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Leukine

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Leukine

INDICATIONS

Use Following Induction Chemotherapy in Acute Myelogenous Leukemia

LEUKINE (sargramostim) is indicated for use following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. The safety and efficacy of LEUKINE (sargramostim) have not been assessed in patients with AML under 55 years of age.

The term acute myelogenous leukemia, also referred to as acute non-lymphocytic leukemia (ANLL), encompasses a heterogeneous group of leukemias arising from various non-lymphoid cell lines which have been defined morphologically by the French-American- British (FAB) system of classification.

Use in Mobilization and Following Transplantation of Autologous Peripheral Blood Progenitor Cells

LEUKINE (sargramostim) is indicated for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment as compared with collection without mobilization. After myeloablative chemotherapy, the transplantation of an increased number of progenitor cells can lead to more rapid engraftment, which may result in a decreased need for supportive care. Myeloid reconstitution is further accelerated by administration of LEUKINE (sargramostim) following peripheral blood progenitor cell transplantation.

Use in Myeloid Reconstitution After Autologous Bone Marrow Transplantation

LEUKINE (sargramostim) is indicated for acceleration of myeloid recovery in patients with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's disease undergoing autologous bone marrow transplantation (BMT). After autologous BMT in patients with NHL, ALL, or Hodgkin's disease, LEUKINE (sargramostim) has been found to be safe and effective in accelerating myeloid engraftment, decreasing median duration of antibiotic administration, reducing the median duration of infectious episodes and shortening the median duration of hospitalization. Hematologic response to LEUKINE (sargramostim) can be detected by complete blood count (CBC) with differential cell counts performed twice per week.

Use in Myeloid Reconstitution After Allogeneic Bone Marrow Transplantation

LEUKINE (sargramostim) is indicated for acceleration of myeloid recovery in patients undergoing allogeneic BMT from HLAmatched related donors. LEUKINE (sargramostim) has been found to be safe and effective in accelerating myeloid engraftment, reducing the incidence of bacteremia and other culture positive infections, and shortening the median duration of hospitalization.

Use in Bone Marrow Transplantation Failure or Engraftment Delay

LEUKINE (sargramostim) is indicated in patients who have undergone allogeneic or autologous bone marrow transplantation (BMT) in whom engraftment is delayed or has failed. LEUKINE (sargramostim) has been found to be safe and effective in prolonging survival of patients who are experiencing graft failure or engraftment delay, in the presence or absence of infection, following autologous or allogeneic BMT. Survival benefit may be relatively greater in those patients who demonstrate one or more of the following characteristics: autologous BMT failure or engraftment delay, no previous total body irradiation, malignancy other than leukemia or a multiple organ failure (MOF) score ≤ two (see Clinical Experience). Hematologic response to LEUKINE (sargramostim) can be detected by complete blood count (CBC) with differential performed twice per week.

DOSAGE AND ADMINISTRATION

Neutrophil Recovery Following Chemotherapy in Acute Myelogenous Leukemia

The recommended dose is 250mcg/m²/day administered intravenously over a 4 hour period starting approximately on day 11 or four days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with < 5% blasts. If a second cycle of induction chemotherapy is necessary, LEUKINE (sargramostim) should be administered approximately four days after the completion of chemotherapy if the bone marrow is hypoplastic with < 5% blasts. LEUKINE (sargramostim) should be continued until an ANC > 1500 cells/mm³ for 3 consecutive days or a maximum of 42 days. LEUKINE (sargramostim) should be discontinued immediately if leukemic regrowth occurs. If a severe adverse reaction occurs, the dose can be reduced by 50% or temporarily discontinued until the reaction abates.

In order to avoid potential complications of excessive leukocytosis (WBC > 50,000 cells/mm³ or ANC > 20,000 cells/mm³) a CBC with differential is recommended twice per week during LEUKINE (sargramostim) therapy. LEUKINE (sargramostim) treatment should be interrupted or the dose reduced by half if the ANC exceeds 20,000 cells/mm³.

Mobilization of Peripheral Blood Progenitor Cells

The recommended dose is 250 mcg/m²/day administered IV over 24 hours or SC once daily. Dosing should continue at the same dose through the period of PBPC collection. The optimal schedule for PBPC collection has not been established. In clinical studies, collection of PBPC was usually begun by day 5 and performed daily until protocol specified targets were achieved (see Clinical Experience, Mobilization and Engraftment of PBPC). If WBC > 50,000 cells/mm³, the LEUKINE (sargramostim) dose should be reduced by 50%. If adequate numbers of progenitor cells are not collected, other mobilization therapy should be considered.

Post Peripheral Blood Progenitor Cell Transplantation

The recommended dose is 250 mcg/m²/day administered IV over 24 hours or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC > 1500 cells/mm³ for three consecutive days is attained.

Myeloid Reconstitution After Autologous or Allogeneic Bone MarrowTransplantation

The recommended dose is 250mcg/m²/day administered IV over a 2-hour period beginning two to four hours after bone marrow infusion, and not less than 24 hours after the last dose of chemotherapy or radiotherapy. Patients should not receive LEUKINE (sargramostim) until the post marrow infusion ANC is less than 500 cells/mm³. LEUKINE (sargramostim) should be continued until an ANC > 1500 cells/mm³ for three consecutive days is attained. If a severe adverse reaction occurs, the dose can be reduced by 50% or temporarily discontinued until the reaction abates. LEUKINE (sargramostim) should be discontinued immediately if blast cells appear or disease progression occurs.

In order to avoid potential complications of excessive leukocytosis (WBC > 50,000 cells/mm³, ANC > 20,000 cells/mm³) a CBC with differential is recommended twice per week during LEUKINE (sargramostim) therapy. LEUKINE (sargramostim) treatment should be interrupted or the dose reduced by 50% if the ANC exceeds 20,000 cells/mm³.

