Venclixto 50 mg film-coated tablets
Spain
Table of Contents
Package Leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Venclyto 10mg film-coated tablets
Venclyxto 50mg film-coated tablets
Venclyxto 100mg film-coated tablets
venetoclax
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Venclyxto is and what it is used for
- What you need to know before taking Venclyxto
- How to take Venclyxto
- Possible side effects
- How to store Venclyxto
- 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 adults with:
- chronic lymphocytic leukemia (CLL). You may receive Venclyxto as monotherapy or in combination with other medicines.
- acute myeloid leukemia (AML). You will receive Venclyxto in combination with other medicines.
CLL is a type of cancer that affects a type of white blood cells called lymphocytes, as well as the lymph nodes. In CLL, lymphocytes multiply too quickly and live too long, resulting in an excess of these cells in the blood.
AML is a type of cancer that affects a type of white blood cells called myeloid cells. In AML, myeloid cells multiply and grow rapidly in the bone marrow and blood, leading to too many of these cells and an insufficient number of red blood cells in the blood.
How Venclyxto works
Venclyxto works by blocking a protein in the body called "BCL-2". This protein is present in high amounts in certain cancer cells and helps cancer cells survive. By blocking this protein, Venclyxto promotes the destruction of cancer cells and reduces their number. It also delays disease progression.
2. What you need to know before taking Venclyxto
Do not take Venclyxto if:
-
you are allergic to the active substance venetoclax or to any of the other ingredients of this medicine (listed in section 6).
-
you have CLL and are taking any of the following medicines at the start of treatment and during dose escalation (usually for 5 weeks). You must not do so, as serious and potentially fatal effects may occur when taking Venclyxto with these medicines:
- itraconazole, ketoconazole, posaconazole, or voriconazole for fungal infections.
- clarithromycin for bacterial infections.
- ritonavir for HIV infection.
Once the dose of Venclyxto has been increased to the full standard dose, consult your doctor about whether you may restart taking these medicines.
- you are taking a herbal medicine called St. John’s wort, used for depression. If you are unsure, speak with your doctor, pharmacist, or nurse before taking Venclyxto.
It is important that you inform your doctor, pharmacist, or nurse about all medicines you are taking, including those available with or without a prescription, vitamins, and herbal supplements. Your doctor may ask you to stop taking certain medicines when you start taking Venclyxto and during the first days or weeks, while the dose is being increased to the full standard dose.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting Venclyxto if:
- you have any kidney problems, as this may increase the risk of experiencing an adverse effect called tumour lysis syndrome.
- you have liver problems, as this may increase the risk of adverse effects. Your doctor may need to reduce your dose of Venclyxto.
- you think you may have an infection or have had a long-standing or recurrent infection.
- you have an appointment to receive a vaccine.
If you are in any of the above situations, or are unsure, consult your doctor, pharmacist, or nurse before taking this medicine.
Tumour Lysis Syndrome (TLS)
Some people may develop unusually high levels of certain salts in the blood (such as potassium and uric acid) due to the rapid breakdown of cancer cells during treatment. This condition may lead to kidney problems, abnormal heart rhythm, or seizures. This condition is known as tumour lysis syndrome (TLS). The risk of TLS occurs during the first days or weeks of treatment with Venclyxto, particularly when the dose is being increased.
If you have CLL
Your doctor, pharmacist, or nurse will perform blood tests to check for TLS.
Before starting treatment with Venclyxto, your doctor will give you medicines to help prevent the buildup of uric acid in your body.
Drinking plenty of water—at least 1.5 to 2 litres per day—helps eliminate waste products from cancer cells through urine and may reduce the risk of TLS (see section 3).
Inform your doctor, pharmacist, or nurse immediately if you experience any of the TLS symptoms listed in section 4.
If you are at risk of TLS, you may receive treatment in hospital so that intravenous fluids can be administered if needed, blood tests can be performed more frequently, and adverse effects can be monitored. This precaution is taken to ensure you can safely continue taking this medicine.
If you have AML
You may receive treatment in hospital, and your doctor or nurse will ensure you receive enough water or fluids. They will also give you medicines to prevent the buildup of uric acid in your body and perform blood tests before starting Venclyxto, during dose escalation, and when you begin taking the full dose.
