Venclyxto

Generic Name/API: venetoclax

Manufacturer: AbbVie

Dosage Forms & Strength & Pack Size:
Venclyxto 10 mg film-coated tablets:
• 10 tablets (5 blisters each with 2 tablets)
• 14 tablets (7 blisters each with 2 tablets)
Venclyxto 50 mg film-coated tablets:
• 5 tablets (5 blisters each with 1 tablet)
• 7 tablets (7 blisters each with 1 tablet)
Venclyxto 100 mg film-coated tablets:
• 7 tablets (7 blisters each with 1 tablet)
• 14 tablets (7 blisters each with 2 tablets)
• 112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets).
Not all pack sizes may be marketed.

Storage:
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

What Venclyxto is
Venclyxto is a cancer medicine that contains the active substance venetoclax. It belongs to a group of medicines called “BCL-2 inhibitors”.
What Venclyxto is used for
Venclyxto is used to treat adults with:
• chronic lymphocytic leukaemia (CLL). Venclyxto may be given to you in combination with other medicines or alone.
• acute myeloid leukaemia (AML). Venclyxto will be given in combination with other medicines.
CLL is a type of cancer affecting white blood cells called lymphocytes and the lymph nodes. In CLL, the lymphocytes multiply too quickly and live for too long, so that there are too many of them in the blood.
AML is a type of cancer affecting white blood cells called myeloid cells. In AML, myeloid blood cells multiply and grow very quickly in bone marrow and blood, so that there are too many of them and not enough red blood cells in the blood.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Venclyxto if:
• you have any kidney problems as your risk for a side effect called tumour lysis syndrome may increase
• you have liver problems as this may increase your risk for side effects. Your doctor may need to reduce
your dose of Venclyxto
• you think you may have an infection or have had a long-lasting or repeated infection
• you are due to have a vaccine.
If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist, or nurse before taking
this medicine.
Tumour Lysis Syndrome
Some people may develop unusual levels of some body salts (such as potassium and uric acid) in the blood
caused by the fast breakdown of cancer cells during treatment. This may lead to changes in kidney function,
abnormal heartbeat, or seizures. This is called tumour lysis syndrome (TLS). The risk for TLS is in the first
days or weeks of treatment with Venclyxto, as you increase your dose.
If you have CLL
Your doctor, pharmacist or nurse will do blood tests to check for TLS.
Your doctor will also give you medicines to help prevent the build-up of uric acid in your body before you
start treatment with Venclyxto.
Drinking plenty of water, at least 1.5 to 2 litres per day, helps to remove cancer cell breakdown products
from your body through urine and may decrease your risk of getting TLS (see section 3).
Tell your doctor, pharmacist, or nurse immediately if you get any of the symptoms of TLS listed in section 4.
If you are at risk of TLS you may be treated in hospital so that you can be given fluids into the vein if
needed, have blood tests done more often and to check for side effects. This is to see if you can continue to
take this medicine safely.
If you have AML
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You may be treated in hospital and your doctor or nurse will make sure that you have enough water/fluids,
give you medicines to prevent the build-up of uric acid in your body and do blood tests before you start to
take Venclyxto, while they increase your dose and when you start to take the full dose.
Children and adolescents
Venclyxto should not be used in children and adolescents. This is because it has not been studied in these age
groups.
Other medicines and Venclyxto
Tell your doctor or pharmacist if you take any of the following medicines as they can increase or decrease
the amount of venetoclax in your blood:
– medicines for fungal infections – fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole
– antibiotics to treat bacterial infections – ciprofloxacin, clarithromycin, erythromycin, nafcillin, or
rifampicin
– medicines to prevent seizures or to treat epilepsy – carbamazepine, phenytoin
– medicines for HIV infection – efavirenz, etravirine, ritonavir
– medicines to treat raised blood pressure or angina – diltiazem, verapamil
– medicines to lower cholesterol levels in the blood – cholestyramine, colestipol, colesevelam
– a medicine used to treat a lung condition called pulmonary arterial hypertension – bosentan
– a medicine to treat sleep disorder (narcolepsy) known as modafinil
– a herbal medicine known as St. John’s wort
Your doctor may change your dose of Venclyxto.
Tell your doctor if you take any of the following medicines as Venclyxto may affect how they work:
• medicines that prevent blood clots, warfarin, dabigatran
• a medicine used to treat heart problems known as digoxin
• a medicine for cancer known as everolimus
• a medicine used to prevent organ rejection known as sirolimus
• medicines to lower cholesterol levels in the blood known as statins
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This
includes medicines obtained without a prescription, herbal medicines and supplements. This is because
Venclyxto may affect the way some other medicines work. Also, some other medicines can affect the way
Venclyxto works.
Venclyxto with food and drink
Do not eat grapefruit products, Seville oranges (bitter oranges, often used in marmalades), or starfruit
(carambola) while you are taking Venclyxto – this includes eating them, drinking the juice or taking a
supplement that might contain them. This is because they can increase the amount of venetoclax in your
blood.
Pregnancy
– Do not get pregnant while you are taking this medicine. If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this
medicine.
– Venclyxto should not be used during pregnancy. There is no information about the safety of venetoclax
in pregnant women.

Contraception
– Women of childbearing age must use a highly effective method of contraception during treatment and for
at least 30 days after receiving Venclyxto to avoid becoming pregnant. If you are using hormonal
contraceptive pills or devices, you must also use a barrier method of contraception (such as condoms) as
the effect of hormonal contraceptive pills or devices may be affected by Venclyxto.
– Tell your doctor immediately if you become pregnant while you are taking this medicine.
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Breast-feeding
Do not breast-feed while you are taking this medicine. It is not known whether the active substance in
Venclyxto passes into breast milk.
Fertility
Based on findings in animals, Venclyxto may cause male infertility (low or no sperm count). This may affect
your ability to father a child. Ask your doctor for advice on sperm storage before starting treatment with
Venclyxto.
Driving and using machines
You may feel tired or dizzy after taking Venclyxto, which may affect your ability to drive or use tools or
machines. If this happens, do not drive or use any tools or machines.
Venclyxto contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”

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