Brukinsa

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Zanubrutinib 80mg

Dostupno od:

BeiGene NZ Unlimited

Doziranje:

80 mg

Farmaceutski oblik:

Capsule

Sastav:

Active: Zanubrutinib 80mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Gelatin Magnesium stearate Microcrystalline cellulose Opacode black S-1-277002 Sodium laurilsulfate Titanium dioxide

Tip recepta:

Prescription

Terapijske indikacije:

Waldenstrom's macroglobulinaemia (WM) BRUKINSA is indicated for the treatment of adult patients with Waldenstr?m's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

Proizvod sažetak:

Package - Contents - Shelf Life: Bottle, HDPE white with polypropylene child resistant cap, foil heat seal in carton - 120 capsules - 36 months from date of manufacture stored at or below 30°C

Datum autorizacije:

2022-01-10

Uputa o lijeku

BRUKINSA®
1
BRUKINSA
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BRUKINSA?
BRUKINSA contains the active ingredient zanubrutinib. BRUKINSA is used
to treat:
•
Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic
lymphoma), a type of cancer causing white blood
cells to make too much of a protein called IgM.
•
Mantle Cell Lymphoma, a type of cancer affecting the lymph nodes.
•
Chronic lymphocytic leukaemia or small lymphocytic lymphoma. These are
closely related types of slowly progressing cancer
involving white blood cells.
For more information, see Section 1. Why am I using BRUKINSA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BRUKINSA?
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
BRUKINSA?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BRUKINSA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE BRUKINSA?
•
The recommended dose is 320 mg per day, either once daily (4 capsules)
or twice daily (2 capsules in the morning and 2
capsules in the evening)
More instructions can be found in Section 4. How do I use BRUKINSA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BRUKINSA?
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine unless your doctor tells you
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how BRUKINSA affects you
•
BRUKINSA may cause fatigue, dizziness or weakness in some people
LOOKING AFTER
YOUR MEDICINE
•
Store it in a cool dry place away from moisture, heat or sunlight
•
Do not use this medicine after the expiry date
For more information, see Sec

Svojstava lijeka

1
NEW ZEALAND DATA SHEET
BRUKINSA (ZANUBRUTINIB)
1
PRODUCT NAME
BRUKINSA 80 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 80 mg zanubrutinib.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
White to off-white opaque hard capsule of 22 mm in length (size 0),
marked with “ZANU 80” in
black ink.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
WALDENSTRÖM’S MACROGLOBULINEMIA (WM)
BRUKINSA 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.
MANTLE CELL LYMPHOMA (MCL)
BRUKINSA is indicated for the treatment of adult patients with mantle
cell lymphoma (MCL) who
have received at least one prior therapy.
CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL)
BRUKINSA is indicated as monotherapy for the treatment of adult
patients with chronic lymphocytic
leukaemia (CLL) or small lymphocytic lymphoma (SLL), including
patients with deletion 17p and/or
TP53 mutation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended total daily oral dose of BRUKINSA is 320 mg. BRUKINSA
may be taken as
either 320 mg (four 80 mg capsules) once daily, or as 160 mg (two 80
mg capsules) twice daily.
DOSE MODIFICATION FOR ADVERSE REACTIONS
Recommended dose modifications of BRUKINSA for severe (Grade 3) or
life-threatening (Grade 4)
adverse reactions are provided in Table 1:
2
TABLE 1:
RECOMMENDED DOSE MODIFICATION FOR ADVERSE REACTION
EVENT
ADVERSE REACTION
OCCURRENCE
DOSE MODIFICATION
(STARTING DOSE: 320 MG ONCE DAILY OR
160 MG TWICE DAILY)
≥ Grade 3 non-haematological
toxicities
Grade 3 febrile neutropenia
Grade 3 thrombocytopenia with
significant bleeding
Grade 4 neutropenia (lasting >10
consecutive days)
Grade 4 thrombocytopenia (lasting >
10 consecutive days)
First
Interrupt
BRUKINSA
Once toxicity has resolved to ≤ Grade 1 or
baseline: Resume at 320 mg once daily or
160 mg twice dai