damaging [55:<10 mcg/mL, add albumin human to minimize adsorption of the drug to drug delivery system components. 1 Add 1 mg of albumin human per 1 mL of 0.9% sodium chloride injection (e.g., dilute 1 mL of 5% albumin human in 50 mL of 0.9% sodium chloride injection). 1 Rate of Administration Patients undergoing BMT: Administer by IV infusion over 2 hours. 1 5 8 21 For mobilization of hematopoietic progenitor cells or for acceleration of myeloid engraftment following autologous PBPC transplantation: Administer by continuous IV infusion over 24 hours. 1 For BMT failure or engraftment delay: Administer by IV infusion over 2 hours. 1 5 18 19 Patients with AML: Administer by IV infusion over 4 hours. 1 Sub-Q Administration For sub-Q injection, administer sargramostim injection or reconstituted solutions without further dilution. 1 Reconstitution Reconstitute vials containing 250 mcg of sargramostim powder for injection with 1 mL of sterile or bacteriostatic water for injection to provide a solution containing 250 mcg/mL. 1 Direct diluent at the side of the vial and gently swirl contents to avoid foaming. 1 Avoid shaking or excessive agitation of vial. 1 Use care to eliminate air bubbles from the needle hub of the syringe containing the diluent to ensure the correct final concentration. 1 Commercially available vials of sargramostim lyophilized powder for injection are for single use only. 1 Do not reenter or reuse vials. 1 Dosage If a severe adverse reaction occurs, reduce dosage by 50% or temporarily discontinue therapy until the reaction abates. 1 Discontinue therapy if blast cells appear on the leukocyte differential or if disease progression occurs. 1 5 Temporarily discontinue therapy or reduce dosage by 50% if the ANC is> 20,000/mm 3 or if the platelet count is >500,000/mm 3 . 1 Base decision to interrupt therapy or reduce dosage on the clinical condition of the patient. 1 Pediatric Patients Neutropenia Associated with HIV Infection and Antiretroviral Therapy IV or Sub-Q Adolescents: Dosage of 250 mcg/m 2 administered by IV infusion or sub-Q injection once daily for 2 4 weeks has been used. 218 Adults Autologous or Allogeneic Bone Marrow Transplantation IV 250 mcg/m 2 once daily, administered by IV infusion over 2 hours. 1 5 8 21 Initiate therapy 2 4 hours after infusion of bone marrow (but no sooner than 24 hours after the last course of radiation therapy or the last dose of chemotherapy). 1 5 8 21 Do not initiate therapy until the posttransplantation ANC is <500/mm 3 . 1 Continue until the ANC is> 1500/mm 3 for 3 consecutive days. 1 Peripheral Blood Progenitor Cell Transplantation Mobilization of Hematopoietic Progenitor Cells IV or Sub-Q 250 mcg/m 2 daily, administered by continuous IV infusion over 24 hours or by sub-Q injection once daily. 1 Continue therapy throughout the period of PBPC collection. 1 Usually, initiate PBPC collection by day 5 of therapy and perform daily until protocol-specified targets are achieved. 1 Reduce dosage by 50% if the leukocyte count increases to >50,000/mm 3 . 1 Administration Following Reinfusion of PBPC Collection IV or Sub-Q To accelerate myeloid engraftment following autologous PBPC transplantation, 250 mcg/m 2 daily, administered by continuous IV infusion over 24 hours or by sub-Q injection once daily. 1 Initiate immediately following infusion of PBPC and continue until the ANC is >1500/mm 3 for 3 consecutive days. 1 Bone Marrow Transplantation Failure or Engraftment Delay IV Initially, 250 mcg/m 2 administered by IV infusion over 2 hours once daily 1 5 18 19 for 14 consecutive days. 1 5 19 Discontinue for 7 consecutive days. 1 5 19 If engraftment has not occurred after this 7-day interval, administer a second course of therapy. 1 5 For the second course of therapy, administer 250 mcg/m 2 by IV infusion over 2 hours once daily for 14 consecutive days. 1 5 Discontinue for 7 consecutive days. 1 5 If engraftment has not occurred after this 7-day interval, administer a third course of therapy. 1 5 For the third course of therapy, administer 500 mcg/m 2 by IV infusion over 2 hours once daily for 14 consecutive days. 1 5 Leukemias Acute Myelogenous Leukemia IV Initially, 250 mcg/m 2 administered by IV infusion over 4 hours once daily. 1 Initiate therapy on approximately day 11 or 4 days following completion of induction therapy; 1 use only if the bone marrow is hypoplastic with <5% blast cells on day 10. 