REC33211: Addition of Bayer AG, Leverkusen as an additional manufacturer

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

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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

[….]

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.

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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.

REC33211: Addition of Bayer AG, Leverkusen as an alternative manufacturer

REC33211: Addition of Bayer AG, Leverkusen as an alternative manufacturer

REC33044: Deletion of local representative UK (Northern Ireland)

REC33044: Deletion of local representative UK (Northern Ireland)

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

REC31225

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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

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

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