Sargramostim

DEA Class; Rx

Common Brand Names; gmcsf, Leukine

• Hematopoietic Growth Factors

Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Used to help increase white blood cell production after bone marrow transplantation (BMT), after BMT failure or engraftment delay, before and after stem-cell transplant, and after induction chemotherapy in older patients with acute myelogenous leukemia
Also used to treat acute radiation exposure in patients who received myelosuppressive doses of radiation

Indicated to shorten time to neutrophil recovery and to reduce incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients ≥55 years with acute myeloid leukemia (AML)

Indicated in adults with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis

Indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adults with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin’s lymphoma (HL)

Indicated for the acceleration of myeloid reconstitution in adults undergoing allogeneic bone marrow transplantation from HLA-matched related donors

Indicated for the treatment of adults undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed

Indicated to increase survival in adults acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])

History of serious allergic reactions (eg, anaphylaxis to human GCSFs [such as sargramostim], yeast-derived products, or any component of the product)

>10% leukemic myeloid blasts in bone marrow or peripheral blood

Do not administer within 24 hr preceding or following chemotherapy or radiotherapy

Autologous BMT

• Abdominal pain (89%)

• Diarrhea (89%)

• Asthenia (66%)

• Malaise (57%)

• Rash (44%)

• Chest pain (11%)

• Peripheral edema (11%)

Acute myelogenous leukemia

• Fever (81%)

• Skin reaction (77%)

• Metabolic disease (58%)

• Nausea (58%)

• Vomiting (46%)

• Weight loss (37%)

Diarrhea (allogenic BMT 81%)

Nausea (allogenic BMT 70%)

Vomiting (allogenic BMT 70%)

Abdominal pain (allogenic BMT 38%)

Hyperbilirubinemia (allogenic BMT 30%)

Rigor (allogenic BMT 25%)

Cardiac dysrhythmia (BMT graft failure 25%)

Pericardial effusion (BMT graft failure 25%)

Pruritis (allogenic BMT 23%)

Increase serum BUN (allogenic BMT 23%)

Pharyngitis (allogenic BMT 23%)

Bone pain (allogenic BMT 21%)

Myalgia (BMT graft failure 18%)

Hypercholesterolemia (allogenic BMT 17%)

Hypomagnesemia (allogenic BMT 15%)

Chest pain (allogenic BMT 15%)

Hematemesis (allogenic BMT 13%)

GI hemorrhage (allogenic BMT 11%)

Intraocular hemorrhage (allogenic BMT 11%)

Dysphagia (allogenic BMT 11%)

Arthralgia (allogenic BMT 11%)

Caution in fluid retention, pulmonary infiltrates, CHF, lung disease, cardiac disease, hypoxia, hepatic/renal impairment; conditions may worsen

Solution should NOT be administered to neonates due to presence of benzyl alcohol in the formulation ant its association with “gasping syndrome”

Discontinue immediately if blast cells appear or disease progression occurs

Reformulated liquid devoid of sodium EDTA now available

Treatment may induce neutralizing anti-drug antibodies; incidence of anti-sargramostim neutralizing antibodies may be related to duration of exposure

A first dose effect characterized by respiratory distress, hypoxia, flushing, hypotension , syncope, and/or tachycardia, may occur with the first dose of the cycle and resolve with appropriate symptomatic treatment; symptoms do not usually occur with subsequent doses within that cycle

Edema, capillary leak syndrome, pleural and/or pericardial effusion; fluid retention shown to be reversible with dosage reduction or discontinuation with or without concomitant use of diuretics

If there is a rapid increase in blood counts (ANC ≥20,000/mm³, WBC >50,000/mm³, platelets >500,000/mm³), decrease dose by 50% or discontinue therapy; excessive blood counts should fall to normal within 3-7 days after discontinuation of therapy; monitor with differential twice weekly during treatment

Sequestration of granulocytes in pulmonary circulation and dyspnea reported; monitor respiratory symptoms during and following IV infusion; decrease infusion rate by 50% if dyspnea occurs; discontinue infusion if dyspnea persists despite reduction in rate of administration; subsequent doses may be administered at standard rate with careful monitoring

Supraventricular arrhythmia reported in uncontrolled studies during administration, particularly in patients with a previous history of cardiac arrhythmia

Serious hypersensitivity reactions, including anaphylactic reactions reported (see Contraindications)

May cause infusion-related reactions

Owing to the possibility of tumor growth potentiation, exercise caution when using this drug in any malignancy with myeloid characteristic

Avoid concomitant use of sargramostim and products that induce myeloproliferation (eg, lithium, corticosteroids)

Limited available data on use in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes

No information regarding the presence of drug in human milk, the effects on the breastfed child, or the effects on milk production

500 mcg/m2 IV daily or 250 mcg/m2 subcutaneously daily.

500 mcg/m2 IV daily or 250 mcg/m2 subcutaneously daily.

250 mcg/m2 IV daily.

2 years and older: 250 mcg/m2 IV daily.

Sargramostim 

injectable solution

• 500mcg/mL

injection, lyophilized powder for reconstitution

• 250mcg/vial