Sargramostim


Generic Medicine Info
Indications and Dosage
Intravenous
Neutrophil recovery following induction chemotherapy for acute myeloid leukaemia
Adult: To shorten the time for neutrophil recovery and decrease the incidence of severe or fatal infections after induction chemotherapy: ≥55 years 250 mcg/m2 daily via infusion over 4 hours, starting approx on day 11 or 4 days after the completion of induction chemotherapy (if the day 10 bone marrow is hypoplastic with <5% blasts). If a 2nd cycle of induction chemotherapy is needed, administer approx 4 days following the completion of chemotherapy (if the bone marrow is hypoplastic with <5% blasts). Continue until an absolute neutrophil count (ANC) of >1,500 cells/mm3 for 3 consecutive days or a Max of 42 days. Do not administer within 24 hours prior to or following radiotherapy or chemotherapy. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).

Intravenous
Acceleration of myeloid reconstitution following allogeneic bone marrow transplantation
Adult: In patients undergoing bone marrow transplantation from HLA-matched related donors: 250 mcg/m2 daily via infusion over 2 hours starting 2-4 hours following bone marrow infusion, and at least 24 hours after the last dose of chemotherapy or radiotherapy. Do not administer until the post marrow infusion ANC is <500 cells/mm3. Continue until an ANC >1,500 cells/mm3 for 3 consecutive days is achieved. Do not administer within 24 hours prior to radiotherapy or chemotherapy. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
Child: ≥2 years Same as adult dose.

Intravenous
Acceleration of myeloid reconstitution following autologous bone marrow transplantation
Adult: In patients with non-Hodgkin lymphoma (NHL), acute lymphoblastic leukaemia (ALL), and Hodgkin lymphoma (HL): 250 mcg/m2 daily via infusion over 2 hours starting 2-4 hours following bone marrow infusion, and at least 24 hours after the last dose of chemotherapy or radiotherapy. Do not administer until the post marrow infusion ANC is <500 cells/mm3. Continue until an ANC >1,500 cells/mm3 for 3 consecutive days is achieved. Do not administer within 24 hours prior to radiotherapy or chemotherapy.
Child: ≥2 years Same as adult dose.

Intravenous, Subcutaneous
Mobilisation of peripheral blood progenitor cells
Adult: In cancer patients who are undergoing autologous haematopoietic stem cell transplantation for the mobilisation of haematopoietic progenitor cells into peripheral blood for collection by leukapheresis: 250 mcg/m2 daily via continuous IV infusion over 24 hours or via SC inj once daily; continue the same dose throughout peripheral blood progenitor cell collection period. Reduce dose by 50% if WBC is >50,000 cells/mm3. Consider other mobilisation therapy if the numbers of the collected progenitor cells are inadequate.

Intravenous, Subcutaneous
Acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell transplantation
Adult: In patients with NHL, ALL, and HL: 250 mcg/m2 daily via continuous IV infusion over 24 hours or via SC inj once daily, starting immediately after infusion of progenitor cells. Continue until an ANC >1,500 cells/mm3 for 3 consecutive days is achieved. Do not administer within 24 hours prior to or following radiotherapy or chemotherapy.
Child: ≥2 years Same as adult dose.

Intravenous
Delayed neutrophil recovery following allogeneic bone marrow transplantation, Delayed neutrophil recovery following autologous bone marrow transplantation, Graft failure following allogeneic bone marrow transplantation, Graft failure following autologous bone marrow transplantation
Adult: 250 mcg/m2 daily for 14 days via infusion over 2 hours; may be repeated after 7 days off-therapy if neutrophil recovery or engraftment has not occurred. If neutrophil recovery still has not occurred, a 3rd course of 500 mcg/m2 daily for 14 days may be attempted after another 7 days off-therapy, if necessary. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
Child: ≥2 years Same as adult dose.

