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Published on 12 March 2007

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Update to ESA prescribing information


US-based drugs firm Amgen today announced that the US Food and Drug Administration (FDA) had approved updated safety information, including a boxed warning in the prescribing information for the class of drugs known as erythropoiesis-stimulating agents (ESAs), including darbepoietin alfa (Aranesp®) and epoietin alfa (Epogen®).

Amgen executive vice-president of research and development Dr Roger Perlmutter said: “Patient safety is unquestionably our top priority. Amgen is committed to providing timely and appropriate communications to physicians and patients whenever we become aware of new safety information that could affect clinical practice.”

Updated patient information in the revised label notes that “patients should be informed of the increased risks of mortality, serious cardiovascular events, thromboembolic events, and tumour progression when used in off-label dose regimens or populations”.

The new boxed warning notes that ESAs, when administered to target a haemoglobin level of greater than 12g/dl:

•    Increased risk of death and serious cardiovascular events.

•    Shortened time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy.

•    Shortened overall survival and increased mortality attributed to disease progression at four months in patients with metastatic breast cancer receiving chemotherapy.

Cardiovascular events and tumour progression have been moved to the “warnings” section from the “precautions” section of all ESA labels.

The new boxed warning also states that ESAs increased the risk of death when administered to target a haemoglobin level of 12g/dl in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population. In addition, for patients receiving ESAs pre-operatively for reduction of allogeneic blood transfusions, a higher incidence of deep venous thrombosis was documented in patients receiving epoietin alfa who were not receiving prophylactic anticoagulation. Aranesp is not approved for this indication.

“The boxed warning includes information from several investigational studies that were previously communicated to the medical community,” Dr Perlmutter added. “The vast majority of oncologists and nephrologists do not appear to be maintaining Hb levels above 12g/dl in approved indications.”

Physicians are advised in the boxed warning and “dosing and administration” section to use the lowest dose of ESAs that will gradually increase the haemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusions, and not to exceed 12g/dl. Additional dosing information for cancer patients has been updated in the “dosage and administration” section of the prescribing information, including new dosing adjustment and withholding guidelines to keep haemoglobin levels from exceeding 12g/dl.

Amgen is informing healthcare professionals about the revisions to the US prescribing information through a joint letter to healthcare professionals with Ortho Biotech and will post the letter and updated prescribing information on Amgen’s website (

The FDA is to review ESA safety and efficacy at an upcoming meeting of the agency’s Oncologic Drugs Advisory Committee on 10 May.

Indications for Aranesp and Epogen have not changed. Aranesp is indicated for treating chemotherapy-induced anaemia and anaemia associated with chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. Epogen is indicated for treating anaemia associated with CKD, for patients on dialysis.

BusinessWire 09/03/2007

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