Ryzneuta — Medical 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