How does it work?

Nexavar tablets contain the active ingredient sorafenib, whichis a type of medicine called a multikinase inhibitor. It works by interferingwith the pathways that signal certain cancer cells to grow.

The way that cells in the body work and grow is regulated byvarious enzymes called kinases. In cancerous cells, these kinases make thecells grow and multiply abnormally. They also stimulate nearby blood vessels togrow into the tumour. The new blood vessels allow the cancer cells to grow andmultiply by supplying them with oxygen and nutrients. They also allow thecancerous cells to spread into other areas of the body through the bloodcirculation.

Sorafenib works by inhibiting the action of various kinaseenzymes. This stops the signals that tell the cancer cells to grow andmultiply. It also stops blood vessels growing into the tumour. This reduces thetumour’s blood supply and with it, its supply of oxygen and nutrients. Boththese effects stop the tumour from growing.

Sorafenib is licensed to treat liver cancer and advanced kidneycancer.

Nexavar tablets are taken by mouth twice a day with a glass ofwater. The tablets should be taken without food, or with a low or moderate fatmeal. If you intend to have a high-fat meal, the tablets should be taken atleast one hour before or two hours after the meal.

What is it used for?

• Liver cancer (hepatocelluar carcinoma).
• Advanced kidney cancer (renal cell carcinoma).

Sorafenib is licensed to treat advanced kidney cancer that hasnot responded to treatment with interferon-alpha or interleukin-2 basedtherapy, or is considered unsuitable for such therapy.

Warning!

• A rash and a skin reaction called hand-foot syndrome are the most common side effects of this medicine. If they occur, they usually appear in the first six weeks of treatment. These side effects can usually be managed with skin creams, or by reducing your dose of medicine or temporarily stopping treatment. You should tell your doctor if you get a skin rash, or any pain, swelling, and redness of your hands and/or feet while you are taking this medicine.
• Tell your doctor straight away if you experience any chest pain while taking this medicine.
• Your blood pressure should be regularly monitored while you are taking this medicine. If your blood pressure increases you may need to take medicines to reduce it.
• This medicine may slow wound healing. For this reason, your doctor may want you to temporarily stop taking this medicine if you are going to have any major surgical procedures.
• This medicine could be harmful to a developing baby. Women who could get pregnant must use a reliable method of contraception to avoid getting pregnant while taking this medicine. Seek further medical advice from your doctor. Tell your doctor immediately if you get pregnant during treatment.
• Your ability to get pregnant or father a child may be affected by treatment with this medicine. It is important to discuss fertility with your doctor before starting treatment.

Use with caution in

• Elderly people.
• Severely decreased liver function.
• High blood pressure (hypertension).
• Angina.
• History of heart attack.
• People with blood clotting problems or at increased risk of bleeding.

Not to be used in

• Allergy to any ingredient.
• Breastfeeding.
• This medicine is not recommended for children and adolescents under 18 years of age.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine could be harmful to a developing baby. It should not be used during pregnancy unless considered essential by your doctor, and only if the potential benefit to the mother outweighs any risks to the developing baby. Women who could get pregnant must use a reliable method of contraception to avoid getting pregnant while taking this medicine. Seek further medical advice from your doctor. Tell your doctor immediately if you get pregnant during treatment.
• It is not known if this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed, because if the medicine does pass into the breast milk it could be harmful to a nursing infant. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

• Rash or itching.
• Hair loss.
• Disturbances of the gut, such as diarrhoea, nausea and vomiting, constipation, indigestion.
• Painful redness, swelling, blistering or ulceration of the palms and soles (hand-foot syndrome or palmar-plantar erythrodysesthesia).
• Sore mouth.
• Fatigue.
• Feeling weak.
• Bleeding.
• Increased blood pressure.
• Flushing.
• Inflamed, dry or scaly skin.
• Loss of appetite and weight loss.
• Headache.
• Pain in the joints or muscles.
• Depression.
• Decreased levels of red blood cells, white blood cells or platelets in the blood.
• Fever.
• Erectile dysfunction.
• Chest pain.
• Yellowing of the skin or whites of the eyes (jaundice).

The side effects listed above may not include all of the sideeffects reported by the drug's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

The following medicines could theoretically decrease theabsorption of sorafenib from the gut and so could make it less effective. Thishas not been studied, so the these medicines should be avoided where possiblewhile you are taking sorafenib:

• antacids for indigestion or heartburn
• H2 antagonists, eg cimetidine, ranitidine, famotidine
• proton pump inhibitors, eg omeprazole, lansoprazole.

The following medicines may increase the breakdown of sorafenibby the body and so could decrease the amount of sorafenib in the blood:

• barbiturates, eg phenobarbital, amobarbital
• carbamazepine
• dexamethasone
• phenytoin
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum).

As these medicines could make sorafenib less effective theyshould be avoided where possible while you are taking thismedicine.

Sorafenib may increase the anti-blood-clotting effect ofanticoagulant medicines such as warfarin. If you are taking an anticoagulant incombination with sorafenib, your blood clotting time (INR) should be monitoredmore frequently.

Sorafenib may increase the blood level of the chemotherapymedicines irinotecan, doxorubicin and docetaxel.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain sorafenib as the active ingredient.