Sargramostim
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Leukocyte Growth Factor
Dosing in kidney impairment
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Preparation and administration
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Preparation and Administration of LEUKINE Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy [see Warnings and Precautions] . LEUKINE for injection is a sterile, preservative-free lyophilized powder that requires reconstitution with 1 mL Sterile Water for Injection (without preservative), USP, to yield a clear, colorless single-dose solution or 1 mL Bacteriostatic Water for Injection, USP (with 0.9% benzyl alcohol as preservative) to yield a clear, colorless single-dose solution.
Use only LEUKINE for injection (lyophilized powder) reconstituted with Sterile Water for Injection without preservatives when administering LEUKINE to neonates or infants to avoid benzyl alcohol exposure [see Warnings and Precautions] . Do NOT use an in-line membrane filter for intravenous infusion of LEUKINE. Store reconstituted solution under refrigeration at 2°C to 8°C (36°F to 46°F); DO NOT FREEZE.
In the absence of compatibility and stability information, do not add other medication to infusion solutions containing LEUKINE. Use only 0.9% Sodium Chloride Injection, USP to prepare intravenous infusion solutions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
If particulate matter is present or the solution is discolored, the vial should not be used. LEUKINE for Injection Preparation Reconstitute the lyophilized powder with 1 mL of diluent. Do not mix the contents of vials reconstituted with different diluents together . Reconstitute with either Sterile Water for Injection, USP (without preservative) or Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) for intravenous or subcutaneous administration.
Discard any unused portions. When reconstituted with Sterile Water for Injection, USP (without preservative) , may store the reconstituted solution refrigerated at 2°C to 8°C and must use within 24 hours following reconstitution. When reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) , may store the reconstituted solution refrigerated at 2°C to 8°C and must use within 20 days following reconstitution.
LEUKINE for Intravenous Administration Dilute reconstituted LEUKINE in 0.9% Sodium Chloride Injection, USP. If the final concentration of LEUKINE is less than 10 mcg/mL, add Albumin (Human) to a final concentration of 0.1% [1 mL 5% Albumin (Human) per 1 mL 0.9% Sodium Chloride Injection, USP] to prevent adsorption of LEUKINE to the drug delivery system.
LEUKINE for intravenous administration must be used immediately after dilution with 0.9 % Sodium Chloride Injection, USP.
Drug interactions
Check sargramostim against a medication listLabel text (2 paragraphs)
Use with caution in patients receiving drugs that may potentiate LEUKINE's myeloproliferative effects, such as lithium and corticosteroids. ( 7.1 )
7.1 Concomitant Use with Products that Induce Myeloproliferation Avoid the concomitant use of LEUKINE and products that induce myeloproliferation (such as lithium and corticosteroids). Such products may increase the myeloproliferative effects of LEUKINE. Monitor patients receiving both LEUKINE and products that induce myeloproliferation frequently for clinical and laboratory signs of excess myeloproliferative effects.
Contraindications
Do not administer LEUKINE to patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor such as sargramostim, yeast-derived products, or any component of the product. Anaphylactic reactions have been reported with LEUKINE [see Warnings and Precautions ( 5.1 )] . Do not administer LEUKINE to patients with a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary LEUKINE for injection reconstituted with Bacteriostatic Water for Injection, USP contain 0.9% benzyl alcohol, which has been associated with gasping syndrome in neonates and infants. The preservative benzyl alcohol can cause serious adverse reactions and death when administered intravenously to neonates and infants. If LEUKINE is needed during pregnancy, reconstitute LEUKINE for injection only with Sterile Water for injection without preservatives [see Dosage and Administration ( 2.7 ) and Use in Specific Populations ( 8.4 )] .
The limited available data on LEUKINE use in pregnant women are insufficient to inform the drug-associated risk of adverse developmental outcomes. Based on animal studies LEUKINE may cause embryofetal harm. In animal reproduction studies, administration of LEUKINE 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 [see Data ] . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively. Data Animal data In an embryofetal developmental study and a prenatal and postnatal study, pregnant rabbits were administered SC doses of LEUKINE during the period of gestation day (GD) 6 to GD19, GD19 to GD28, or GD19 to parturition at 25, 70, and 200 mcg/kg/day.
An increase in spontaneous abortions, late resorptions, and post implantation loss, and a reduction in viable fetuses, mean live litter size, and offspring body weight were evident in rabbits treated with LEUKINE at 200 mcg/kg/day. No adverse effects were observed at ≤70 mcg/kg/day.
After the first administration in rabbits, the dose of 200 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 11-25.3 times the exposures observed in patients treated with the clinical LEUKINE dose of 250 mcg/m 2 ; however, due to the production of anti-LEUKINE antibodies with repeat administration, the AUC in rabbits was reduced to 1.3-5.5 times the clinical exposure by the end of the dosing periods. Similarly, after the first administration in rabbits, the dose of 70 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 7…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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