Nubeqa
Authorised
This medicine is authorised for use in the European Union
darolutamide
MedicineHumanAuthorised
Overview
Nubeqa is a medicine used to treat men with prostate cancer.
It is used when the cancer is castration-resistant (worsens despite treatment to lower testosterone levels, including surgical removal of the testes) and is at high risk of metastasis (spreading to other parts of the body).
It is also used when the cancer has spread to other parts of the body but responds to treatment that lowers testosterone levels (hormone sensitive). It is used in combination with docetaxel (another cancer medicine) and a treatment called androgen deprivation therapy (treatment to lower male sex hormones).
Nubeqa contains the active substance darolutamide.
Nubeqa is available as tablets (300 mg) and can only be obtained with a prescription. Treatment should be started and supervised by a specialist doctor experienced in the treatment of prostate cancer.
The recommended dose of Nubeqa is 600 mg (two tablets) taken twice a day with food. Patients who have not had their testes surgically removed (castration) should continue treatment with a medicine known as an ‘LHRH analogue’ to lower production of testosterone.
If the patient develops severe side effects, the dose may have to be reduced or treatment may have to be interrupted. For more information about using Nubeqa, see the package leaflet or contact your doctor or pharmacist.
The active substance in Nubeqa, darolutamide, is an androgen receptor inhibitor. This means that it binds to the receptor (target) of sex hormones called androgens, such as testosterone, and blocks them from stimulating prostate cancer cells from growing.
Nubeqa was compared with placebo (a dummy treatment) in one ongoing main study involving 1,509 men with non-metastatic cancer of the prostate. The main measure of effectiveness was how long patients lived before their cancer spread to other parts of the body. Patients treated with Nubeqa lived for an average of 40 months without the cancer spreading, compared with around 18 months for patients given placebo.
In a second main study involving 1,306 men with metastatic, hormone-sensitive prostate cancer, around 63% of patients given Nubeqa were alive 4 years after starting treatment compared with 50% of those who were given placebo. Both Nubeqa and placebo were given together with docetaxel and androgen deprivation therapy.
The most common side effects with Nubeqa (which may affect more than 1 in 10 patients) are tiredness, weakness, lethargy (lack of energy) and feeling unwell.
The most common side effects with Nubeqa given together with docetaxel are rash and hypertension (high blood pressure).
For the full list of side effects of Nubeqa, see the package leaflet.
Nubeqa is not for use in women and must not be used in women who are or who may be pregnant. For the full list of restrictions, see the package leaflet.
The European Medicines Agency decided that Nubeqa’s benefits are greater than its risks and it can be authorised for use in the EU. Nubeqa has been shown to delay the onset of metastases compared with placebo. When given together with docetaxel and androgen deprivation therapy, the medicine has been shown to increase the time patients with metastatic hormone-sensitive prostate cancer live. Nubeqa is well tolerated and its risks are considered manageable.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nubeqa have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Nubeqa are continuously monitored. Side effects reported with Nubeqa are carefully evaluated and any necessary action taken to protect patients.
Nubeqa received a marketing authorisation valid throughout the EU on 27 March 2020.
Product information
Latest procedure affecting product information: II/0009
27/02/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Nubeqa
- Active substance
- darolutamide
- International non-proprietary name (INN) or common name
- darolutamide
- Therapeutic area (MeSH)
- Prostatic Neoplasms, Castration-Resistant
- Anatomical therapeutic chemical (ATC) code
- L02BB
Pharmacotherapeutic group
Endocrine therapyTherapeutic indication
NUBEQA is indicated for the treatment of adult men with
- non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).
- metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).
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