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.
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).
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.
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.
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?
6. Are there any side effects?
The more serious side effects can include Tumour Lysis Syndrome (TLS), low white blood
cell count (neutropenia) and infection.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help 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 .
Active ingredient:
Venetoclax (ven-eat-oh-claks)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking Venclexta. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking Venclexta.
Where to find information in this leaflet:
1. Why am I taking Venclexta?
Venclexta contains the active ingredient venetoclax.
Venclexta is used to treat certain blood cancers, including:
Chronic lymphocytic leukaemia (CLL), a condition where the blood and bone marrow contain
too many of a type of white blood cells (lymphocytes).
Small lymphocytic lymphoma (SLL), a condition where the lymph nodes contain too many
of a type of white blood cells (lymphocytes).
Acute myeloid leukaemia (AML), a condition where blood cells do not develop properly
in the bone marrow. This results in a build-up of these immature cells in the blood
and fewer red blood cells (that carry oxygen around the body), white blood cells (that
fight infection) and/or platelets (that form clots when you are injured).
2. What should I know before I take Venclexta?
Warnings
Tumour Lysis Syndrome (TLS)
Tumour Lysis Syndrome (TLS), which can be fatal, has occurred rarely in patients receiving
Venclexta.
There are some things you can do to help prevent TLS occurring:
Follow all your doctor’s instructions carefully, especially when you start treatment
with Venclexta.
To help prevent TLS, it is important to stay hydrated and drink water every day when
taking Venclexta. Particularly, starting two days before and on the day of your first
dose of Venclexta, and every time the dose is increased, drink 6 to 8 glasses (approximately
1.5 to 2 litres total) of water each day.
Keep all your appointments, including those for your blood tests, since the changes
in your blood that can lead to TLS may not have any symptoms until the situation becomes
very serious.
Tell your doctor, nurse or pharmacist if you have or have had kidney problems, as
this can increase the risk of TLS.
Take any additional medicines your doctor may prescribe to help prevent TLS (if you
are at higher risk).
Do not take Venclexta if:
1. you are allergic to venetoclax, or any of the ingredients listed at the end of this
leaflet.
2. you are pregnant or think you might be pregnant.
Check with your doctor if you:
have any problems with your liver or kidneys
think you may have an infection
have had any recent immunisations
take any medicines for any other condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take Venclexta if you are pregnant or are breastfeeding.
If you are a woman of child-bearing age, you must use a highly effective form of contraception
during treatment with Venclexta and for at least 30 days after your last dose.
Male fertility
Venclexta may cause low sperm count in men.
Use in Children
Do not give Venclexta to children younger than 18 years.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Venclexta and affect how it works.
For patients with CLL or SLL, do not take Venclexta if you are taking any of the following
medicines:
medicines used to treat or prevent fungal infections, including ketoconazole, posaconazole,
voriconazole or itraconazole
clarithromycin (a medicine used to treat infections caused by bacteria - antibiotic)
conivaptan (a medicine used to treat low sodium levels)
medicines used to treat HIV or hepatitis C infection, including ritonavir, indinavir,
lopinavir or telaprevir.
Medicines that may
increase
the effect of Venclexta include:
ketoconazole, posaconazole, voriconazole, itraconazole, fluconazole (medicines used
to treat or prevent fungal infections)
clarithromycin, ciprofloxacin, erythromycin (medicines used to treat infections caused
by bacteria - antibiotic)
conivaptan (a medicine used to treat low sodium levels)
indinavir, lopinavir (medicines used to treat HIV)
telaprevir (a medicine used to treat hepatitis C)
ritonavir (a medicine used to treat HIV and hepatitis C)
diltiazem, verapamil, captopril (medicines used to treat high blood pressure, angina
and other heart conditions)
felodipine (a medicine used to treat high blood pressure)
dronedarone, amiodarone, quinidine (medicines used to treat certain heart conditions)
rifampicin (a medicine used to treat tuberculosis and other serious infections)
carvedilol (a medicine used to treat heart failure)
ciclosporin (a medicine used to suppress the immune system to treat conditions like
rheumatoid arthritis, nephrotic syndrome, psoriasis, transplant rejection)
quercetin (a herbal product used for many conditions)
ranolazine (a medicine used to treat angina)
ticagrelor (a medicine used to help stop clots forming to reduce the chance of a heart
attack, stroke).
Medicines that may
reduce
the effect of Venclexta include:
azithromycin, nafcillin (medicines used to treat infections caused by bacteria - antibiotic)
rifampicin (a medicine used to treat tuberculosis and other serious infections)
carbamazepine, phenytoin (medicines used to prevent seizures, fits)
St John’s wort (a herbal product used to improve mood)
bosentan (a medicine used to treat high blood pressure in the lungs)
efavirenz, etravirine (a medicine used to treat HIV)
modafinil (to treat certain sleep disorders).
Medicines where Venclexta may
increase
their effect: include:
warfarin (a medicine used to thin the blood)
digoxin (a medicine used to treat certain heart conditions)
everolimus, (a medicine used to treat certain cancers)
sirolimus (a medicine used to help in organ transplants).
Foods that may
increase
the effect of Venclexta include:
grapefruit
Seville oranges
star fruit
(Including as juice, jams or marmalades).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Venclexta.
4. How do I take Venclexta?
How much to take
Two days before you start taking Venclexta, drink at least 6 to 8 glasses of water
each day and continue to do this throughout your treatment, especially each time your
dose is increased.
For patients with CLL or SLL:
You will start on a low dose and gradually increase as follows:
Week 1: Take two 10 mg tablets together once every day
Week 2: Take one 50 mg tablet once every day
Week 3: Take one 100 mg tablet once every day
Week 4: Take two 100 mg tablets together once every day
Week 5: Take four 100 mg tablets all together once every day
After week 5, continue to take four 100 mg tablets all together once every day.
