Uses of Soranix: - Liver cancer - Kidney cancer - Thyroid cancer Renal cell carcinoma, Hepatocellular Carcinoma, Thyroid Cancer Hypersensitivity

How to use Sorafenib: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sorafenib is to be taken empty stomach. Administration: Should be taken on an empty stomach. Take on an empty stomach or w/ a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush. Adult Dose: Oral Advanced renal cell carcinoma, Hepatocellular Carcinoma, Thyroid Cancer Adult: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs. Hepatic Impairment Mild to moderate: Dose adjustment not necessary Severe hepatic impairment: Not studied Child Dose: Safety and efficacy not established Renal Dose: Renal Impairment Mild to moderate: Dose adjustment not necessary Severe renal impairment: Not studied

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Hypersensitivity

Common - Fatigue - Nausea - Loss of appetite - Diarrhea - Abdominal pain - Hair loss - Weight loss - Rash - Painful blisters on hands and feet >10% Thrombocytopenia (12-46%),Anemia (44%),Diarrhea (43%),Rash/desquamation (40%),Fatigue (37%),Abd 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%) 1-10% Headache (10%),Joint pain (10%),Congestive heart failure, MI (1.9%),QT prolonation (rare) <1% Acute renal failure,Angioedema and arrhythmia may occur,Bone pain reported Frequency Not Defined Stevens-Johnson Syndrome,Hyperthyroidism,Interstitial lung disease Potentially Fatal: Bleeding fatalities. Hypertensive crisis.

Precaution: Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs. Lactation: not known whether distributed in breast milk, discouraged

Sorafenib inhibits cell surface and intracellular kinases to reduce proliferation of tumour cells.