VENCLYXTO 10 mg Film-Coated Tablets

Зміст інструкції

1. Venclyxto 10 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Venclyxto and what is it used for
   2. What you need to know before taking Venclyxto
   3. How to take Venclyxto
   4. Possible side effects
   5. How to store Venclyxto
   6. Contents of the pack and other information

Venclyxto 10 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

venetoclax

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Venclyxto and what is it used for

What is Venclyxto
Venclyxto is an anti-cancer medicine that contains the active substance venetoclax. It belongs to a
group of medicines called “BCL-2 inhibitors”.

What is Venclyxto used for
Venclyxto is used to treat adults with:

• chronic lymphocytic leukemia (CLL). Venclyxto can be taken in combination with other medicines or alone.
• acute myeloid leukemia (AML). Venclyxto will be taken in combination with other medicines.

CLL is a type of cancer that affects white blood cells called lymphocytes and lymph nodes. In CLL, the
lymphocytes multiply too quickly and live too long, therefore the amount of lymphocytes
present in the blood is high.
AML is a type of cancer that affects white blood cells called myeloid cells. In AML, the
myeloid blood cells multiply and grow very rapidly in the bone marrow and in the
blood; therefore, there is an excess of these cells and an insufficient number of red blood cells.

How Venclyxto works
Venclyxto works by blocking a protein in the body called “BCL-2”. This protein is present in
large quantities in some cancer cells and helps cancer cells to survive. Blocking this
protein helps to kill and reduce the number of cancer cells, and also slows down the worsening
of the disease.

2. What you need to know before taking Venclyxto

Do not take Venclyxto if:

• you are allergic to the active ingredient venetoclax or to any of the other ingredients of this medicine (listed in section 6).
• you have CLL and are taking any of the medicines listed below when you start treatment and while the dose is gradually increased (usually over 5 weeks). This is because serious and potentially life-threatening effects can occur when Venclyxto is taken with these medicines:
• itraconazole, ketoconazole, posaconazole or voriconazole for fungal infections
• clarithromycin for bacterial infections
• ritonavir for HIV infection.

When the dose of Venclyxto has been increased to the full standard dose, consult your
doctor to find out if you can start taking these medicines again.

• you are taking a herbal medicine called St John's Wort, used for depression. If you are unsure, ask your doctor, pharmacist or nurse before taking Venclyxto.

It is important to tell your doctor, pharmacist or nurse if you are taking any medicines,
including prescription or over-the-counter medicines, vitamins and herbal supplements. Your
doctor may need to stop you from taking some medicines when you start taking
Venclyxto and during the first days or weeks, when the 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, as the risk of a side effect called tumor lysis syndrome may increase
• you have liver problems, as this may increase the risk of side effects. Your doctor may need to reduce the dose of Venclyxto.
• you think you have an infection or have had a long-lasting or recurring infection
• you are due to have a vaccination.

If any of the above situations apply to you or if you have any doubts, talk to your doctor, pharmacist or
nurse before taking this medicine.

Tumor Lysis Syndrome
Some people may develop unusual levels of electrolytes (such as potassium and uric acid) in the
blood due to the rapid breakdown of cancer cells during treatment. This can
cause changes in kidney function, abnormal heartbeat or convulsions, and this is
called tumor lysis syndrome (TLS). The risk of tumor lysis syndrome applies to the first
days or weeks of treatment with Venclyxto, when the dose is increased.

If you have CLL
Your doctor, pharmacist or nurse will perform blood tests to check if you have tumor lysis syndrome.
Your doctor will prescribe medicines to help prevent uric acid from building up
in your body before you start treatment with Venclyxto.
Drink plenty of water, at least 1.5-2 liters a day, to help remove the breakdown products of cancer cells from your body through your urine and to reduce the risk of tumor
lysis syndrome (see section 3).
Tell your doctor, pharmacist or nurse immediately if you develop any of the symptoms of
tumor lysis syndrome listed in section 4.
If you are at risk of tumor lysis syndrome you may be treated in hospital, so that you can receive
fluids through a vein if necessary, have blood tests more often and monitor for any side
effects. This will help to establish whether you can continue to take this medicine safely.

If you have AML
You may be treated in hospital and your doctor or nurse will make sure you receive enough fluids, give you medicines to prevent uric acid from building up
in your body and perform blood tests before starting treatment with Venclyxto,
during the dose escalation phase and when you start taking the full dose.

Children and adolescents
Venclyxto should not be used in children and adolescents.

