Sargramostim Dosage
Medically reviewed by Drugs.com. Last updated on Oct 4, 2024.
Applies to the following strengths: 250 mcg; 500 mcg/mL; 500 mcg
Usual Adult Dose for:
- Neutropenia Associated with Chemotherapy
- Bone Marrow Transplantation - Failure or Engraftment Delay
- Bone Marrow Transplantation - Myeloid Reconstruction
- Peripheral Progenitor Cell Transplantation
- Neutropenia Associated with Radiation
Usual Pediatric Dose for:
- Peripheral Progenitor Cell Transplantation
- Bone Marrow Transplantation - Myeloid Reconstruction
- Bone Marrow Transplantation - Failure or Engraftment Delay
- Neutropenia Associated with Radiation
Additional dosage information:
Usual Adult Dose for Neutropenia Associated with Chemotherapy
55 years and older: 250 mcg/m2/day administered IV over a 4-hour period
Comments:
- Start approximately on day 11 or 4 days after completion of induction chemotherapy if on day 10 bone marrow is hypoplastic (less than 5% blasts).
- If a second cycle of induction chemotherapy is necessary, administer this drug approximately 4 days after the completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts.
- Continue treatment until an absolute neutrophil count (ANC) greater than 1500 cells/mm3 for 3 consecutive days or a maximum of 42 days.
- Do not administer this drug within 24 hours preceding or following receipt of chemotherapy or radiotherapy
Use: 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).
Usual Adult Dose for Bone Marrow Transplantation - Failure or Engraftment Delay
250 mcg/m2/day for 14 days as a 2-hour IV infusion
Comments:
- 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.
Use: For the treatment of adult patients who have undergone allogeneic or autologous BMT in whom neutrophil recovery is delayed or failed.
Usual Adult Dose for Bone Marrow Transplantation - Myeloid Reconstruction
Autologous and Allogenic Bone Marrow Transplantation (BMT):
250 mcg/m2/day IV over a 2-hour period
Comments:
- Begin infusion 2 to 4 hours after bone marrow infusion, and not less than 24 hours after the last dose of chemotherapy or radiotherapy.
- Do not administer this drug until the post marrow infusion ANC is less than 500 cells/mm3.
- Continue therapy until ANC is greater than 1500 cells/mm3 for 3 consecutive days.
- Do not administer this drug within 24 hours preceding or following receipt of chemotherapy or radiotherapy.
Uses:
- For the acceleration of myeloid reconstitution following autologous BMT in adults with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).
- For the acceleration of myeloid reconstitution in adult patients undergoing allogeneic BMT from HLA-matched related donors.
Usual Adult Dose for Peripheral Progenitor Cell Transplantation
MOBILIZATION OF PERIPHERAL BLOOD PROGENITOR CELLS (PBPC):
250 mcg/m2 IV over 24 hours OR via subcutaneous injection once a day
Comments:
- 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 was usually begun after 5 days of administering this drug and performed daily until protocol specified targets were achieved.
- If WBC is greater than 50,000 cells/mm3, reduce dose by 50%.
- Consider other mobilization therapy if adequate numbers of progenitor cells are not collected.
POST PBPC TRANSPLANTATION :
250 mcg/m2 IV over 24 hours OR subcutaneous injection once a day beginning immediately following the infusion of PBPC
Comments:
- Continue treatment until ANC is greater than 1500 cells/mm3 for 3 consecutive days.
- Do not administer this drug within 24 hours preceding or following receipt of chemotherapy or radiotherapy.
Uses:
- 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.
- For the acceleration of myeloid reconstitution following autologous PBPC transplantation in adult patients with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).
Usual Adult Dose for Neutropenia Associated with Radiation
Patients acutely exposed to myelosuppressive doses of radiation:
Once a day as a subcutaneous injection
- Adults weighing greater than 40 kg: 7 mcg/kg
Comments:
- Administer this drug 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 the administration of this drug if a CBC is not readily available.
- Continue administration until the ANC remains greater than 1,000/mm3 for three consecutive CBCs or exceeds 10,000/mm3 after a radiation-induced nadir.
Use: To increase survival in adults acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Usual Pediatric Dose for Peripheral Progenitor Cell Transplantation
Post PBPC Transplantation :
2 years or older: 250 mcg/m2 IV over 24 hours OR via subcutaneous injection once a day beginning immediately following the infusion of PBPC
Comments:
- Continue treatment until ANC is greater than 1500 cells/mm3 for 3 consecutive days.
- Do not administer this drug within 24 hours preceding or following receipt of chemotherapy or radiotherapy.
Use: For the acceleration of myeloid reconstitution following autologous PBPC transplantation in pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).
