LEUKINE Rx

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LEUKINE

White blood cell disorders
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Generic Name and Formulations:

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.

Select therapeutic use:

Indications for LEUKINE:

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).

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.

Contraindications:

Allergy to yeast-derived products.

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).

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.

Pharmacological Class:

Granulocyte-macrophage colony stimulating factor (recombinant).

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).

How Supplied:

Single-dose vials (pwd)—5; Multi-dose vials (soln)—5

LEUKINE 250mcg vials (Qty:30)

appx. price $7628.00