sargramostim (Rx)

Brand and Other Names:gmcsf, Leukine
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 500mcg/mL

injection, lyophilized powder for reconstitution

  • 250mcg/vial

Acute Myeloid Leukemia Following Induction Chemotherapy

Indicated to shorten time to neutrophil recovery and to reduce incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients ≥55 years with acute myeloid leukemia (AML)

250 mcg/m²/day IV over a 4-hr period starting ~ Day 11 or 4 days following completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with <5% blasts  

If a second cycle of induction chemotherapy is necessary, administer ~4 days after completion of chemotherapy if the bone marrow is hypoplastic with <5% blasts

Continue until an absolute neutrophil count (ANC) >1500 cells/mm³ for 3 consecutive days (not to exceed 42 days); do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Autologous Peripheral Blood Progenitor Cell Mobilization and Collection

Indicated in adults with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis

250 mcg/m²/day IV over 24 hr or SC qDay; continue at the same dose through PBPC collection  

Optimal schedule for PBPC collection not established

In clinical studies, collection of PBPC was usually begun after 5 days of sargramostim and performed daily until protocol specified targets were achieved

Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation

Indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adults with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL)

Autologous peripheral blood progenitor cell transplantation

  • 250 mcg/m²/day IV over 24 hr or SC qDay beginning immediately following infusion of progenitor cells and continuing until an ANC >1500 cells/mm³ for 3 consecutive days is attained  
  • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Autologous bone marrow transplantation

  • 250 mcg/m²/day IV over a 2-hr period beginning 2-4 hr after bone marrow infusion, and not <24 hr after the last dose of chemotherapy or radiotherapy  
  • Do not administer sargramostim until post marrow infusion ANC is <500 cells/mm³
  • Continue until an ANC >1500 cells/mm³ for 3 consecutive days is attained
  • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Allogeneic Bone Marrow Transplantation

Indicated for the acceleration of myeloid reconstitution in adults undergoing allogeneic bone marrow transplantation from HLA-matched related donors

250 mcg/m²/day IV over a 2-hr period beginning 2-4 hr after bone marrow infusion, and not <24 hr after the last dose of chemotherapy or radiotherapy  

Do not administer sargramostim until post marrow infusion ANC is <500 cells/mm³

Continue until an ANC >1500 cells/mm³ for 3 consecutive days is attained

Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Treatment of Delayed Neutrophil Recovery or Graft Failure

Indicated for the treatment of adults undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed

250 mcg/m²/day IV over a 2hr for 14 days  

If neutrophil recovery not occurred, dose can be repeated after 7 days off; if neutrophil recovery still not occurred, a third course of 500 mcg/m²/day for 14 days may be tried after another 7 days off therapy

If still no improvement, it is unlikely further dose escalation will be beneficial

Acute Radiation Syndrome

Indicated to increase survival in adults acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])

7 mcg/kg SC qDay  

Administer as soon as possible after suspected or confirmed exposure to radiation doses >2 gray (Gy)

Estimate a patient’s absorbed radiation dose (ie, level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics

H-ARS monitoring and dose duration

  • Obtain baseline CBC with differential and then serial CBCs ~every 3 days until the ANC remains >1000/mm³ for 3 consecutive CBCs
  • Do not delay administration if a CBC is not readily available
  • Continue administration until the ANC remains >1000/mm³ for 3 consecutive CBCs or exceeds 10,000/mm³ after a radiation-induced nadir

MDS (Off-label)

15-500 mcg/m² IV infusion qDay over 1-12 hr OR 30-500 mcg/m² continuous infusion over 24 hr  

Aplastic Anemia (Off-label)

15-480 mcg/m² IV infusion qDay over 1-12 hr OR 120-500 mcg/m² continuous infusion over 24 hr  

Dosage Modifications

Obtain a CBC with differential twice a week during therapy and modify dose

Neutrophil recovery following induction chemotherapy for AML

  • Leukemic regrowth: Discontinue sargramostim immediately
  • Grade 3 or 4 adverse reactions: Reduce dose of sargramostim by 50% or interrupt dosing until the reaction abates
  • ANC >20,000 cells/mm³: Interrupt sargramostim treatment or reduce dose by 50%

