Janssen-Cilag Ltd

Change to section 4.4 - Special warnings and precautions for Use

Amend Section 4.4 to update the existing Pure Red Cell Aplasia (PRCA) related warnings and to advise physicians of the observed risks associated with the unapproved use of erythropoiesis stimulating agents (ESAs) to treat anaemia related to ribavirin/interferon therapy for chronic hepatitis C.

Change to section 5.1 - Pharmacodynamic Properties

Revision of section 5.1 (Pharmacodynamic Properties) in accordance with the recommendations of the Committee for Human Medicinal Products’ (CHMP) and the Pharmacovigilance Working Party’s (PhVWP) safety review of epoetins, concluded in September 2009

Change to section 10 - Date of revision of the text

Changed to 2^nd April 2010

Change to section 4.2 – Posology and Method of Administration

Change of sub heading from Adult cancer patients with symptomatic anaemia receiving chemotherapy  to Treatment of patients with chemotherapy induced anaemia.

Update to section regarding haemoglobin concentration - aim for between 10 and 12g/dl. Eprex should be administered in order to increase haemoglobin to not greater than 12g/dl. Plus additional text on the administration of Eprex and monitoring of the patient.

Patients should be monitored closely to ensure that the lowest approved dose of erythropoiesis-stimulating agent (ESA) is used to provide adequate control of the symptoms of anaemia.

Change to section 4.4 – Special Warnings and Precautions for Use

Addition of - In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the target for the indication of use.

Change of sub heading from Adult cancer patients with symptomatic anaemia receiving chemotherapy to Treatment of patients with chemotherapy induced anaemia.

Paragraph added on clinical studies and additional information on tumour progression.

Addition of - This medicinal product contains less than 1 mmol sodium (23 mg) per dose i.e. essentially “sodium free”.

Addition of - In order to improve the traceability of the ESA all measures necessary and possible to ensure it should be taken (e.g. exact information on the product used should be documented in an appropriate way).  Furthermore, patients should only be switched from one ESA to another under appropriate supervision.

Change to section 4.8 – Undesirable effects

Reclassified according to the MedDRA system organ classes.

Change to section 5.1 - Pharmacodynamic properties

Addition of information on studies regarding  survival and tumour progression.

Change to section 6.4 – Special Precautions for Storage

Addition of - For the purpose of ambulatory use, the patient may remove EPREX from the refrigerator and store it not above 25°C for one single period of up to 3 days.

Change to section 6.5 – Nature and Contents of Container

Addition of information regarding needle safety device.

Change to section 6.6 –  Instructions for use, handling and disposal

Addition of - Before use, leave the EPREX syringe to stand until it reaches room temperature. This usually takes between 15 and 30 minutes.

Addition of - The product is for single use only. Only take one dose of EPREX from each syringe removing unwanted solution before injection. Refer to section 3. How to use EPREX (instructions on how to inject EPREX) of the package leaflet.

Deletion of - if you know or suspect that the product has been left at room temperature for more than 60 minutes before injection

Change due to harmonisation of SPC

Change from Epoetinum alfa to Epoetin alfa throughout SmPC