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Leukine Generic Name & Formulations
Legal Class
Rx
General Description
Sargramostim 250mcg/vial; lyophilized pwd for SC inj or IV infusion after reconstitution; preservative-free; 500mcg/mL; soln for SC inj or IV infusion after dilution; contains benzyl alcohol.
Pharmacological Class
Granulocyte-macrophage colony stimulating factor (recombinant).
How Supplied
Single-dose vials (pwd)—5; Multi-dose vials (soln)—5
Manufacturer
Leukine Indications
Indications
To speed neutrophil recovery and reduce infections after induction chemotherapy for acute myelogenous leukemia (AML) in patients ≥55yrs. To mobilize autologous hematopoietic progenitor cells into peripheral blood for collection by leukapheresis in adults with cancer. To speed myeloid recovery in non-Hodgkin's lymphoma, acute lymphoblastic leukemia (ALL), and Hodgkin's lymphoma after autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation (BMT). To speed myeloid recovery in allogeneic BMT. To treat delayed neutrophil recovery or graft failure in BMT. To increase survival in hematopoietic syndrome of acute radiation syndrome (H-ARS).
Leukine Dosage and Administration
Adults and Children
See full labeling for timing and duration of dosing, and for repeat courses of therapy. Individualize. Neutrophil recovery in AML: 250mcg/m2/day IV over 4hrs. PBPC mobilization: 250mcg/m2/day IV over 24hrs or SC once daily. Myeloid recovery post PBPC transplantation: <2yrs: not established. ≥2yrs: 250mcg/m2/day IV over 24hrs or SC once daily. Myeloid recovery in BMT: <2yrs: not established. ≥2yrs: 250mcg/m2/day IV over 2hrs. BMT failure or engraftment delay: <2yrs: not established. ≥2yrs: 250mcg/m2/day IV over 2hrs for 14 days. H-ARS (<15kg): 12mcg/kg SC once daily; (15–40kg): 10mcg/kg SC once daily; (>40kg): 7mcg/kg SC once daily. Dose modifications: see full labeling.
Leukine Contraindications
Contraindications
Allergy to yeast-derived products.
Leukine Boxed Warnings
Not Applicable
Leukine Warnings/Precautions
Warnings/Precautions
Monitor for infusion-related reactions (esp. in lung disease); reduce infusion rate by ½ if dyspnea occurs; discontinue if worsens. Fluid retention, pleural or pericardial effusions. Pulmonary infiltrates. CHF. Cardiac disease. Monitor CBC and differential twice weekly. Myeloid malignancies (discontinue if disease progresses). Monitor body weight and hydration. Use for shortest duration required. Neonates/infants: avoid benzyl alcohol-containing solns. Pregnancy. Nursing mothers: not recommended (during and for ≥2 weeks after last dose).
Leukine Pharmacokinetics
See Literature
Leukine Interactions
Interactions
Avoid concomitant or within 24 hours preceding cytotoxic chemotherapy or radiotherapy, or within 24 hours after chemotherapy. Avoid lithium, corticosteroids, others that may enhance myeloproliferative effects.
Leukine Adverse Reactions
Adverse Reactions
Fever, GI disturbances, mucous membrane disorder, alopecia, asthenia, malaise, anorexia, rash/skin reactions, edema, stomatitis, high glucose, abdominal pain, low albumin, headache, hypertension, liver toxicity, infections, metabolic or GU abnormalities, pulmonary toxicity, neurotoxicity, weight loss; hypersensitivity reactions (discontinue if occur).
Leukine Clinical Trials
See Literature
Leukine Note
Not Applicable
Leukine Patient Counseling
See Literature