1 If a second cycle of induction chemotherapy is necessary, administer sargramostim therapy approximately 4 days after completion of chemotherapy; 1 use only if the bone marrow is hypoplastic with> <5% blast cells. 1 Continue sargramostim until the ANC is> 1500/mm 3 for 3 consecutive days or for a maximum of 42 days. 1 Temporarily discontinue therapy or reduce dosage by 50% if the ANC is >20,000/mm 3 . 1 Discontinue therapy immediately if leukemia regrowth occurs. 1 Myelodysplastic Syndromes andAplastic Anemia Myelodysplastic Syndromes IV Dosages of 15 500 mcg/m 2 once daily, administered by IV infusion over 1 12 hours, have been used. 44 129 172 Alternatively, dosages of 30 500 mcg/m 2 daily, administered by continuous IV infusion over 24 hours, have been used. 47 48 Aplastic Anemia IV Dosages of 15 480 mcg/m 2 once daily, administered by IV infusion over 1 12 hours, have been used. 129 Alternatively, dosages of 120 500 mcg/m 2 daily, administered by continuous IV infusion over 24 hours, have been used. 134 Neutropenia Associated with HIV Infection and Antiretroviral Therapy IV or Sub-Q Dosage of 250 mcg/m 2 administered by IV infusion or sub-Q injection once daily for 2 4 weeks has been used. 218 Prescribing Limits Adults Bone Marrow Transplantation Failure or Engraftment Delay IV Maximum 3 courses of therapy (500 mcg/m 2 daily during the third course) recommended. 1 5 Leukemias Acute Myelogenous Leukemia IV Maximum 250 mcg/m 2 once daily for 42 days. 1 Cautions for Sargramostim Contraindications Excessive (i.e., 10%) leukemic myeloid blasts in the bone marrow or peripheral blood. 1 5 Known hypersensitivity to sargramostim, any ingredient in the formulation, or yeast-derived products. 1 Concomitant use of chemotherapy or radiation therapy. 1 Warnings/Precautions Warnings Fluid Retention Possible edema, capillary leak syndrome, and pleural and/or pericardial effusion. 1 5 8 Possible precipitation or aggravation of fluid retention, especially in patients with preexisting pleural and pericardial effusions. 1 Monitor body weight and hydration status during therapy. 201 Use with caution in patients with preexisting fluid retention, pulmonary infiltrates, or CHF. 1 5 Respiratory Effects Possible sequestration of granulocytes in the pulmonary circulation; dyspnea reported occasionally. 1 Use with caution in patients with preexisting lung disease and/or hypoxia. 1 5 Give special attention to respiratory symptoms that develop during or immediately following administration. 1 If dyspnea develops during administration, decrease the IV infusion rate by 50%; 1 5 administer oxygen to provide symptomatic relief if necessary. 5 106 108 If respiratory symptoms worsen despite reduction in the infusion rate, discontinue the infusion. 1 Subsequent doses may be administered according to the usual dosage schedule with careful monitoring. 1 Cardiovascular Effects Possible transient, reversible supraventricular arrhythmia. 1 Use with caution in patients with preexisting cardiac disease. 1 Increased incidence of syncope with or without hypotension reported with edetate disodium (EDTA)-containing sargramostim injection (formulation no longer commercially available in the US). 232 233 234 (See Preparations.) A similar increase in such adverse effects not observed with commercially available sargramostim lyophilized powder for injection (without EDTA). 232 233 234 Sensitivity Reactions Serious allergic or anaphylactic reactions reported rarely. 1 Discontinue sargramostim and initiate appropriate therapy if such reactions occur. 1 General Precautions First-dose Reaction Syndrome characterized by respiratory distress, hypoxia, flushing, hypotension, syncope, and/or tachycardia reported following the first dose of sargramostim in each treatment cycle. 1 Manifestations usually resolve with symptomatic treatment and generally do not recur with subsequent doses in the same treatment cycle. 1 If a first-dose reaction occurs, provide symptomatic treatment (e.g., oxygen, IV fluids, acetaminophen or NSAIA). 106 108 Chemotherapy and Radiation Therapy Safety and efficacy of concomitant radiation therapy or myelosuppressive antineoplastic agents not established. 1 Do not administer sargramostim within 24 hours of radiation therapy or a dose of a myelosuppressive antineoplastic agent. 