Nubeqa 300 mg film-coated tablets
*Company:
Bayer LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company

Updated on 21 July 2025
File name
20250721_PL_CC_NUB_REC32025.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Extension of indication for Nubeqa to include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), based on final results from study 21140 (ARANOTE).
REC32025
Note:
Text in black = unchanged text
Text in blue = added text
Text in red with strikethrough = deleted text
1. What NUBEQA is and what it is used for
NUBEQA contains the active substance darolutamide.
It is used to treat adult men with prostate cancer that:
- has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (also called non-metastatic castration‑resistant prostate cancer)
or
- has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (also called metastatic hormone‑sensitive prostate cancer).
For this your doctor may also give you docetaxel.
How NUBEQA works
NUBEQA blocks the activity of male sex hormones called androgens, such as testosterone. Androgens can cause the prostate cancer to grow. By blocking these hormones, darolutamide stops prostate cancer cells from growing and dividing.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects of NUBEQA occur with the following frequencies:
In patients with non-metastatic castration-resistant prostate cancer
Very common side effects (may affect more than 1 in 10 people):
- tiredness
- blood tests showing reduced number of a white blood cell type called neutrophils
- blood tests showing increased levels of substances produced by the liver: bilirubin, alanine transaminase and aspartate transaminase
Common side effects (may affect up to 1 in 10 people):
- blockage of the arteries in the heart
- heart failure
- rash
- pain in arms and legs
- pain in muscles and bones
- broken bones
Side effects of NUBEQA when used in combination with docetaxel occur with the following frequencies:In patients with metastatic hormone‑sensitive prostate cancer
Very common side effects (may affect more than 1 in 10 people):
- high blood pressure
- rash
- blood tests showing reduced number of a white blood cell type called neutrophils
- blood tests showing increased levels of substances produced by the liver: bilirubin, alanine transaminase and aspartate transaminase
[….]
Updated on 21 July 2025
File name
20250721_SmPC_CC_NUB_REC32025.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
REC32025
Extension of indication for Nubeqa to include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), based on final results from study 21140 (ARANOTE); this is a randomized, double-blind, placebo-controlled Phase 3 study of darolutamide to demonstrate the superiority of darolutamide in addition to ADT over placebo plus ADT in patients with mHSPC. As a consequence, sections 4.1, 4.2, 4.8, and 5.1 of the SmPC are updated.
Note:
Text in black = unchanged text
Text in blue = added text
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
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 androgen deprivation therapy (see section 5.1).
- metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).
4.2 Posology and method of administration
Treatment should be initiated and supervised by a specialist physician experienced in treatment of prostate cancer.
Posology
The recommended dose is 600 mg darolutamide (two tablets of 300 mg) taken twice daily, equivalent to a total daily dose of 1200 mg (see section 5.2).
Darolutamide should be continued until disease progression or unacceptable toxicity.
Medical castration with a luteinising hormone‑releasing hormone (LHRH) agonist or antagonist (GnRH analogue) should be continued during treatment of patients not surgically castrated.
metastatic hormone‑sensitive prostate cancer (mHSPC) – treatment with darolutamide in combination with docetaxel
mHSPC patients should start darolutamide in combination with docetaxel (see section 5.1). The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of darolutamide treatment. The recommendation in the product information of docetaxel should be followed. Treatment with darolutamide should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued.
Updated on 07 May 2025
File name
20250317_SmPC_CC_NUB_REC33211.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 17 March 2025
File name
20250317_SmPC_CC_NUB_REC33211.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
REC33211: Addition of Bayer AG, Leverkusen as an alternative manufacturer
Updated on 17 March 2025
File name
20250317_PL_CC_NUB_REC33211.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
REC33211: Addition of Bayer AG, Leverkusen as an alternative manufacturer
Updated on 09 January 2025
File name
20240106_SmPC_CC_NUB_REC33044.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
REC33044: Deletion of local representative UK (Northern Ireland)
Updated on 09 January 2025
File name
20250107_PIL_CC_NUB_REC33044.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
REC33044: Deletion of local representative UK (Northern Ireland)
Updated on 31 October 2024
File name
20241024_SmPC_CC_NUB_REC31225.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
REC31225
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
6.5 Nature and contents of container
PVC/Aluminium foil blisters containing 16 film‑coated tablets.
Each pack contains 96 or 112 film‑coated tablets.
Not all pack sizes may be marketed.
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/20/1432/001 112 film‑coated tablets
EU/1/20/1432/002 96 film‑coated tablets
10. DATE OF REVISION OF THE TEXT
October 2024
Updated on 31 October 2024
File name
20241024_PIL_CC_NUB_REC31225.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
REC31225
Note:
Text in blue = added text
Text in red with strikethrough = deleted text
Package leaflet: Information for the patient
NUBEQA 300 mg film‑coated tablets
Darolutamide
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
6. Contents of the pack and other information
Each carton contains:
- 96 film‑coated tablets consisting of 6 blisters or
- 112 film‑coated tablets consisting of 7 blisters
Each blister contains 16 film‑coated tablets. each with 16 film‑coated tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in 10/2024
Updated on 28 May 2024
File name
20240527_SmPC_CC_NUB_REC31524PSUSA7.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Hepatotoxicity
In case of liver function test abnormalities suggestive of idiosyncratic drug‑induced liver injury, permanently discontinue treatment with darolutamide (see section 4.8).
4.8 Undesirable effects
Description of selected adverse reactions
Liver function tests
Updated on 06 March 2023
File name
20230301_SmPC_CC_NUB_Arasens.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 06 March 2023
File name
20230301_PIL_CC_NUB_Arasens.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2023
File name
20230228_SmPC_CC_NUB_REC30977.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 January 2023
File name
20211209_SmPC_CC_NUB_REC15506.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reuploaded
Updated on 11 March 2022
File name
20211209_PL_CC_NUB_REC15506.pdf
Reasons for updating
- New PIL for new product
Updated on 11 March 2022
File name
20211209_SmPC_CC_NUB_REC15506.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Bayer Limited

Address:
1st Floor The Grange Offices, The Grange, Brewery Road, Stillorgan, Co. Dublin, A94 H2K7, IrelandMedical Information E-mail:
Medinfo.ireland@bayer.comMedical Information Direct Line:
+353 1 216 3300 Option 2