Allogeneic bone marrow transplantation or treatment of delayed neutrophil recovery or graft failure

  • Disease progression or blast cell appearance: Discontinue sargramostim immediately
  • Grade 3 or 4 adverse reactions: Reduce dose of sargramostim by 50% or temporarily discontinue until reaction abates
  • WBC >50,000 cells/mm³ or ANC >20,000 cells/mm³ : Interrupt sargramostim treatment or reduce dose by 50%

Orphan Designations

Cystic fibrosis

  • Orphan sponsor: DrugRecure Aps; Cobis Building, 2200 Copenhagen N; Denmark

Pulmonary alveolar proteinosis (PAP)

  • Orphan sponsor: Partner Therapeutics, Inc; 19 Muzzey Street; Lexington, Massachusetts 02421

Melanoma stage IIb-IV

  • Orphan sponsor: Partner Therapeutics, Inc; 19 Muzzey Street; Lexington, Massachusetts 02421

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 250mcg/vial

Autologous Peripheral Blood Progenitor Cell and Bone Marrow Transplantation

Indicated for the acceleration of myeloid reconstitution following autologous PBPC or bone marrow transplantation in pediatric patients ≥2 years with NHL, ALL, and HL

Autologous peripheral blood progenitor cell transplantation

  • ≤2 years;: Safety and efficacy not established
  • >2 years
    • 250 mcg/m²/day IV over 24 hr or SC qDay beginning immediately following infusion of progenitor cells and continuing until an ANC >1500 cells/mm³ for 3 consecutive days is attained  
    • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy

Autologous bone marrow transplantation

  • ≤2 years;: Safety and efficacy not established
  • >2 years
    • 250 mcg/m²/day IV over a 2-hr period beginning 2-4 hr after bone marrow infusion, and not <24 hr after the last dose of chemotherapy or radiotherapy  
    • Do not administer sargramostim within 24 hr preceding or following receipt of chemotherapy or radiotherapy
    • Continue until an ANC >1500 cells/mm³ for 3 consecutive days is attained

Acute Radiation Syndrome

Indicated to increase survival in children and adolescents acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])

<15 kg: 12 mcg/kg SC qDay  

15-40 kg:10 mcg/kg SC qDay  

>40 kg:7 mcg/kg SC qDay  

Administer as soon as possible after suspected or confirmed exposure to radiation doses >2 gray (Gy)

Estimate a patient’s absorbed radiation dose (ie, level of radiation exposure) based on information from public health authorities, biodosimetry if available, or clinical findings such as time to onset of vomiting or lymphocyte depletion kinetics

H-ARS monitoring and dose duration

  • Obtain baseline CBC with differential and then serial CBCs ~every 3 days until the ANC remains >1000/mm³ for 3 consecutive CBCs
  • Do not delay administration if a CBC is not readily available
  • Continue administration until the ANC remains >1000/mm³ for 3 consecutive CBCs or exceeds 10,000/mm³ after a radiation-induced nadir

Clinical studies did not include sufficient numbers of subjects aged ≥65 to determine whether they respond differently from younger subjects

Other reported clinical experience has not identified differences in responses between the elderly and younger patients

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Interactions

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            Adverse Effects

            >10%

            Autologous BMT

            • Abdominal pain (89%)
            • Diarrhea (89%)
            • Asthenia (66%)
            • Malaise (57%)
            • Rash (44%)
            • Chest pain (11%)
            • Peripheral edema (11%)

            Acute myelogenous leukemia

            • Fever (81%)
            • Skin reaction (77%)
            • Metabolic disease (58%)
            • Nausea (58%)
            • Vomiting (46%)
            • Weight loss (37%)

            Diarrhea (allogenic BMT 81%)

            Nausea (allogenic BMT 70%)

            Vomiting (allogenic BMT 70%)

            Abdominal pain (allogenic BMT 38%)

            Hyperbilirubinemia (allogenic BMT 30%)

