10 mg, 50 mg, and 100 mg film-coated tablets
venetoclax
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 leukemia ( CLL ). Venclyxto can be given to you with other medicines or as a single medicine.
- acute myeloid leukemia (AML). Venclyxto is given to you together with other medicines.
CLL is a type of cancer that affects the white blood cells called lymphocytes and the lymph nodes. In CLL, the lymphocytes are formed too quickly and live too long, which means that there are too many of them in the blood.
AML is a type of cancer that affects the white blood cells called myeloid cells. In AML, the myeloid cells become more numerous and grow very quickly in the bone marrow and the blood. This means that there are too many myeloid cells and too few red blood cells in the blood.
How Venclyxto works
Venclyxto works by blocking a protein in the body called ‘BCL-2’. This protein helps cancer cells survive. By blocking this protein, the cancer cells die and their number decreases. It also slows down the deterioration of the disease.
What you need to know before you take Venclyxto
Do not take Venclyxto if:
- you are allergic to the active substance venetoclax or any other ingredient in this medicine (listed in section 6).
- you have CLL and are taking some of the medicines listed below when you start treatment or while the dose is gradually increased (usually over 5 weeks). This is because serious and life-threatening side effects can occur if Venclyxto is taken at the same time as these medicines:
- itraconazole, ketoconazole , posaconazole or voriconazole for fungal infections
- clarithromycin against bacterial infections
- ritonavir against HIV infection.
Ask your doctor if you can start using these medicines again once your dose of Venclyxto has been increased to the full standard dose.
- you are taking a herbal medicine called St. John’s wort, which is used for mild depression and mild anxiety. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Venclyxto.
You must inform your doctor, pharmacist, or nurse about all medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements. Your doctor may ask you to stop using certain medicines when you start taking Venclyxto and for the first few days or weeks while your dose is increased to the full standard dose.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Venclyxto if:
- you have kidney problems because you may have an increased risk of a side effect called tumor lysis syndrome
- you have liver problems because you may have an increased risk of side effects. Your doctor may need to lower your dose of Venclyxto
- you think you have an infection, have had an infection for a long time, or have several repeated infections
- you must be vaccinated.
If any of the above apply to you or you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.
Tumor lysis syndrome
Some people may develop abnormal levels of certain body salts (such as potassium and uric acid ) in their blood during treatment because the cancer cells are broken down so quickly. This can lead to changes in kidney function, abnormal heartbeats, or seizures. This is called tumor lysis syndrome (TLS). There is a risk of TLS during the first days or weeks of treatment with Venclyxto while the dose is increased.
The following applies if you have CLL
Your doctor, pharmacist, or nurse will take blood tests to check for signs of TLS.
Before you start treatment with Venclyxto, your doctor will also give you medicines that prevent uric acid from accumulating in the body.
By drinking a lot of water, at least 1.5 to 2 liters a day, you help the body to get rid of the breakdown products of the cancer cells through the urine and this can reduce the risk of TLS (see section 3).
Tell your doctor, pharmacist, or nurse straight away if you get any of the symptoms of TLS listed in section 4.
If there is a risk that you will get TLS, you may need to be treated in the hospital so that you can receive fluids in a vein if needed, have blood tests more often, and be checked for side effects. This is done so that you can continue to take this medicine safely.
The following applies if you have AML
You may be treated in a hospital where a doctor or nurse will make sure you have enough water/fluids, give you medicine to prevent uric acid from building up in your body, and take blood tests before you start taking Venclyxto, while they increase your dose and when you start taking the full dose one.
Children and young people
Venclyxto should not be used by 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 are taking any of the following medicines as they may 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 high blood pressure or angina – diltiazem, verapamil
- medicines that lower cholesterol levels in the blood – cholestyramine, colestipol, colesevelam
- a medicine used to treat a lung disease called pulmonary arterial hypertension – bosentan
- a medicine used to treat a sleep disorder ( narcolepsy ) called modafinil
- a herbal medicine called St. John’s wort
Your doctor may need to change your dose of Venclyxto.
Tell your doctor if you are taking any of the following medicines as Venclyxto can affect their effect:
- medicines that prevent blood clotting, warfarin, dabigatran
- a medicine called digoxin which is used to treat heart problems
- a medicine called everolimus used to treat cancer
- a medicine called sirolimus which is used to prevent organ rejection
- medicines called statins which lower cholesterol levels in the blood
Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking other medicines, including over-the-counter medicines and herbal medicines, and dietary supplements. This is because Venclyxto can affect the effectiveness of certain other medicines. In addition, some other medicines can affect the effect of Venclyxto.
