Tablets: 200 mg

for the treatment of advanced renal cell carcinoma when treatment with interferon alfa or interleukin-2 has failed or is contra-

indicated……… for the treatment of hepatocellular

carcinoma………

Sorafenib is a type of biological therapy called a protein tyrosine kinase inhibitor (TKI) .Tyrosine kinase is a protein which acts as a chemical messenger (an enzyme). There are a number of different tyrosine kinases that encourage cancer cells to grow.Sorafenib blocks a number of protein kinases and is called a multi kinase inhibitor. It works in two ways.

It stops Signals that tell cancer cells to grow

Cancel cells forming blood vessels, which they need to growTreatment that stops blood vessels

forming is called anti angiogenesis treatment

Sorafenib is a tablet take with a glass of water.It should take either an hr before eat or 2 hrs after.

ADULT over 18 years, 400 mg twice daily

*Antibacterial:plasma conc. of sorafenib reduced by rifampicin

*Anticoagulants:sorafenib possibly enhances anticoagulanteffect of coumarins

*Antiepileptics: cytotoxics possibly reduce absorptionof phenytoin

*Antipsychotics:avoid concomitant use of cytotoxicswith clozapine (increased risk of agranulocytosis)

*Cardiac Glycosides: cytotoxics reduce absorption of digoxin tablets

*Cytotoxics: sorafenib possibly increases plasma conc.of doxorubicin and irinotecan, increases plasma concentration of docetaxel

Bioavailability 29-49%

Protein binding99,5%

MetabolismHepatic oxidation and glucuronidation (CYP3A4 mediated)

Half life25-48hours

ExcretionFecal (77%) and renal (19%)

major surgical procedures cardiac ischaemia,

hepatic impairment Pregnancy (category D)

breast-feeding

Common side effects **Diarrhoea **Hand-foot syndrome

**rash, or red, dry itchy skin **Fatigue **Hair thinning **Feeling sick

**Raised blood pressure (hypertension) **Increased risk of bleedingRare side effects

**Breast tenderness and swelling because sorafenib may lower male sex hormone (testosterone) levels

**Heart problems including chest pain **Bleeding of the stomach lining occurs in less than (1%)

With this drug, some people have a temporary drop in the number of blood cells made by the bone marrow, leading to the following side effects

**Increased risk of getting an infection from a drop in WBC **Tiredness and breathlessness due to a drop in RBC

**Bruising more easily due to a drop in platelets Some of these side effects can be life threatening, particularly infections

Other occasional side effects includeSkin flushing, Aching joints, Constipation

,sore mouth, Indigestion, Weakness Pain Loss of appetite, Flu like symptoms A hoarse voice, Low mood

A mild effect on the liver -

BNF September 2009 page 467,489BNF for children 2009 page 867http://en.wikipedia.org/wiki/Sorafenibhttp://www.rxlist.com/nexavar-drug.htmhttp://www.cancerhelp.org.uk/about-cancer/treatment/cancer-drugs/sorafenib