1 (See Interactions.) Patients who previously received extensive radiation therapy or were exposed to multiple myelotoxic agents (e.g., alkylating agents, anthracycline antibiotics, antimetabolites) may have a limited response to sargramostim therapy following autologous BMT. 1 93 122 Patients Receiving Purged Bone Marrow Is effective in accelerating myeloid recovery following BMT when the marrow is purged by anti-B lymphocyte monoclonal antibodies. 1 Patients receiving chemically purged marrow may not respond to sargramostim if the chemical agents cause a clinically important decrease in the number of responsive hematopoietic progenitors; 1 if the purging process preserves a sufficient number of progenitors (>1.2 10 4 per kg), sargramostim may provide a beneficial effect on myeloid engraftment. 1 Excessive Hematologic Effects Possible rapid rise in leukocyte count. 1 134 Marked leukocytosis (leukocyte count 100,000/mm 3 ) reported occasionally. 47 Various effects on platelet counts reported in patients receiving biosynthetic GM-CSFs. 5 11 24 29 36 94 108 109 122 129 Monitor CBC and platelet counts twice weekly during therapy to avoid potential complications of excessive leukocytosis and/or thrombocytosis. 1 5 95 Temporarily discontinue therapy or reduce dosage by 50% if the ANC is >20,000/mm 3 or if the platelet count is >500,000/mm 3 . 1 Effect on Malignant Cells The possibility that sargramostim could act as a growth factor for any tumor type, particularly myeloid malignancies, has not been excluded. 1 54 72 Caution recommended in patients with any malignancy with myeloid characteristics. 1 43 44 45 47 49 51 88 96 129 215 216 Discontinue therapy if disease progression is detected in patients with non-Hodgkin s lymphoma, ALL, or Hodgkin s disease. 1 Has been used in patients with MDS or AML without evidence of increased relapse rates; 1 43 44 45 47 48 49 52 54 91 96 129 220 however, regrowth of leukemic cells and an increase in leukemic blasts have occurred in a few patients with AML who were receiving the drug. 54 When used for mobilization of hematopoietic progenitor cells, possible release of tumor cells from the marrow and subsequent collection in the leukapheresis product; effect of reinfusion of tumor cells not well studied and limited data available to date are inconclusive. 1 Laboratory Monitoring Perform CBC and platelet counts prior to initiation of therapy and routinely (e.g., twice weekly) during therapy. 1 5 95 Immunogenicity Development of anti-GM-CSF antibodies reported occasionally in patients receiving sargramostim. 1 100 212 Consider the possibility that formation of anti-GM-CSF antibodies during sargramostim therapy theoretically could result in drug-induced neutropenia, neutralization of endogenous GM-CSF activity, or decreased effectiveness of sargramostim. 1 87 100 Specific Populations Pregnancy Category C. 1 Lactation Not known whether sargramostim is distributed into milk; use only if clearly needed. 1 193 Pediatric Use Safety and efficacy not established. 1 5 30 42 59 However, no unusual adverse effects reported during use in children 4 months to 18 years of age (at daily dosages of 60 1000 mcg/m 2 IV or 4 1500 mcg/m 2 sub-Q). 1 5 30 42 59 Some evidence that children may tolerate higher dosages of biosynthetic GM-CSF compared with adults in the treatment of chemotherapy-induced neutropenia . 5 30 82 Avoid administration of solutions containing benzyl alcohol (sargramostim injection, sargramostim powder reconstituted with bacteriostatic water for injection) in neonates. 1 Large amounts of benzyl alcohol (i.e., 100 400 mg/kg daily) have been associated with toxicity in neonates. 224 225 226 227 228 Geriatric Use Experience in patients 65 years of age limited to those with AML. 1 Analysis of general trends in safety and efficacy demonstrate a response in geriatric patients similar to that in younger adults. 76 1 The possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out. 1 Hepatic Impairment Possible increased concentrations of serum bilirubin and hepatic enzymes. 1 21 44 Monitor hepatic function every other week during therapy in patients with hepatic impairment. 1 206 Renal Impairment Possible increased S cr . 1 21 44 Monitor renal function every other week during therapy in patients with renal impairment. 