Leukine

LEUKINE- sargramostim injection, powder, lyophilized, for solution
LEUKINE- sargramostim injection, solution
Partner Therapeutics, Inc

1 INDICATIONS AND USAGE

1.1 Acute Myeloid Leukemia Following Induction Chemotherapy

LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).

1.2 Autologous Peripheral Blood Progenitor Cell Mobilization and Collection

LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.

1.3 Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation

LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin’s lymphoma (HL).

1.4 Allogeneic Bone Marrow Transplantation

LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.

1.5 Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure

LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.

1.6 Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS)

LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).

2 DOSAGE AND ADMINISTRATION

2.1 Neutrophil Recovery Following Induction Chemotherapy for Acute Myeloid Leukemia

The recommended dose is 250 mcg/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 less than 5% blasts. If a second cycle of induction chemotherapy is necessary, administer LEUKINE approximately four days after the completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts. Continue LEUKINE until an absolute neutrophil count (ANC) greater than 1500 cells/mm3 for 3 consecutive days or a maximum of 42 days. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiotherapy [see Warnings and Precautions (5.3)].

Dose Modifications
Obtain a CBC with differential twice per week during LEUKINE therapy and modify the dose for the following:

  • Leukemic regrowth: Discontinue LEUKINE immediately
  • Grade 3 or 4 adverse reactions: Reduce the dose of LEUKINE by 50% or interrupt dosing until the reaction abates
  • ANC greater than 20,000 cells/mm3: Interrupt LEUKINE treatment or reduce the dose by 50%

2.2 Autologous Peripheral Blood Progenitor Cell Mobilization and Collection

The recommended dose is 250 mcg/m2 /day administered intravenously over 24 hours or subcutaneously once daily. 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 after 5 days of LEUKINE and performed daily until protocol specified targets were achieved [see Clinical Studies (14)].

If WBC greater than 50,000 cells/mm3 , reduce the LEUKINE dose by 50%. Consider other mobilization therapy if adequate numbers of progenitor cells are not collected.

2.3 Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation

Autologous Peripheral Blood Progenitor Cell Transplantation

The recommended dose is 250 mcg/m2 /day administered intravenously over 24 hours or subcutaneously once daily beginning immediately following infusion of progenitor cells and continuing until an ANC greater than 1500 cells/mm3 for three consecutive days is attained. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiotherapy.

Autologous Bone Marrow Transplantation

The recommended dose is 250 mcg/m2 /day administered intravenously 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. Do not administer LEUKINE until the post marrow infusion ANC is less than 500 cells/mm3. Continue LEUKINE until an ANC greater than 1500 cells/mm3 for three consecutive days is attained. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiotherapy [see Warnings and Precautions (5.3)].

2.4 Allogeneic Bone Marrow Transplantation

The recommended dose is 250 mcg/m2 /day administered intravenously 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. Do not administer LEUKINE until the post marrow infusion ANC is less than 500 cells/mm3. Continue LEUKINE until an ANC greater than 1500 cells/mm3 for three consecutive days is attained. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiotherapy [see Warnings and Precautions (5.3)].

Dose Modifications
Obtain a CBC with differential twice per week during LEUKINE therapy and modify the dose as for the following:

  • Disease progression or blast cell appearance: Discontinue LEUKINE immediately
  • Grade 3 or 4 adverse reactions: Reduce the dose of LEUKINE by 50% or temporarily discontinue until the reaction abates
  • WBC greater than 50,000 cells/mm3 or ANC greater than 20,000 cells/mm3: Interrupt LEUKINE treatment or reduce the dose by 50%

2.5 Allogeneic or Autologous Bone Marrow Transplantation: Treatment of Delayed Neutrophil Recovery or Graft Failure

The recommended dose is 250 mcg/m2 /day for 14 days as a 2-hour intravenous infusion. The dose can be repeated after 7 days off therapy if neutrophil recovery has not occurred. If neutrophil recovery 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.

Dose ModificationsObtain a CBC with differential twice per week during LEUKINE therapy and modify the dose as for the following:

  • Disease progression or blast cell appearance: Discontinue LEUKINE immediately
  • Grade 3 or 4 adverse reactions: Reduce the dose of LEUKINE by 50% or temporarily discontinue until the reaction abates
  • WBC greater than 50,000 cells/mm3 or ANC greater than 20,000 cells/mm3: Interrupt LEUKINE treatment or reduce the dose by 50%

2.6 Acute Exposure to Myelosuppressive Doses of Radiation (H-ARS)

For patients with H-ARS, the recommended dose of LEUKINE is a subcutaneous injection administered once daily as follows:

  • 7 mcg/kg in adult and pediatric patients weighing greater than 40 kg
  • 10 mcg/kg in pediatric patients weighing 15 kg to 40 kg
  • 12 mcg/kg in pediatric patients weighing less than 15 kg

Administer LEUKINE as soon as possible after suspected or confirmed exposure to radiation doses greater than 2 gray (Gy).

Estimate a patient’s absorbed radiation dose (i.e., level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics.

Obtain a baseline CBC with differential and then serial CBCs approximately every third day until the ANC remains greater than 1,000/mm3 for three consecutive CBCs. Do not delay administration of LEUKINE if a CBC is not readily available.

Continue administration of LEUKINE until the ANC remains greater than 1,000/mm3 for three consecutive CBCs or exceeds 10,000/mm3 after a radiation-induced nadir.

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