Eporatio

HOS-154492 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile Approximately 9% of patients can be expected to experience an adverse reaction. The most frequent adverse reactions are hypertension, influenza-like illness and headache. Tabulated list of adverse reactions The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients. Adverse reactions listed below in table 1 are classified according to System Organ Class. Frequency groupings are defined according to 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 1: Adverse reactions System organ class Adverse reaction Frequency Symptomatic anaemia Symptomatic anaemia associated with in cancer patients with chronic renal failure non-myeloid malignancies receiving chemotherapy Blood and lymphatic Pure red cell aplasia Not known — system disorders (PRCA)* Immune system Hypersensitivity Not known disorders reactions Nervous system Headache Common disorders Vascular disorders Hypertension* Common Hypertensive crisis* Common — Shunt thrombosis* Common — Thromboembolic — Not known events Skin and subcutaneous Skin reactions* Common tissue disorders Musculoskeletal and Arthralgia — Common connective tissue disorders General disorders and Influenza-like illness*

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HOS-154488 · has-contraindication-information · PDF-Seite 5

- Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients listed in section 6.1. - Uncontrolled hypertension.

HOS-154487 · has-indication-information · PDF-Seite 3

- Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

HOS-154490 · has-interaction-information · PDF-Seite 7

No interaction studies have been performed. 7

HOS-154491 · has-pregnancy-information · PDF-Seite 8

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin theta in pregnant women. Animal studies with other epoetins do not indicate direct harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Eporatio during pregnancy. Breast-feeding It is unknown whether epoetin theta/metabolites are excreted in human milk, but data in neonates show no absorption or pharmacological activity of erythropoietin when given together with breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eporatio therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility No data are available.

HOS-154489 · has-warning-information · PDF-Seite 5

General Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/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. Non-response to therapy with epoetin theta should prompt a search for causative factors. Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of epoetins and should therefore be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, aluminium intoxication, underlying haematological diseases or bone marrow fibrosis may also compromise the erythropoietic response. A reticulocyte count should be considered as part of the evaluation. Pure red cell aplasia (PRCA) If typical causes of non-response are excluded, and the patient has a sudden drop in haemoglobin associated with reticulocytopenia, an examination of anti-erythropoietin antibodies and the bone marrow for diagnosis of pure red cell aplasia should be considered. Discontinuation of treatment with epoetin theta should be taken into account. PRCA caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including with epoetin theta. These antibodies have been shown to cross-react with all epoetins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to epoetin theta (see section 4.8). 5 In order to improve the traceability of epoetins, the name of the administered epoetin should be clearly recorded in the patient file. A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly. Epoetins are not approved in the management of anaemia associated with hepatitis C. Hypertension Patients on epoetin theta therapy can experience an increase in blood pressure or aggravation of existing hypertension particularly during the initial treatment phase. Therefore, in patients treated with epoetin theta, special care should be taken to monitor closely and control blood pressure. Blood pressure should be controlled adequately before initiation

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