Sargramostim
Generic Name: sargramostim
Brand Names:
Leukine
11 DESCRIPTION Sargramostim is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast ( S. cerevisiae ) expression system. Sargramostim is a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800 and 15,500 Daltons.
Overview
11 DESCRIPTION Sargramostim is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast ( S. cerevisiae ) expression system. Sargramostim is a glycoprotein of 127 amino acids characterized by three primary molecular species having molecular masses of 19,500, 16,800 and 15,500 Daltons.
Uses
1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.
Dosage
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for dosage adjustments and timing of administration ( 2.1 - 2.6 ). AML, Neutrophil recovery following chemotherapy: 250 mcg/m 2 /day administered intravenously over a 4-hour period. ( 2.1 ) Mobilization of peripheral blood progenitor cells: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. ( 2.2 ) Post peripheral blood progenitor cell transplantation: 250 mcg/m 2 /day administered intravenously over 24 hours or subcutaneous injection once daily. ( 2.3 ) Myeloid reconstitution after autologous or allogeneic BMT: 250 mcg/m 2 /day administered intravenously over a 2-hour period. ( 2.4 ) BMT failure or engraftment delayed: 250 mcg/m 2 /day for 14 days as a 2-hour intravenous infusion.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Risk of Severe Myelosuppression when LEUKINE Administered within 24 Hours of Chemotherapy or Radiotherapy [see Warnings and Precautions ( 5.3 )] Effusions and Capillary Leak Syndrome [see Warnings and Precautions ( 5.4 )] Supraventricular Arrhythmias [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Potential Effect on Malignant Cells [see Warnings and Precautions ( 5.7 )] Immunogenicity [see Warnings and Precautions ( 5.8 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Pre...
Interactions
7 DRUG INTERACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Permanently discontinue LEUKINE in patients with serious allergic reactions. ( 5.1 ) Infusion Related Reactions: Manage using infusion rate reductions or discontinuations. ( 5.2 ) Effusions and Capillary Leak Syndrome: Manage with dose-reduction, discontinuation, or diuretics. Monitor body weight and hydration status during therapy. ( 5.4 ) Supraventricular Arrhythmias: Risk may be increased in patients with history of cardiac arrhythmias. Manage medically and discontinue LEUKINE. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. 4 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 )] .
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 )] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LEUKINE (sargramostim) for injection is a sterile, preservative-free, white lyophilized powder supplied in a carton containing five 250 mcg single-dose vials. (NDC 71837-5843-5). Storage and Handling Store LEUKINE vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
Frequently Asked Questions
What is Sargramostim used for?▼
1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older.
What are the side effects of Sargramostim?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Risk of Severe Myelosuppression when LEUKINE Administered within 24 Hours of Chemotherapy or Radiotherapy [see Warnings and Precautions ( 5.3 )] Effusions and Capillary Leak Syndrome [see Warnings and Precautions ( 5.4 )] Supraventricular Arrhythmias [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Potential Effect on Malignant Cells [see Warnings and Precautions ( 5.7 )] Immunogenicity [see Warnings and Precautions ( 5.8 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Pre...
Can I take Sargramostim during 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 )] .
What are the important warnings for Sargramostim?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Permanently discontinue LEUKINE in patients with serious allergic reactions. ( 5.1 ) Infusion Related Reactions: Manage using infusion rate reductions or discontinuations. ( 5.2 ) Effusions and Capillary Leak Syndrome: Manage with dose-reduction, discontinuation, or diuretics. Monitor body weight and hydration status during therapy. ( 5.4 ) Supraventricular Arrhythmias: Risk may be increased in patients with history of cardiac arrhythmias. Manage medically and discontinue LEUKINE. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. 4 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 )] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.