BRUKINSA™ CAPSULE 80MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Zanubrutinib

Available from:

BEIGENE SINGAPORE PTE. LTD.

ATC code:

L01EL03

Pharmaceutical form:

CAPSULE

Composition:

Zanubrutinib 80mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Catalent CTS (Kansas City), LLC (Primary packager)

Authorization status:

ACTIVE

Authorization date:

2021-10-01

Summary of Product characteristics

1
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
1.1
MANTLE CELL LYMPHOMA
BRUKINSA is indicated for the treatment of adult patients with mantle
cell lymphoma
(MCL) who have received at least one prior therapy.
1.2
WALDENSTRÖM’S MACROGLOBULINEMIA
BRUKINSA as monotherapy is indicated for the treatment of adult
patients with
Waldenström’s macroglobulinemia (WM) who have received at least one
prior therapy, or in
first line treatment for patients unsuitable for chemo-immunotherapy
_[see Clinical Studies _
_(14.2)]._
1.3
MARGINAL ZONE LYMPHOMA
BRUKINSA as monotherapy is indicated for the treatment of adult
patients with relapsed or
refractory marginal zone lymphoma (MZL) who have received at least one
prior anti-CD20-
based regimen
_[see Clinical Studies (14.3)]._
1.4
CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
BRUKINSA is indicated for the treatment of adult patients with chronic
lymphocytic
leukemia (CLL) or small lymphocytic lymphoma (SLL)
_[see Clinical Studies (14.4)]._
2
DOSAGE AND ADMINISTRATION
2.1
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.
2.2
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 (8.7) and Clinical Pharmacology _
_(12.3)]_
.
2.3
DOSAGE MODIFICATIONS FOR DRUG INTERACTIONS
Recommended dosage modifications of BRUKINSA for drug interactions are
provided in Table 1
_[see Drug Interactions (7.1)]. _
TABLE 1: DOSAGE MODIFICATIONS FOR USE WITH CYP3A INHIBITORS OR
INDUCERS
COADMINISTERED DRUG
RECOMMENDED BRUKINSA DOS