Refer to the Quick Start Guide provided with your Starting Pack for instructions on which tablets to take and when
to take them.
For patients with AML taking Venclexta
in combination with azacitidine
:
You will start on a low dose and gradually increase as follows:
Day 1: Take one 100 mg tablet
Day 2: Take two 100 mg tablets together
Day 3: Take four 100 mg tablets all together
After day 3, continue to take four 100 mg tablets all together once every day.
For patients with AML taking Venclexta
in combination with low-dose cytarabine
:
You will start on a low dose and gradually increase as follows:
Day 1: Take one 100 mg tablet
Day 2: Take two 100 mg tablets together
Day 3: Take four 100 mg tablets all together
Day 4: Take six 100 mg tablets all together
After day 4, continue to take six 100 mg tablets all together once every day.
For CLL, SLL and AML, take Venclexta every day as instructed, until your doctor tells
you to stop.
Do not break, crush or chew the tablets. Swallow them whole with a full glass of water.
In some instances, Venclexta needs to be taken with other medicines. Your doctor will
let you know which medicines, how to take them and how long to take them.
When to take Venclexta
Take Venclexta during a meal or immediately after a meal at about the same time every
day.
Please look for the QR code on the medicine pack. Scan this code with your smart phone
for more information on Venclexta.
If you forget to take Venclexta
It is important that you take your medicine every day as prescribed.
If you miss your dose by
less than 8 hours
, take the tablet(s) as soon as you remember, and take the next dose at the usual
time the next day.
If you miss your dose by
more than 8 hours
, skip the missed tablet(s) for that day and take your next tablets at the usual time
the next day.
Do not take a double dose to make up for the dose you missed.
If you vomit after taking Venclexta
Do not take any extra tablets. Just take the correct dose the next day at your usual
time.
If you take too much Venclexta
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there appear to be no signs of discomfort or poisoning.
5. What should I know while taking Venclexta?
Things you should do
Call your doctor straight away if you:
think you may have symptoms of TLS, especially at the beginning of treatment, such
as fever or chills, feeling sick or vomiting, being short of breath, changes in your
heart rate, feeling unusually tired, dark cloudy urine, joint pain, feeling confused,
convulsions.
become pregnant while taking Venclexta.
Remind any doctor or dentist you visit that you are taking Venclexta.
Keep all your appointments, including those for blood tests.
Things you should not do
Do not stop taking this medicine or change the dose without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Venclexta
affects you.
Drinking alcohol
If you drink alcohol, symptoms, such as nausea and vomiting may be worse.
Looking after your medicine
Follow the instructions on the pack or bottle on how to take care of your medicine
properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example:
do not store it in the bathroom or near a sink, or
do not store it in the car or on window sills.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor advises that you no longer need to take this medicine or it is out
of date, take it to any pharmacy for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Tumour Lysis Syndrome (TLS)
Tumour Lysis Syndrome (TLS) is caused by the rapid breakdown of cancer cells resulting
in high levels of certain chemicals and low levels of calcium circulating in the blood.
This situation can cause serious damage to the kidneys as well as other organs in
the body.
Neutropenia
You may experience a low number of neutrophils (neutropenia), a type of white blood
cells – this can be severe and need treatment. Your doctor or healthcare professional
will check your blood counts during treatment with Venclexta.
Infections
You may experience infections during treatment with Venclexta. Some infections can
be very serious or even fatal. Your doctor will closely monitor and treat you right
away if you have fever or any signs of infection during treatment with Venclexta.
Less serious side effects
Serious side effects
|
Serious side effects
|
What to do
|
|
Symptoms of TLS:
fever or chills
feeling sick or vomiting
being short of breath
feeling unusually tired
changes in your heart rate – slow, fast or irregular
your urine looks dark or cloudy
feeling confused
convulsions or fits
pain in the muscles or joints
Symptoms of an infection:
fever or chills
feeling weak
feeling confused
cough, runny nose, sore throat
congestion on the chest
pain or burning when passing urine.
|
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Venclexta contains
Do not take this medicine if you are allergic to any of these ingredients.
Venclexta does not contain lactose or gluten.
What Venclexta looks like
Venclexta 10 mg tablets are pale yellow, round tablets with "V" on one side and "10" on the other.
They are supplied in a blister pack containing 2 or 14 tablets (Aust R 267441).
Venclexta 50 mg tablets are beige, oblong tablets with "V" on one side and "50" on the other. They
are supplied in a blister pack containing 1 or 7 tablets (Aust R 267444).
Venclexta 100 mg tablets are pale yellow, oblong tablets with "V" on one side and "100" on the other.
They are supplied in:
a bottle containing 120 or 180 tablets (Aust R 267445) and
a blister pack containing 1, 7, 14 or 112 tablets (Aust R 267442).
For patients with CLL or SLL, Venclexta is available in a Starting Pack, which is designed to provide you with the first four weeks of your tablets. (Aust
R 267443)
Each Starting Pack is presented as a carton containing four weekly wallets:
Week 1 (14 x 10 mg tablets)
Week 2 (7 x 50 mg tablets)
Week 3 (7 x 100 mg tablets)
Week 4 (14 x 100 mg tablets).
(Not all presentations may be available.)
Who distributes Venclexta?
Venclexta is distributed in Australia by:
AbbVie Pty Ltd
241 O’Riordan Street
MASCOT NSW 2020
This leaflet was prepared in August 2023.
Version 10
© 2023 AbbVie. All rights reserved.
VENCLEXTA® is a registered trademark of AbbVie Manufacturing Management Unlimited Company.