VENCLEXTA STARTING PACK venetoclax 10 mg, 50 mg, 100 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

venetoclax, Quantity: 50 mg

Available from:

Abbvie Pty Ltd

INN (International Name):

venetoclax

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium stearylfumarate; copovidone; polysorbate 80; colloidal anhydrous silica; calcium hydrogen phosphate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide

Administration route:

Oral

Units in package:

42 tablets (14 x 10 mg tablets, 7 x 50 mg tablets, 7 x 100 mg tablets, 14 x 100 mg tablets)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: Oblong, biconvex shaped, beige debossed with V on one side and 50 on the other side.; Container Type: Multiple containers; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-01-05

Patient Information leaflet

VENCLEXTA
®
V
E
N
C
L
E
X
T
A
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.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details
1.
WHY AM I TAKING VENCLEXTA?
Venclexta contains the active ingredient venetoclax. Venclexta is used
to treat some specific blood cancers, including chronic
lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and
acute myeloid leukaemia (AML).
For more information, see Section 1. Why am I taking Venclexta? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE VENCLEXTA?
Check the list of ingredients at the end of this CMI. Do not take
Venclexta if you have ever had an allergic reaction to any of them.
Talk to your doctor before you take this medicine if he/she is not
aware that 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 take
Venclexta? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Venclexta and affect how it works,
or Venclexta may interfere with other medicines and affect
how they work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE VENCLEXTA?
It is very important that you follow all directions carefully,
particularly when you first start taking Venclexta. There can be
serious
consequences if you do not. These instructions can be found in Section
4. How do I take Venclexta? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING VENCLEXTA?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Venclexta.
•
Drink plenty of water every day when taking Venclexta.
•
Keep all your appointments, including those for blood tests.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly without c

Summary of Product characteristics

VENCLEXTA PI
Version 12
28 September 2021
Page 1 of 64
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
VENCLEXTA
® (VENETOCLAX) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Venetoclax
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
VENCLEXTA 10 mg tablets: each film-coated tablet contains 10 mg
venetoclax.
VENCLEXTA 50 mg tablets: each film-coated tablet contains 50 mg
venetoclax.
VENCLEXTA 100 mg tablets: each film-coated tablet contains 100 mg
venetoclax.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
VENCLEXTA 10 mg tablets: round, biconvex shaped, pale yellow debossed
with “V” on one
side and “10” on the other side.
VENCLEXTA 50 mg tablets: oblong, biconvex shaped, beige debossed with
“V” on one side
and “50” on the other side.
VENCLEXTA 100 mg tablets: oblong, biconvex shaped, pale yellow
debossed with “V” on one
side and “100” on the other side.


VENCLEXTA PI
Version 12
28 September 2021
Page 2 of 64
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 cytarab