Subcutaneous
Haematopoietic subsyndrome of acute radiation syndrome
Adult: 7 mcg/kg once daily. Initiate as soon as possible after confirmed or suspected exposure to radiation doses >2 gray (Gy). Continue until the ANC remains >1,000/mm3 for 3 consecutive CBCs or >10,000/mm3 after a radiation-induced nadir.
Child: <15 kg: 12 mcg/kg once daily; 15-40 kg: 10 mcg/kg once daily; >40 kg: Same as adult dose. Initiate as soon as possible after confirmed or suspected exposure to radiation doses >2 Gy. Continue until the ANC remains >1,000/mm3 for 3 consecutive CBCs or >10,000/mm3 after a radiation-induced nadir.
Reconstitution
Powder for inj: Reconstitute vial with 1 mL of either preservative-free sterile water for inj or bacteriostatic water for inj (use the preservative-free sterile water for inj when administering to neonates or infants). Direct the diluent toward the side of the vial and gently swirl to reconstitute. Do not shake. IV infusion: Dilute further with 0.9% NaCl inj. If the final concentration of sargramostim is <10 mcg/mL, add human albumin at a final concentration of 0.1% or 1 mg of human albumin per 1 mL of 0.9% NaCl inj (e.g. add 1 mL of 5% human albumin per 50 mL of 0.9% NaCl inj) to the normal saline prior to adding sargramostim to prevent adsorption to the drug delivery system.
Contraindications
Hypersensitivity to human granulocyte-macrophage colony-stimulating factor or yeast-derived products. Concomitant use with or within 24 hours prior to or following cytotoxic chemotherapy or radiotherapy. Lactation.
Special Precautions
Patient with history of cardiac arrhythmia or pre-existing cardiac disease; pre-existing pulmonary disease, fluid retention, pulmonary infiltrates; malignancies with myeloid characteristics. Children. Pregnancy.
Adverse Reactions
Significant: Serious hypersensitivity reactions (e.g. anaphylaxis), supraventricular arrhythmia, capillary leak syndrome, oedema, pleural and/or pericardial effusion, antibody formation, leucocytosis, infusion-related reactions (including dyspnoea, flushing, hypoxia, hypotension, respiratory distress, syncope, tachycardia).
Blood and lymphatic system disorders: Blood dyscrasia.
Eye disorders: Eye haemorrhage.
Gastrointestinal disorders: Diarrhoea, abdominal pain, nausea, vomiting, dyspepsia, stomatitis, gastrointestinal disorder or haemorrhage, dysphagia, haematemesis.
General disorders and administration site conditions: Fever, asthenia, malaise, pain, chills.
Hepatobiliary disorders: Liver damage, hyperbilirubinaemia.
Infections and infestations: Sepsis.
Investigations: Increased serum glucose, BUN, creatinine or SGPT; low albumin, metabolic laboratory abnormalities, weight loss.
Metabolism and nutrition disorders: Anorexia, hypomagnesaemia.
Musculoskeletal and connective tissue disorders: Arthralgia, bone pain.
Nervous system disorders: Headache, paraesthesia, CNS disorder.
Psychiatric disorders: Anxiety, insomnia.
Renal and urinary disorders: Urinary tract disorder.
Respiratory, thoracic and mediastinal disorders: Lung disorder, rhinitis, pharyngitis, epistaxis.
Skin and subcutaneous tissue disorders: Alopecia, rash, pruritus.
Vascular disorders: Hypertension, hypotension, haemorrhage.
Monitoring Parameters
Monitor CBC with differential (twice weekly during treatment); renal, hepatic and pulmonary functions; vital signs, hydration status, weight. Obtain CBC approx every 3 days when monitoring for haematopoietic radiation injury syndrome. Observe closely for signs or symptoms of hypersensitivity or infusion-related reactions.
Overdosage
Symptoms: Increased WBC (up to 200,000 cells/mm3), dyspnoea, malaise, fever, rash, headache, nausea, sinus tachycardia, and chills. Management: Discontinue therapy. Observe for increase in WBC and respiratory symptoms.
Drug Interactions
Drugs that induce myeloproliferation (e.g. lithium, corticosteroids) may potentiate the myeloproliferative effects of sargramostim.
Potentially Fatal: May increase the risk of severe myelosuppression when administered with or within 24 hours before or after chemotherapy or radiotherapy.
Action
Description: Sargramostim, a recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF), stimulates the proliferation and differentiation of haematopoietic progenitor cells. It induces partially committed progenitor cells to differentiate and divide in the granulocyte-macrophage pathways which include neutrophils, myeloid-derived dendritic cells, and monocytes or macrophages.
Onset: Increase in WBC: 7-14 days.
Duration: Return of WBC to baseline: Within 1-2 weeks of discontinuation.
Pharmacokinetics:
Absorption: Bioavailability: SC: 75% (compared to IV). Time to peak plasma concentration: During or immediately following administration (IV); 2.5-4 hours (SC).
Distribution: Volume of distribution: 96.8 L (IV).
Excretion: Elimination half-life: Approx 3.84 hours (IV); 1.4 hours (SC).
Storage
Store unopened vials between 2-8°C. Do not freeze. Solution for inj: Store between 2-8°C for up to 20 days. Reconstituted powder for inj: Use as soon as possible or within 6 hours after reconstitution and/or dilution for IV infusion.
ATC Classification
L03AA09 - sargramostim ; Belongs to the class of colony stimulating factors. Used as immunostimulants.
References
Anon. Sargramostim. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 21/05/2021.

Buckingham R (ed). Sargramostim. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/05/2021.

Leukine Injection (Sanofi-Aventis U.S. LLC). U.S. FDA. https://www.fda.gov. Accessed 21/05/2021.

Leukine Liquid and Injection, Powder for Solution (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 21/05/2021.

Disclaimer: This information is independently developed by MIMS based on Sargramostim from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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