Sargramostim (Granulocyte Macrophage Colony–Stimulating Factor, GM-CSF)(sar gram’ oh stim)
Leukine
PREGNANCY CATEGORY C
Drug Class
Colony-stimulating factor
Therapeutic Actions
Human GM-CSF produced by recombinant DNA technology; increases the proliferation and differentiation of hematopoietic progenitor cells; can activate mature granulocytes and macrophages.
Indications
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Myeloid reconstitution after autologous bone marrow transplantation and allogeneic bone marrow transplantation
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Treatment of neutropenia associated with bone marrow transplantation failure or engraftment delay
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Induction chemotherapy in AML to shorten neutrophil recovery time
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Mobilization of hematopoietic progenitor cells for collection by leukapheresis and to accelerate myeloid reconstitution following peripheral blood progenitor cell (PBPC) transplantation
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Unlabeled uses: Treatment of myelodysplastic syndrome, decreases nadir of leukopenia related to myelosuppression of chemotherapy, corrects neutropenia in aplastic anemia patients, decreases transplant-associated organ system damage, promotes early grafting; stomatitis, melanoma, drug-induced neutropenia, Crohn’s disease, oral mucositis
Contraindications and Cautions
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Contraindicated with hypersensitivity to yeast products; excessive leukemic myeloid blasts in bone marrow or peripheral blood; in neonates (benzyl alcohol is a constituent of Leukine liquid and bacteriostatic water for injection diluent and should not be administered to neonates because of association with fatal “gasping syndrome”); concomitant use with chemotherapy and radiation therapy or within 24 hr preceding or following chemotherapy or radiation therapy.
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Use cautiously with renal or hepatic failure, pregnancy, lactation.
Available Forms
Powder for injection—250 mcg; solution for injection—500 mg/mL
Dosages
Adults
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Myeloid reconstitution after autologous or allogeneic bone marrow transplantation: 250 mcg/m2/day for 21 days as a 2-hr IV infusion beginning 2–4 hr after the autologous bone marrow infusion and not less than 24 hr after the last dose of chemotherapy and radiation therapy. Patient should not receive sargramostim until post-marrow infusion ANC is less than 500 cells/mm3. Continue until ANC is greater than 1,500 cells/mm3 for 3 consecutive days. If severe adverse reactions occur, decrease dose by 50% or stop drug. If patient has blast cells or disease progression, stop drug immediately.
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