Galsulfase Side Effects
Not all side effects for galsulfase may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to galsulfase: intravenous solution
In addition to its needed effects, some unwanted effects may be caused by galsulfase. 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 galsulfase, check with your doctor or nurse immediately: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 of the side effects that can occur with galsulfase 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
- 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 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 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 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.
Hematologic side effects have included rare cases of thrombocytopenia during postmarketing experience.
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