Sargramostim

Sargramostim (GM-CSF) belongs to a group of growth factors termed colony-stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. GM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells.

• LEUKINE is a leukocyte growth factor indicated: 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 adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients.ICD-10: C95.90

• Do not administer LEUKINE to patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor such as sargramostim, yeast-derived products, or any component of the product. Anaphylactic reactions have been reported with LEUKINE [see Warnings and Precautions ( 5.1 )] .contraindicated

See Full Prescribing Information for dosage adjustments and timing of administration ( 2.1 - 2.6 ). AML, Neutrophil recovery following chemotherapy: 250 mcg/m 2 /day administered intravenously over a 4-hour period. ( 2.1 ) Mobilization of peripheral blood progenitor cells: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. ( 2.2 ) Post peripheral blood progenitor cell transplantation: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. ( 2.3 ) Myeloid reconstitution after autologous or allogeneic BMT: 250 mcg/m 2 /day administered intravenously over a 2-hour period. ( 2.4 ) BMT failure or engraftment delayed: 250 mcg/m 2 /day for 14 days as a 2-hour intravenous infusion. ( 2.5 ) Patients acutely exposed to myelosuppressive doses of radiation, administer once daily as subcutaneous injection: Adults and pediatric patients weighing >40 kg: 7 mcg/kg Pediatric patients 15 kg to 40 kg: 10 mcg/kg Pediatric patients <15 kg: 12 mcg/kg ( 2.6 ) 2.1 Neutrophil Recovery Following Induction Chemotherapy for Acute Myeloid Leukemia The recommended dose is 250 mcg/m 2 /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.

Hypersensitivity Reactions: Permanently discontinue LEUKINE in patients with serious allergic reactions. ( 5.1 ) Infusion Related Reactions: Manage using infusion rate reductions or discontinuations. ( 5.2 ) Effusions and Capillary Leak Syndrome: Manage with dose-reduction, discontinuation, or diuretics. Monitor body weight and hydration status during therapy. ( 5.4 ) Supraventricular Arrhythmias: Risk may be increased in patients with history of cardiac arrhythmias. Manage medically and discontinue LEUKINE. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. Parenteral administration of LEUKINE should be attended by appropriate precautions in case an allergic or untoward reaction occurs. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Discontinue LEUKINE permanently for patients with serious allergic reactions. 5.2 Infusion Related Reactions LEUKINE can cause infusion-related reactions. Infusion-related reactions may be characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia following the first administration of LEUKINE in a particular cycle. These signs have resolved with symptomatic treatment and usually do not recur with subsequent doses in the same cycle of treatment. Observe closely during infusion for symptoms, particularly in patients with pre-existing lung disease. If patients display dyspnea or other acute symptoms, reduce the rate of infusion by 50%.

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Risk of Severe Myelosuppression when LEUKINE Administered within 24 Hours of Chemotherapy or Radiotherapy [see Warnings and Precautions ( 5.3 )] Effusions and Capillary Leak Syndrome [see Warnings and Precautions ( 5.4 )] Supraventricular Arrhythmias [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Potential Effect on Malignant Cells [see Warnings and Precautions ( 5.7 )] Immunogenicity [see Warnings and Precautions ( 5.8 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [see Warnings and Precautions ( 5.9 )] The most common adverse reactions (incidence >30%) were ( 6.1 ): In recipients of autologous BMT: fever, nausea, diarrhea, vomiting, mucous membrane disorder, alopecia, asthenia, malaise, anorexia, rash, gastrointestinal disorder and edema. In recipients of allogeneic BMT: diarrhea, fever, nausea, rash, vomiting, stomatitis, anorexia, high glucose, alopecia, abdominal pain, low albumin, headache and hypertension. In patients with AML: fever, liver toxicity, skin reactions, infections, metabolic laboratory abnormalities, nausea, diarrhea, genitourinary abnormalities, pulmonary toxicity, vomiting, neurotoxicity, stomatitis, alopecia and weight loss.

Pregnancy: Benzyl alcohol–free formulation recommended. May cause fetal harm. ( 8.1 ) Pediatrics: In infants, avoid use of benzyl alcohol–containing solutions when feasible. ( 2.7 , 5.9 , 8.4 ) Lactation: Advise women not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP contain 0.9% benzyl alcohol, which has been associated with gasping syndrome in neonates and infants. The preservative benzyl alcohol can cause serious adverse reactions and death when administered intravenously to neonates and infants. If LEUKINE is needed during pregnancy, reconstitute LEUKINE for injection only with Sterile Water for injection without preservatives [see Dosage and Administration ( 2.7 ) and Use in Specific Populations ( 8.4 )] . The limited available data on LEUKINE use in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes. Based on animal studies LEUKINE may cause embryofetal harm. In animal reproduction studies, administration of LEUKINE to pregnant rabbits during organogenesis resulted in adverse developmental outcomes including increased spontaneous abortion at systemic exposures ≥1.3 times the human exposure expected at the recommended human dose [see Data ] . Advise pregnant women of the potential risk to a fetus.

