BRUKINSA

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ZANUBRUTINIB

Fáanlegur frá:

MEDISON PHARMA LTD

Lyfjaform:

CAPSULES

Samsetning:

ZANUBRUTINIB 80 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

BEIGENE USA, INC., USA

Ábendingar:

• BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.• BRUKINSA is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM).• BRUKINSA is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.• BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Leyfisdagur:

2021-01-24

Upplýsingar fylgiseðill

BRUKINSA-PIL-0522-V1
BRUKINSA-80mg-PIL-ENG-D27-F
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
BRUKINSA 80 MG
EACH CAPSULE CONTAINS 80 MG OF ZANUBRUTINIB
Inactive ingredients and allergens in the medicine: see 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 illness
is similar to yours.
WOMEN: Should not become pregnant during treatment and for one week
after receiving the
last dose of BRUKINSA. You should use contraception during treatment
and for one week
after completing the last dose of BRUKINSA.
MEN: You should avoid impregnating your partner during treatment and
for one week after
receiving the last dose of BRUKINSA. You should use contraception
during treatment and for
one week after receiving the last dose of BRUKINSA.
Use means of sun protection when you are exposed to sunlight.
1. WHAT IS THIS MEDICINE INTENDED FOR?
BRUKINSA is intended to treat adult patients with:
•
Mantle cell lymphoma (MCL) who have received at least one prior
therapy for their disease.
•
Waldenström’s macroglobulinemia (WM) .
•
Relapsed or refractory marginal zone lymphoma (MZL) who have received
at least one anti-
CD20-based regimen.
THERAPEUTIC GROUP - Anti-neoplastic agents, protein kinase inhibitors.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

you are sensitive (allergic) to zanubrutinib or to any of the other
ingredients of this medicine
(see section 6, “ADDITIONAL INFORMATION”).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE THE TREATMENT WITH BRUKINSA, TELL YOUR DOCTOR IF:
•
you have bleeding problems.
•
your doctor may consider stopping the therapy with BRU

Vara einkenni

PHYSICIAN’S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
BRUKINSA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 80 mg Zanubrutinib
For full list of excipients , see section 6.1
3.
PHARMACEUTICAL FORM
Capsules
4 . THERAPEUTIC INDICATION
BRUKINSA is indicated for: the treatment of adult patients with
•
mantle cell lymphoma (MCL) who have received at least one prior
therapy.
•
Waldenström’s macroglobulinemia (WM).
•
relapsed or refractory marginal zone lymphoma (MZL) who have received
at least
one anti-CD20-based regimen.
5. DOSAGE AND ADMINISTRATION
5.1 RECOMMENDED DOSAGE
The recommended dosage of BRUKINSA is 160 mg taken orally twice daily
or 320 mg taken
orally once daily until disease progression or unacceptable toxicity.
BRUKINSA can be taken with or without food. Advise patients to swallow
capsules whole
with water. Advise patients not to open, break, or chew the capsules.
If a dose of BRUKINSA
is missed, it should be taken as soon as possible on the same day with
a return to the normal
schedule the following day.
.
5.2 DOSAGE MODIFICATION FOR USE IN HEPATIC IMPAIRMENT
The recommended dosage of BRUKINSA for patients with severe hepatic
impairment is 80
mg orally twice daily
_[see Use in Specific Populations (11.7) and Clinical Pharmacology _
_(13.3)]_
.
5.3 DOSAGE MODIFICATIONS FOR DRUG INTERACTIONS
Recommended dosage modifications of BRUKINSA for drug interactions are
provided in Table
1
_[see Drug Interactions (10.1)]. _
TABLE 1:
DOSE MODIFICATIONS FOR USE WITH CYP3A INHIBITORS OR INDUCERS
CO-ADMINISTERED DRUG
RECOMMENDED BRUKINSA DOSE
Strong CYP3A inhibitor
80 mg once daily
Interrupt dose as recommended for adverse reactions
_[see Dosage and Administration (5.4)]. _
Moderate CYP3A inhibitor
80 mg twice daily
Modify dose as recommended for adverse reactions
_[see _
_Dosage and Administration (5.4)]. _
Moderate or strong CYP3A inducer
Avoid concomitant use.
After discontinuation of a CYP3A inhibitor, resume previous dose of
BRUKINSA
_[see Dosage _
_and Administration