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RyzneutaMedical Mutual

Prophylactic use in patients with non-myeloid malignancy undergoing myelosuppressive chemotherapy

Initial criteria

  • Patient age ≥ 18 years
  • Will not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation
  • No history of serious allergic reactions to granulocyte stimulating factor products (e.g., pegfilgrastim, filgrastim, etc.)
  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia >20%; OR
  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10% to 20% AND at least one of the following:
  • Age >65 years receiving full dose intensity chemotherapy
  • Extensive prior exposure to chemotherapy
  • Previous exposure of pelvis or other areas of large amounts of bone marrow to radiation
  • Pre-existing neutropenia (ANC ≤ 1000/mm3)
  • Bone marrow involvement with tumor
  • 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

Reauthorization criteria

  • Patient continues to meet indication-specific relevant criteria (such as concomitant therapy requirements and performance status)
  • Absence of unacceptable toxicity from the drug (e.g., splenic enlargement/rupture, acute respiratory distress syndrome, severe hypersensitivity reactions/anaphylaxis, severe sickle cell crises, glomerulonephritis, hematologic effects, capillary leak syndrome, tumor cell mobilization, MDS/AML in breast and lung cancer patients, aortitis)

Approval duration

4 months