Names and pronunciation
(sar-gram′oh-stim) Leukine
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Drug reference
(sar-gram′oh-stim) Leukine
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Func. class.: Biologic modifier, hematopoietic agent
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Chem. class.: Granulocyte mac- rophage colony-stimulating factor (GM-CSF)
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ACTION: Stimulates proliferation and differentiation of hematopoietic progeni- tor cells (granulocytes, macrophages)
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USES: Acceleration of myeloid recovery in patients with non–Hodgkin’s lymphoma, acute lymphoblastic leukemia, acute myelogenous leukemia, autologous bone marrow transplantation in Hodgkin’s dis- ease; bone marrow transplantation failure or engraftment delay, mobilization and transplant of peripheral blood progenitor cells (PBPCs)
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Unlabeled uses: Aplastic anemia, Crohn’s disease, ganciclovir- or zidovudine-induced neutropenia, malignant melanoma, myelo- dysplastic syndrome (MDS)
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CONTRAINDICATIONS: Neo- nates; hypersensitivity to GM-CSF, benzyl alcohol, yeast products; excessive leuke- S mic myeloid blast in bone marrow, peripheral blood Precautions: Pregnancy, breastfeeding, children; lung/cardiac/renal/hepatic dis- ease; pleural, pericardial effusions, peripheral edema, leukocytosis, manni- tol hypersensitivity, hepatic/renal disease
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SIDE EFFECTS CNS: Fever, malaise, CNS disorder, weak- ness, chills, dizziness, syncope, headache CV: Transient supraventricular tachycar- dia, peripheral edema, pericardial effu- sion, hypotension, tachycardia GI: Nausea, vomiting, diarrhea, anorexia, GI hemorrhage, stomatitis, liver damage, hyperbilirubinemia GU: Urinary tract disorder, abnormal kidney function HEMA: Blood dyscrasias, hemorrhage INTEG: Alopecia, rash, peripheral edema MS: Bone pain, myalgia RESP: Dyspnea
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INTERACTIONS Increase: myeloproliferation—lithium, corticosteroids Drug/Lab Test Increase: bilirubin, BUN, creatinine, eosinophils, LFTs, leukocytes
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DOSAGE AND ROUTES Myeloid recovery in Hodgkin’s disease, non-Hodgkin’s lymphoma, acute lymphocytic leukemia • Adult/adolescent/child ≥2 yr: IV 250 mcg/m2/day over a 2-hr period begin- ning 2-4 hr after infusion of bone mar- row and not <24 hr after last dose of chemotherapy or radiotherapy Following engraftment failure • Adult/adolescent/child ≥2 yr: IV 250 mcg/m2/day × 14 days; give over 2 hr; may repeat in 7 days; may repeat 500 mcg/m2/day × 14 days after another 7 days if no improvement Mobilization of PBPCs • Adult: CONT IV 250 mcg/m2/24 hr or SUBCUT daily; continue through collection After PBPC transplantation • Adult: CONT IV 250 mcg/m2/day until ANC >1500 cells/mm3 Aplastic anemia (unlabeled) • Adult: SUBCUT 250-500 mcg/day or 5 mcg/kg/day × 14-90 days, used with eryth- ropoietin or immunosuppressive therapy
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Available forms: Powder for inj lyophi- lized 250 mcg; sol for inj 500 mcg/mL
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Administer: • Store in refrigerator; do not freeze SUBCUT route • No further dilution of reconstituted sol is needed; take care not to inject intrader- mally Intermittent IV INFUSION route • After reconstituting with 1 mL sterile water for inj without preservative; do not reenter vial; discard unused portion; di- rect reconstitution sol at side of vial; ro- tate contents; do not shake • Dilute in 0.9% NaCl inj to prepare IV in- fusion; if final concentration is <10 mcg/ mL, add human albumin to make final concentration of 0.1% to NaCl before add- ing sargramostim to prevent adsorption; for a final concentration of 0.1% albumin, add 1 mg human albumin/1 mL 0.9% NaCl inj run over 2 hr (bone marrow transplant or failure of graft); over 4 hr (chemo- therapy for AML); over 24 hr as cont in- fusion (PBPCs); give within 6 hr after re- constitution Y-site compatibilities: Amikacin, ami nophylline, aztreonam, bleomycin, butorphanol, calcium gluconate, CAR- BOplatin, carmustine, ceFAZolin, cefepime, cefotaxime, cefoTEtan, cefti- zoxime, cefTRIAXone, cefuroxime, cimetidine, CISplatin, clindamycin, cyclophosphamide, cycloSPORINE, cytara- bine, dacarbazine, DACTINomycin, dexamethasone, diphenhydrAMINE, DOPamine, DOXOrubicin, doxycycline, droperidol, etoposide, famotidine, fen- taNYL, floxuridine, fluconazole, fluoro- uracil, furosemide, gentamicin, granis- etron, heparin, IDArubicin, ifosfamide, immune globulin, magnesium sulfate, mannitol, mechlorethamine, meperi- dine, mesna, methotrexate, metoclo- pramide, metroNIDAZOLE, minocycline, mitoXANTRONE, netilmicin, pentostatin, piperacillin/tazobactam, potassium chloride, prochlorperazine, prometha- zine, ranitidine, teniposide, ticarcillin, ticarcillin-clavulanate, trimethoprim- sulfamethoxazole, vinBLAStine, vinCRIS- tine, zidovudine
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Assess: • Blood studies: CBC, differential count before treatment, 2× weekly; leukocyto- sis may occur (WBC >50,000 cells/mm3, ANC >20,000 cells/mm3), platelets; if ANC >20,000/mm3 or 10,000/mm3 after nadir has occurred or platelets >500,000/mm3, reduce dose by ½ or discontinue; if blast cells occur, discontinue • Renal, hepatic studies before treat- ment: BUN, creatinine, urinalysis; AST, ALT, alk phos; 2× weekly monitoring is needed in renal/hepatic disease • Hypersensitivity, anaphylaxis rashes, local inj-site reactions; usually transient • Body weight, hydration status; in- creased fluid retention in cardiac dis- ease; pulmonary function • Constitutional symptoms: asthenia, chills, fever, headache, malaise • Myalgia, arthralgia in legs, feet; use analgesics, antipyretics • Gasping syndrome in neonates: due to benzyl alcohol hypersensitivity, do not use • Pregnancy/breastfeeding: use only if clearly needed; cautious use in breast- feeding, excretion unknown
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Evaluate: • Therapeutic response: WBC and dif- ferential recovery
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That bone pain may occur with use of the product and is normal • To report excessive diarrhea, B/P in- crease, or respiratory symptoms to health care provider immediately • To review all aspects of product use
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PHARMACOKINETICS Half-life elimination: IV 60 min, SUBCUT 2-3 hr; detected within 5 min after administration, peak 2 hr
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• Adult/adolescent/child ≥2 yr: IV 250 mcg/m2/day over a 2-hr period begin- ning 2-4 hr after infusion of bone mar- row and not <24 hr after last dose of chemotherapy or radiotherapy Following engraftment failure
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• Adult/adolescent/child ≥2 yr: IV 250 mcg/m2/day × 14 days; give over 2 hr; may repeat in 7 days; may repeat 500 mcg/m2/day × 14 days after another 7 days if no improvement Mobilization of PBPCs
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