sargramostim


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sargramostim

 [sahr-gram´o-stim]
granulocyte-macrophage colony-stimulating factor produced by recombinant technology; used to enhance neutrophil function, stimulating hematopoiesis and decreasing neutropenia; administered intravenously or subcutaneously.

sargramostim (GM-CSF)

Leukine

Pharmacologic class: Granulocytemacrophage colony stimulating factor

Therapeutic class: Hematopoietic agent

Pregnancy risk category C

Action

Stimulates proliferation and differentiation of hematopoietic cells that activate mature granulocytes and macrophages of target cells

Availability

Liquid: 500 mcg/ml

Powder for injection: 250 mcg

Indications and dosages

Post peripheral blood progenitor cell (PBPC) transplantation

Adults: 250 mcg/m2/day I.V. over 24 hours or subcutaneously once daily, starting immediately after progenitor cell infusion

Mobilization of PBPCs into peripheral blood for collection by leukapheresis

Adults: 250 mcg/m2/day I.V. over 24 hours or subcutaneously once daily, continued throughout harvesting

Neutrophil recovery after chemotherapy in acute myelogenous leukemia Adults: 250 mcg/m2/day I.V. over 4 hours, starting 4 days after completion of chemotherapy induction

Bone-marrow transplantation failure or engraftment delay

Adults: 250 mcg/m2/day as 2-hour I.V. infusion for 14 days. If engraftment doesn't occur, may repeat after 7 days of drug hiatus.

Myeloid reconstitution after autologous or allogeneic bone-marrow transplantation

Adults: 250 mcg/m2/day as a 2-hour I.V. infusion, starting 2 to 4 hours after autologous bone marrow infusion and at least 24 hours after last chemotherapy or radiotherapy dose

Off-label uses

• Crohn's disease
• Melanoma
• Wound healing
• Mucositis
• Stomatitis
• Vaccine adjuvant

Contraindications

• Hypersensitivity to drug, its components, or yeast products
• Excessive leukemic myeloid blasts in bone marrow or peripheral blood (10% or more)
• Within 24 hours before or after chemotherapy or radiation therapy

Precautions

Use cautiously in:
• renal or hepatic insufficiency, fluid retention, pulmonary disorders, pulmonary infiltrates, heart failure, leukocytosis, transient supraventricular arrhythmias
• cancer patients undergoing sargramostim-mobilized PBPC collection
• patients receiving purged bone marrow or previously exposed to intensive chemotherapy or radiation therapy
• pregnant or breastfeeding patients
• children.

Administration

Don't give within 24 hours of chemotherapy or radiation therapy.
• Add 1 ml of sterile water to powder for injection by directing water stream against side of vial and swirling vial gently to disperse contents.
• Avoid shaking or agitating solution.
• For a final drug concentration below 10 mcg/ml, add human albumin 0.1% to saline solution; then dilute drug in normal saline solution.
• Infuse as soon as possible after reconstitution, but no more than 6 hours after mixing.
• Don't add other drugs to infusion; don't use in-line filter.

Adverse reactions

CNS: malaise, asthenia

CV: peripheral edema, tachycardia, hypotension, transient supraventricular tachycardia, pericardial effusion

GI: nausea, vomiting, diarrhea, anorexia, stomatitis, GI hemorrhage

GU: urinary tract disorder, abnormal renal function

Hematologic: blood dyscrasias, hemorrhage

Hepatic: hepatic damage

Musculoskeletal: joint pain, myalgia, bone pain

Respiratory: dyspnea, lung disorder

Skin: rash, alopecia

Other: fever, chills, sepsis, edema, first-dose reaction (respiratory distress, hypoxia, syncope, tachycardia, hypotension, flushing)

Interactions

Drug-drug.Corticosteroids, lithium: potentiation of myeloproliferative effects

Vincristine: severe peripheral neuropathy

Patient monitoring

• Monitor for dyspnea. Halve dosage and contact prescriber if dyspnea occurs.
• Assess CBC with white cell differential. Check for presence of blast cells, and watch for signs and symptoms of blood dyscrasias.
• Closely monitor vital signs and fluid intake and output. Stay alert for signs and symptoms of fluid overload.

