Sargramostim

What it is and how it works

Mechanism of Action 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. GM-CSF is also capable of activating mature granulocytes and macrophages. GM-CSF is a multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, can promote the proliferation of megakaryocytic and erythroid progenitors.

Indications

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). For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older.

Dosage and administration (summary)

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. Mobilization of peripheral blood progenitor cells: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. Post peripheral blood progenitor cell transplantation: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. Myeloid reconstitution after autologous or allogeneic BMT: 250 mcg/m 2 /day administered intravenously over a 2-hour period.

Contraindications

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 .

Warnings and precautions

Hypersensitivity Reactions: Permanently discontinue LEUKINE in patients with serious allergic reactions. Infusion Related Reactions: Manage using infusion rate reductions or discontinuations. Effusions and Capillary Leak Syndrome: Manage with dose-reduction, discontinuation, or diuretics. Monitor body weight and hydration status during therapy. Supraventricular Arrhythmias: Risk may be increased in patients with history of cardiac arrhythmias. Manage medically and discontinue LEUKINE.

Pregnancy

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.

Storage and supply

How Supplied LEUKINE (sargramostim) for injection is a sterile, preservative-free, white lyophilized powder supplied in a carton containing five 250 mcg single-dose vials. (NDC 71837-5843-5). Storage and Handling Store LEUKINE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

Source: Sargramostim (Leukine) — US FDA prescribing information, 2024-12-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.