Bone Marrow Transplantation Failure or Engraftment Delay

The recommended dose is 250 mcg/m²/day for 14 days as a 2-hour IV infusion. The dose can be repeated after 7 days off therapy if engraftment has not occurred. If engraftment still has not occurred, a third course of 500 mcg/m²/day for 14 days may be tried after another 7 days off therapy. If there is still no improvement, it is unlikely that further dose escalation will be beneficial. If a severe adverse reaction occurs, the dose can be reduced by 50% or temporarily discontinued until the reaction abates. LEUKINE (sargramostim) should be discontinued immediately if blast cells appear or disease progression occurs.

In order to avoid potential complications of excessive leukocytosis (WBC > 50,000 cells/mm³, ANC > 20,000 cells/mm³) a CBC with differential is recommended twice per week during LEUKINE (sargramostim) therapy. LEUKINE (sargramostim) treatment should be interrupted or the dose reduced by half if the ANC exceeds 20,000 cells/mm³.

Preparation of LEUKINE (sargramostim)

  1. Liquid LEUKINE (sargramostim) is formulated as a sterile, preserved (1.1% benzyl alcohol), injectable solution (500 mcg/mL) in a vial. Lyophilized LEUKINE (sargramostim) is a sterile, white, preservative-free powder (250mcg) that requires reconstitution with 1mL SterileWater for Injection, USP, or 1 mL Bacteriostatic Water for Injection, USP.
  2. Liquid LEUKINE (sargramostim) may be stored for up to 20 days at 2-8°C once the vial has been entered. Discard any remaining solution after 20 days.
  3. Lyophilized LEUKINE (sargramostim) (250 mcg) should be reconstituted aseptically with 1.0 mL of diluent (see below). The contents of vials reconstituted with different diluents should not be mixed together.
    Sterile Water for Injection, USP (without preservative): Lyophilized LEUKINE (sargramostim) vials contain no antibacterial preservative, and therefore solutions prepared with Sterile Water for Injection, USP should be administered as soon as possible, and within 6 hours following reconstitution and/or dilution for IV infusion. The vial should not be re-entered or reused. Do not save any unused portion for administration more than 6 hours following reconstitution.
    Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol): Reconstituted solutions prepared with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) may be stored for up to 20 days at 2-8°C prior to use. Discard reconstituted solution after 20 days. Previously reconstituted solutions mixed with freshly reconstituted solutions must be administered within 6 hours following mixing. Preparations containing benzyl alcohol (including liquid LEUKINE (sargramostim) and lyophilized LEUKINE (sargramostim) reconstituted with Bacteriostatic Water for Injection) should not be used in neonates (see WARNINGS).
  4. During reconstitution of lyophilized LEUKINE (sargramostim) the diluent should be directed at the side of the vial and the contents gently swirled to avoid foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
  5. LEUKINE (sargramostim) should be used for SC injection without further dilution. Dilution for IV infusion should be performed in 0.9% Sodium Chloride Injection, USP. If the final concentration of LEUKINE (sargramostim) is below 10 mcg/mL, Albumin (Human) at a final concentration of 0.1% should be added to the saline prior to addition of LEUKINE (sargramostim) to prevent adsorption to the components of the drug delivery system. To obtain a final concentration of 0.1% Albumin (Human), add 1 mg Albumin (Human) per 1 Ml 0.9%SodiumChloride Injection, USP (e.g., use 1mL 5%Albumin [Human] in 50 mL 0.9% Sodium Chloride Injection, USP).
  6. An in-line membrane filter should NOT be used for intravenous infusion of LEUKINE (sargramostim) .
  7. Store liquid LEUKINE (sargramostim) and reconstituted lyophilized LEUKINE (sargramostim) solutions under refrigeration at 2-8°C (36-46°F); DO NOT FREEZE.
  8. In the absence of compatibility and stability information, no other medication should be added to infusion solutions containing LEUKINE (sargramostim) . Use only 0.9% Sodium Chloride Injection, USP to prepare IV infusion solutions.
  9. Aseptic technique should be employed in the preparation of all LEUKINE (sargramostim) solutions. To assure correct concentration following reconstitution, care should be exercised to eliminate any air bubbles from the needle hub of the syringe used to prepare the diluent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, the vial should not be used.

HOW SUPPLIED

Liquid LEUKINE (sargramostim) is available in vials containing 500 mcg/mL (2.8 x 106 IU/mL) sargramostim. Lyophilized LEUKINE (sargramostim) is available in vials containing 250 mcg (1.4 x 106 IU/vial) sargramostim.

Each dosage form is supplied as follows:

Lyophilized LEUKINE (sargramostim)

Carton of five vials of lyophilized LEUKINE (sargramostim) 250 mcg (NDC 50419-002-33)

Liquid LEUKINE (sargramostim)

Carton of one multiple-use vial; each vial contains 1 mL of preserved 500 mcg/mL liquid LEUKINE (sargramostim) (NDC 50419-050-14)

Carton of five multiple-use vials; each vial contains 1 mL of preserved 500 mcg/mL liquid LEUKINE (sargramostim) . (NDC 50419-050-30)

Storage

LEUKINE (sargramostim) should be refrigerated at 2-8°C (36-46°F). Do not freeze or shake. Do not use beyond the expiration date printed on the vial.

Manufactured by: Bayer HealthCare Pharmaceuticals, LLC., Seattle, WA 98101. Revised April 2008. FDA rev date: 03/05/91

Last reviewed on RxList: 8/12/2008
This monograph has been modified to include the generic and brand name in many instances.

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