1 206 Common Adverse Effects Fever, asthenia, chills, headache, nausea, diarrhea, myalgia, bone pain. 1 5 47 55 73 87 112 134 172 Interactions for Sargramostim Specific Drugs Drug Interaction Comments Antineoplastic agents Sensitivity of rapidly dividing cells to cytotoxic chemotherapy may be increased 1 Safety and efficacy of concomitant administration not established. 1 Administration of sargramostim within 24 hours of administration of chemotherapy is not recommended 1 Didanosine No evidence of synergism against HIV 133 200 Myeloproliferative agents (e.g., corticosteroids, lithium) Possible additive myeloproliferative effects 1 Use with caution 1 Zalcitabine No evidence of synergism against HIV 133 200 Zidovudine Possible pharmacologic and/or pharmacokinetic interaction resulting in additive or synergistic antiretroviral effect 3 5 35 39 133 135 136 137 149 157 158 161 200 Sargramostim Pharmacokinetics Absorption Bioavailability Peak serum concentrations are attained during or immediately after completion of an IV infusion. 1 Rapidly absorbed following sub-Q injection, 1 67 104 with peak serum concentrations generally attained within 1 4 hours. 1 67 104 Duration In patients with sargramostim-associated leukocytosis or thrombocytosis, excessive blood cell counts usually return to normal or baseline levels within 2 10 days following interruption of therapy. 1 11 43 44 47 87 91 94 121 129 Distribution Extent Murine GM-CSF is distributed into various tissues including liver, spleen, and kidney in mice. 102 Not known whether sargramostim distributes into CSF 193 or milk or crosses the placenta in humans. 1 193 Elimination Metabolism Not known whether sargramostim is metabolized. 193 Elimination Route Elimination route not known. 193 Half-life Terminal elimination half-life is approximately 60 minutes following IV infusion over 2 hours. 1 Following sub-Q administration, terminal elimination half-life is approximately 162 minutes. 1 Stability Storage Parenteral Powder and Solution 2 8 C; 1 206 do not freeze. 1 Use solutions reconstituted with sterile water for injection within 6 hours. 1 206 Use solutions reconstituted with bacteriostatic water for injection within 20 days. 1 206 Administer previously reconstituted solution mixed with freshly reconstituted solution within 6 hours following mixing. 1 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Drug Compatibility Y-Site CompatibilityHID Compatible Amikacin sulfate Aminophylline Aztreonam Bleomycin sulfate Butorphanol tartrate Calcium gluconate Carboplatin Carmustine Cefazolin sodium Cefepime HCl Cefotaxime sodium Ceftizoxime sodium Ceftriaxone sodium Cefuroxime sodium Cimetidine HCl Cisplatin Clindamycin phosphate Co-trimoxazole Cyclophosphamide Cyclosporine Cytarabine Dacarbazine Dactinomycin Dexamethasone sodium phosphate Diphenhydramine HCl Dopamine HCl Doxorubicin HCl Doxycycline hyclate Droperidol Etoposide Famotidine Fentanyl citrate Floxuridine Fluconazole Fluorouracil Furosemide Gentamicin sulfate Granisetron HCl Heparin sodium Idarubicin HCl Ifosfamide Immune globulin intravenous Magnesium sulfate Mannitol Meperidine HCl Mesna Methotrexate sodium Metoclopramide HCl Metronidazole Mitoxantrone HCl Pentostatin Piperacillin sodium tazobactam sodium Potassium chloride Prochlorperazine edisylate Promethazine HCl Ranitidine HCl Teniposide Ticarcillin disodium clavulanate potassium Vinblastine sulfate Vincristine sulfate Zidovudine Incompatible Acyclovir sodium Ampicillin sodium Ampicillin sodium sulbactam sodium Chlorpromazine HCl Ganciclovir sodium Haloperidol lactate Hydrocortisone sodium phosphate Hydrocortisone sodium succinate Hydromorphone HCl Hydroxyzine HCl Imipenem cilastatin sodium Lorazepam Methylprednisolone sodium succinate Mitomycin Morphine sulfate Nalbuphine HCl Ondansetron HCl Sodium bicarbonate Tobramycin sulfate Variable Amphotericin B Amsacrine Ceftazidime Vancomycin HCl Actions Exerts the pharmacologic effects usually produced by endogenous human GM-CSF. 1 5 11 85 86 95 132 Influences leucopoiesis; 1 5 85 95 affects the proliferation and differentiation of a variety of hematopoietic progenitor cells, 1 5 131 132 principally in the granulocyte-macrophage lineage. 1 11 78 83 84 85 86 87 90 91 132 Acts directly on various progenitor target cells 5 98 150 203 by binding to GM-CSF-specific receptors on their cell surfaces. 