Venclyxto with food and drink
Do not eat products containing grapefruit, bitter orange (a citrus fruit with a bitter taste), or star fruit (carambola) while taking Venclyxto. This includes eating fruits, drinking juice from them, or taking a dietary supplement containing them. This is because they can increase the amount of venetoclax in your blood.
Pregnancy, breastfeeding, and fertility
Pregnancy
- You must not become pregnant while 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 on how safe it is to treat pregnant women with venetoclax.
Contraceptive
- Women of childbearing potential must use highly effective contraception during and for at least 30 days after stopping treatment with Venclyxto to avoid pregnancy. If you use birth control pills or other hormonal methods of contraception, you must also use a barrier method (e.g. a condom). This is because the effect of birth control pills or other hormonal methods of contraception can be affected by Venclyxto.
- Tell your doctor right away if you become pregnant while taking this medicine.
Breast-feeding does not breast-feed while taking this medicine. It is unknown whether the active substance in Venclyxto is excreted in breast milk.
FertilityAnimal studies suggest that Venclyxto may cause male infertility (low or no sperm). This can affect your ability to have children. Ask your doctor for advice on saving sperm before you start treatment with Venclyxto.
Driving ability and use of machinery
You may feel tired or dizzy after taking Venclyxto, which may affect your ability to drive and use tools or machines.
How to take Venclyxto
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Consult a doctor, pharmacist, or nurse if you are unsure.
How much to take
The following applies if you have CLL
You will start treatment with a low dose of Venclyxto for 1 week. The doctor will gradually increase the dose by one over the next 4 weeks until you reach the full standard dose. During the first 4 weeks, you will receive a new pack every week.
- the starting dose is 20 mg (two 10 mg tablets) once daily for 7 days.
- the dose is increased to 50 mg (one 50 mg tablet) once daily for 7 days.
- the dose is increased to 100 mg (one 100 mg tablet) once daily for 7 days.
- dose one is increased to 200 mg (two 100 mg tablets) once daily for 7 days.
- dose one is increased to 400 mg (four 100 mg tablets) once daily for 7 days
- When you receive Venclyxto as the only treatment, you continue with a dose of 400 mg daily, which is the standard dose, for as long as needed.
- When you receive Venclyxto together with rituximab, you will receive a daily dose of 400 mg for 24 months.
- When you receive Venclyxto together with obinutuzumab, you will receive a single daily dose of 400 mg for approximately 10 months.
Your dose may need to be adjusted due to side effects. The doctor will inform you about the dose to take.
The following applies if you have AML
You start treatment with Venclyxto at a lower dose. The doctor increases the dose gradually by one each day during the first 3 days. After 3 days, take the full standard dose. Does one (the tablets) is taken once a day.
The doses are given in the table below
| Day | A daily dose of Venclyxto |
| 1 | 100 mg (one 100 mg tablet) |
| 2 | 200 mg (two 100 mg tablets) |
| 3 and beyond | 400 mg (four 100 mg tablets) |
The doctor will give you Venclyxto together with another medicine (azacytidine or decitabine).
You will continue to take the full dose of Venclyxto until your AML gets worse or until you cannot take Venclyxto because you have had serious side effects.
How to take Venclyxto
- Take the tablets with meals at approximately the same time each day
- Swallow the tablets whole with a glass of water
- Do not chew, crush or split the tablets
- During the first days or weeks of treatment while the dose is being increased, take the tablets in the morning to facilitate follow-up blood sampling, if necessary.
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. Talk to your doctor if you have problems taking this medicine.
drink a lot of water
The following applies if you have CLL
You must drink plenty of water while taking Venclyxto during the first 5 weeks of treatment. It helps remove the cancer cells’ breakdown products from the blood via the urine.
You should start by drinking at least 1.5 to 2 liters of water daily, two days before you start taking Venclyxto. You can also count non-alcoholic and caffeine-free drinks in that amount, but don’t drink juice with grapefruit, orange, or star fruit (carambola). You should continue to drink at least 1.5 to 2 liters of water on the day you start taking Venclyxto. Drink the same amount of water (at least 1.5 to 2 liters daily) two days before and on the day your dose is increased.
If your doctor thinks you are at risk of developing TLS, you may need to be treated in the hospital so that you can receive extra fluids in a vein if needed, have more frequent blood tests, and be monitored for side effects. This is done to check that you can continue to take this medicine safely.
The following applies if you have AML
You must drink plenty of water while taking Venclyxto, especially when starting treatment and increasing the dose. Drinking water helps to remove the cancer cells’ breakdown products from the blood via the urine. If you are in the hospital, a doctor or nurse may give you fluids into a vein if needed to make sure this happens.
If you have taken too much Venclyxto
If you take too much Venclyxto, you should immediately contact a doctor, pharmacist, or nurse or seek hospital care. Take the tablets and this leaflet with you.
