Sargramostim (Leukine)

Trade Name : Leukine

sanofi-aventis U.S. LLC

INJECTION, POWDER, FOR SOLUTION

Strength 250 ug/mL

Storage and handling for Leukine

SARGRAMOSTIM Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sargramostim (Leukine) which is also known as Leukine and Manufactured by sanofi-aventis U.S. LLC. It is available in strength of 250 ug/mL per ml. Read more

Sargramostim (Leukine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

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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). ()
For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ()
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. ()
For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ()
For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ()
To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). ()

See Full Prescribing Information for dosage adjustments and timing of administration (2.1u20132.6).

AML, Neutrophil recovery following chemotherapy:n
Mobilization of peripheral blood progenitor cells:n
Post peripheral blood progenitor cell transplantation: n
Myeloid reconstitution after autologous or allogeneic BMT:n
BMT failure or engraftment delayed:n
Patients acutely exposed to myelosuppressive doses of radiation, administer once daily as subcutaneous injection:n

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For injection (lyophilized powder): 250 mcg of sargramostim in single-dose vial for reconstitution ()
Injection (solution): 500 mcg per mL sargramostim in multiple-dose vial ()

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 n

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. ()

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Hypersensitivity Reactions: Permanently discontinue LEUKINE in patients with serious allergic reactions. ()
Infusion Related Reactions: Manage using infusion rate reductions or discontinuations. ()
Effusions and Capillary Leak Syndrome: Manage with dose-reduction, discontinuation, or diuretics. Monitor body weight and hydration status during therapy. ()
Supraventricular Arrhythmias: Risk may be increased in patients with history of cardiac arrhythmias. Manage medically and discontinue LEUKINE. ()

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
The most common adverse reactions (incidence >30%) were ():
To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-888-4RX-LEUKINE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In recipients of autologous BMT: fever, nausea, diarrhea, vomiting, mucous membrane disorder, alopecia, asthenia, malaise, anorexia, rash, gastrointestinal disorder and edema.
In recipients of allogeneic BMT: diarrhea, fever, nausea, rash, vomiting, stomatitis, anorexia, high glucose, alopecia, abdominal pain, low albumin, headache and hypertension.
In patients with AML: fever, liver toxicity, skin reactions, infections, metabolic laboratory abnormalities, nausea, diarrhea, genitourinary abnormalities, pulmonary toxicity, vomiting, neurotoxicity, stomatitis, alopecia and weight loss.

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.

Use with caution in patients receiving drugs that may potentiate LEUKINE's myeloproliferative effects, such as lithium and corticosteroids. ()

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Pregnancy: Benzyl alcoholu2013free formulation recommended. May cause fetal harm. ()
Pediatrics: In infants, avoid use of benzyl alcoholu2013containing solutions when feasible. (, , )
Lactation: Advise women not to breastfeed. ()

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.

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 u2013 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 u2013 7.7 with a deliverable volume of 1 mL (250 mcg).

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Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
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 . If home use is prescribed, patients should be instructed in the importance of proper disposal and cautioned against the reuse of needles, syringes, drug product, and diluent. A puncture resistant container should be used by the patient for the disposal of used needles.
Advise patients of the following risks and potential risks with LEUKINE:
Instruct patients who self-administer LEUKINE:

LEUKINE is a registered trademark licensed to Genzyme Corporation
Manufactured by:sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
US License No. 1752u00a92018 sanofi-aventis U.S. LLC
Phone: 1-888-4RX-LEUKINE

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Instructions for UseLEUKINEu00ae (loo'-kine)(sargramostim)Injection, for subcutaneous useMultiple-dose vial
Important:
Read the Patient Information for important information you need to know about LEUKINE before using these Instructions for Use.
Storing the LEUKINE vial
Keep LEUKINE, needles and syringes out of the reach of children.
Using LEUKINE vials
Step 1: Draw up the dose
Step 2:n
Step 3: Choose and prepare the injection site
You can use
Step 4: Subcutaneous (under the skin) injection
Step 5: Dispose of (throw away) needles and syringes
Important: Always keep the sharps disposal container out of the reach of children.
Step 6: Examine the injection site
IMPORTANT NOTES
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by: Sanofi-aventis U.S. LLCBridgewater, NJ 08807US License No. 1752u00a9 2018 sanofi-aventis U.S. LLCLEUKINE is a registered trademark licensed to Genzyme Corporation
Revised: 03/2018

NDC 0024-5843-05
5 u00d7 250 mcg/vial
Leukinen- sargramostim
1.4 u00d7 10IU/vial
Sterile
Lyophilizedn- Rx only
SANOFI
u2013 250 mcg
u2013 5 vials
u2013 Injection

NDC 0024-5844-05
5 u00d7 500 mcg/mL
Leukinen- sargramostim
2.8 u00d7 10IU/mL
Sterile
liquid injection, contains preservativen- Rx only
SANOFI
u2013 5 multipleuse vials

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