Children and adolescents
Venclyxto must not be used in children and adolescents.
Other medicines and Venclyxto
Inform 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 for 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 for high blood pressure or angina – diltiazem, verapamil
- medicines to lower blood cholesterol levels – cholestyramine, colestipol, colesevelam
- a medicine used to treat a lung condition called pulmonary arterial hypertension – bosentan
- a medicine used to treat a sleep disorder (narcolepsy) called modafinil
- a herbal medicine known as St. John’s wort
Your doctor may need to adjust your dose of Venclyxto.
Inform your doctor if you are taking 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 called digoxin
- a cancer medicine called everolimus
- a medicine used to prevent organ rejection called sirolimus
- medicines to lower blood cholesterol levels known as statins
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, herbal medicines, and supplements. This is important because Venclyxto may affect how some medicines work, and other medicines may affect how Venclyxto works.
Taking Venclyxto with food and drink
Do not consume grapefruit, Seville oranges (bitter oranges, often used in marmalades), or starfruit (carambola) while taking Venclyxto – do not eat them, drink their juice, or take supplements that may contain them. This is because they can increase the amount of venetoclax in your blood.
Pregnancy
- Do not become pregnant while taking this medicine. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.
- Venclyxto must not be used during pregnancy. There is no information on the safety of venetoclax in pregnant women.
Contraception
- Women of childbearing potential 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 contraceptives (such as pills or devices), you must also use a barrier method of contraception (such as a condom), because the effectiveness of hormonal contraceptives (oral or device) may be affected by Venclyxto.
- Inform your doctor immediately if you become pregnant while taking this medicine.
Breastfeeding
Do not breastfeed while taking this medicine. It is unknown whether the active substance of Venclyxto passes into breast milk.
Fertility
Based on results from animal studies, Venclyxto may cause male infertility (low or no sperm count), which may affect your ability to have children. Discuss sperm storage with your doctor before starting treatment with Venclyxto.
Driving and using machines
After taking Venclyxto, you may feel tired or dizzy, which could affect your ability to drive or operate tools or machinery. If this occurs, do not drive or use any tools or machinery.
Venclyxto contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially “sodium-free”.
3. How to take Venclyxto
Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.
Dosage
If you have CLL
You will start treatment with Venclyxto at a low dose for 1 week. Your doctor will gradually increase your dose over the next 4 weeks to the full standard dose. During the first 4 weeks, you will receive a new pack each week.
- The starting dose is 20 mg (two 10 mg tablets) once daily for 7 days.
- The dose will be increased to 50 mg (one 50 mg tablet) once daily for 7 days.
- The dose will be increased to 100 mg (one 100 mg tablet) once daily for 7 days.
- The dose will be increased to 200 mg (two 100 mg tablets) once daily for 7 days.
- The dose will be increased to 400 mg (four 100 mg tablets) once daily for 7 days.
- If you are receiving Venclyxto as monotherapy, you will continue taking the recommended daily dose of 400 mg for as long as necessary.
- If you are receiving Venclyxto in combination with rituximab, you will take the daily dose of 400 mg for 24 months.
- If you are receiving Venclyxto in combination with obinutuzumab, you will take the daily dose of 400 mg for approximately 10 months.
Dose adjustments may be necessary due to adverse effects. Your doctor will advise you on the appropriate dose to take.
If you have AML
You will start treatment with Venclyxto at a lower dose. Your doctor will gradually increase your dose each day over the first 3 days. After these 3 days, you will take the full standard dose. The dose (tablets) is taken once daily.
The following table shows the dosing schedule
Day | Daily dose of Venclyxto |
1 | 100 mg (one 100 mg tablet) |
2 | 200 mg (two 100 mg tablets) |
3 and onwards | 400 mg (four 100 mg tablets) |
Your doctor will administer Venclyxto in combination with another medicine (azacitidine or decitabine).
You will continue taking the full dose of Venclyxto until your AML worsens or until you can no longer take Venclyxto due to serious adverse effects.
How to take Venclyxto
- Take the tablets with a meal 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 few days or weeks of treatment when the dose is being increased, you should take the tablets in the morning to facilitate blood monitoring, if necessary.
