Nexavar (sorafenib)

How does it work?

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

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

Sorafenib works by inhibiting the action of various kinase enzymes. This stops the signals that tell the cancer cells to grow and multiply. It also stops blood vessels growing into the tumour. This reduces the tumour's blood supply and with it, its supply of oxygen and nutrients. Both these effects stop the tumour from growing.

Sorafenib is licensed to treat advanced kidney cancer.

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

What is it used for?

Advanced kidney cancer.

Sorafenib is licensed to treat advanced kidney cancer that has not responded to treatment with interferon-alpha or interleukin-2 based therapy, 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

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 or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

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

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, 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 individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or 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 side effects reported by the drug's manufacturer.

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

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