Precautions for Imiglucerase (Cerezyme)
General Precautions
(1) Pulmonary hypertension and pneumonia have occurred in less than 1% of patients during treatment with imiglucerase. Pulmonary hypertension and pneumonia are known complications of Gaucher disease, and have been found in patients who have received or not received imiglucerase. The causal relationship between imiglucerase and these symptoms is not clear. Patients with or without febrile respiratory symptoms should be examined to determine the presence of pulmonary hypertension.
(2) Treatment with imiglucerase should be conducted under the guidance of doctors experienced in the treatment of Gaucher disease.
(3) Patients who have received Ceredase (alglucerase injection) and have developed antibodies against alglucerase injection or have had allergic reactions to alglucerase injection should use imiglucerase with caution.
Warnings
(1) To date, approximately 15% of patients have developed IgG antibodies against imiglucerase (imiglucerase for injection) during the first year of treatment. Most of these occur within the first 6 months of treatment, and the occurrence of anti-imiglucerase antibodies after 12 months of treatment is rare. Approximately 46% of patients with positive IgG antibodies experience allergic symptoms.
(2) Patients with anti-imiglucerase antibodies have a higher risk of allergic reactions. However, not all patients with allergic symptoms can be detected with IgG antibodies. It is recommended to regularly monitor the formation of IgG antibodies in patients during the first year of treatment.
(3) Patients who have had allergic symptoms to this product should use this product with caution during treatment.
(4) Rapid-like allergic reactions have been reported in less than 1% of patients. Caution should be exercised when further treatment with imiglucerase is administered. Most patients can successfully continue treatment after reducing the infusion rate and pre-treating with antihistamines and/or corticosteroids.