If you vomit after taking Venclyxto, do not take an additional dose that day. Take your next dose at the usual time the following day. If you have difficulty taking this medicine, inform your doctor.
Drink plenty of water
If you have CLL
It is very important to drink plenty of water while taking Venclyxto during the first 5 weeks of treatment. This will help remove waste products from cancer cells through the urine.
You should start drinking at least 1.5 to 2 liters of water per day, beginning two days before starting Venclyxto. You may include non-caffeinated and non-alcoholic beverages in this amount, but do not drink grapefruit juice, bitter orange juice, or starfruit (carambola). You must continue drinking at least 1.5 to 2 liters of water on the day you start taking Venclyxto. Drink the same amount (at least 1.5 to 2 liters per day) for two days before your dose is increased and on the day of the dose increase.
If your doctor considers you to be at risk of developing tumor lysis syndrome (TLS), you may receive treatment in the hospital so that additional intravenous fluids can be administered if needed, blood tests can be performed more frequently, and adverse effects can be monitored. This precaution is taken to ensure that you can continue taking this medicine safely.
If you have AML
It is very important to drink plenty of water while taking Venclyxto, especially when starting treatment and when the dose is increased. Drinking water will help remove waste products from cancer cells through the urine. If you are in the hospital, your doctor or nurse will administer intravenous fluids if necessary to ensure this occurs.
If you take more Venclyxto than you should
If you take more Venclyxto than you should, consult your doctor, pharmacist, or nurse, or go to the hospital immediately. Take the tablets and this leaflet with you.
If you forget to take Venclyxto
- If less than 8 hours have passed since your usual dosing time, take the missed dose as soon as possible.
- If more than 8 hours have passed since your usual dosing time, do not take the missed dose that day. Resume your regular dosing schedule the next day.
- Do not take a double dose to make up for a missed dose.
- If in doubt, consult your doctor, pharmacist, or nurse.
If you stop treatment with Venclyxto
Do not stop treatment with this medicine unless instructed by your doctor. If you have any further questions about how to use this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. This medicine may cause the following serious adverse effects:
Tumour lysis syndrome (TLS) (common – may affect up to 1 in 10 people)
Stop taking Venclyxto and seek immediate medical attention if you experience any of the following TLS symptoms:
- fever or chills
- nausea or vomiting
- confusion
- difficulty breathing
- irregular heartbeat
- dark or cloudy urine
- unusual tiredness
- muscle pain or joint discomfort
- seizure or convulsions
- abdominal pain and swelling
Decrease in white blood cell count (neutropenia) and infections (very common – may affect more than 1 in 10 people)
Your doctor will monitor your blood cell counts during treatment with Venclyxto. A decrease in white blood cells may increase the risk of infections. Signs may include fever, chills, weakness, confusion, cough, or pain or burning sensation when urinating. Some infections, such as pneumonia or blood infection (sepsis), may be severe and lead to death. Inform your doctor immediately if you develop signs of infection during treatment with this medicine.
Inform your doctor if you experience any of the following adverse effects:
If you have CLL
Very common (may affect more than 1 in 10 people)
- pneumonia
- upper respiratory tract infection (symptoms include runny nose, sore throat, or cough)
- diarrhoea
- nausea or vomiting
- constipation
- fatigue
The following may also be observed in blood tests:
- decrease in red blood cell count
- decrease in white blood cells called lymphocytes
- increased potassium levels
- increased levels of a body salt (electrolyte) called phosphate
- decreased calcium levels
Common (may affect up to 1 in 10 people)
- severe blood infection (sepsis)
- urinary tract infection
- decrease in white blood cells with fever (febrile neutropenia)
The following may also be observed in blood tests:
- increased creatinine levels
- increased urea levels
If you have AML
Very common (may affect more than 1 in 10 people)
- feeling sick (nausea or vomiting)
- diarrhoea
- mouth sores
- feeling tired or weak
- lung or blood infection
- loss of appetite
- joint pain
- dizziness or fainting
- headache
- difficulty breathing
- bleeding
- low blood pressure
- urinary tract infection
- weight loss
- stomach pain (abdominal pain)
Blood tests may show:
- lower platelet count (thrombocytopenia)
- lower white blood cell count with fever (febrile neutropenia)
- lower red blood cell count (anaemia)
- higher total bilirubin levels
- low blood potassium levels
Common (may affect up to 1 in 10 people)
- gallstones or gallbladder infection
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Venclyxto
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister label and packaging, after EXP:.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Venclyxto
The active substance is venetoclax.
- Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of venetoclax.
- Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of venetoclax.
- Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of venetoclax.
The other components 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 film coating:
- 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 of the product and contents of the pack
Venclyxto 10 mg film-coated tablet is pale yellow, round, 6 mm in diameter, marked with a "V" on one side and "10" on the other.
Venclyxto 50 mg film-coated tablet is beige, oblong, 14 mm long, marked with a "V" on one side and "50" on the other.
Venclyxto 100 mg film-coated tablet is pale yellow, oblong, 17.2 mm long, marked with a "V" on one side and "100" on the other.
Venclyxto tablets are supplied in blisters or bottles contained in cartons as follows:
Venclyxto 10 mg film-coated tablets:
- 10 tablets (5 blisters each containing 2 tablets)
- 14 tablets (7 blisters each containing 2 tablets)
Venclyxto 50 mg film-coated tablets:
- 5 tablets (5 blisters each containing 1 tablet)
- 7 tablets (7 blisters each containing 1 tablet)
Venclyxto 100 mg film-coated tablets:
- 7 tablets (7 blisters each containing 1 tablet)
- 14 tablets (7 blisters each containing 2 tablets)
- 112 (4 x 28) tablets (4 packs of 7 blisters each containing 4 tablets)
- 360 tablets (3 bottles each containing 120 tablets)
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany
AbbVie S.r.l.
S.R. 148 Pontina, km 52 SNC
04011 Campoverde di Aprilia (Latina)
Italy
Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium AbbVie SA Tel/Tel: +32 10 477811 | Lithuania AbbVie UAB Tel: +370 5 205 3023 |
| Luxembourg/Luxembourg AbbVie SA Belgium/Belgium Tél/Tel: +32 10 477811 |
Czech Republic AbbVie s.r.o. Tel: +420 233 098 111 | Hungary AbbVie Kft. Tel:+36 1 455 8600 |
Denmark AbbVie A/S Tlf: +45 72 30‑20‑28 | Malta V.J.Salomone Pharma Limited Tel: +356 22983201 |
Germany AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (toll-free) Tel: +49 (0) 611 / 1720‑0 | Netherlands AbbVie B.V. Tel: +31 (0)88 322 2843 |
Estonia AbbVie OÜ Tel: +372 623 1011 | Norway AbbVie AS Tlf: +47 67 81 80 00 |
Greece AbbVie PHARMACEUTICAL COMPANY S.A. Tel: +30 214 4165 555 | Austria AbbVie GmbH Tel: +43 1 20589‑0 |
Spain AbbVie Spain, S.L.U. Tel: +34 91 384 09 10 | Poland AbbVie Sp. z o.o. Tel.: +48 22 372 78 00 |
France AbbVie Tél: +33 (0) 1 45 60 13 00 | Portugal AbbVie, Lda. Tel: +351 (0)21 1908400 |
Croatia AbbVie d.o.o. Tel: + 385 (0)1 5625 501 | Romania AbbVie S.R.L. Tel: +40 21 529 30 35 |
Ireland AbbVie Limited Tel: +353 (0)1 4287900 | Slovenia AbbVie Pharmaceutical Company d.o.o. Tel: +386 (1)32 08 060 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia AbbVie s.r.o. Tel: +421 2 5050 0777 |
Italy AbbVie S.r.l. Tel: +39 06 928921 | Finland AbbVie Oy Puh/Tel: +358 (0)10 2411 200 |
Cyprus Lifepharma (Z.A.M.) Ltd Tel: +357 22 34 74 40 | Sweden AbbVie AB Tel: +46 (0)8 684 44 600 |
Latvia AbbVie SIA Tel: +371 67605000 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.
To listen to this leaflet or request a copy in Braille, large font, or audio format, please contact the local representative of the marketing authorization holder.