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Leukine
Overview
What is Leukine?
LEUKINE (sargramostim) injection and LEUKINE (sargramostim) for injection for subcutaneous or intravenous use are recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast () expression system. LEUKINE 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.
The amino acid sequence of LEUKINE differs from the natural human GM-CSF by a substitution of leucine at position 23, and the carbohydrate moiety may be different from the native protein. LEUKINE differs from human GM-CSF by one amino acid at position 23, where leucine is substituted for arginine.
LEUKINE (sargramostim) injection is a sterile, clear, colorless solution preserved with 1.1% benzyl alcohol in a multiple-dose vial. Each 1 mL vial contains 500 mcg sargramostim and has a pH range of 6.7 – 7.7. LEUKINE (sargramostim) for injection is supplied as a sterile, preservative-free, white lyophilized powder in a single-dose vial. Each single-dose vial delivers 250 mcg sargramostim. Inactive ingredients are mannitol (40 mg), sucrose (10 mg), and tromethamine (1.2 mg). Reconstitution with 1 mL of the appropriate diluent (sterile water for injection or bacteriostatic water for injection) yields a solution containing 250 mcg/mL sargramostim at a pH range of 7.1 – 7.7 with a deliverable volume of 1 mL (250 mcg).
What does Leukine look like?
What are the available doses of Leukine?
What should I talk to my health care provider before I take Leukine?
How should I use Leukine?
LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
The recommended dose is 250 mcg/m/day administered intravenously over a 4-hour period starting approximately on day 11 or four days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with less than 5% blasts. If a second cycle of induction chemotherapy is necessary, administer LEUKINE approximately four days after the completion of chemotherapy if the bone marrow is hypoplastic with less than 5% blasts. Continue LEUKINE until an absolute neutrophil count (ANC) greater than 1500 cells/mm for 3 consecutive days or a maximum of 42 days. Do not administer LEUKINE within 24 hours preceding or following receipt of chemotherapy or radiotherapy .
What interacts with Leukine?
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What are the warnings of Leukine?
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What are the precautions of Leukine?
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What are the side effects of Leukine?
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What should I look out for while using Leukine?
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
What might happen if I take too much Leukine?
Doses up to 100 mcg/kg/day (4,000 mcg/m/day or 16 times the recommended dose) were administered to four patients in a Phase 1 uncontrolled clinical study by continuous IV infusion for 7 to 18 days. Increases in WBC up to 200,000 cells/mm were observed. Adverse events reported were dyspnea, malaise, nausea, fever, rash, sinus tachycardia, headache, and chills. All these events were reversible after discontinuation of LEUKINE.
In case of overdosage, discontinue LEUKINE therapy and monitor the patient for WBC increase and respiratory symptoms.
How should I store and handle Leukine?
Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–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.Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–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.Rocuronium Bromide Injection, 10 mg/mL is available in:NDC 67457-228-0550 mg/5 mL, 5 mL Multi-dose vial, cartons of 10NDC 67457-228-10100 mg/10 mL, 10 mL Multi-dose vial, cartons of 10 Rocuronium Bromide Injection should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days.Safety and Handling:Rocuronium Bromide Injection, 10 mg/mL is available in:NDC 67457-228-0550 mg/5 mL, 5 mL Multi-dose vial, cartons of 10NDC 67457-228-10100 mg/10 mL, 10 mL Multi-dose vial, cartons of 10 Rocuronium Bromide Injection should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days.Safety and Handling:Rocuronium Bromide Injection, 10 mg/mL is available in:NDC 67457-228-0550 mg/5 mL, 5 mL Multi-dose vial, cartons of 10NDC 67457-228-10100 mg/10 mL, 10 mL Multi-dose vial, cartons of 10 Rocuronium Bromide Injection should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days.Safety and Handling:Rocuronium Bromide Injection, 10 mg/mL is available in:NDC 67457-228-0550 mg/5 mL, 5 mL Multi-dose vial, cartons of 10NDC 67457-228-10100 mg/10 mL, 10 mL Multi-dose vial, cartons of 10 Rocuronium Bromide Injection should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days.Safety and Handling:Rocuronium Bromide Injection, 10 mg/mL is available in:NDC 67457-228-0550 mg/5 mL, 5 mL Multi-dose vial, cartons of 10NDC 67457-228-10100 mg/10 mL, 10 mL Multi-dose vial, cartons of 10 Rocuronium Bromide Injection should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use Rocuronium Bromide Injection within 60 days. Use opened vials of Rocuronium Bromide Injection within 30 days.Safety and Handling:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Sargramostim (GM-CSF) belongs to a group of growth factors termed colony stimulating factors which support survival, clonal expansion, and differentiation of hematopoietic progenitor cells. GM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways which include neutrophils, monocytes/macrophages and myeloid-derived dendritic cells.
GM-CSF is also capable of activating mature granulocytes and macrophages. GM-CSF is a multilineage factor and, in addition to dose-dependent effects on the myelomonocytic lineage, can promote the proliferation of megakaryocytic and erythroid progenitors. However, other factors are required to induce complete maturation in these two lineages. The various cellular responses (i.e., division, maturation, activation) are induced through GM-CSF binding to specific receptors expressed on the cell surface of target cells.
The biological activity of GM-CSF is species-specific. Consequently, studies have been performed on human cells to characterize the pharmacological activity of GM-CSF. exposure of human bone marrow cells to GM-CSF at concentrations ranging from 1–100 ng/mL results in the proliferation of hematopoietic progenitors and in the formation of pure granulocyte, pure macrophage and mixed granulocyte macrophage colonies. Chemotactic, anti-fungal, and anti-parasitic activities of granulocytes and monocytes are increased by exposure to GM-CSF ro. GM-CSF increases the cytotoxicity of monocytes toward certain neoplastic cell lines and activates polymorphonuclear neutrophils to inhibit the growth of tumor cells.
Non-Clinical Toxicology
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 LEUKINEThere has been a report of a patient who passed an orange rubbery precipitate in his stool the day after ingesting carbamazepine suspension immediately followed by Thorazine solution. Subsequent testing has shown that mixing carbamazepine suspension and chlorpromazine solution (both generic and brand name) as well as carbamazepine suspension and liquid Mellaril resulted in the occurrence of this precipitate. Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medicinal agents or diluents (See ).
Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to, the following:
Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. Parenteral administration of LEUKINE should be attended by appropriate precautions in case an allergic or untoward reaction occurs. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Discontinue LEUKINE permanently for patients with serious allergic reactions.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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