Usual Adult Dose for Neutropenia Associated with Chemotherapy

250 mcg/m2/day IV over a 4 hour period beginning on or around day 11 or 4 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 needed, administer approximately 4 days after the completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts. Continue until absolute neutrophil count (ANC) is greater than 1500 cells/mm3 for 3 consecutive days or a maximum of 42 days.

Use: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML). Safety and efficacy have not been assessed in AML patients younger than 55 years.

Usual Adult Dose for Bone Marrow Transplantation - Myeloid Reconstruction

250 mcg/m2/day IV over 2 hours beginning 2 to 4 hours after bone marrow infusion and at least 24 hours after the last dose of chemotherapy or radiotherapy when absolute neutrophil count (ANC) is less than 500 cells/mm3; continue until ANC is greater than 1500 cells/mm3 for 3 consecutive days.

Uses:

• To accelerate myeloid recovery in patients with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL), and Hodgkin's disease undergoing autologous bone marrow transplantation (BMT).
• To accelerate myeloid recovery in patients undergoing allogeneic BMT from human leukocyte antigen (HLA)-matched related donors.

Usual Adult Dose for Bone Marrow Transplantation - Failure or Engraftment Delay

250 mcg/m2/day IV for 14 days as a 2 hour infusion. The dose can be repeated 7 days later if engraftment has not been achieved. If engraftment has not taken place after the second administration of this drug, a dose of 500 mcg/m2/day for 14 days may be administered beginning 7 days after the previous dose (14 days after the initial dose).

Use: To prolong survival of patients who are experiencing graft failure or engraftment delay, in the presence or absence of infection, following autologous or allogeneic bone marrow transplantation (BMT).

Usual Adult Dose for Peripheral Progenitor Cell Transplantation

MOBILIZATION:
250 mcg/m2/day IV over 24 hours or subcutaneously once a day. Continue at the same dose throughout peripheral blood progenitor cell (PBPC) collection.

Comments: Optimal PBPC collection times have not been established; in clinical studies, collection usually began by day 5 and was performed daily until protocol targets were achieved.

Use: Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.

POST-TRANSPLANT:
250 mcg/m2/day IV over 24 hours or subcutaneously once a day immediately following progenitor cell infusion and continuing until absolute neutrophil count (ANC) is greater than 1500 cells/mm3 for 3 consecutive days.

Use: To further accelerate myeloid reconstitution following PBPC transplantation.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

If dyspnea occurs during administration: Reduce the infusion rate by half; if respiratory symptoms worsen despite infusion rate reduction: Discontinue this drug; subsequent IV infusions may be administered following the standard dose schedule with careful monitoring.

Neutrophil recovery following chemotherapy in acute myelogenous leukemia (AML):

• If leukemic regrowth occurs: Discontinue this drug immediately.
• If a severe adverse reaction occurs: May reduce dose by 50% or temporarily discontinue until the reaction subsides.

• If WBC is greater than 50,000 cells/mm3: Reduce dose by 50%.
• If inadequate progenitor cells are collected: Consider other mobilization therapy.

• If a severe adverse reaction occurs: May reduce dose by 50% or temporarily discontinue until the reaction subsides.
• If blast cells appear or disease progression occurs: Discontinue this drug immediately.

• If a severe adverse reaction occurs: May reduce dose by 50% or temporarily discontinue until the reaction subsides.
• If blast cells appear or disease progression occurs: Discontinue this drug immediately.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration advice: This drug should be used under the guidance and supervision of a health care professional unless determined otherwise by the physician.

Storage requirements: The manufacturer product information should be consulted.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: No other medication should be added to infusion solutions containing this drug.

Monitoring:

• Hematologic: Complete blood count (CBC) with differential and examination for blast cells twice a week.
• Hepatic: Hepatic function in patients displaying liver dysfunction prior to initiation of treatment and at least every other week during treatment.
• Metabolic: Body weight and hydration status.
• Renal: Renal function in patients displaying kidney dysfunction prior to initiation of treatment and at least every other week during treatment.
• Respiratory: Respiratory symptoms during and immediately after infusion of this drug, especially in patients with preexisting lung disease.

• If the physician determines that this drug may be used outside of the hospital or office setting, the people who will be administering this drug should be instructed regarding proper reconstitution, administration, and disposal of this drug.
• Female patients of childbearing potential should be apprised of the potential harm to the fetus.