Other medicines and Venclyxto
Tell your doctor or pharmacist if you are taking any of the following medicines, because
they can increase or decrease the amount of venetoclax in the 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 convulsions or to treat epilepsy carbamazepine, phenytoin
• medicines for HIV infection - efavirenz, etravirine, ritonavir
• medicines to treat high blood pressure or angina - diltiazem, verapamil
• medicines to lower cholesterol levels in the blood - colestiramina, colestipol, colesevelam
• a medicine used to treat a lung condition called pulmonary arterial hypertension - bosentan
• a medicine to treat sleep disorders (narcolepsy) called modafinil
• a herbal medicine called St John's Wort

Your doctor may change the dose of Venclyxto.
Tell your doctor if you take any of the following medicines, because Venclyxto may
change their effect:

• medicines that prevent blood clotting, such as 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 reduce 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 without a prescription, herbal medicines and supplements. Venclyxto can in fact affect how other medicines work. Also
some other medicines can affect how Venclyxto works.

Venclyxto with food and drink
Do not consume grapefruit, Seville oranges (often used in marmalade) or
star fruit while being treated with Venclyxto, this includes eating them, drinking their juice or taking a
supplement that may contain them. They may increase the amount of venetoclax in the blood.

Pregnancy

• Do not become pregnant while taking this medicine. If you are pregnant, suspect you might be or are planning a pregnancy, ask your doctor, pharmacist or nurse for advice before taking this medicine.
• Venclyxto should not be used during pregnancy. There is no safety information on venetoclax in pregnant women.

Contraception

• Women of childbearing potential must use a highly effective method of contraception during therapy and for at least 30 days after taking Venclyxto, to avoid pregnancy.
• If you are using the pill or hormonal contraceptive devices, you should also use a barrier method of contraception (such as condoms), because the effect of the pill or hormonal contraceptive devices may be affected by Venclyxto.
• Tell your doctor immediately if you become pregnant while taking this medicine.

Breast-feeding
Do not breast-feed while taking this medicine. It is not known whether the active ingredient of Venclyxto
passes into breast milk.

Fertility
Based on results in animals, Venclyxto may cause male infertility (low or absent sperm count). This may affect your ability to have children. Ask your doctor about
preserving sperm before starting treatment with Venclyxto.

Driving and using machines
You may feel tired or dizzy after taking Venclyxto, this may affect your
ability to drive or use machines. If this happens, do not drive and do not use tools or
machinery.

Venclyxto contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say
essentially “sodium-free”.

3. How to take Venclyxto

Take this medicine following exactly the instructions of your doctor, pharmacist or
nurse. If you have any doubts, ask your doctor, pharmacist or nurse.

How much medicine to take
If you have CLL
You will start 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 receive a new pack every week.

• the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days.
• the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days.
• the dose will be increased to 100 mg (one 100 mg tablet) once a day for 7 days.
• the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days.
• the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days.

o When you take Venclyxto as a single therapy, you will remain on the 400 mg dose per
day, the standard dose, for as long as necessary.
o When you take Venclyxto as combination therapy with rituximab, you will receive the
400 mg dose per day for 24 months.
o When you take Venclyxto as combination therapy with obinutuzumab, you will receive
the 400 mg dose per day for approximately 10 months.
A dose adjustment may be necessary if side effects occur. Your
doctor will indicate the appropriate dose.

If you have AML
You will start treatment with Venclyxto at a lower dose. Your doctor will gradually increase the dose
each day for the first 3 days. After 3 days, you will take the full standard dose. The dose (tablets)
should be taken once a day.

The doses are listed in the table below
Your doctor will give you Venclyxto in combination with another medicine (azacitidine or decitabine).
You will continue to take Venclyxto at the full dose until there is a worsening of the
AML or until you are unable to continue treatment with Venclyxto due to serious side
effects.

How to take Venclyxto

• Take the tablets during a meal, at approximately the same time each day
• Swallow the tablets whole with a glass of water
• Do not chew, crush or break the tablets
• During the first few days or weeks of treatment when the dose is increased, you should take the tablets in the morning, to help you perform blood tests if necessary.

If you vomit after taking Venclyxto, do not take an extra dose that day. Take the next dose
the following day at the usual time. If you have problems taking this medicine, talk
to your doctor.