            Rigor (allogenic BMT 25%)

            Cardiac dysrhythmia (BMT graft failure 25%)

            Pericardial effusion (BMT graft failure 25%)

            Pruritis (allogenic BMT 23%)

            Increase serum BUN (allogenic BMT 23%)

            Pharyngitis (allogenic BMT 23%)

            Bone pain (allogenic BMT 21%)

            Myalgia (BMT graft failure 18%)

            Hypercholesterolemia (allogenic BMT 17%)

            Hypomagnesemia (allogenic BMT 15%)

            Chest pain (allogenic BMT 15%)

            Hematemesis (allogenic BMT 13%)

            GI hemorrhage (allogenic BMT 11%)

            Intraocular hemorrhage (allogenic BMT 11%)

            Dysphagia (allogenic BMT 11%)

            Arthralgia (allogenic BMT 11%)

            1-10%

            Cardiac dysrhythmia (autologous BMT 4%)

            Pericardial effusion (autologous BMT 4%)

            <1%

            Capillary leak syndrome

            Frequency Not Defined

            Anorexia

            Fever

            Malaise

            Cerebral hemorrhage

            Stomatitis

            Elevated BUN and cholesterol

            Renal failure

            Sepsis

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            Warnings

            Contraindications

            History of serious allergic reactions (eg, anaphylaxis to human GCSFs [such as sargramostim], yeast-derived products, or any component of the product)

            >10% leukemic myeloid blasts in bone marrow or peripheral blood

            Do not administer within 24 hr preceding or following chemotherapy or radiotherapy

            Cautions

            Caution in fluid retention, pulmonary infiltrates, CHF, lung disease, cardiac disease, hypoxia, hepatic/renal impairment; conditions may worsen

            Solution should NOT be administered to neonates due to presence of benzyl alcohol in the formulation ant its association with "gasping syndrome"

            Discontinue immediately if blast cells appear or disease progression occurs

            Reformulated liquid devoid of sodium EDTA now available

            Treatment may induce neutralizing anti-drug antibodies; incidence of anti-sargramostim neutralizing antibodies may be related to duration of exposure

            A first dose effect characterized by respiratory distress, hypoxia, flushing, hypotension , syncope, and/or tachycardia, may occur with the first dose of the cycle and resolve with appropriate symptomatic treatment; symptoms do not usually occur with subsequent doses within that cycle

            Edema, capillary leak syndrome, pleural and/or pericardial effusion; fluid retention shown to be reversible with dosage reduction or discontinuation with or without concomitant use of diuretics

            If there is a rapid increase in blood counts (ANC ≥20,000/mm³, WBC >50,000/mm³, platelets >500,000/mm³), decrease dose by 50% or discontinue therapy; excessive blood counts should fall to normal within 3-7 days after discontinuation of therapy; monitor with differential twice weekly during treatment

            Sequestration of granulocytes in pulmonary circulation and dyspnea reported; monitor respiratory symptoms during and following IV infusion; decrease infusion rate by 50% if dyspnea occurs; discontinue infusion if dyspnea persists despite reduction in rate of administration; subsequent doses may be administered at standard rate with careful monitoring

            Supraventricular arrhythmia reported in uncontrolled studies during administration, particularly in patients with a previous history of cardiac arrhythmia

            Serious hypersensitivity reactions, including anaphylactic reactions reported (see Contraindications)

            May cause infusion-related reactions

            Owing to the possibility of tumor growth potentiation, exercise caution when using this drug in any malignancy with myeloid characteristic

            Avoid concomitant use of sargramostim and products that induce myeloproliferation (eg, lithium, corticosteroids)

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            Pregnancy & Lactation

            Pregnancy

            Limited available data on use in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes

            Based on animal studies, sargramostim may cause embryofetal harm; administration to pregnant rabbits during organogenesis resulted in adverse developmental outcomes including increased spontaneous abortion at systemic exposures ≥1.3 times the human exposure expected at the recommended human dose

            Advise pregnant women of the potential risk to a fetus

            Lactation

            No information regarding the presence of drug in human milk, the effects on the breastfed child, or the effects on milk production

