Ryzneuta®

Drug - RRyzneuta® (efbemalenograstim alfa-vuxw) [Acrotech Biopharma, Inc.]

January 2026

Therapeutic Area - Colony stimulating factors

Initial approval criteria

  • Patient is at least 18 years of age; AND
  • Will not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation; AND
  • Patient does not have a history of serious allergic reactions to granulocyte stimulating factor products (e.g., pegfilgrastim, filgrastim, etc.); AND

Prophylactic use in patients with non-myeloid malignancy

  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia* of greater than 20% OR
  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia* of 10% to 20% AND one or more of the following co-morbidities:
    • Age >65 years receiving full dose intensity chemotherapy
    • Prior exposure to chemotherapy or radiation therapy
    • Persistent neutropenia (ANC ≤ 1000/mm3)
    • Bone marrow involvement by tumor
    • Patient has a condition that can potentially increase the risk of serious infection (i.e., HIV/AIDS with low CD4 counts)
    • Recent surgery and/or open wounds
    • Poor performance status
    • Renal dysfunction (creatinine clearance <50 mL/min)
    • Liver dysfunction (elevated bilirubin >2.0 mg/dL)
    • Chronic immunosuppression in the post-transplant setting, including organ transplant

      Note: Dose-dense therapy, in general, requires growth factor support to maintain dose intensity and schedule. In the palliative setting, consideration should be given to dose reduction or change in regimen.

*Febrile neutropenia is defined as:
− Temperature: a single temperature ≥38.3 °C orally or ≥38.0 °C over 1 hour; AND
− Neutropenia: <500 neutrophils/mcL or <1,000 neutrophils/mcL and a predicted decline to ≤500 neutrophils/mcL over the next 48 hours

Renewal criteria

  • Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in the initial approval criteria; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include splenic rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions/anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential for tumor growth stimulation of malignant cells, aortitis, myelodysplastic syndrome and acute myeloid leukemia in patients with breast and lung cancer, etc.

Quantity limits

  • 20 mg administered subcutaneously once per chemotherapy cycle

Billing for Ryzneuta

Ryzneuta must be billed as a professional claim.

Background

Ryzneuta is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Ryzneuta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Questions

Provider Call Center: (844) 575-7887