Mircera Special Precautions

General: Supplementary iron therapy: In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary and conducted in accordance with treatment guidelines.
Lack of effect: The most common reasons for incomplete response to ESAs are iron deficiency and inflammatory disorders. The following conditions may also compromise the effectiveness of ESAs therapy: chronic blood loss, bone marrow fibrosis, severe aluminium overload due to treatment of renal failure, folic acid or vitamin B₁₂ deficiencies, and haemolysis. 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. If PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
PRCA: PRCA caused by anti-erythropoietin antibodies has been reported in association with ESAs including MIRCERA. These antibodies have been shown to cross-react with all ESAs and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA.
Blood pressure monitoring: As with other ESAs, blood pressure may rise during treatment of anemia with MIRCERA. Blood pressure should be adequately controlled before, at initiation of and during treatment with MIRCERA. If high blood pressure is difficult to control by drug treatment or dietary measures, the dose of MIRCERA must be reduced or withheld (see Dosage & Administration).
Effect on tumor growth: MIRCERA, like other ESAs, is a growth factor that primarily stimulates red blood cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumor cells. As with all growth factors, there is a concern that ESAs could stimulate the growth of any type of malignancy. Controlled clinical studies in which epoetins were administered to patients with various cancers including head and neck cancers and breast cancer have shown an unexplained excess mortality.
The safety and efficacy of MIRCERA therapy has not been established in patients with haemoglobinopathies, seizures or with a platelet level greater than 500 x 10⁹/L. Therefore, caution should be used in these patients.
Drug Abuse and Dependence: Misuse by non-anaemic persons may lead to an excessive increase in Hb. This may be associated with life threatening complications of the cardiovascular system.
Laboratory Tests: No data to report.
Renal Impairment: No data to report.
Hepatic Impairment: No data to report.
Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed. However, no effects are expected based on the mechanism of action and the known safety profile of MIRCERA.
Use in Children: No dose recommendations can be made for use in patients aged less than 18 years due to the limited data on safety and efficacy (see PHARMACOLOGY: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
Use in the Elderly: Of the 1789 MIRCERA-treated CKD patients in Phase II and Phase III clinical studies of MIRCERA, 24% were age 65 to 74 years, while 20% were age 75 years and over. Based on population analyses, no adjustment of the starting dose is required in patients aged 65 years or older. See Special Dosage Instructions under Dosage & Administration.