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Releuko Generic Name & Formulations
Legal Class
Rx
General Description
Filgrastim-ayow 300mcg, 480mcg; for SC inj or IV infusion; preservative-free.
Pharmacological Class
Granulocyte colony stimulating factor.
How Supplied
Prefilled syringes (0.5mL, 0.8mL)—10; Vials (1mL, 1.6mL)—10
Manufacturer
Generic Availability
NO
Releuko Indications
Indications
See full labeling. To decrease incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever. To reduce time to neutrophil recovery and fever duration after induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia (AML). To reduce duration of neutropenia and related clinical sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT). For chronic administration to reduce the incidence and duration of neutropenia sequelae in symptomatic patients with severe chronic neutropenia (SCN).
Releuko Dosage and Administration
Adult
See full labeling. Do not give for at least 24hrs before or after cytotoxic chemotherapy dose. BMT: Give 1st dose at least 24hrs after bone marrow infusion. SCN: Give on a daily basis.
Children
See full labeling.
Releuko Contraindications
Not Applicable
Releuko Boxed Warnings
Not Applicable
Releuko Warnings/Precautions
Warnings/Precautions
Monitor blood, including CBCs, differentials, and platelets, before and during therapy (myelosuppressive chemotherapy: monitor twice weekly; BMT: frequently after transplant; SCN: during initial 4 weeks of therapy and during 2 weeks after dose adjustment). Discontinue if post nadir absolute neutrophil count (ANC) reaches >10,000/mm3 for patients receiving myelosuppressive chemotherapy; other indications: see full labeling. Monitor for splenomegaly/splenic rupture and for acute respiratory distress syndrome (ARDS); discontinue if ARDS occurs. Confirm diagnosis and do appropriate pretreatment hematological workup in SCN. Sickle cell disease: may cause severe sickle cell crisis (discontinue if occurs). Glomerulonephritis. Monitor for MDS/AML in those with severe chronic neutropenia, breast or lung cancer. Monitor for aortitis; discontinue if suspected. Avoid simultaneous use with chemo- and radiation therapy. Permanently discontinue if serious allergic reactions occur. Possible transient (+) bone imaging changes in nuclear imaging. Pregnancy. Nursing mothers.
Releuko Pharmacokinetics
See Literature
Releuko Interactions
Releuko Adverse Reactions
Adverse Reactions
Pyrexia, pain, rash, cough, dyspnea, epistaxis, bone pain, headache, anemia, diarrhea, hypoesthesia, alopecia; thrombocytopenia, cutaneous vasculitis, splenomegaly, ARDS, capillary leak syndrome (monitor), others (see full labeling).
Releuko Clinical Trials
See Literature
Releuko Note
Not Applicable
Releuko Patient Counseling
See Literature
