Mircera · 4.4 Special warnings and precautions for use · 1

HOS-094600 · has-adverse-reaction-information · PDF-Seite 8

(a) Summary of the safety profile The safety data base from clinical trials comprised 3,042 CKD adult patients, including 1,939 adult patients treated with methoxy polyethylene glycol-epoetin beta and 1,103 with another ESA. Approximately 6% of adult patients treated with methoxy polyethylene glycol-epoetin beta are expected to experience adverse reactions. The most frequent reported adverse reaction was hypertension (common). (b) Tabulated list of adverse reactions Adverse reactions in Table 3 are listed according to MedDRA system organ class and frequency category. Frequency categories are defined using the following convention: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 8 Table 3: Adverse reactions attributed to the treatment with methoxy polyethylene glycol- epoetin beta in CKD adult patients. Adverse reactions observed only during post-marketing are marked (*). System organ class Frequency Adverse reaction Blood and lymphatic system Uncommon Thrombocytopenia* disorders Not known Pure red cell aplasia* Rare Hypersensitivity Immune system disorders Not known Anaphylactic reaction* Uncommon Headache Nervous system disorders Rare Hypertensive encephalopathy Common Hypertension Uncommon Thrombosis* Vascular disorders Rare Hot flush Rare Pulmonary embolism* Rare Rash, maculopapular Skin and subcutaneous Stevens-Johnson syndrome / toxic disorders Not known epidermal necrolysis* Injury, poisoning and Uncommon Vascular

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HOS-094596 · has-contraindication-information · PDF-Seite 6

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

HOS-094595 · has-indication-information · PDF-Seite 3

Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1). Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).

HOS-094598 · has-interaction-information · PDF-Seite 8

No interaction studies have been performed. There is no evidence that methoxy polyethylene glycol- epoetin beta alters the metabolism of other medicinal products.

HOS-094599 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are no data from the use of methoxy polyethylene glycol-epoetin beta in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryofoetal development, parturition or postnatal development but indicate a class-related reversible reduction in foetal weight (see section 5.3). Caution should be exercised when prescribing to pregnant women. Breast-feeding It is unknown whether methoxy polyethylene glycol-epoetin beta is excreted in human breast milk. One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk. A decision on whether to continue or discontinue breast-feeding or to continue or discontinue therapy with methoxy polyethylene glycol-epoetin beta should be made taking into account the benefit of breast-feeding to the child and the benefit of methoxy polyethylene glycol-epoetin beta therapy to the woman. Fertility Studies in animals have shown no evidence of impaired fertility (see section 5.3). The potential risk for humans is unknown.

HOS-094597 · has-warning-information · PDF-Seite 6

The safety and efficacy of methoxy polyethylene glycol-epoetin beta therapy in other indications, including anaemia in patients with cancer, has not been established. Caution should be exercised with escalation of methoxy polyethylene glycol-epoetin beta doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events. In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see section 4.2 and 5.1). Paediatric population: Paediatric patients, especially children <1 year of age, should be carefully evaluated before switching from another ESA treatment and the haemoglobin level should be stabilised prior to switching. Following ESA conversion, it is recommended that haemoglobin is monitored every 4 weeks. If the current ESA dose is <9 microgram/week of darbepoetin alfa or <2000 IU/week of epoetin, the patient should not be switched to methoxy polyethylene glycol-epoetin beta, as the lowest available pre-filled syringe dose strength is 30 micrograms. Administration of partial doses with pre-filled syringes is not recommended. Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 microgram/l or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment. Failure to respond to treatment should prompt for a search for causative factors. Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminium toxicity, underlying haematologic diseases, or bone marrow fibrosis may also compromise the erythropoietic response. A reticulocyte count should be considered as part of the evaluation. If all the conditions mentioned are excluded and the patient has a sudden drop of haemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA) should be considered. In case PRCA is diagnosed, treatment must be discontinued and patients should not be switched to another ESA. 6 Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has bee

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