Classes
DEA Class; Rx
Common Brand Names; Nexavar
- Antineoplastics, Tyrosine Kinase Inhibitor;
- Antineoplastics, VEGF Inhibitor
Description
Multi-kinase inhibitor targeting several intracellular and cell surface kinases
Used for the treatment of hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid cancer refractory to radioactive iodine treatment
Dermatologic toxicities are among the most common adverse reactions associated with sorafenib treatment and may require an interruption of therapy or dose reduction
Indications
Indicated for advanced renal cell carcinoma
Indicated for unresectable hepatocellular carcinoma
Indicated for locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) that is refractory to radioactive iodine treatment
Contraindications
Hypersensitivity
Coadministration with carboplatin and paclitaxel in patients with squamous cell lung cancer
Adverse Effects
- Thrombocytopenia (12-46%)
- Anemia (44%)
- Diarrhea (43%)
- Rash/desquamation (40%)
- Fatigue (37%)
- Abdominal pain (31%)
- Hand-foot skin reaction (30%)
- Weight loss (30%)
- Anorexia (29%)
- Alopecia (27%)
- Nausea (24%)
- Lymphopenia (23%)
- Neutropenia (18%)
- Hemorrhage (15-18%)
- Hypertension (9-17%)
- Vomiting (16%)
- Constipation (15%)
- Neuropathy (13%)
- Dry skin (11%)
Warnings
Osteonecrosis of jaw reported
Increased risk of cardiac ischemia/HTN/hemorrhage; consider temporary or permanent discontinuation of therapy in patients who develop cardiovascular events
Withhold therapy for at least 10 days prior to elective surgery; do not administer for at least 2 weeks following major surgery and until adequate wound healing; safety of resumption of therapy after resolution of wound healing complications has not been established
Hepatitis reported; characterized by a hepatocellular pattern of liver damage with significant increases of transaminases which may result in hepatic failure and death
QT Prolongation: Monitor for prolonged QT intervals with CHF, bradyarrhythmias, drugs known to prolong QT interval, and electrolyte abnormalities; avoid with congenital long QT syndrome
Congestive heart failure reported; temporary or permanent discontinuation of therapy should be considered in patients who develop cardiovascular events
Monitor blood pressure weekly during first 6 weeks and periodically thereafter; consider temporary or permanent discontinuation for severe or persistent hypertension despite antihypertensive therapy
Avoid pregnancy
High incidence of skin toxicity and rash
Pregnancy and Lactation
There are no available data in pregnant women to inform a drug associated risk
There are no data on presence of drug or its metabolites in human milk, or its effects on breast-fed child or on milk production
Maximum Dosage
800 mg/day PO.
800 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Sorafenib
tablet
- 200mg