Venclexta

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Venetoclax 10mg;  ; Venetoclax 50mg; Venetoclax 100mg

Available from:

AbbVie Limited

INN (International Name):

Venetoclax 10 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Venetoclax 10mg   Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Copovidone Opadry II yellow 85F32450 Polysorbate 80 Purified water Sodium stearyl fumarate Active: Venetoclax 50mg Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Copovidone Opadry II beige 85F97497 Polysorbate 80 Purified water Sodium stearyl fumarate Active: Venetoclax 100mg Excipient: Calcium hydrogen phosphate Colloidal silicon dioxide Copovidone Opadry II yellow 85F32450 Polysorbate 80 Purified water Sodium stearyl fumarate

Prescription type:

Prescription

Manufactured by:

AbbVie Operations Singapore Pte Ltd

Therapeutic indications:

VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard wallet 100mg tablet - 7 tablets -   - Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard wallet 50mg tablet - 7 tablets -   - Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard wallet 100mg tablet - 14 tablets -   - Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard wallet 10mg tablet - 14 tablets -   - Combination pack, Carton of 10mg wallet (14 tabs), 50mg wallet (7 tabs), 100mg wallet (7 tabs), 100mg wallet (14 tabs) - 42 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

2017-03-13

Patient Information leaflet

VENCLEXTA_ CMI - VERSION 11 _
1
VENCLEXTA
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or
pharmacist.
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 taking 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 checking with your
doctor.
DRIVING OR USING
MACHINES
•
Take care when driving or using machinery unt

Summary of Product characteristics

VENCLEXTA
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Version 15
NEW ZEALAND DATA SHEET
1.
VENCLEXTA 10 MG, 50 MG AND 100 MG TABLETS
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VENCLEXTA is indicated for the treatment of patients with chronic
lymphocytic leukaemia (CLL) or
small lymphocytic lymphoma (SLL).
VENCLEXTA is indicated for the treatment of adult patients with newly
diagnosed acute myeloid
leukaemia (AML) who are ineligible for intensive chemotherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
VENCLEXTA should be taken orally once daily. Patients should be
instructed to take VENCLEXTA
tablets with a meal and water at approximately the same time each day.
VENCLEXTA tablets should
be swallowed whole and not chewed, crushed, or broken prior to
swallowing (see section 5.2).
CHRONIC LYMPHOCYTIC LEUKAEMIA/SMALL LYMPHOCYTIC LYMPHOMA
5-week Dose Titration Schedule
The starting dose of VENCLEXTA is 20 mg once daily for 7 days. The
VENCLEXTA dose must be
administered according to a weekly dose titration schedule to the
daily dose of 400 mg over a period of
5 weeks as shown in Table 1.
VENCLEXTA
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The 5-week dose titration schedule is designed to gradually reduce
tumour burden (debulking) and
decrease the risk of tumour lysis syn