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sargramostim (Rx)Brand and Other Names:gmcsf, Leukine

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 500mcg/mL

powder for injection

  • 250mcg/vial
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Myloid Reconstitution Following Allogeneic or Autologous Bone Marrow Transplant

250 mcg/m²/day IV over 2-4 hours after bone marrow infusion & not less than 24 hours after last dose of chemo or radiation; hold Leukine until post-BMT ANC is <500 cells/m³ & continue until ANC>1500 cells/m³ for 3 consecutive days 

Administer 2-4hr after bone marrow infusion and >24hr after chemotherapy or radiotherapy

If severe adverse reaction occurs, can reduce dose by 50% or temporarily discontinue until reaction ceases

Post-chemo Neutrophil Recovery in AML

250 mcg/m²/day IV over 4 hours beginning on approximately day 11 or 4 days after completion of induction treatment  

If day 10 bone marrow is hypoplastic with <5% blasts; continue until ANC>1500 cells/m³ or for a max of 42 days

Stem Cell Mobilization

250 mcg/m²/day IV over 24 hours or as a daily SC dose during collection; reduce dose by 50% if WBC >50,000 cells/mm³ 

Post-stem Cell Transplant

250 mcg/m²/day IV over 24 hours or as a daily SC dose immediately following transplant & until ANC>1500 cells/m³ for 3 consecutive days 

MDS (Off-label)

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

Aplastic Anemia (Off-label)

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

Cystic Fibrosis (Orphan)

Orphan indication sponsor

  • DrugRecure Aps; Cobis Building, 2200 Copenhagen N; Denmark

Other Indications & Uses

Acceleration of myeloid recovery in patients requiring bone marrow transplant; hematopoietic stem cell mobilization for leukapharesis; peripheral blood progenitor cell transplantation; induction chemotherapy in AML

Off-label: Increased WBCs in myelodysplastic syndromes, AIDS patients receiving zidovudine, myelosuppressive chemotherapy

Dosage Forms & Strengths

powder for injection

  • 250mcg/vial
more...

Myloid Reconstitution Following Allogeneic or Autologous Bone Marrow Transplant

Safety & efficacy not eatablished; no special adverse effects reported at dosages similar to adult

250 mcg/m²/day IV over 2-4 hours after bone marrow infusion & not less than 24 hours after last dose of chemo or radiation; hold Leukine until post-BMT ANC is <500 cells/m³ & continue until ANC>1500 cells/m³ for 3 consecutive days

Administer 2-4hr after bone marrow infusion and >24hr after chemotherapy or radiotherapy

If severe adverse reaction occurs, can reduce dose by 50% or temporarily discontinue until reaction ceases

Solution has benzyl alcohol; do not administer to neonates (benzyl alcohol associated with gasping syndrome in neonates)

If severe adverse reaction occurs, can reduce dose by 50% or temporarily discontinue until reaction ceases

Myloid Reconstitution Following Allogeneic or Autologous Bone Marrow Transplant

250 mcg/m²/day IV over 2-4 hours after bone marrow infusion & not less than 24 hours after last dose of chemo or radiation; hold Leukine until post-BMT ANC is <500 cells/m³ & continue until ANC>1500 cells/m³ for 3 consecutive days 

Administer 2-4hr after bone marrow infusion and >24hr after chemotherapy or radiotherapy

If severe adverse reaction occurs, can reduce dose by 50% or temporarily discontinue until reaction ceases

Post-chemo Neutrophil Recovery in AML

250 mcg/m²/day IV over 4 hours beginning on approximately day 11 or 4 days after completion of induction treatment 

If day 10 bone marrow is hypoplastic with <5% blasts; continue until ANC>1500 cells/m³ or for a max of 42 days

Stem Cell Mobilization

250 mcg/m²/day IV over 24 hours or as a daily SC dose during collection; reduce dose by 50% if WBC >50,000 cells/mm³ 

Post-stem Cell Transplant

250 mcg/m²/day IV over 24 hours or as a daily SC dose immediately following transplant & until ANC>1500 cells/m³ for 3 consecutive days 

MDS (Off-label)

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

Aplastic Anemia (Off-label)

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

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Interactions

Interaction Checker

sargramostim and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
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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

            Hypersensitivity to drug or yeast proteins

            >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

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known if excreted in breast milk

            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.

            more...
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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

            Pharmacokinetics

            Half-life elimination: 60 min (IV); 2.7hr (SC)

            Peak plasma time: 1-3hr (SC)

            Clearance: 420 mL/min/m²

            Duration: WBC are at baseline within 1 week of stopping the therapy

            Onset of action: 7-14 days (increase in WBC)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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