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Galsulfase Side Effects

In Summary

Commonly reported side effects of galsulfase include: severe infusion related reaction, conjunctivitis, rigors, pain, dyspnea, pharyngitis, otalgia, infusion related reaction, development of igg antibodies, and chest pain. See below for a comprehensive list of adverse effects.

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
  • 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

Severity: Minor

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:
  • 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

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]

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]

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

Very common (10% or more): Development of antidrug antibodies (98%)[Ref]

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]

Renal

Postmarketing reports: Membranous nephropathy[Ref]

Hematologic

Postmarketing reports: Thrombocytopenia[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

3. "Product Information. Naglazyme (galsulfase)." BioMarin Pharmaceutical Inc, Novato, CA.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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