Metabolism

Intravenous Administration (IV) Peak concentrations of sargramostim were observed in blood samples obtained during or immediately after completion of LEUKINE infusion. Subcutaneous Administration (SC) Based on a population pharmacokinetics analysis of lyophilized LEUKINE data, the mean C max after a 7 mcg/kg SC dose (equivalent to a 250 mcg/m 2 dose in a 70 kg human with a body surface area of 1.96) was 3.03 ng/mL and mean AUC 0-24 was 21.3 ng•h/mL ( Table 4 ).

Doses up to 100 mcg/kg/day (4,000 mcg/m 2 /day or 16 times the recommended dose) were administered to four patients in a Phase 1 uncontrolled clinical study by continuous IV infusion for 7 to 18 days. Increases in WBC up to 200,000 cells/mm 3 were observed. Adverse events reported were dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache, and chills. All these events were reversible after discontinuation of LEUKINE. In case of overdosage, discontinue LEUKINE therapy and monitor the patient for WBC increase and respiratory symptoms.

• Mar 5, 1991BLABLA103362Berlex Labs

1. 1Pyrexia1539.1%
2. 2Off Label Use1368.1%
3. 3Nausea1187.0%
4. 4Pain1116.6%
5. 5Dyspnoea1106.6%
6. 6Hypotension1106.6%
7. 7Fatigue945.6%
8. 8Diarrhoea865.1%
9. 9Death845.0%
10. 10Vomiting835.0%
11. 11Dizziness613.6%
12. 12Chills573.4%
13. 13Dehydration553.3%
14. 14Syncope543.2%
15. 15Headache492.9%

The 10 most recently updated of 671 ClinicalTrials.gov registrations naming Sargramostim as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
  Recruiting · Phase 2 · Interventional · 62 enrolled · New Approaches to Neuroblastoma Therapy Consortium
  NCT06450041updated 2026-06-10
• Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma
  Recruiting · Phase 1 · Interventional · 12 enrolled · University of Florida
  NCT06514898updated 2026-06-10
• A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma
  Recruiting · Phase 2 · Interventional · 54 enrolled · St. Jude Children's Research Hospital
  NCT07085338updated 2026-06-04
• Testing the SurVaxM Vaccine for Lung Cancer Prevention
  Not yet recruiting · Phase 2 · Interventional · 80 enrolled · National Cancer Institute (NCI)
  NCT07169617updated 2026-06-03
• Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
  Completed · Phase 2 · Interventional · 42 enrolled · National Cancer Institute (NCI)
  NCT03786783updated 2026-06-02
• A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma
  Active not recruiting · Phase 1 · Interventional · 35 enrolled · Children's Oncology Group
  NCT04978727updated 2026-06-02
• pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
  Active not recruiting · Phase 2 · Interventional · 19 enrolled · University of Wisconsin, Madison
  NCT03600350updated 2026-06-01
• A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 600 enrolled · National Cancer Institute (NCI)
  NCT02339571updated 2026-05-29
• Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
  Active not recruiting · Phase 2 · Interventional · 245 enrolled · National Cancer Institute (NCI)
  NCT01134614updated 2026-05-29
• Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas
  Recruiting · Phase 2 · Interventional · 60 enrolled · Roswell Park Cancer Institute
  NCT06202066updated 2026-05-28

Frequently asked questions

How does Sargramostim work?

Sargramostim (GM-CSF) belongs to a group of growth factors termed colony-stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. GM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells.

What is Sargramostim used for?

According to FDA labeling, Sargramostim carries indications including: LEUKINE is a leukocyte growth factor indicated: 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 adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sargramostim?

Sargramostim is classified as Colony stimulating factors, Leukocyte Growth Factor, Biological Response Modifiers, Increased Cytokine Production, Increased Myeloid Cell Production.

What are the brand names for Sargramostim?

Sargramostim is marketed under brand names including Leukine.

What are the contraindications for Sargramostim?

Sargramostim labeling lists contraindications including: Do not administer LEUKINE to patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor such as sargramostim, yeast-derived products, or any component of the product. Anaphylactic reactions have been reported with LEUKINE [see Warnings and Precautions ( 5.1 )] .. Always consult the full prescribing information and a clinician.