Brukinsa TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: zanubrutinib
Pack: Brukinsa 80 mg capsule, 120, bottle
Brand name
(ARTG)
: BRUKINSA zanubrutinib 80 mg capsule bottleDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
Waldenströms Macroglobulinaemia (WM),BRUKINSA is indicated for the treatment of adult patients with Waldenströms macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,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.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.,This indication was approved via the provisional approval pathway, based on objective response rate. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.,Marginal Zone Lymphoma (MZL),BRUKINSA is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy.,This indication was approved via the provisional approval pathway, based on objective response rate. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Capsule
- Oral
- Size 0, white to off-white opaque capsule of 22 mm in length, printed with 'ZANU 80' in black ink containing white to off-white powder
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Store in Original Container
- Shelf lifetime is 36 Months.
Do I need a prescription ?
(ARTG)
This medicine is available from a pharmacist and requires a prescription. It is
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient zanubrutinib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
