Active ingredient
- venetoclax
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/16/1138/001 , EU/1/16/1138/002.
Venclyxto film-coated tablets
Package leaflet: Information for the patient
Venclyxto 10 mg film-coated tablets
Venclyxto 50 mg film-coated tablets
Venclyxto 100 mg film-coated tablets
venetoclax
▼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. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Venclyxto is and what it is used for
2. What you need to know before you take Venclyxto
3. How to take Venclyxto
4. Possible side effects
5. How to store Venclyxto
6. Contents of the pack and other information
1. What Venclyxto is and what it is used for
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 patients with chronic lymphocytic leukaemia (CLL).
Venclyxto may be given to you in combination with other medicines or alone.
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.
How Venclyxto works
Venclyxto works by blocking a protein in the body called “BCL-2”. This protein helps cancer cells survive.
Blocking this protein helps to kill and lower the number of cancer cells. It also slows down the worsening of the disease.
2. What you need to know before you take Venclyxto
Do not take Venclyxto if:
It is important that you tell your doctor, pharmacist, or nurse about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your doctor may need to stop certain medicines when you first start taking Venclyxto and during the first five weeks when your dose is gradually increased to the full standard dose.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Venclyxto if:
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 5 weeks of treatment with Venclyxto.
Your doctor, pharmacist or nurse will do blood tests to check for TLS.
Your doctor may 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.
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:
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:
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), 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
Contraception
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 after taking Venclyxto, which may affect your ability to drive or use tools or machines.
3. How to take Venclyxto
Always take this medicine exactly as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are not sure.
How much to take
You will begin treatment with Venclyxto at a low dose for 1 week. Your doctor will gradually increase the dose over the next 4 weeks to the full standard dose. For the first 4 weeks you will get a new pack each week.
Your dose may need to be adjusted for side effects. Your doctor will advise what your dose should be.
How to take Venclyxto
If you vomit after taking Venclyxto, do not take an extra dose that day. Take the next dose at the usual time the next day. If you have problems taking this medicine, talk to your doctor.
Drink plenty of water
It is very important that you drink plenty of water when taking Venclyxto during the first 5 weeks of treatment. This will help to remove cancer cell breakdown products from your blood through your urine.
You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto. You may also include non-alcoholic and non-caffeinated drinks in this amount, but exclude grapefruit, Seville orange, or starfruit (carambola) juices. You should continue to drink at least 1.5 to 2 litres of water on the day you start Venclyxto. Drink the same amount of water (at least 1.5 to 2 litres daily) two days before and on the day that your dose is increased.
If your doctor thinks that you are at risk of TLS, you may be treated in the hospital so that you can be given extra fluids into the vein if needed, have your blood tests more often and be checked for side effects. This is to see if you can continue to take this medicine safely.
If you take more Venclyxto than you should
If you take more Venclyxto than you should, talk to your doctor, pharmacist, or nurse or go to hospital immediately. Take the tablets and this leaflet with you.
If you forget to take Venclyxto
Do not stop taking Venclyxto
Do not stop taking this medicine unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following serious side effects may happen with this medicine:
Tumour lysis syndrome (common – may affect up to 1 in 10 people)
Stop taking Venclyxto and seek medical attention immediately if you notice any of the symptoms of TLS:
Low white blood cell count (neutropenia) and infections (very common – may affect more than 1 in 10 people)
Your doctor will check your blood count during treatment with Venclyxto. Low white blood cell count can increase your risk for infection. Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine. Some infections can be serious and may lead to death. Tell your doctor immediately if you have signs of an infection while taking this medicine.
Tell your doctor if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)
Blood tests may also show
Common (may affect up to 1 in 10 people)
Blood tests may also show:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Venclyxto
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.
6. Contents of the pack and other information
What Venclyxto contains
The active substance is venetoclax.
The other ingredients are:
In the film-coating:
What Venclyxto looks like and contents of the pack
Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other.
Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other.
Venclyxto 100 mg film-coated tablet is pale yellow, oblong 17.2 mm long with V on one side and 100 on the other.
Venclyxto tablets are provided in blisters which are packed in cartons as follows:
Venclyxto 10 mg film-coated tablets:
Venclyxto 50 mg film-coated tablets:
Venclyxto 100 mg film-coated tablets:
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 04/2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the local representative of the Marketing Authorisation Holder.
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+44 (0)1628 561 092
+44 (0)1628 561 092