Sargramostim
Also known as: CSL795, GM-CSF, Leukine, Molgramostim, rhu GM-CSF, rhuGM‑CSF, SAR
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Summary
Recombinant human GM‑CSF (Sargramostim) accelerates bone‑marrow recovery and treats neutropenia in patients undergoing chemotherapy, stem‑cell transplantation, or with acute myeloid leukemia.
Mechanism of Action
Binds GM-CSF receptor on hematopoietic progenitors, stimulating proliferation, differentiation, and activation of neutrophils, monocytes, and macrophages.
Routes of Administration
Goals & Uses
- Treatment of acute radiation syndrome (ARS)Radiation Emergency CountermeasureModerate
- Neutrophil recovery in AML induction chemotherapyOncology Supportive CareHigh
- Accelerate neutrophil recoveryHematologyHigh
- Graft failure or engraftment delayHematopoietic SupportModerate
- Treat pulmonary alveolar proteinosisRespiratoryModerate
- Mobilization of hematopoietic progenitor cellsHematologyHigh
- Accelerate myeloid recovery after bone marrow transplantationHematopoietic SupportHigh
- Immunomodulation in COVID-19 (investigational)ImmunotherapyLow
Contraindications
- Hypersensitivity to sargramostim or yeast proteinsAllergyModerate
- Hypersensitivity to sargramostim, yeast-derived products, or any componentAllergyHigh
- Active systemic infection without adequate antimicrobial coverageInfectionModerate
- Neonates (benzyl alcohol-containing formulation)PediatricHigh
- Concurrent use with chemotherapy or radiotherapyOncologyHigh
- Excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%)OncologyHigh
Adverse Effects
- Bone painMusculoskeletalCommon
- Fever and constitutional symptomsGeneralCommon
- Fluid retention / peripheral edemaCardiovascularUncommon
- Injection site reactionsLocalCommon
- Capillary leak syndromeVascularRareLeakage of fluid from blood vessels into tissues
- First-dose reaction (flushing, hypotension, tachycardia, dyspnea)HypersensitivityUncommon
- FeverSystemicCommonElevated body temperature
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
Drug Interactions
- Cytotoxic chemotherapy agentsHigh
- WarfarinModerate
- Cytotoxic chemotherapyLow
- CorticosteroidsModerate
- LithiumLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Neonates / premature infants (benzyl alcohol formulation)PediatricAbsolute
- Patients with pre-existing pulmonary diseaseRespiratoryRelative
- Patients with pre-existing cardiac diseaseCardiovascularRelative
- Pediatrics (<2 years)AgeRelative
- Renal or hepatic impairmentOrgan DysfunctionRelative
Regulatory Status
- European UnionApprovedApproved: Myeloid recovery, Pulmonary alveolar proteinosis (inhaled)Inhaled sargramostim (Leukine® Inhalation) approved for PAP.
- United StatesApprovedApproved: Myeloid recovery after bone‑marrow transplant, Acute myeloid leukemia, Infection prophylaxis in neutropenic patientsSubcutaneous or intravenous; inhaled formulation not FDA‑approved.
- United KingdomApprovedApproved: Myeloid recovery, Acute myeloid leukemiaSame indications as US; inhaled use off‑label.
FDA‑approved (US) for myeloid recovery post‑bone‑marrow transplant, for acute myeloid leukemia, and for infection prophylaxis; EMA‑approved (EU) for similar indications and for pulmonary alveolar proteinosis (inhaled formulation).
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Sargramostim?
Recombinant human GM‑CSF (Sargramostim) accelerates bone‑marrow recovery and treats neutropenia in patients undergoing chemotherapy, stem‑cell transplantation, or with acute myeloid leukemia.
What is Sargramostim used for?
Sargramostim is educationally associated with: Treatment of acute radiation syndrome (ARS), Neutrophil recovery in AML induction chemotherapy, Accelerate neutrophil recovery, Graft failure or engraftment delay, Treat pulmonary alveolar proteinosis, Mobilization of hematopoietic progenitor cells, Accelerate myeloid recovery after bone marrow transplantation, Immunomodulation in COVID-19 (investigational). Educational only — not medical advice.
How is Sargramostim administered?
Recorded routes of administration: Inhalation, Intravenous, Subcutaneous.
What are the potential side effects of Sargramostim?
Reported adverse effects include: Bone pain, Fever and constitutional symptoms, Fluid retention / peripheral edema, Injection site reactions, Capillary leak syndrome, First-dose reaction (flushing, hypotension, tachycardia, dyspnea), Fever, Injection site reaction. This list is not exhaustive — consult a qualified clinician.
Who should avoid Sargramostim?
Recorded contraindications: Hypersensitivity to sargramostim or yeast proteins, Hypersensitivity to sargramostim, yeast-derived products, or any component, Active systemic infection without adequate antimicrobial coverage, Neonates (benzyl alcohol-containing formulation), Concurrent use with chemotherapy or radiotherapy, Excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%). Consult a qualified clinician before use.