Brukinsa

国: 欧州連合

言語: 英語

ソース: EMA (European Medicines Agency)

有効成分:

zanubrutinib

から入手可能:

BeiGene Ireland Ltd

ATCコード:

L01EL03

INN（国際名）:

zanubrutinib

治療群:

Antineoplastic agents

治療領域:

Waldenstrom Macroglobulinemia

適応症:

Brukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).

製品概要:

Revision: 7

認証ステータス:

Authorised

承認日:

2021-11-22

情報リーフレット

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRUKINSA 80 MG HARD CAPSULES
zanubrutinib
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BRUKINSA is and what it is used for
2.
What you need to know before you take BRUKINSA
3.
How to take BRUKINSA
4.
Possible side effects
5.
How to store BRUKINSA
6.
Contents of the pack and other information
1.
WHAT BRUKINSA IS AND WHAT IT IS USED FOR
BRUKINSA is an anticancer medicine that contains the active substance
zanubrutinib. It belongs to a
class of medicines called protein kinase inhibitors. This medicine
works by blocking Bruton's tyrosine
kinase, a protein in the body that helps cancer cells grow and
survive. By blocking this protein,
BRUKINSA reduces the number of cancer cells and slows down the
worsening of the cancer.
BRUKINSA is used to treat Waldenström’s macroglobulinaemia (also
known as lymphoplasmacytic
lymphoma), a cancer affecting a type of white blood cells called B
lymphocytes or B cells that make
too much of a protein called IgM. This medicine is used when the
disease has come back, or treatment
has not worked or in patients who cannot have chemotherapy together
with an antibody.
BRUKINSA is also used to treat marginal zone lymphoma. This is a type
of cancer that also affects

製品の特徴

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.
_ _
1.
NAM
E OF THE MEDICINAL PRODUCT
BRUKINSA 80 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 80 mg of zanubrutinib.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard capsule.
White to off-white opaque hard capsule of 22 mm in length, marked with
“ZANU 80” in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BRUKINSA as monotherapy is indicated for the treatment of adult
patients with Waldenström’s
macroglobulinaemia (WM) who have received at least one prior therapy,
or in first line treatment for
patients unsuitable for chemo-immunotherapy.
BRUKINSA as monotherapy is indicated for the treatment of adult
patients with marginal zone
lymphoma (MZL) who have received at least one prior anti-CD20-based
therapy.
BRUKINSA as monotherapy is indicated for the treatment of adult
patients with chronic lymphocytic
leukemia (CLL).
BRUKINSA in combination with obinutuzumab is indicated for the
treatment of adult patients with
refractory or relapsed follicular lymphoma (FL) who have received at
least two prior systemic
therapies.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with this medicinal product should be initiated and
supervised by a physician experienced
in the use of anticancer medicinal products.
Posology
The recommended total daily dose of zanubrutinib is 320 mg. The daily
dose may be taken either
once daily (four 80 mg capsules) or divided into two doses of 160 mg
twice daily (two 80 mg
capsules). Treatment with BRUKINSA should be continued until disease
progression or unacceptable
toxicity.
3
_BRUKINSA in combination with obinutuzumab _
Zanubrutinib must be administered orally before obinutuzumab infusion.
The recommended