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
Along with its needed effects, galsulfase (the active ingredient contained in Naglazyme) 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 galsulfase:Less common
- Blurred or decreased vision
- chest pain
- difficult or labored breathing
- hernia of the naval
- pounding in the ears
- slow or fast heartbeat
- swelling of the face
- tightness in the chest
- Back pain
- bluish lips or skin
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever, chills, or sweating
- hives or welts
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of bladder control
- loss of bowel control
- nausea or vomiting
- paralysis of the limbs
- stomach pain
Some side effects of galsulfase 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
- ear pain
- loss of appetite
- Body aches or pain
- burning, dry, or itching eyes
- dryness or soreness of the throat
- excessive tearing
- loss of or increase in reflexes
- runny or stuffy nose
- tender, swollen glands in the neck
- trouble with swallowing
- unusual tiredness or weakness
- voice changes
- Difficulty with moving
- loss of voice
- muscle pain or stiffness
For Healthcare Professionals
Applies to galsulfase: intravenous solution
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 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 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 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 side effects have included arthralgia (42%).
Dermatologic side effects have included rash (21%), pruritus, and urticaria.
Ocular side effects have included conjunctivitis (21%) and corneal opacity/increased corneal opacification (11%).
Gastrointestinal side effects have included gastroenteritis (11%), nausea, and vomiting.
Nervous system side effects have included areflexia (11%), hearing impairment (11%), and headache.
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 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 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.
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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