Brand Name
Leukine
Generic Name
Sargramostim
View Brand Information FDA approval date: September 01, 2023
Classification: Leukocyte Growth Factor
Form: Injection
What is Leukine (Sargramostim)?
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 .
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Brand Information
Leukine (SARGRAMOSTIM)
1DOSAGE FORMS AND STRENGTHS
- For injection: 250 mcg of sargramostim as a white lyophilized powder in a single-dose vial for reconstitution
2CONTRAINDICATIONS
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
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Hypersensitivity Reactions
- Infusion Related Reactions
- Risk of Severe Myelosuppression when LEUKINE Administered within 24 Hours of Chemotherapy or Radiotherapy
- Effusions and Capillary Leak Syndrome
- Supraventricular Arrhythmias
- Leukocytosis
- Potential Effect on Malignant Cells
- Immunogenicity
- Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Autologous Peripheral Blood Progenitor Cell (PBPC) and Bone Marrow Transplantation
Studies 301, 302 and 303 enrolled a total of 156 patients after autologous or allogeneic marrow or PBPC transplantation. In these placebo-controlled studies, pediatric and adult patients received once-daily intravenous infusions of LEUKINE 250 mcg/m
In Studies 301, 302, and 303, there was no difference in relapse rate between the LEUKINE and placebo-treated patients. Adverse reactions reported in at least 10% of patients who received intravenous LEUKINE or at a rate that was at least 5% higher than the placebo arm are shown in
Additional Clinically Significant Adverse Reactions Occurring in Less than 10% Incidence
Investigations: Elevated creatinine, elevated bilirubin, elevate transaminases
Allogeneic Bone Marrow Transplantation
In the placebo-controlled trial of 109 patients after allogeneic BMT (Study 9002), acute graft-vs-host disease occurred in 55% on the LEUKINE arm and in 59% on the placebo arm. Adverse reactions reported in at least 10% of patients who received IV LEUKINE or at a rate at least 5% higher than the placebo arm are shown in
Acute Myeloid Leukemia Following Induction Chemotherapy
Nearly all patients in both arms developed leukopenia, thrombocytopenia, and anemia. Adverse reactions reported in at least 10% of patients who received LEUKINE or at least 5% higher than the placebo arm are reported in
There was no significant difference between the arms in the proportion of patients achieving complete remission (CR; 69% in the LEUKINE group and 55% in the placebo group). There was also no significant difference in relapse rates; 12 of 36 patients who received LEUKINE and five of 26 patients who received placebo relapsed within 180 days of documented CR (p=0.26). The study was not sized to assess the impact of LEUKINE treatment on response.
Graft Failure
In a historically controlled study of 86 patients with AML, the LEUKINE treated group exhibited an increased incidence of weight gain (p=0.007), low serum proteins, and prolonged prothrombin time (p=0.02) when compared to the control group. Two LEUKINE treated patients had progressive increase in circulating monocytes and promonocytes and blasts in the marrow, which reversed when LEUKINE was discontinued. The historical control group exhibited an increased incidence of cardiac events (p=0.018), liver function abnormalities (p=0.008), and neurocortical hemorrhagic events (p=0.025). Headache (26%), pericardial effusion (25%), arthralgia (21%), and myalgia (18%) were also reported in patients treated with LEUKINE in the graft failure study.
3.2Immunogenicity
As with all therapeutic proteins, there is the potential for immunogenicity with LEUKINE. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, duration of treatment, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to sargramostim in the studies described below with the incidence of antibodies in other studies or other products may be misleading.
In 214 patients with a variety of underlying diseases, neutralizing anti-sargramostim antibodies were detected in 5 patients (2.3%) after receiving LEUKINE by continuous IV infusion (3 patients) or SC injection (2 patients) for 28 to 84 days in multiple courses (as assessed by GM-CSF dependent human cell-line proliferation assay). All 5 patients had impaired hematopoiesis before the administration of LEUKINE, and consequently the effect of the development of anti-sargramostim antibodies on normal hematopoiesis could not be assessed.
