Leukine

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.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

Leukine®

Sargramostim Oncology A formulation of GM-CSF used for cell recovery in Pts with ↓ cell counts due to chemotherapy with Immunex. See GM-CSF.

McGraw-Hill Concise Dictionary of Modern Medicine. © 2002 by The McGraw-Hill Companies, Inc.