Releuko™ (filgrastim-ayow – Kashiv Biosciences) for subcutaneous or intravenous use is now FDA approved as a biosimilar for Neupogen® (filgrastim – Amgen).
- Releuko is indicated to:
- Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients who have nonmyeloid malignancies and are receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
- Reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy treatment of patients who have acute myeloid leukemia.
- Reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g.‚ febrile neutropenia) in patients who have nonmyeloid malignancies and are undergoing myeloablative chemotherapy followed by bone marrow transplantation.
- Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients who have congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
- Unlike Neupogen, Relueko has not received FDA approval to:
- Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
- Increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).
- Recommended dosing for Releuko is based on the patient’s weight and the indication. If administration via subcutaneous injection rather than intravenous infusion is appropriate, Releuko can be given at home by a patient or caregiver trained in proper procedure.
- Although considered a therapeutic alternative for Neupogen, Releuko has not received FDA approval to be automatically interchanged for Neupogen at the pharmacy. Its wholesale acquisition cost (WAC) is $2,280 per syringe or vial.
