LEUKINE - BERLEX - Marketed Lyophilized Drug Products

LEUKINE Dosing and Administration
LEUKINE? (sargramostim) should not be administered simultaneously with cytotoxic chemotherapy or radiotherapy or within 24 hours preceding or following chemotherapy or radiotherapy.1
Once LEUKINE therapy is initiated, it should be continued until an absolute neutrophil count (ANC) of > 1500 cells/mm? is achieved for 3 days (or a maximum of 42 days) following induction chemotherapy in older adults with AML or until an ANC of > 1500 cells/mm? is achieved for 3 days in AuBMT, AlloBMT, or post-transplant PBPC.1,2
As shown in the landmark study by Bodey, et al, an ANC of 1500 cells/mm? is the critical level for neutrophils above which there is no additional protection against infection for your patients.3
Note that neutrophil counts are used to monitor therapy but represent only surrogate markers of infection risk. Clinical outcomes are crucial when evaluating the efficacy of growth factors.
LEUKINE Dosing ?
The recommended dosage for LEUKINE is 250 mcg/m?/day.1 The dosing chart below shows the correct dose for different body surface areas.
Body Surface Area (m?) LEUKINE Dose (mcg) Volume (mL)
1.0 250 0.5
1.2 300 0.6
1.4 350 0.7
1.6 400 0.8
1.8 450 0.9
2.0 500 1.0
For other dosing information, please see the full prescribing information for LEUKINE.
LEUKINE Supply ?
LEUKINE is available in a 500 mcg liquid formulation multiuse vial and a 250 mcg single-use vial of lyophilized powder. The multiuse vial permits dosing flexibility based on your patient?s body surface area vs using a predetermined, set dose. It also allows you to choose the type of syringe you prefer and, at the same time, may reduce the waste associated with prefilled syringes. Partially used vials can be appropriately stored for future use.
LEUKINE liquid contains benzyl alcohol and should not be administered to neonates.
1. LEUKINE (sargramostim) package insert. 2002 June.
2. Rowe JM, Rubin A, Maza JJ, et al. Incidence of infections in adult patients (> 55 years) with acute myeloid leukemia treated with yeast-derived GM-CSF (sargramostim): results of a double-blind prospective study by the Eastern Cooperative Oncology Group. In: Hiddemann W, ed. Acute Leukemias V: Experimental Approaches of Management of Refractory Disease. Berlin, Germany: Springer-Verlag; 1996.
3. Bodey GP, Buckley M, Sathe YS, et al. Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann Intern Med. 1966;64(2):328-40.