Note: This document contains side effect information about galsulfase. Some dosage forms listed on this page may not apply to the brand name Naglazyme.
Summary
Common side effects of Naglazyme include: severe infusion related reaction, conjunctivitis, rigors, chest pain, development of igg antibodies, dyspnea, infusion related reaction, otalgia, pain, and pharyngitis. Continue reading for a comprehensive list of adverse effects.
Applies to galsulfase: intravenous solution.
Serious side effects of Naglazyme
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
- dizziness
- headache
- hernia of the naval
- nervousness
- pounding in the ears
- slow or fast heartbeat
- swelling of the face
- tightness in the chest
Incidence not known
- Back pain
- bluish lips or skin
- confusion
- cough
- 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
Other side effects of Naglazyme
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
- Diarrhea
- ear pain
- loss of appetite
Less common
- Body aches or pain
- burning, dry, or itching eyes
- congestion
- 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
Incidence not known
- Difficulty with moving
- loss of voice
- muscle pain or stiffness
- sneezing
For Healthcare Professionals
Applies to galsulfase: intravenous solution.
General
The most frequently reported adverse reactions included rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain, and dyspnea.
The most frequently reported adverse reactions requiring interventions are infusion-related reactions.[Ref]
Hypersensitivity
Frequency not reported: Anaphylaxis/anaphylactoid reaction, allergic reaction[Ref]
Dermatologic
Very common (10% or more): Rash (21%), angioedema, urticaria, pruritus
Common (1% to 10%): Erythema[Ref]
Gastrointestinal
Very common (10% or more): Abdominal pain (47%), gastroenteritis (11%), umbilical hernia (11%), nausea, vomiting[Ref]
Other
Infusion reactions, which occurred in 56% of patients across 5 clinical studies were defined as adverse reactions occurring during infusions or until the end of the infusion day. Infusion reactions were observed as early as week 1 and as late as week 146 of treatment and occurred during multiple infusions, however, not always in consecutive weeks. The most common signs/symptoms included pruritus, vomiting, abdominal pain, nausea, hypertension, headache, chest pain, erythema, cough, hypotension, angioedema, respiratory distress, tremor, conjunctivitis, malaise, bronchospasm, and arthralgia.[Ref]
Very common (10% or more): Infusion reactions (56%), ear pain (42%), pain (32%), chills/rigors (21%), chest pain (16%), malaise (11%), hearing impairment (11%), pyrexia[Ref]
Cardiovascular
Very common (10% or more): Hypertension (11%)
Common (1% to 10%): Hypotension
Frequency not reported: Pallor, bradycardia, tachycardia, cyanosis, shock[Ref]
Nervous system
Very common (10% or more): Areflexia (11%), headache
Common (1% to 10%): Tremor
Frequency not reported: Paresthesia[Ref]
Respiratory
Very common (10% or more): Dyspnea (21%), pharyngitis (11%), nasal congestion (11%)
Common (1% to 10%): Apnea, cough, respiratory distress, asthma, bronchospasm
Frequency not reported: Laryngeal edema, hypoxia, tachypnea, sleep apnea
Postmarketing reports: Respiratory failure[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (42%)[Ref]
Ocular
Very common (10% or more): Conjunctivitis (21%), corneal opacity (11%)[Ref]
Immunologic
During clinical trials, 53 out of 54 patients tested positive for antidrug IgG antibodies within 4 to 8 weeks of treatment. In the placebo controlled study, 19 patients were evaluated for a potential relationship between development of antidrug antibodies to clinical outcome measures. While all 19 patients developed antidrug antibodies, there was no consistent predictive relationship between total antibody titer, neutralizing or IgE antibodies, and infusion-associated reactions, urinary glycosaminoglycan (GAG) levels, or endurance measures.[Ref]
Very common (10% or more): Development of antidrug antibodies (98%)[Ref]
Renal
Postmarketing reports: Membranous nephropathy[Ref]
Hematologic
Postmarketing reports: Thrombocytopenia[Ref]