If you forget to take Venclyxto
- If it is less than 8 hours since you would normally have taken your dose, take it as soon as possible.
- If it is more than 8 hours since you would normally have taken your dose, do not take a dose that day. Take your usual dose as scheduled the next day.
- Do not take a double dose to make up for a missed dose.
- If you are not sure, talk to your doctor, pharmacist, or nurse.
Do not stop taking Venclyxto
Do not stop taking this medicine unless your doctor tells you to. If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following serious side effects can occur with this medicine:
Tumor lysis syndrome (common – may affect up to 1 in 10 people)
Stop taking Venclyxto and seek medical attention immediately if you experience any of the symptoms of TLS:
- fever or chills
- feel nauseous or vomit
- feeling confused
- feel like you have trouble breathing
- irregular heartbeat
- dark or cloudy urine
- feeling unusually tired
- muscle pain or joint discomfort
- convulsions or convulsions
- stomach pain and bloating
Low white blood cell count ( neutropenia ) and infection (very common – may affect more than 1 in 10 people )
The doctor will check your blood levels during treatment with Venclyxto. A low number of white blood cells can increase the risk of infection. Signs of infection may include fever, chills, feeling weak or confused, coughing, pain, or burning when urinating. Some infections can be serious and lead to death. Tell your doctor right away if you develop signs of an infection while taking this medicine.
Tell your doctor if you get any of the following side effects:
The following applies if you have CLL
Very common (may affect more than 1 in 10 users)
- pneumonia
- upper respiratory tract infection – signs include runny nose, sore throat, or cough
- diarrhea
- feel nauseous or vomit
- constipation
- feeling tired
Blood tests can also show:
- decreased number of red blood cells
- reduced number of white blood cells, so-called lymphocytes
- increased potassium content
- elevated levels of a body salt ( electrolyte ) called phosphate
- reduced calcium content
Common (may affect up to 1 in 10 users)
- serious infection in the blood ( sepsis )
- urinary tract infection
- low white blood cell count with fever (febrile neutropenia )
Blood tests can also show:
- elevated creatinine level
- elevated urea content
The following applies if you have AML
Very common (may affect more than 1 in 10 users)
- feel nauseous or vomit
- diarrhea
- mouth ulcers
- feel tired or weak
- lung or blood infection
- reduced appetite
- pain in the joints
- dizziness or fainting
- headache
- respiratory distress
- bleeding
- low blood pressure
- urinary tract infection
- weight loss
- stomach ache (abdominal pain)
Blood tests can also show
- decreased number of blood platelets ( thrombocytopenia )
- decreased number of white blood cells with fever (febrile neutropenia )
- reduced number of red blood cells ( anemia )
- higher level of total bilirubin
- low level of potassium in the blood
Common (may affect up to 1 in 10 users)
- gallstone scars or gallbladder infection
How to store Venclyxto
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and blister after EXP.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is venetoclax.
- Venclyxto 10 mg film-coated tablets: One film-coated tablet contains 10 mg venetoclax.
- Venclyxto 50 mg film-coated tablets: One film-coated tablet contains 50 mg venetoclax.
- Venclyxto 100 mg film-coated tablets: One film-coated tablet contains 100 mg venetoclax.
Other ingredients are:
- In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551), anhydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
In the filming:
- Venclyxto 10 mg film-coated tablets: yellow iron oxide (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
- Venclyxto 50 mg film-coated tablets: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
- Venclyxto 100 mg film-coated tablets: yellow iron oxide (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Appearance and package sizes of the medicine
Venclyxto 10 mg film-coated tablet is light yellow, round, and 6 mm in diameter, with V on one side and 10 on the other side.
Venclyxto 50 mg film-coated tablet is beige, oblong, and 14 mm long, with V on one side and 50 on the other side.
Venclyxto 100 mg film-coated tablet is light yellow, oblong, and 17.2 mm long, with V on one side and 100 on the other side.
Venclyxto tablets are packed in blisters in the following cartons:
Venclyxto 10 mg film-coated tablets:
- 10 tablets (5 blisters with 2 tablets each)
- 14 tablets (7 blisters with 2 tablets each)
Venclyxto 50 mg film-coated tablets:
- 5 tablets (5 blisters with 1 tablet each)
- 7 tablets (7 blisters with 1 tablet each)
Venclyxto 100 mg film-coated tablets:
- 7 tablets (7 blisters with 1 tablet each)
- 14 tablets (7 blisters with 2 tablets each)
- 112 (4 x 28) tablets (4 boxes of 7 blisters containing 4 tablets each).
Not all pack sizes may be marketed.
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
AbbVie AB
Phone: +46 (0)8 684 44 600