Leukine (sargramostim)

Do not administer sargramostim concomitantly with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.

Sargramostim is administered by IV infusion or subcutaneous injection depending on the indication for use. The drug is commercially available as a lyophilized powder that must be reconstituted prior to use.

Sargramostim should be administered under the guidance and supervision of a clinician, but may be self-administered outside of a hospital or medical office setting (e.g., at home) if the clinician determines that the patient and/or caregiver is competent to prepare and safely administer the drug. If home use is prescribed, instruct patients and/or caregivers on proper dosage, reconstitution procedures, and administration of the drug. Additionally, caution against reuse of syringes and needles and diluent and instruct on proper disposal of such equipment using puncture-resistant containers.

Store sargramostim single-dose vials under refrigeration (2degrees to 8degreesC) in their original carton; do not freeze or shake, and protect from light.

Sargramostim lyophilized powder should be reconstituted by adding 1 mL of sterile water for injection (without preservative) or bacteriostatic water for injection (with 0.9% benzyl alcohol) to provide a single-dose solution containing 250 mcg/mL. Do not mix the contents of vials reconstituted with different diluents together. Reconstitute only with sterile water for injection (without preservative) when administering sargramostim to neonates or infants in order to avoid benzyl alcohol exposure.

Store reconstituted sargramostim solution under refrigeration (2degrees to 8degreesC); do not freeze. When reconstituted with sterile water for injection (without preservative), use within 24 hours. When reconstituted with bacteriostatic water for injection (with 0.9% benzyl alcohol), use within 20 days.

Prior to administration, visually inspect the solution for discoloration and/or the presence of particulate matter. Do not administer the solution if discoloration or particulate matter is present.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factor (GM-CSF), yeast-derived products, or any product component.

There are no contraindication contraindications for this drug.

• Capillary leak syndrome
• Cardiac arrhythmia
• Chronic heart failure
• Edema
• Pericardial effusion
• Pleural effusions
• Pre-existing fluid retention
• Pulmonary infiltrates

• Leukocytosis

The most common (>30%) adverse reactions in recipients of autologous BMT include fever, nausea, diarrhea, vomiting, mucus membrane disorder, alopecia, asthenia, malaise, anorexia, rash, GI disorder, and edema.

The most common (>30%) adverse reactions in recipients of allogeneic BMT include diarrhea, fever, nausea, rash, vomiting, stomatitis, anorexia, increased glucose, alopecia, abdominal pain, low albumin, headache, and hypertension.

The most common (>30%) adverse reactions in patients with AML include fever, liver toxicity, skin reactions, infections, metabolic laboratory abnormalities, nausea, diarrhea, genitourinary abnormalities, pulmonary toxicity, vomiting, neurotoxicity, stomatitis, alopecia, and weight loss.

More Frequent

• Hypertension

Less Frequent

• Abnormal hepatic function tests
• Body fluid retention
• Fever
• Hyperbilirubinemia
• Leukocytosis
• Pericardial effusion
• Pleural effusions
• Sepsis

Rare or Very Rare

• Anaphylaxis
• Capillary leak syndrome
• Eosinophilia
• Hypotension
• Pericarditis
• Shortened time to tumor progression
• Supraventricular arrhythmias
• Thromboembolic disorder
• Thrombophlebitis
• Vasculitis

More Frequent

• Arthralgia
• Bone pain
• Headache disorder
• Myalgia
• Pruritus of skin
• Skin rash
• Vomiting
• Weight loss

Less Frequent

• Alopecia
• Diarrhea
• Dyspnea
• Edema
• Injection site sequelae
• Insomnia
• Malaise
• Peripheral edema
• Pharyngitis
• Stomatitis
• Symptoms of anxiety
• Tachycardia

Rare or Very Rare

• Acute abdominal pain
• Chest pain
• Erythema
• Flushing
• General weakness
• Syncope
• Urticaria

No enhanced messaging available.

The efficacy and safety of sargramostim have been established in pediatric patients >=2 years of age for autologous peripheral blood progenitor cells and BMT, allogeneic BMT, and treatment of delayed neutrophil recovery or graft failure based on studies performed in adults and a limited number of pediatric patients. The efficacy and safety of sargramostim have also been established in the setting of acute exposure to myelosuppressive doses of radiation among pediatric patients from birth to 17 years of age. This approval is based on studies conducted in animals and clinical data supporting the use of sargramostim in patients undergoing autologous or allogeneic BMT following myelosuppressive chemotherapy with or without total body irradiation. Modeling and simulations were performed in order to develop pediatric dosage regimens that provide effects comparable to those seen in adults.

In neonates and low birth weight infants, avoid the use of sargramostim solutions reconstituted with Bacteriostatic Water for Injection due to the presence of the preservative, benzyl alcohol. Benzyl alcohol may result in fatal reactions and the ''gasping syndrome'' in this patient population. Additional potential adverse reactions of benzyl alcohol exposure include gradual neurologic deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse.

There are limited data on sargramostim use in pregnant women; however, the drug may cause embryofetal harm based on animal findings. In pregnant rabbits, sargramostim administration during organogenesis was associated with adverse developmental outcomes including increased spontaneous abortion at exposures >=1.3 times the human exposure expected at the recommended human dose. Advise women of childbearing potential of the potential fetal risks.

Benzyl alcohol is a preservative present during reconstitution of sargramostim with Bacteriostatic Water for Injection. Benzyl alcohol has been associated with gasping syndrome in neonates and low birth weight infants. If sargramostim is necessary during pregnancy, reconstitute the drug only with Sterile Water for Injection without preservatives.

It is not known whether sargramostim is distributed into milk, affects milk production, or affects the breast-fed infant. Use in rabbits during lactation was associated with a reduction in postnatal offspring survival. Advise lactating women not to breast-feed during treatment and for at least 2 weeks after the last dose of sargramostim.

The manufacturer makes no specific dosage recommendations for geriatric patients.

Experience in patients >=65 years of age is insufficient to determine whether they respond differently to sargramostim than younger patients