RUBRACA 300 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

RUCAPARIB AS CAMSYLATE

から入手可能:

NEOPHARM LTD, ISRAEL

ATCコード:

L01XX55

医薬品形態:

FILM COATED TABLETS

構図:

RUCAPARIB AS CAMSYLATE 300 MG

投与経路:

PER OS

処方タイプ:

Required

製:

CLOVIS ONCOLOGY, INC., USA

治療領域:

RUCAPARIB

適応症:

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube,or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

承認日:

2019-10-22

情報リーフレット

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied upon a physician's prescription only
RUBRACA 200 MG
FILM-COATED TABLETS
RUBRACA 250 MG
FILM-COATED TABLETS
RUBRACA 300 MG
FILM-COATED TABLETS
ACTIVE INGREDIENT:
Rubraca 200 mg film-coated tablets contains rucaparib 200 mg
Rubraca 250 mg film-coated tablets contains rucaparib 250 mg
Rubraca 300 mg film-coated tablets contains rucaparib 300 mg
For the list of excipients of the medicine, please see section 6:
“Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, contact the physician or the 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.
1. WHAT IS THE MEDICINE INTENDED FOR?
Rubraca is used for the maintenance treatment of Adults with recurrent
epithelial ovarian cancer, fallopian tube, or primary peritoneal
cancer who
have a complete or partial response to platinum-based chemotherapy.
THERAPEUTIC GROUP: anti-neoplastics, PARP enzyme inhibitors.
2. BEFORE USING THIS MEDICINE
DO NOT TAKE RUBRACA IF:
-
You are hypersensitive (allergic) to the active ingredient or any of
the
other ingredients of this medicine (See section 6 'Additional
information')
-
You are breast-feeding
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
Talk to your physician or pharmacist before taking Rubraca if:
-
You have the following signs and symptoms of low blood cell counts,
which may be caused by Rubraca: fever, infection, bruising or
bleeding.
A low blood-cell count may be a sign of a serious bone marrow problem
-
such as ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid
leukaemia’
(AML).
-
You are a woman of childbearing age or planning a pregnancy , a
pregnancy test is recommended before starting treatment with Rubraca.
It
is advised to u

製品の特徴

FULL PRESCRIBING INFORMATION
RUBRACA 200 MG
Each film coated tablet contains rucaparib camsylate corresponding to
200 mg rucaparib
RUBRACA 250 MG
Each film coated tablet contains rucaparib camsylate corresponding to
250 mg rucaparib
RUBRACA 300 MG
Each film coated tablet contains rucaparib camsylate corresponding to
300 mg rucaparib
1 INDICATIONS AND USAGE
1.1
MAINTENANCE TREATMENT OF RECURRENT OVARIAN CANCER
Rubraca is indicated for the maintenance treatment of adult patients
with recurrent epithelial ovarian, fallopian tube, or
primary peritoneal cancer who are in a complete or partial response to
platinum-based chemotherapy
_ _
2
DOSAGE AND ADMINISTRATION
2.2 RECOMMENDED DOSE
The recommended dose of Rubraca is 600 mg (two 300 mg tablets) taken
orally twice daily with or without food, for a
total daily dose of 1,200 mg.
Continue treatment until disease progression or unacceptable toxicity.
If a patient misses a dose of Rubraca, instruct the patient to take
the next dose at its scheduled time. Vomited doses should
not be replaced.
2.3 DOSE MODIFICATIONS FOR ADVERSE REACTIONS
To manage adverse reactions, consider interruption of treatment or
dose reduction. Recommended Rubraca dose
modifiactions for adverse reactions are indicated in Table 1.
TABLE 1.
RECOMMENDED DOSE MODIFICATIONS FOR ADVERSE REACTIONS
DOSE REDUCTION
DOSE
Starting Dose
600 mg twice daily (two 300 mg tablets)
First Dose Reduction
500 mg twice daily (two 250 mg tablets)
Second Dose Reduction
400 mg twice daily (two 200 mg tablets)
Third Dose Reduction
300 mg twice daily (one 300 mg tablet)
3
DOSAGE FORMS AND STRENGTHS
•
Tablets (200 mg): blue, round, immediate-release, film-coated,
debossed with “C2”.
•
Tablets (250 mg): white, diamond, immediate-release, film-coated,
debossed with “C25”.
•
Tablets (300 mg): yellow, oval, immediate-release, film-coated,
debossed with “C3”.
4
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 11.
5
WARNINGS AND PRECAUTIONS
5.1 MYELODYSPLASTIC S