1 5 78 83 84 87 88 91 105 140 141 142 Induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways. 1 11 78 83 84 85 86 87 90 91 132 150 151 Also stimulates the proliferation of eosinophils, megakaryocytes, erythroid progenitors, and mast-cell precursors. 1 11 46 83 84 85 87 90 132 150 Alters the kinetics of myeloid progenitor cells within the bone marrow. 5 82 94 198 203 204 Causes rapid entry of cells into the cell cycle and decreases the cell cycle time. 5 82 94 198 203 204 Produces a dose-dependent 11 32 78 84 87 91 122 and biphasic increase in the leukocyte count. 24 93 122 Enhances certain functions of normal mature neutrophils, eosinophils, basophils, and macrophages 78 79 83 85 119 150 (e.g., oxidative metabolism of neutrophils, phagocytosis, eosinophil cytotoxicity, antibody-dependent cellular cytotoxicity, chemotaxis, and hydrogen peroxide production). 5 11 24 40 41 78 79 83 85 98 119 150 Initiates proliferation in erythroid and megakaryocytic lineages; 85 94 122 however, other factors are necessary for production of mature cells in these lineages. 85 94 122 Variable effects on platelet counts have been reported. 5 11 24 29 36 94 108 109 122 129 Leukocyte differentials usually demonstrate a shift to the left (toward progenitor cells) during therapy; 24 87 93 94 myelocytes, promyelocytes, and myeloblasts may be present on the differential. 24 87 93 94 Absolute lymphocyte and basophil counts generally are unaffected. 5 94 108 122 Advice to Patients Importance of clinicians providing patients adequate oral and written instructions regarding proper administration technique. 1 Importance of providing a copy of the manufacturer s information for patients or their caregivers. 1 Importance of instructing patients who self-administer sargramostim in the home setting on proper dosage and administration of drug; advise patients not to reuse syringes or needles and to properly dispose of such equipment using puncture-resistant containers. 1 Importance of recognizing and reporting adverse effects (e.g., sensitivity reactions). 1 Importance of adhering to the treatment regimen, including regular monitoring of blood counts. 1 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Advise women of childbearing potential about possible risks to fetus. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 1 Importance of informing patients of other important precautionary information. (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Sargramostim injection containing EDTA was withdrawn from the US market as of January 2008 because of reports of increased adverse effects associated with its use. 232 233 Any remaining stock of EDTA-containing sargramostim injection should not be used but should be returned to the manufacturer. 233 Commercially available sargramostim injection has been reformulated without EDTA. 232 Sargramostim (Recombinant DNA Origin) Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection 250 mcg (1.4 million units) Leukine Bayer Injection 500 mcg/mL (2.8 million units/mL) Leukine Bayer AHFS DI Essentials. Copyright 2017, Selected Revisions August 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 1. Bayer Healthcare. Leukine (sargramostim) prescribing information. Seattle, WA; 2008 Apr. 2. Herrmann F, Brugger W, Kanz L et al. In vivo biology and therapeutic potential of hematopoietic growth factors and circulating progenitor cells. Semin Oncol . 1992; 19: 422-31. 3. Rose RM. The role of colony-stimulating factors in infectious disease: current status, future challenges. Semin Oncol . 1992; 19:415-21. [PubMed 1380731] 4. Crosier PS, Clark SC. Basic biology of the hematopoietic growth factors. Semin Oncol . 1992; 19:349-61. [PubMed 1380728] 5. Grant SM, Heel RC. Recombinant granulocyte-macrophage colony-stimulating factor (rGM-CSF): a review of its pharmacological properties and prospective role in the management of myelosuppression. Drugs . 1992; 43:516-60. 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Semin Hematol . 1990; 27(Suppl 3):15-24. [PubMed 2198660] 28. Gulati SC, Bennett CL. Granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy in relapsed Hodgkin disease. Ann Intern Med . 