Generic Name and Formulations:
Tbo-filgrastim 300mcg, 480mcg; soln for SC inj; preservative- and latex-free.
Indications for GRANIX:
To reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Adults and Children:
<1 month: not established. Administer the 1st dose no earlier than 24hrs following myelosuppressive chemotherapy. Do not administer within 24hrs prior to chemotherapy. Give by SC inj into abdomen (except for the 2-inch area around navel), front of middle thighs, upper outer area of buttocks, or upper back portion of upper arms; rotate inj sites. Avoid injecting into tender, red, bruised or hard areas, or that has scars or stretch marks. ≥1 month: 5mcg/kg once daily until expected neutrophil nadir is passed and neutrophil count has recovered to normal range.
Serious allergy to filgrastim or pegfilgrastim products.
Monitor CBC prior to chemotherapy and twice per week until recovery; discontinue if ANC >10,000/mm3 after chemotherapy-induced ANC nadir has occurred. Risk of splenic rupture; discontinue and evaluate if symptoms of enlarged spleen or rupture occur. Evaluate for acute respiratory distress syndrome (ARDS) if fever and lung infiltrates or respiratory distress develop after treatment; discontinue if ARDS is confirmed. Permanently discontinue if serious allergic reactions occur. Sickle cell disease: consider potential risks and benefits prior to treatment and discontinue if sickle cell crisis develops. Consider reducing or interrupting dose if glomerulonephritis occurs. Hepatic or moderate-to-severe renal impairment: not studied. Pregnancy. Nursing mothers.
Granulocyte colony stimulating factor.
Concomitant chemotherapy, radiation: not recommended. May cause transient positive changes in bone-imaging test results.
Bone pain; splenic rupture (may be fatal), ARDS, serious allergic reactions, sickle cell crisis, potential for tumor growth stimulatory effects on malignant cells, glomerulonephritis, capillary leak syndrome (monitor), leukocytosis, aortitis (discontinue if suspected).
Single-dose prefilled syringe (0.5mL, 0.8mL)—1, 10 (w. safety needle guard) or 1, 5 (w.o safety needle guard); Single-dose vial (1mL, 1.6mL)—10