Nurses Compass
Drug Guide
Sorafenib Tosylate
Classification
Therapeutic: Antineoplastic agent
Pharmacological: Multikinase inhibitor
FDA Approved Indications
- Hepatocellular carcinoma (liver cancer)
- Advanced renal cell carcinoma
- Thyroid carcinoma (differentiated thyroid carcinoma after radioactive iodine failure)
Mechanism of Action
Sorafenib inhibits multiple intracellular and cell surface kinases involved in tumor cell proliferation and angiogenesis, including RAF kinases, VEGFR, PDGFR, and KIT, thereby reducing tumor growth and vascularization.
Dosage and Administration
Adult: 400 mg orally twice daily, with or without food. Dose adjustments may be necessary based on tolerance.
Pediatric: Not approved for pediatric use.
Geriatric: Use with caution; consider age-related decline in organ function.
Renal Impairment: Adjust dose in severe renal impairment; no specific dose adjustment recommended for mild to moderate impairment.
Hepatic Impairment: Use with caution; no specific dose recommendation for mild impairment; contraindicated in severe impairment.
Pharmacokinetics
Absorption: Well absorbed orally, with peak concentrations in about 3 hours.
Distribution: Extensive distribution; protein binding >99.5%.
Metabolism: Primarily metabolized by hepatic CYP3A4 and UGT1A9.
Excretion: Excreted mostly in feces; minor amount in urine.
Half Life: Approximately 25 to 48 hours.
Contraindications
- Hypersensitivity to sorafenib or any component of the formulation.
Precautions
- Risk of bleeding, hypertension, cardiac ischemia, wound healing complications, gastrointestinal perforation, hepatic toxicity, renal failure, skin reactions. Use with caution in patients with cardiovascular disease, bleeding risk, or impaired liver function.
Adverse Reactions - Common
- Hand-foot skin reaction (Very common)
- Diarrhea (Common)
- Fatigue (Common)
- Nausea (Common)
- Hair depigmentation or alopecia (Common)
Adverse Reactions - Serious
- Hypertension (Uncommon)
- Bleeding complications (hemorrhage) (Uncommon)
- Cardiac ischemia or infarction (Rare)
- Hepatic toxicity (Rare)
- Gastrointestinal perforation (Rare)
Drug-Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase sorafenib levels.
- CYP3A4 inducers (e.g., rifampin) may decrease efficacy.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor blood pressure, liver function tests, complete blood counts, wound assessment, and signs of bleeding.
Diagnoses:
- Risk for bleeding
- Impaired skin integrity
- Risk for hypertension
Implementation: Administer with or without food. Monitor patient for adverse effects, especially bleeding and hypertension. Adjust dose as needed based on tolerance and side effects.
Evaluation: Assess efficacy through tumor response, and safety by monitoring side effects and lab parameters.
Patient/Family Teaching
- Report any unusual bleeding or bruising.
- Protect skin from excessive sun and injury.
- Avoid strenuous activity if bleeding risk exists.
- Maintain adherence to medication regimen.
- Monitor and report symptoms of hypertension or hepatic issues.
Special Considerations
Black Box Warnings:
- Hepatotoxicity, hemorrhage, and developmental risk of fetal harm.
Genetic Factors: None specific.
Lab Test Interference: May alter levels of blood pressure and liver function tests.
Overdose Management
Signs/Symptoms: Severe skin reactions, bleeding, hypertension, or other serious toxicity.
Treatment: Supportive care; consider activated charcoal if ingestion is recent; hemodialysis is unlikely to be effective due to high protein binding.
Storage and Handling
Storage: Store at room temperature, away from moisture, light, and heat.
Stability: Stable under recommended storage conditions.