Drug Guide

Generic Name

Sargramostim

Brand Names Leukine

Classification

Therapeutic: Hematopoietic growth factor

Pharmacological: Granulocyte-macrophage colony-stimulating factor (GM-CSF)

FDA Approved Indications

  • Neutropenia post-hematopoietic stem cell transplant
  • Neutropenia induced by chemotherapy in acute myeloid leukemia (AML) patients
  • Autologous marrow transplantation to shorten neutropenia

Mechanism of Action

Stimulates proliferation and differentiation of granulocyte and macrophage progenitor cells by binding to GM-CSF receptors, enhancing hematopoiesis.

Dosage and Administration

Adult: Based on indication; generally, 250 mcg/m2/day subcutaneously or intravenously, adjusted according to clinical response.

Pediatric: Dosage varies; consult specific protocols depending on condition and weight.

Geriatric: No specific adjustments, but caution due to potential comorbidities.

Renal Impairment: Adjust dosage based on clinical response and tolerability.

Hepatic Impairment: No specific adjustments established.

Pharmacokinetics

Absorption: Subcutaneous and intravenous administration; rapid onset.

Distribution: Distributed in plasma and tissues; crosses biological membranes.

Metabolism: Metabolized and cleared primarily via renal pathways.

Excretion: Renal excretion of metabolites.

Half Life: Approx. 2-4 hours in plasma.

Contraindications

  • Hypersensitivity to Sargramostim or other GM-CSF products.

Precautions

  • Use with caution in patients with bone marrow disorders, or those at risk for leukemic proliferation. Avoid in patients with eosinophilia, pulmonary infiltrates, or active infections.

Adverse Reactions - Common

  • Bone pain (Frequent)
  • Fever, chills (Often)
  • Malaise, fatigue (Common)

Adverse Reactions - Serious

  • Capillary leak syndrome (Rare)
  • Severe allergic reactions including anaphylaxis (Rare)
  • Progression of leukemia or other malignancies (Rare)

Drug-Drug Interactions

  • Chemotherapy agents that suppress marrow

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor complete blood counts regularly to assess hematopoietic response. Observe for signs of allergic reactions.

Diagnoses:

  • Risk for infection due to neutropenia
  • Impaired skin integrity

Implementation: Administer as ordered, preferably subcutaneously. Evaluate for side effects and response.

Evaluation: Assess for improvement in neutrophil counts and resolution of clinical symptoms. Watch for adverse effects.

Patient/Family Teaching

  • Report any fever, chills, or signs of allergic reaction immediately.
  • Maintain good hygiene to reduce infection risk.
  • Understand the purpose of the medication and comply with dosing schedules.

Special Considerations

Black Box Warnings:

  • Potential for leukemic transformation or other hematologic malignancies (monitor closely).

Genetic Factors: N/A

Lab Test Interference: May elevate baseline white cell counts, complicating interpretation.

Overdose Management

Signs/Symptoms: Severe leukocytosis, capillary leak syndrome.

Treatment: Discontinue drug, provide supportive care, and monitor hematologic status.

Storage and Handling

Storage: Store refrigerated at 2-8°C (36-46°F). Protect from light.

Stability: Stable for up to 3 months when refrigerated.

This guide is for educational purposes only and is not intended for clinical use.