Package:
FILM COATED TABLETS: 112. Dosage:
The recommended daily dose is 400 mg (2 x 200 mg tablets) 2 x daily without food (at least 1 hour before or 2 hours after a meal). Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of therapy. When dose reduction is necessary, the dose may be reduced to 400 mg once daily. If additional dose reduction is required, treatment may be reduced to a single 400 mg dose every other day. See prescribing information for full details. Prescribing Restrictions:
Indications:
Treatment of patients with advanced renal cell carcinoma (RCC), treatment of patients with unresectable hepatocellular carcinoma (HCC). Contra-Indications:
Known severe hypersensitivity to sorafenib or any other component. Special Precautions:
Temporary or permanent discontinuation should be considered in patients who develop cardiac ischemia and/or infarction. An increased risk of bleeding may occur following administration. If any bleeding necessitates medical intervention, permanent discontinuation of therapy should be considered. In cases of severe or persistent hypertension, despite institution of antihypertensive therapy, temporary or permanent discontinuation should be considered. Management of dermatologic toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification, or in severe or persistent cases, permanent discontinuation. In the event of a GI perforation, therapy should be discontinued. Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes. Temporary interruption of therapy is recommended in patients undergoing major surgical procedures. The decision to resume therapy following a major surgical intervention should be based on clinical judgment of adequate wound healing. Pregnancy and lactation: Women of childbearing potential should be advised to avoid becoming pregnant while treated. a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. See prescribing information for full details. Side Effects:
Fatigue, rash/desquamation, pruritus, hand-foot skin reaction, dry skin, alopecia. Diarrhea, anorexia, nausea, vomiting, constipation. Liver dysfunction, pain (abdomen, joint, headache). Hemorrhage (all sites), neuropathy-sensory, dyspnea. See prescribing information for full details. Drug Interactions:
UGT1A1 and UGT1A9 substrates; docetaxel; doxorubicin; fluorouracil, CYP2B6 and CYP2C8 substrates, CYP3A4 inducers. See prescribing information for full details.