Antibody studies of 75 patients with Crohn's disease (a disease for which LEUKINE is not indicated), with normal hematopoiesis and no other immunosuppressive drugs, receiving LEUKINE daily for 8 weeks by SC injection, showed 1 patient (1.3%) with detectable neutralizing anti-sargramostim antibodies (as assessed by GM-CSF dependent human cell-line proliferation assay).
In an experimental use trial where LEUKINE was given for an extended period, 53 patients with melanoma in complete remission (a disease for which LEUKINE is not indicated) received adjuvant therapy with LEUKINE 125 mcg/m
Serious allergic and anaphylactoid reactions have been reported with LEUKINE, but the rate of occurrence of antibodies in such patients has not been assessed.
3.3Postmarketing Experience
The following adverse reactions have been identified during postapproval use of LEUKINE in clinical trials and/or postmarketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Infusion related reactions including dyspnea, hypoxia, flushing, hypotension, syncope and/or tachycardia [see Warnings and Precautions
- Serious allergic reactions/hypersensitivity, including anaphylaxis, skin rash, urticaria, generalized erythema, and flushing
- Effusions and capillary leak syndrome
- Supraventricular arrhythmias
- Leukocytosis including eosinophilia
- Thromboembolic events
- Pain, including chest, abdominal, back, and joint pain
- Injection site reactions
4OVERDOSAGE
Doses up to 100 mcg/kg/day (4,000 mcg/m
In case of overdosage, discontinue LEUKINE therapy and monitor the patient for WBC increase and respiratory symptoms.
5DESCRIPTION
Sargramostim is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (
The amino acid sequence of sargramostim 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. Sargramostim differs from human GM-CSF by one amino acid at position 23, where leucine is substituted for arginine.
LEUKINE (sargramostim) for injection is supplied as a sterile, preservative-free, white lyophilized powder in a single-dose vial for subcutaneous or intravenous use. Reconstitute each single-dose vial with 1 mL of diluent (i.e., sterile water for injection or bacteriostatic water for injection). After reconstitution each single-dose vial contains 250 mcg/mL sargramostim and the inactive ingredients mannitol (40 mg), sucrose (10 mg), and tromethamine (1.21 mg) per mL with a pH range of 7.1 - 7.7 with a deliverable volume of 1 mL (250 mcg).
6HOW 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. Do not use beyond the expiration date printed on the vial.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
LEUKINE should be used under the guidance and supervision of a health care professional. However, if the physician determines that LEUKINE may be used outside of the hospital or office setting, persons who will be administering LEUKINE should be instructed as to the proper dose, and the method of reconstituting and administering LEUKINE
Advise patients of the following risks and potential risks with LEUKINE:
- Serious allergic reactions
- Infusion related reactions
- Risk of severe myelosuppression when LEUKINE administered within 24 hours of chemotherapy or radiotherapy
- Effusions and capillary leak syndrome
- Supraventricular arrhythmias
- Leukocytosis including eosinophilia
- Potential effect on malignant cells
- Pain including chest, abdominal, back, and joint pain
- Thromboembolic events
- Embryofetal Toxicity: Advise females of reproductive potential that LEUKINE may cause fetal harm and to inform their prescriber of a known or suspected pregnancy
- Lactation: Advise lactating woman not to breastfeed during treatment and for at least 2 weeks after the last dose
- Advise patients acutely exposed to myelosuppressive doses of radiation (H-ARS) that efficacy studies of LEUKINE for this indication could not be conducted in humans for ethical and feasibility reasons and that, therefore, approval of this use was based on efficacy studies conducted in animals
Instruct patients who self-administer LEUKINE:
- Do not reuse needles, syringes, or unused portions of vials
- Follow local requirements for proper disposal of used syringes, needles, and unused vials
LEUKINE
(VER-AW009-02) Phone: 1-888-4RX-LEUKINE
8PRINCIPAL DISPLAY PANEL - NDC: 71837-5843-1 - 250 mcg Lyophilized Powder for Injection Vial Label
9PRINCIPAL DISPLAY PANEL - NDC: 71837-5843-5 - 250 mcg Lyophilized Powder for Injection 5-count Carton Label
