Cerezyme® safety profile

Summary of safety information

Please refer to the Summary of Product Characteristics before prescribing.

Dosage and Administration¹

Cerezyme^® dosage should be individualised for each patient based on a comprehensive evaluation of the clinical manifestations of the disease and individual treatment goals. Initial doses of 60 U/kg of body weight once every 2 weeks have shown improvement in haematological and visceral parameters within 6 months of therapy, and continued use has either stopped progression of, or improved, bone disease.¹
Administration of doses as low as 15 U/kg of body weight once every 2 weeks has been shown to improve hematological parameters and organomegaly, although not bone parameters.

The usual frequency of infusion is once every 2 weeks, where most data is available.

For the pediatric population, no dose adjustment is required.

Administration¹ Cerezyme is administered by intravenous infusion after reconstitution and dilution. Initially, the infusion rate should not exceed 0.5 unit per kg body weight per minute, with subsequent administrations allowing an increase, not surpassing 1 unit per kg body weight per minute. Rate adjustments should be supervised by a healthcare professional.

Contraindications¹

Hypersensitivity to imiglucerase or to any of the excipients of this medicine (listed in section 6.1 of the Summary of Product Characteristics).

Precautions and Warnings¹

• Periodic monitoring for IgG antibody formation is suggested for patients suspected of a decreased response to treatment, as approximately 15% of treated patients may develop IgG antibodies to imiglucerase during the first year of therapy. Patients likely to develop antibodies do so within 6 months, rarely after 12 months
• Patients with imiglucerase antibodies have a higher risk of hypersensitivity reactions. If a patient experiences a reaction suggesting hypersensitivity, subsequent testing for imiglucerase antibodies is advised
• Severe allergic-type hypersensitivity reactions, while uncommon, may occur. In such cases, immediate discontinuation of Cerezyme® infusion is recommended, and appropriate medical treatment should be initiated.
• Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase® (alglucerase) should be treated with caution when administering Cerezyme® (imiglucerase)
• This medicinal product contains 41 mg sodium per vial, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult. It is to be administered in 0.9% sodium chloride intravenous solution. This should be taken into consideration by patients on a controlled sodium diet
• To enhance traceability, it is recommended to clearly record the name and batch number of the administered product

Adverse reactions¹

Adverse reactions are listed by system organ class and frequency in the list below. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.¹

Common (≥1/100 to <1/10)

Respiratory, thoracic and mediastinal disorders
Dyspnoea*, coughing*

Immune system disorders
Hypersensitivity reactions

Skin and subcutaneous tissue disorders
Urticaria/angioedema*, pruritus*, rash*

Symptoms suggestive of hypersensitivity (*marked in the table above) have been noted, overall in approximately 3% of the patients. Onset of such symptoms has occurred during or shortly after infusions. These symptoms generally respond to treatment with antihistamines and/or corticosteroids. Patients should be advised to discontinue infusion of the product and contact their physician if these symptoms occur.

During the first year of treatment, immunoglobulin G antibodies to Cerezyme® may form in approximately 15% of patients. Patients with antibodies to Cerezyme® have a higher risk of hypersensitivity reactions.

Limited experience from 150 pregnancy outcomes suggests that Cerezyme® is beneficial in controlling the underlying Gaucher disease during pregnancy. Risk-benefit treatment assessment is required for each pregnancy. Consult section 4.6 of SmPC.

Did you know?

A carrier of Gaucher disease has a 50% chance of having a child which carries the Gaucher gene.

Learn more about Cerezyme^®

References

1. Cerezyme^®. Summary of Product Characteristics.