Venclexta Starting Pack 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: venetoclax
Pack: Venclexta Starting Pack (14 x 10 mg tablets, 7 x 50 mg tablets, 7 x 100 mg tablets, 14 x 100 mg tablets), 1 pack
Brand name
(ARTG)
: VENCLEXTA STARTING PACK venetoclax 10 mg, 50 mg, 100 mg film-coated tablets blister packDownload 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)
Acute Myeloid Leukaemia,VENCLEXTA, as part of combination therapy, is indicated for the treatment of newly diagnosed adult patients with Acute Myeloid Leukaemia (AML) who are ineligible for intensive chemotherapy.,This medicine has provisional approval in Australia for the treatment of newly diagnosed patients with AML who are ineligible for intensive chemotherapy. The decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.Chronic Lymphocytic Leukaemia/Small Lymphocytic Lymphoma,VENCLEXTA in combination with obinutuzumab is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who are considered unfit or unsuitable for chemo-immunotherapy.,VENCLEXTA in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.,VENCLEXTA monotherapy is indicated for the treatment of:, patients with relapsed or refractory CLL with 17p deletion, or, patients with relapsed or refractory CLL for whom there are no other suitable treatment options.,Acute Myeloid Leukaemia,VENCLEXTA, in combination with azacitidine or low-dose cytarabine, is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
How to use this medicine
(ARTG)
This medicine is a pack that contains more than one component.
Component :
- Tablet, film coated
- Oral
- Round, biconvex shaped, pale yellow debossed with v on one side and 10 on the other side.
Component :
- Tablet, film coated
- Oral
- Oblong, biconvex shaped, pale yellow debossed with v on one side and 100 on the other side.
Component :
- Tablet, film coated
- Oral
- Oblong, biconvex shaped, beige debossed with v on one side and 50 on the other side.
Storage conditions
(ARTG)
- Store below 30 degrees Celsius
- Shelf lifetime is 24 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 42 tablets (14 x 10 mg tablets, 7 x 50 mg tablets, 7 x 100 mg tablets, 14 x 100 mg tablets) pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient venetoclax
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.
For the active ingredient venetoclax
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
