Nexavar 200 mg film-coated tablets

ATC Code
L01XE05
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About this drug

Admission country
Manufacturer Bayer Schering Pharma AG
Narcotic drug No
Psychotropic No
Anatomical group Antineoplastische und immunmodulierende mittel
Therapeutic group Antineoplastische mittel
Pharmacological group Andere antineoplastische mittel
Chemical group Proteinkinase-inhibitoren
Substance Sorafenib

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All to know

Author

Bayer Schering Pharma AG

What is it?

Nexavar is a medicine that contains the active substance sorafenib. It is available as red, round tablets (200 mg).

What is it used for?

Nexavar is used to treat patients who have the following diseases:
- hepatocellular carcinoma (a type of liver cancer);
- advanced renal cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin-2 has failed or cannot be used.
Because the numbers of patients with hepatocellular carcinoma and renal cell carcinoma are low, the diseases are considered ?rare?, and Nexavar was designated an ?orphan medicine? (a medicine used in rare diseases) on 11 April 2006 and on 29 July 2004.
The medicine can only be obtained with a prescription.

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How is it used?

Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.
Nexavar is given as two tablets twice a day, without food or with a meal that is low in fat. The treatment is continued as long as the patient continues to benefit from it without too many side effects.

How does it work?

The active substance in Nexavar, sorafenib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels. Nexavar works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.

How has it been studied?

Nexavar has been compared with placebo (a dummy treatment) in two main studies. The first study involved 602 patients with hepatocellular carcinoma and the second involved 903 patients with advanced renal cell carcinoma in whom one previous anticancer treatment had stopped working. The main measure of effectiveness in the hepatocellular carcinoma study was how long the patients survived. The main measures of effectiveness in the advanced renal cell carcinoma study were how long the patients survived and how long the patients lived without their disease getting worse.

What benefits has it shown during the studies?

Nexavar was more effective than placebo in increasing how long the patients survived. In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
In the study of renal cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo. This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study. The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months). This finding was based on the results from 769 patients.

What is the risk associated?

In studies, the most common side effects with Nexavar (seen in more than 1 patient in 10) were lymphopenia (low levels of lymphocytes, a type of white blood cell), hypophosphataemia (low levels of phosphate in the blood), haemorrhage (bleeding), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, rash, alopecia (hair loss), ?hand foot syndrome? (rash and pain on the palms of the hands and soles of the feet), erythema (redness), pruritus (itchiness), fatigue (tiredness), pain, and increased levels of amylase and lipase (enzymes produced by the pancreas). For the full list of all side effects reported with Nexavar, see the Package Leaflet.
Nexavar should not be used in people who may be hypersensitive (allergic) to sorafenib or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Nexavar?s benefits are greater than its risks for the treatment of hepatocellular carcinoma, and of advanced renal cell carcinoma in patients who have failed prior interferon alfa or interleukin-2 based therapy, or who are considered unsuitable for such therapy. The Committee recommended that Nexavar be given marketing authorisation.

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