Monitor liver function tests, and watch for evidence of hepatic damage and bleeding (especially GI hemorrhage).

Patient teaching

Tell patient sargramostim is a powerful drug that can cause significant adverse reactions. Teach him to recognize and report serious reactions at once.

Instruct patient to immediately report unusual bleeding or bruising or yellowing of skin or eyes.
• Tell patient drug may cause weakness and musculoskeletal pain.
• Inform patient that he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

sar·gra·mos·tim

(sar'gra-mos'tim),
A recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF); used to reduce the duration of neutropenia and incidence of infection in patients receiving myelosuppressive chemotherapy or bone marrow transplantation.

sargramostim

/sar·gram·os·tim/ (sahr-gram´o-stim) granulocyte-macrophage colony-stimulating factor developed by recombinant technology; used to enhance neutrophil function, stimulating hematopoiesis and decreasing neutropenia.

CSF2

A gene on chromosome 5q23-q31 that encodes colony stimulating factor 2 (granulocyte-macrophage), a cytokine that controls the production, differentiation and function of granulocytes and macrophages.

Molecular pathology
CSF2 is localised to a cluster of related genes at chromosome 5q31, a region associated with deletions in the 5q- syndrome and acute myelogenous leukaemia.

Sargramostim®

Recombinant GM-CSF Immunology A biological response modifier that accelerates myeloid recovery in Pts with lymphomas and ALL with BM suppression by chemotherapy and/or RT Side effects Rash, diarrhea, asthenia, malaise. See G-CSF, GM-CSF. Cf Pseudo-orphan drug.

sar·gra·mos·tim

(sahr'gră-mos'tim)
A recombinant human granulocyte-macrophage colony-stimulating factor; used to protect against infection in the presence of acute myelogenous leukemia and in bone marrow transplants.

sargramostim

A granulocyte-macrophage colony-stimulating factor. Sargramostim is a haematopoietic growth factor that stimulates cells of the intestinal immune system.

Sargramostim

A medication made from yeast that stimulates WBC production. It is sold under the trade names Leukine and Prokine.
Mentioned in: Neutropenia
References in periodicals archive ?
The role of sargramostim (rhGM-CSF) as immunotherapy.
Myeloid growth factors currently used for the prophylaxis of febrile neutropenia and maintenance of scheduled dose delivery include filgrastim, pegfilgrastim (category 1), and sargramostim (category 2B).
They were randomized 2:1 to sargramostim (Leukine)--a granulocyte-macrophage, colony-stimulating factor--at 6 mcg/kg per day subcutaneously, or to placebo for 8 weeks.
In addition to reducing disease severity scores, sargramostim appears to significantly improve quality of life," as measured with both the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form-36, Joshua R.
1, a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial, demonstrated treatment with sargramostim resulted in significant improvements in quality-of-life from baseline to Day 57 versus placebo, as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form 36 (SF-36) health surveys.
Sargramostim is marketed in the United States as LEUKINE(R) by Berlex, Inc.
PST) -- Comparison of Infection-Related Hospitalization Risk and Associated Costs Among Patients Receiving Sargramostim (Leukine), Filgrastim (Neupogen), and Pegfilgrastim (Neulasta) for Chemotherapy-Induced Neutropenia -- Poster 3173 (December 8, 5:30 p.
Previous findings suggest that sargramostim may be a potential adjuvant therapy for high-risk melanoma patients," said E.
To read the complete abstract and research on GM-CSF Sargramostim please visit: www.
The reintroduction of liquid sargramostim without EDTA is welcome news to oncologists and hematologists," said Mark Heaney, MD, PhD, Associate Attending Physician, Memorial Sloan-Kettering Cancer Center, New York, NY, who has studied the biology of the receptor of this drug for more than a decade.
Myeloid growth factors recommended in the guidelines are filgrastim (Neupogen(R), Amgen), sargramostim (Leukine(R), Berlex), and pegfilgrastim (Neulasta(R), Amgen).
The trial, called PREMIER (Primary Evaluation Measuring Improved Efficacy of Rituximab with Sargramostim) is evaluating the efficacy and safety of combining therapy with the monoclonal antibody rituximab and the cytokine sargramostim compared to treatment with rituximab alone in patients with relapsed follicular B-cell lymphoma.