Cerezyme · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-083526 · has-adverse-reaction-information · PDF-Seite 5

Tabulated list of adverse reactions Adverse reactions are listed by system organ class and frequency (common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)) in the table below. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 5  MedDRA System Common Uncommon Rare Not known Organ Class Nervous system Dizziness, disorders headache, paraesthesia Cardiac disorders Tachycardia, cyanosis Vascular Flushing, Transient disorders hypotension hypertension Respiratory, Dyspnoea, coughing thoracic and mediastinal disorders Gastrointestinal Vomiting, disorders nausea, abdominal cramping, diarrhoea Immune system Hypersensitivity Anaphylactoid disorders reactions reactions Skin and Urticaria, angioedema, subcutaneous pruritus, rash tissue disorders Musculoskeletal Arthralgia, and connective backache tissue disorders General disorders Infusion site and discomfort, administration infusion site site conditions burning, infusion site swelling, injection site sterile abscess, chest discomfort, fever, rigors, fatigue Description of selected

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HOS-083522 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3

HOS-083521 · has-indication-information · PDF-Seite 2

Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: • anaemia after exclusion of other causes, such as iron deficiency • thrombocytopenia • bone disease after exclusion of other causes such as Vitamin D deficiency • hepatomegaly or splenomegaly

HOS-083524 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. 4

HOS-083525 · has-pregnancy-information · PDF-Seite 5

Pregnancy Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial to control the underlying Gaucher disease in pregnancy. Furthermore, these data indicate no malformative toxicity for the foetus by Cerezyme, although the statistical evidence is low. Foetal demise has been reported rarely, although it is not clear whether this related to the use of Cerezyme or to the underlying Gaucher disease. No animal studies have been carried out with respect to assessing the effects of Cerezyme on pregnancy, embryonal/foetal development, parturition and postnatal development. It is not known whether Cerezyme passes via the placenta to the developing foetus. In pregnant Gaucher patients and those intending to become pregnant, a risk-benefit treatment assessment is required for each pregnancy. Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium. This includes an increased risk of skeletal manifestations, exacerbation of cytopenia, haemorrhage, and an increased need for transfusion. Both pregnancy and lactation are known to stress maternal calcium homeostasis and to accelerate bone turnover. This may contribute to skeletal disease burden in Gaucher disease. Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health. In women receiving Cerezyme treatment continuation throughout pregnancy should be considered. Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualization of dose according to the patient’s needs and therapeutic response. Breast-feeding It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child’s gastrointestinal tract

HOS-083523 · has-warning-information · PDF-Seite 4

Hypersensitivity Current data using a screening ELISA followed by a confirmatory radioimmunoprecipitation assay, suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients. It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy. It is suggested that patients suspected of a decreased response to the treatment be monitored periodically for IgG antibody formation to imiglucerase. Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions (see section 4.8). If a patient experiences a reaction suggestive of hypersensitivity, subsequent testing for imiglucerase antibodies is advised. As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly. If these reactions occur, immediate discontinuation of the Cerezyme infusion is recommended and appropriate medical treatment should be initiated. The current medical standards for emergency treatment are to be observed. Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase (alglucerase) should be treated with caution when administering Cerezyme (imiglucerase). Infusion-Associated Reactions (IAR) Infusion-associated reactions (IAR) such as angioedema, pruritus, rash, urticaria, chest discomfort, chills, fatigue, infusion-site burning, infusion-site discomfort, infusion-site swelling, pyrexia and transient hypertension have been observed in patients treated with imiglucerase (see section 4.8). Careful consideration should be given to the patient’s clinical status prior to administration of Cerezyme. Antihistamines, antipyretics, and/or corticosteroids can be given to prevent or reduce IARs. However, IARs may still occur in patients after receiving pre-treatment. If mild or moderate IARs occur regardless of pre-treatment, decreasing the infusion rate or temporarily stopping the infusion may ameliorate the symptoms. If severe IARs occur, immediate discontinuation of the administration of Cerezyme should be considered and appropriate medical treatment should be initiated. The benefits and risks of re-administering Cerezyme following severe IARs should be considered (see section 4.8). Sodium This medicinal product contains 41 mg sodium per vial, equivalent to 2% of the WHO recommended maximum daily

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