Usual Pediatric Dose for Bone Marrow Transplantation - Myeloid Reconstruction
Autologous and Allogenic BMT:
2 years and older: 250 mcg/m2/day IV over a 2-hour period
Comments:
- Begin infusion 2 to 4 hours after bone marrow infusion, and not less than 24 hours after the last dose of chemotherapy or radiotherapy.
- Do not administer this drug until the post marrow infusion ANC is less than 500 cells/mm3.
- Continue therapy until ANC is greater than 1500 cells/mm3 for 3 consecutive days.
- Do not administer this drug within 24 hours preceding or following receipt of chemotherapy or radiotherapy.
Uses:
- For the acceleration of myeloid reconstitution following autologous bone marrow transplantation in pediatric patients 2 years of age and older with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL).
- For the acceleration of myeloid reconstitution in pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
Usual Pediatric Dose for Bone Marrow Transplantation - Failure or Engraftment Delay
2 years and older: 250 mcg/m2/day for 14 days as a 2-hour IV infusion
Comments:
- 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.
Use: For the treatment of pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.
Usual Pediatric Dose for Neutropenia Associated with Radiation
Patients from birth to 17 years acutely exposed to myelosuppressive doses of radiation:
Once a day as a subcutaneous injection
- Pediatric patients weighing greater than 40 kg: 7 mcg/kg
- Pediatric patients weighing 15 kg to 40 kg: 10 mcg/kg
- Pediatric patients weighing less than 15 kg: 12 mcg/kg
Comments:
- Administer this drug 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 the administration of this drug if a CBC is not readily available.
- Continue administration until the ANC remains greater than 1,000/mm3 for three consecutive CBCs or exceeds 10,000/mm3 after a radiation-induced nadir.
Use: To increase the survival in pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
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):
Obtain a CBC with differential twice per week during therapy and modify the dose if:
- Leukemic regrowth occurs: Discontinue this drug immediately.
- A grade 3 or 4 adverse reaction occurs: Reduce dose by 50% or temporarily discontinue until the reaction subsides.
- ANC is greater than 20,000 cells/mm3: Interrupt treatment or reduce the dose by 50%.
Mobilization of peripheral blood progenitor cells (PBPCs):
- If WBC is greater than 50,000 cells/mm3: Reduce dose by 50%.
- If inadequate progenitor cells are collected: Consider other mobilization therapy.
Myeloid reconstitution after allogenic bone marrow transplantation (BMT):
Obtain a CBC with differential twice per week during therapy and modify the dose if:
- Blast cells appear, or disease progression occurs: Discontinue this drug immediately.
- A grade 3 or 4 adverse reaction occurs: Reduce dose by 50% or temporarily discontinue until the reaction subsides.
- WBC is greater than 50,000 cells/mm3 or ANC is greater than 20,000 cells/mm3: Interrupt treatment or reduce dose by 50%.
BMT failure or engraftment delay:
Obtain a CBC with differential twice per week during therapy and modify the dose if:
- Blast cells appear, or disease progression occurs: Discontinue this drug immediately.
- If a grade 3 or 4 adverse reaction occurs: Reduce dose by 50% or temporarily discontinue until the reaction subsides.
- WBC is greater than 50,000 cells/mm3 or ANC is greater than 20,000 cells/mm3: Interrupt treatment or reduce the dose by 50%.
Precautions
CONTRAINDICATIONS:
- In patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor, yeast-derived products, or any component of the product.
Safety and efficacy have not been established in patients younger than 2 years old for autologous peripheral blood progenitor cells and bone marrow transplantation, allogeneic bone marrow transplantation, and treatment of delayed neutrophil recovery or graft failure have not been established.
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.
- Do not administer this drug simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
- Do NOT administer using an in-line membrane filter during IV infusion.
- The lyophilized powder for injection should be reconstituted ONLY with Sterile Water for Injection without preservatives when administering this drug to neonates or infants to avoid benzyl alcohol exposure.
Reconstitution/preparation techniques: The manufacturer product information should be consulted.
Storage requirements :
- Store vials and reconstituted solution under refrigeration at 2C to 8C (36F to 46F).
- When reconstituted with Sterile Water for Injection, USP (without preservative), may store the reconstituted solution refrigerated and must use within 24 hours following reconstitution.
- When reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol), may store the reconstituted solution refrigerated and must use within 20 days following reconstitution.
- Do not freeze or shake.
- Do not use beyond the expiration date printed on the vial.
IV compatibility: Use only 0.9% Sodium Chloride Injection to prepare IV infusion solutions. 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.
- Hypersensitivity: Signs or symptoms of allergic reactions during infusions.
- Metabolic: Body weight and hydration status during treatment.
- 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.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
- Women of childbearing potential should let their healthcare provider know if they are pregnant, plan to become pregnant, or are breastfeeding.
- Tell your healthcare provider if you have heart or lung disease.
More about sargramostim
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