What is Xtandi and what is it used for?
Xtandi is an anticancer drug used to treat men with prostate cancer that has spread to other parts of the body and is resistant to castration (for example, it gets worse despite treatments that lower testosterone production or following surgical removal testicles) Xtandi is used in the following cases:
- when treatment with docetaxel (an anticancer medicine) has not been effective or is no longer effective;
- when hormone therapy has not worked and the patient reports no symptoms or mild symptoms and does not require chemotherapy (another type of cancer treatment)
The drug contains the active ingredient enzalutamide.
How is Xtandi used - Enzalutamide?
Xtandi is available as capsules (40 mg) and can only be obtained with a prescription. The recommended dose is 160 mg (4 capsules) once a day with water. Treatment may need to be interrupted or the dose reduced if patients experience certain side effects. Xtandi should not be used concomitantly with certain medicines known as 'potent CYP2C8 inhibitors' which affect the way Xtandi is eliminated from the body, or else the dose of Xtandi should be reduced when used in combination with other medicines. For more information, see the package leaflet.
How does Xtandi - Enzalutamide work?
The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens. For this purpose, enzalutamide blocks the receptors to which these hormones bind and prevents their response. Since prostate cancer requires testosterone and other male hormones to survive and grow, blocking these hormones enzalutamide slows the growth of the prostate cancer.
What benefit has Xtandi - Enzalutamide shown during the studies?
Xtandi was compared with placebo (a dummy treatment) in one main study involving 1,199 patients with castration-resistant prostate cancer previously treated with docetaxel. This study showed that Xtandi was more effective than placebo in prolonging patients' lives: on average, patients treated with Xtandi lived for 18.4 months compared to 13.6 months for patients who were given placebo. Xtandi was also compared with placebo in a second main study involving 1,717 patients with castration-resistant prostate cancer in whom hormone therapy had not been effective but had no or mild symptoms and had no symptoms. previously underwent chemotherapy. Median survival times for patients treated with Xtandi were approximately 32.4 months compared to 30.2 months for patients treated with placebo. In addition, patients treated with Xtandi lived for a longer period of time without their disease showing signs of worsening on radiographs: 19.7 months versus 5.4 months for patients treated with placebo.
What is the risk associated with Xtandi - Enzalutamide?
The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, headache, hot flashes and hypertension (high blood pressure). Seizures have occurred in four out of 1,000 patients. For a full list of side effects reported with Xtandi, see the package leaflet. Xtandi is not for use in women and must not be given to women who are or may be pregnant. . For the full list of restrictions, see the package leaflet.
Why has Xtandi - Enzalutamide been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Xtandi's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the anticancer effects of Xtandi were clearly demonstrated and that the life-prolonging effects are important for patients. Regarding safety, the committee concluded that the side effects of Xtandi are generally moderate and can be managed adequately.
What measures are being taken to ensure the safe and effective use of Xtandi - Enzalutamide?
A risk management plan has been developed to ensure that Xtandi is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Xtandi, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company will provide long-term data on the benefits from the second main study (as reported above) to further verify the benefits of Xtandi with regard to survival times and how long the patients lived without their disease getting worse.
Other information about Xtandi - Enzalutamide
On 21 June 2013, the European Commission issued a "Marketing Authorization" for Xtandi, valid throughout the European Union. For more information on Xtandi therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 11-2014.
The information on Xtandi - Enzalutamide published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
