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sargramostim [GM-CSF] (Leukine, Prokine, Leucomax)

Tradenames: Leukine, Prokine. Market withdrawal of liquid formulation Jan 2008 Indications: - neutropenia - myeloid reconstitution after autologous bone marrow transplantation or stem-cell transplantation - HIV-associated neutropenia - to accelerate myeloid engraftment following chemotherapy - acute myeloid leukemia (AML) - accelerate myeloid recovery in patients with non-Hodgkin's lymphoma - Hodgkin's lymphoma undergoing autologous stem-cell transplantation - acute lymphoblastic leukemia - myelodysplastic syndrome [5] - investigational treatment of Alzheimer's disease [6] Contraindications: Pregnancy category C Safety in lactation ? Dosage: 1) bone marrow transplant: a) 250 ug/m2/day IV or SC (IV dose over 2 hours) b) begin 2-4 hours after marrow infusion & not < 24 hours after chemotherapy or < 12 h after radiotherapy c) therapy should be continued for 30 days or until absolute neutrophil count has reached 1000/mm3 2) cancer chemotherapy recovery a) 3-15 ug/kg/day IV over 2 hours for 14-21 days 3) discontinue if neutrophil count > 20,000/mm3 Injectable: 250 & 500 ug powder vials 500 ug/mL liquid preservative-free or multi-dose Pharmacokinetics: 1) onset of action: increase in WBC in 7-14 days 2) WBC will return to baseline within 1 week of discontinuing drug 3) elimination 1/2 life 1 hour Adverse effects: 1) common (> 10%) - nausea/vomiting, skeletal (bone) pain, alopecia, diarrhea, neutropenic fever, mucositis, thrombocytopenia, tachycardia 2) less common (1-10%) - anorexia, dyspnea, headache, cough, rash, chest pain, weakness, sore throat, stomatitis, constipation, pain at site of injection, leukocytosis, fluid retention, peripheral edema, capillary leak syndrome 3) uncommon (< 1%) - transient supraventricular arrhythmia, anaphylactic reaction, pericarditis, thrombophlebitis 4) other - neutrophilic dermatosis - pyoderma gangrenosum, Sweet syndrome [5] 5) Market withdrawal of liquid formulation [3] because of an upward trend in spontaneous reports of adverse reactions, including syncope (temporally correlated with change in formulation to include include edetate disodium, EDTA)

General

pharmaceutical growth factor granulocyte-macrophage colony-stimulating factor; GM-CSF; colony-stimulating factor 2; molgramostin; sargramostim (CSF2, GMCSF)

References

  1. The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  3. FDA MedWatch (Jan 2008) http://www.fda.gov/medwatch/safety/2008/safety08.htm#Leukine
  4. Deprecated Reference
  5. Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015
  6. George J Marrow Cell Stimulator to Treat Alzheimer's s Disease? - Unusual approach pans out in mid-stage trial. MedPage Today March 24, 2021 https://www.medpagetoday.com/neurology/alzheimersdisease/91795 - Potter H et al Safety and efficacy of sargramostim (GM-CSF) in the treatment of Alzheimer's disease. Alzheimer's & Dementia. 2021. March 24. PMID: 33778150 PMCID: PMC7988877 Free PMC article https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12158
  7. Department of Veterans Affairs, VA National Formulary