Galsulfase Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 9, 2024.

Applies to galsulfase: intravenous solution.

Precautions

If you will be using this medicine for a long time, it is very important that your doctor check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have dizziness, lightheadedness, a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you or your child are using this medicine.

This medicine may cause headaches and skin reactions, such as a rash or itching, while you are receiving the injection or within 24 hours after you receive it. Check with your doctor or nurse right away if you or your child have any of these symptoms.

This medicine can cause fever and allergic-type reactions. You or your child will receive medicines to prevent these side effects, and that medicine may make you drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Tell your doctor right away if you have back pain, paralysis of the limbs, or loss of bladder or bowel control after receiving this medicine. These could be symptoms of a condition called spinal or cervical cord compression (SCC).

Your doctor may want you or your child to join a patient registry for patients using this medicine. This will help you monitor the progress of your disease while on long-term treatment using this medicine.

Common side effects of galsulfase

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:

Serious side effects of galsulfase

Along with its needed effects, galsulfase 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:

For healthcare professionals

Applies to galsulfase: intravenous solution.

General adverse events

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]

See also:

Further information

Galsulfase side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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