1992; 116:177-82. [PubMed 1728202] 29. Gianni AM, Bregni M, Siena S et al. Recombinant human granulocyte-macrophage colony-stimulating factor reduces hematologic toxicity and widens clinical applicability of high-dose cyclophosphamide treatment in breast cancer and non-Hodgkin s lymphoma. J Clin Oncol . 1990; 8:768-78. [PubMed 2185337] 30. Furman WL, Fairclough DL, Huhn RD et al. Therapeutic effects and pharmacokinetics of recombinant human granulocyte-macrophage colony-stimulating factor in childhood cancer patients receiving myelosuppressive chemotherapy. J Clin Oncol . 1991; 9:1022-8. [PubMed 2033415] 31. deVries EG, Biesma B, Willemse PH et al. A double-blind placebo-controlled study with granulocyte-macrophage colony-stimulating factor during chemotherapy for ovarian carcinoma. Cancer Res . 1991; 51:116-22. [PubMed 1988077] 32. Delannoy A. GM-CSF therapy for drug-induced agranulocytosis. J Intern Med . 1992; 231:269-71. [PubMed 1556524] 33. Antmann KS, Griffin JD, Elias A et al. Effect of recombinant human granulocyte-macrophage colony-stimulating factor on chemotherapy-induced myelosuppression. N Engl J Med . 1988; 319:593-8. [PubMed 3045544] 34. Scadden DT, Bering HA, Levine JD et al. Granulocyte-macrophage colony-stimulating factor mitigates the neutropenia of combined interferon alfa and zidovudine treatment of acquired immune deficiency syndrome-associated Kaposi s sarcoma. J Clin Oncol . 1991; 9:802-8. [PubMed 2016623] 35. Mitsuyasu RT. Use of recombinant interferons and hematopoietic growth factors in patients infected with human immunodeficiency virus. Rev Infect Dis . 1991; 13:979-84. [PubMed 1720567] 36. Levine JD, Allan JD, Tessitore JH et al. Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome (AIDS)/AIDS-related complex. Blood . 1991; 78:3148-54. [PubMed 1742482] 37. Israel DS, Plaisance KI. Neutropenia in patients infected with human immunodeficiency virus. Clin Pharm . 1991; 10:268-79. [PubMed 2032444] 38. Groopman JE. Status of colony-stimulating factors in cancer and AIDS. Semin Oncol . 1990; 17(Suppl 1):31-7. [PubMed 2405493] 39. Groopman JE. Antiretroviral therapy and immunomodulators in patients with AIDS. Am J Med . 1991; 90(Suppl 4A):18-21S. 40. Baldwin GC, Fuller ND, Roberts RL et al. Granulocyte and granulocyte-macrophage colony-stimulating factors enhance neutrophil cytotoxicity toward HIV-infected cells. Blood . 1989; 74:1673-7. [PubMed 2477084] 41. Baldwin GC, Gasson JC, Quan SG et al. 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Subcutaneous granulocyte-macrophage colony-stimulating factor in patients with myelodysplastic syndrome: toxicity, pharmacokinetics, and hematological effects. J Clin Oncol . 1989; 7:629-37. [PubMed 2651578] 47. Vadhan-Raj S, Keating M, Le Maistre A et al. Effects of recombinant human granulocyte-macrophage colony-stimulating factor in patients with myelodysplastic syndromes. N Engl J Med . 1987; 317:1545-52. [PubMed 3500414] 48. Vadhan-Raj S, Broxmeyer HE, Spitzer G et al. Stimulation of nonclonal hematopoiesis and suppression of the neoplastic clone after treatment with recombinant human granulocyte-macrophage colony-stimulating factor in a patient with therapy-related myelodysplastic syndrome. Blood . 1989; 74:1491-8. [PubMed 2676013] 49. Smith T. Successful use of granulocyte-macrophage colony-stimulating factor in patients with acute lymphocytic leukemia. Am J Med . 1990; 89:384-5. [PubMed 2203265] 50. Sallerfors S, Olofsson T. Granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF) in serum during induction treatment of acute leukemia. Br J Haematol . 1991; 78:343-51. [PubMed 1714757] 51. Estey E, Thall PF, Kantarjian H et al. Treatment of newly diagnosed acute myelogenous leukemia with granulocyte-macrophage colony-stimulating factor (GM-CSF) before and during continuous-infusion high-dose Ara-C + daunorubicin: comparison to patients treated without GM-CSF. Blood . 1992; 79:2246-55. [PubMed 1571541] 52. Estey EH, Dixon D, Kantarjian HM et al. Treatment of poor-prognosis, newly diagnosed acute myeloid leukemia with Ara-C and recombinant human granulocyte-macrophage colony-stimulating factor. Blood . 1990; 75:1766-9. [PubMed 2184901] 53. Cannistra SA, DiCarlo J, Groshek P et al. Simultaneous administration of granulocyte-macrophage colony-stimulating factor and cytosine arabinoside for take into account that
the right Sargramostim treatments
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