Sorafenib (NEXAVAR)

Renal cell carcinoma, advanced or metastatic

Hepatocellular carcinoma, advanced

Renal cell carcinoma, advanced or metastatic

• Dose – Oral: 400 mg twice daily continuously until disease progression or unacceptable toxicity

Hepatocellular carcinoma, advanced

• Dose – Oral: 400 mg twice daily continuously until disease progression or unacceptable toxicity

Available as 200 mg film-coated tablet. Tablets should NOT be crushed or broken.Store at room temperature.

Multi-targeted TKI (tyrosine kinase inhibitor) which includes action as a Vascular Endothelial Growth Factor (VEGF) Inhibitor

Take at least one hour before or two hours after a meal

If a dose is missed, patients should be instructed to take it as soon as they can if it is within 6 hours of the missed dose. If it is over 6 hours since the missed dose, patients should skip the missed dose and resume with the next scheduled dose.

Common: Fatigue, Hand-foot skin reaction, Rash/desquamation, Diarrhea.

Less Common: Cardiac ischemia/infarction, Hypertension, Erythema, Yellow skin discoloration, Gastrointestinal perforation, Cerebral hemorrhage, Hemorrhage, Osteonecrosis of the jaw.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, sodium, potassium, magnesium, creatinine, total protein, albumin, bilirubin, alkaline phosphatase, urine analysis, TSH, INR.

During treatment: CBC & differential, platelets, creatinine, ALT, bilirubin.

If clinically indicated: MUGA scan or echocardiogram, electrolytes.

• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Avoid grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
• May increase the risk for QT interval prolongation. Avoid concurrent therapy with drugs associated with QTc prolongation and/or Torsades de pointes, if possible. If unavoidable, monitor for QT prolongation or cardiac arrhythmias.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.
• Hand-foot skin reaction (HFSR) has been reported with sorafenib and usually appears during the first eight weeks of treatment. Follow local guidelines for dose modifications. Treatment with urea cream may be considered for prophylaxis or improvement of HFSR grade in VEGF treated patients.
• Hypertension is common with VEGF inhibitors. Monitor blood pressure closely and manage with antihypertensives and dose hold/reductions. Hypertension should be well controlled prior to starting sorafenib.
• Bleeding - An increase in the risk of bleeding may occur following sorafenib administration. If any bleeding event necessitates medical intervention, it is recommended that permanent discontinuation of sorafenib should be considered.
• Impaired wound healing is associated with VEGF inhibitors, drug may need to be held and restarted if patient requires surgery, discuss with team.

BC Cancer. BC Cancer Drug Manual. Sorafenib. Vancouver, British Columbia: BC Cancer Agency. Available at :http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Sorafenib_monograph_1Dec2014.pdf. Updated January 1, 2010. Accessed January 22, 2024.

Lexicomp. Sorafenib Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Available at: https://online-lexi-com.qe2a-proxy.mun.ca/lco/action/doc/retrieve/docid/patch_f/329282?cesid=4xV5N53fF04&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dsorafenib%26t%3Dname%26acs%3Dfalse%26acq%3Dsorafenib. Updated January 24, 2024. Accessed January 28, 2024.

Cancer Care Ontario. Sorafenib Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/43761. Updated July 2023. Accessed January 22, 2024.

Bayer Inc. NEXAVAR® Product monograph. Toronto, Ontario. Updated September 27, 2022.