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21-05-2018 | FDA | News | Article


Epoetin alfa biosimilar approved for chemotherapy-related anemia

medwireNews: US patients who develop anemia related to myelosuppressive chemotherapy may now be treated with a biosimilar formulation of epoetin alfa during their treatment.

Epoetin alfa-epbx is indicated only for patients who are not anticipated to achieve a cure and its use should be stopped at the end of the chemotherapy regimen.

The full prescribing information also includes a Boxed Warning for the increased risk of tumor progression or recurrence in patients with breast, non-small-cell lung, head and neck, or cervical cancer, and lymphoid tumors, as well as death, stroke, myocardial infarction, venous thromboembolism, tumor progression or recurrence, and other serious events.

Epoetin alfa-epbx may also be used for patients in other settings, such as anemia associated with chronic kidney disease or the anti-HIV therapy zidovudine, or to reduce the need for allogeneic red blood cell transfusion in surgery.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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