Sargramostim

Sargramostim
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Overview

Sargramostim is a colony stimulating factor that is FDA approved for the treatment of granulocytopnia following induction chemotherapy in acute myelogenous leukemia, mobilization and following transplantation of autologous peripheral blood progentior cells, myeloid reconstitution after autologous bone marrow transplantation, myeloid reconstitution after allogeneic bone marrow transplantation and bone marrow transplantation failure or engraftment delay. Common adverse reactions include chest pain, peripheral edema, pruritus, rash, hypercholesterolemia, hypomagnesemia, weight loss, abdominal pain, diarrhea, dysphagia, GI hemorrhage, hematemesis, nausea, vomiting, acute myelogenous leukemia, increased bilirrubin, arthralgia, bone pain, myalgia, asthenia, intraocular hemorrhage, anxiety, elevated BUN, pharyngitis, fever, malaise and rigor.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Sargramostim FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sargramostim in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sargramostim in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sargramostim FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sargramostim in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sargramostim in pediatric patients.

Contraindications

LEUKINE is contraindicated:

• in patients with excessive leukemic myeloid blasts in the bone marrow or peripheral blood (≥ 10%);
• in patients with known hypersensitivity to GM-CSF, yeast-derived products or any component of the product;
• for concomitant use with chemotherapy and radiotherapy.

Due to the potential sensitivity of rapidly dividing hematopoietic progenitor cells, LEUKINE should not be administered simultaneously with cytotoxic chemotherapy or radiotherapy or within 24 hours preceding or following chemotherapy or radiotherapy. In one controlled study, patients with small cell lung cancer received LEUKINE and concurrent thoracic radiotherapy and chemotherapy or the identical radiotherapy and chemotherapy without LEUKINE. The patients randomized to LEUKINE had significantly higher incidence of adverse events, including higher mortality and a higher incidence of grade 3 and 4 infections and grade 3 and 4 thrombocytopenia.

Warnings

There is limited information regarding Sargramostim Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sargramostim Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sargramostim Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sargramostim Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sargramostim in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sargramostim in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sargramostim during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sargramostim in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sargramostim in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sargramostim in geriatric settings.

Gender

There is no FDA guidance on the use of Sargramostim with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sargramostim with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sargramostim in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sargramostim in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sargramostim in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sargramostim in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sargramostim Administration in the drug label.

Monitoring

There is limited information regarding Sargramostim Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sargramostim and IV administrations.

Overdosage

There is limited information regarding Sargramostim overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sargramostim Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sargramostim Mechanism of Action in the drug label.

Structure

There is limited information regarding Sargramostim Structure in the drug label.

Pharmacodynamics

There is limited information regarding Sargramostim Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sargramostim Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sargramostim Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sargramostim Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sargramostim How Supplied in the drug label.

Storage

There is limited information regarding Sargramostim Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Sargramostim Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sargramostim interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Sargramostim Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sargramostim Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Sargramostim

Clinical data
ATC code	L03AA09 (WHO)
Identifiers
IUPAC name Human granulocyte macrophage colony stimulating factor
CAS Number	83869-56-1
DrugBank	BTD00035
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C639H1006N168O196S8
Molar mass	14434.5 g/mol

Sargramostim is a recombinant granulocyte macrophage colony-stimulating factor which functions as a immunostimulator.

It is produced in yeast.