Drug

ZEJULA®

niraparib

Zejula Overview

This is a summary of the European public assessment report (EPAR) for Zejula. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zejula.

For practical information about using Zejula, patients should read the package leaflet or contact their doctor or pharmacist.

Zejula is available as capsules (100 mg) to be taken by mouth. The dose is 3 capsules per day, taken together at the same time each day. Treatment should continue until the disease gets worse. Treatment may be interrupted and the dose may be reduced in patients who experience side effects.

The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the use of cancer medicines.

For further information, see the package leaflet.

The active substance in Zejula, niraparib, blocks the action of enzymes called PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells. By blocking PARP enzymes, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.

Zejula has been shown to increase the time patients lived without their disease getting worse in one main study involving 553 patients. Patients in the study had high grade serous epithelial ovarian cancer, including fallopian tube or peritoneal cancers. Patients had undergone treatment with two or more platinum-based therapies, with a lasting response (the cancer had not progressed for at least 6 months) before the last platinum-based therapy.

Patients treated with Zejula lived on average 11.3 months without their disease getting worse compared with 4.7 months in patients treated with placebo (a dummy treatment).

Although treatments for advanced, relapsed ovarian cancer are available, the disease inevitably comes back again. Zejula has been shown to prolong the time before the disease gets worse again in patients who have responded to platinum-based therapies. This may allow the next cycle of platinum-based therapy to be delayed. Regarding safety, side effects are generally manageable with dose reductions.

The European Medicines Agency therefore decided that Zejula’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zejula have been included in the summary of product characteristics and the package leaflet.

The European Commission granted a marketing authorisation valid throughout the European Union for Zejula on 16 November 2017.

For more information about treatment with Zejula, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

What are the risks associated with Zejula?

The most common side effects with Zejula (which may affect more than 1 in 10 people) are nausea (feeling sick), thrombocytopenia (low blood platelet counts), tiredness and weakness, anaemia (low red blood cell counts), constipation, vomiting, abdominal (belly) pain, neutropenia (low levels of neutrophils, a type of white blood cell), insomnia (difficulty sleeping), headache, lack of appetite, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dyspnoea (difficulty breathing), hypertension (high blood pressure), dyspepsia (heartburn), back pain, dizziness, cough, urinary tract infection (infection of the structures that carry urine), joint pain, palpitations and dysgeusia (taste disturbances). Serious side effects include thrombocytopenia and anaemia.

Zejula must not be used in women who are breastfeeding. 

Owner of copyright and other intellectual property rights to European Medicines Agency

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