naglazyme) 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 (the active ingredient contained in Naglazyme) 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 (the active ingredient contained in Naglazyme)

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

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