            Administration of sargramostim to rabbits during lactation resulted in reduction in postnatal offspring survival; advise a lactating woman not to breastfeed during treatment and for at least 2 weeks after last dose

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant granulocyte macrophage colony stimulating factor; acts on hematopoietic cells to stimulate proliferation & differentiation particularly into neutrophils, monocytes/macrophages & myeloid-derived dendritic cells & some end cell function activity

            Absorption

            Peak plasma concentration: 16.7 ng/mL (IV); 3.03 ng/mL (SC)

            AUC: 32.9 ng·hr /mL (IV); 21.3 ng·hr/mL (SC)

            Bioavailability: 75% (SC)

            Distribution

            Vd: 96.8 L (IV)

            Excretion

            Half-life elimination: 3.84 h (IV); 1.4 h (SC)

            Clearance: 17.2 L/h (IV); 23 L/h

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            Administration

            IV Incompatibilities

            Y-site: acyclovir, amphotericin B(?), ampicillin, ampicillin/sulbactam, amsacrine(?), cefoperazone, ceftazidime(?), chlorpromazine, ganciclovir, haloperidol, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, hydromorphone, hydroxyzine, imipenem/cilastatin, lorazepam, methylprednisolone sodium succinate, mitomycin, morphine, nalbuphine, ondansetron, piperacillin, sodium bicarbonate, tobramycin, vancomycin in albumin-containing solns

            IV Compatibilities

            Y-site (partial list): bleomycin, carboplatin, carmustine, cisplatin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, diphenhydramine, dopamine, doxorubicin, doxycycline, fentanyl, fluorouracil, furosemide, heparin, idarubicin, ifosfamide, MgSO4, mechlorethamine, meperidine, methotrexate, metronidazole, teniposide, vancomycin in albumin-free solns, vinblastine

            Preparation

            Lyophilized powder

            • Reconstitute with 1 mL of diluent; do not mix contents of vials reconstituted with different diluents together
            • Reconstitute with either sterile water for injection (without preservative) or bacteriostatic water for injection
            • Use reconstituted sargramostim vials within 6 hr following dilution for IV infusion; do not re-enter or reuse the vial
            • Discard any unused portions

            Solution

            • For SC injection: Administer without further dilution
            • For IV infusion
              • Dilute in 0.9% NaCl Final concentration of diluted sargramostim <10 mcg/mL, add albumin (Human) at a final concentration of 0.1% to 0.9% NaCl prior to addition of sargramostim to prevent adsorption to the components of the drug delivery system
              • To obtain a final concentration of 0.1% albumin (Human), add 1 mg Albumin (Human) per 1 mL 0.9% NaCl (eg, use 1 mL 5% albumin [Human] in 50 mL 0.9% NaCl)

            SC Administration

            Do not administer simultaneously with or within 24 hr preceding cytotoxic chemotherapy or radiotherapy or within 24 hr following chemotherapy

            Sargramostim injection is formulated as a sterile solution preserved with 1.1% benzyl alcohol; injection should appear clear, colorless single-dose solution

            Use only sargramostim for injection (lyophilized powder) reconstituted with sterile water for injection without preservatives when administering to neonates or infants to avoid benzyl alcohol exposure

            IV Administration

            Do NOT use an inline membrane filter for IV infusion In absence of compatibility and stability information, do not add other medication to infusion solutions containing sargramostim

            Use only 0.9% NaCl to prepare IV infusion solutions

            Visually inspect for particulate matter and discoloration prior to administration; if particulate matter is present or the solution is discolored, vial should not be used

            Usual infusion over 2-4 hr, although longer, shorter or continuous infusions have been done

            Storage

            Unused vials

            • Refrigerate at 2-8°C (36-46°F) in the original carton to protect from light; do not freeze or shake; do not use beyond the expiration date printed on the vial

            Diluted solutions or reconstituted vials

            • Refrigerate at 2-8°C (36-46°F) for up to 20 days once the vial has been entered; discard any remaining solution after 20 days; do not freeze
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            Formulary

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            Tier Description
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