Carboplatin and Paclitaxel: Caution, sorafenib and paclitaxel AUC increases when co-administered.

• UGT1A1 (for example, irinotecan) and UGT1A9 substrates: Caution, drug AUC increases when co-administered with Sorafenib

• Docetaxel: Caution, docetaxel AUC increases when co-administered with Sorafenib

• Doxorubicin: Caution, doxorubicin AUC increases when coadministered with Sorafenib

• Fluorouracil: Caution, fluorouracil AUC changes when coadministered with Sorafenib

• CYP2B6 and CYP2C8 substrates: Caution, systemic exposure is expected to increase when co-administered with Sorafenib

• CYP3A4 inducers: Expected to increase metabolism of sorafenib and decrease Sorafenib concentrations

• Neomycin: Caution, Sorafenib AUC decreases when coadministered with oral neomycin.

• 400 mg (2 tablets) orally twice daily without food

• Treatment interruption and/or dose reduction may be needed to manage suspected adverse drug reactions. Dose may be reduced to 400 mg once daily or to 400 mg every other day.

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib.

• Sorafenib in combination with carboplatin & paclitaxel is contraindicated in patients with squamous cell lung cancer.

Common: Fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, anorexia, nausea and abdominal pain

Pregnancy Category D
Nursing Mothers: It is not known whether sorafenib is excreted in human milk.

Pediatric Use
The safety and effectiveness of Sorafenib in pediatric patients have not been studied.

• Cardiac ischemia or infarction may occur. Consider temporary or permanent discontinuation of Sorafenib

• Bleeding may occur. If bleeding necessitates medical intervention, consider discontinuation of Sorafenib

• Hypertension usually occurred early in the course of treatment and was managed with antihypertensive therapy. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required

• Hand-foot skin reaction and rash are common. Management may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification, or in severe or persistent cases, permanent discontinuation

• Gastrointestinal perforation is an uncommon adverse reaction. In the event of a gastrointestinal perforation, Sorafenib therapy should be discontinued

• Temporary interruption of Sorafenib therapy is recommended in patients undergoing major surgical procedures. Caution is recommended when co-administering substances metabolized/eliminated predominantly by the UGT1A1 pathway (for example, irinotecan)

• Caution is recommended when co-administering docetaxel

• Caution is recommended when co-administering doxorubicin

• Sorafenib may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while on Sorafenib

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic.

Store at temperature not exceeding 300 C. in a dry place.

Medicine: Keep out of reach of children