NUBEQA 300 MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

DAROLUTAMIDE

제공처:

BAYER ISRAEL LTD

ATC 코드:

L02BB06

약제 형태:

FILM COATED TABLETS

구성:

DAROLUTAMIDE 300 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

ORION CORPORATION, ORION PHARMA, FINLAND

치료 영역:

DAROLUTAMIDE

치료 징후:

NUBEQA ,in combination with ADT 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 NUBEQA is indicated for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

승인 날짜:

2021-04-11

환자 정보 전단

Patient leaflet in accordance with the
Pharmacists' Regulations (Preparations) - 1986
The medicine is dispensed with a doctor’s prescription only
NUBEQA
300 mg
Film-coated tablets
Active ingredient
Each tablet of NUBEQA contains: darolutamide 300 mg.
Inactive ingredients and allergens in this medicine: See section 2
under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional
information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their medical condition is
similar to
yours.
1.
What is this medicine intended for?
NUBEQA in combination with androgen deprivation therapy (ADT) is
intended to treat
adult men who have castration resistant prostate cancer with no
metastases and
who are at high risk of developing a metastatic disease.
NUBEQA in combination with docetaxel is intended to treat adult men
with prostate
cancer that has spread to other parts of the body and responds to
medical or
surgical treatment that lowers testosterone.
Mechanism of action:
NUBEQA blocks the activity of the male sex hormones called androgens,
such as
testosterone.
By blocking these hormones, darolutamide stops prostate cancer cells
from growing
and dividing.
Therapeutic group: endocrine therapy, anti-androgen
2.
Before using this medicine
Do not use this medicine if:
•
you are sensitive (allergic) to the active ingredient darolutamide or
to any of
the other ingredients in this medicine. For a list of the inactive
ingredients, see
section 6 ‘Additional information’.
•
you are a woman who is or may become pregnant.
Special warnings about using this medicine
Before using NUBEQA, tell your doctor if:
- you have problems with your kidneys
- you have problems with your liver
- you have any heart c

제품 특성 요약

1
1.
NAME OF THE MEDICINAL PRODUCT
NUBEQA 300 mg
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated oral tablet contains 300 mg of darolutamide.
Excipient with known effect
Each film-coated tablet contains 186 mg of lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off-white, oval tablets with a length of 16 mm and a width of
8 mm, marked with “300” on
one side, and “BAYER” on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
•
NUBEQA
,in combination with ADT
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).
•
NUBEQA is indicated for the treatment of adult patients with
metastatic hormone-sensitive
prostate cancer (mHSPC) in combination with docetaxel (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)
analogue should be
continued during treatment of patients not surgically castrated.
_ _
_metastatic hormone-sensitive prostate cancer (mHSPC) _
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
unaccepatble toxicity even if a cycle of
docetaxel is delayed, interrupted, or discontinued.
2
_Missed dose _
If