Drink plenty of water
If you have CLL
It is very important to drink plenty of water when taking Venclyxto during the first 5 weeks of
treatment. This will help remove breakdown products from cancer cells from the blood
through urine.
You should start drinking at least 1.5-2 liters of water a day two days before starting to take
Venclyxto. You can also include non-alcoholic and caffeine-free beverages in this amount, but you should
exclude grapefruit juice, Seville oranges or star fruit. Continue to drink at least 1.5-2 liters of
water on the day you start taking Venclyxto. Drink the same amount of water (at least
1.5-2 liters per day) two days before the dose increase and on the day the dose is
increased.
If your doctor believes you are at risk of tumor lysis syndrome, you may be treated in hospital in
order to receive additional fluids if necessary, have blood tests more frequently and be

monitored for any side effects. All of this is to establish whether you can continue to take
this medicine safely.

If you have AML
It is very important that you drink plenty of water when you take Venclyxto, especially when you start
treatment and during the dose escalation phase. Drinking water will help remove the
breakdown products from cancer cells from the blood through urine. If necessary, your doctor or
nurse will administer fluids intravenously if you are in hospital, to ensure appropriate
removal of these breakdown products.

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

If you forget to take Venclyxto

• If less than 8 hours have passed since the time you usually take the dose, take it as soon as possible.
• If more than 8 hours have passed since the time you usually take the dose, do not take it that day. Resume your normal dosing schedule the next day.
• Do not take a double dose to make up for a missed dose.
• If you have any doubts, ask your doctor, pharmacist or nurse.

Do not stop taking Venclyxto
Do not stop taking this medicine unless your doctor tells you to do so. If you have
any doubts about using 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.
With this medicine the following serious side effects may occur:

Tumor lysis syndrome(common -may affect up to 1 in 10 people)
Stop taking Venclyxto and contact your doctor immediately if you notice any of the following
symptoms of tumor lysis syndrome:

• fever or chills
• feeling unwell or sick (nausea or vomiting)
• feeling confused
• feeling short of breath
• irregular heartbeat
• dark or cloudy urine
• feeling unusually tired
• muscle pain or joint discomfort
• seizures or convulsions
• abdominal pain and distension

Low white blood cell count (neutropenia) and infections(very common -may affect more than
1 in 10 people)
Your doctor will check your blood counts during treatment with Venclyxto. A low white blood cell
count can also increase your risk of infections. Signs may include fever, chills,
feeling weak or confused, cough, pain or burning when you urinate.
Some infections, such as pneumonia or blood infection (sepsis), can be serious and
can be fatal. Tell your doctor immediately if you develop signs of an infection while
taking this medicine.

Tell your doctor if you notice any of the following side effects:
If you have CLL
Very common(may affect more than 1 in 10 people)

• pneumonia
• upper respiratory tract infection - signs include runny nose, sore throat or cough
• diarrhoea
• feeling unwell or sick (nausea or vomiting)
• constipation
• feeling tired

Blood tests may also show

• a low number of red blood cells
• a low number of white blood cells called lymphocytes
• increased potassium level
• a higher level of a salt (electrolyte) in the body called phosphate
• decreased calcium level

Common(may affect up to 1 in 10 people)

• serious blood infection (sepsis)
• urinary tract infection
• low white blood cell count with fever (febrile neutropenia)

Blood tests may also show:

• increased creatinine level
• increased urea level

If you have AML
Very common(may affect more than 1 in 10 people)

• feeling unwell or sick (nausea or vomiting)
• diarrhoea
• mouth sores
• feeling tired or weak
• infection of the lungs or blood
• loss of appetite
• joint pain
• dizziness or fainting
• headache
• shortness of breath
• bleeding
• low blood pressure
• urinary tract infection
• weight loss
• abdominal pain

Blood tests may also show

• a low number of platelets (thrombocytopenia)
• a low number of white blood cells with fever (febrile neutropenia)
• a low number of red blood cells (anaemia)
• an elevated level of total bilirubin
• a low level of potassium in the blood

Common(may affect up to 1 in 10 people):

• gallstones or gallbladder infection

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects
not listed in this leaflet. You can also report side effects directly through the national reporting
system listed in Annex V. By reporting side effects you can help provide more information on the
safety of this medicine.

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 that is stated on the blister after EXP on the label
and on the package after Scad.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Venclyxto contains
The active ingredient 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 ingredients are:

• In the tablet core: copovidone (K 28), polysorbate 80 (E433), anhydrous colloidal silica (E551), anhydrous dibasic calcium 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).

Description of Venclyxto and contents of the pack
The 10 mg Venclyxto film-coated tablet is pale yellow in colour, round, with a
diameter of 6 mm, with V imprinted on one side and 10 on the other.
The 50 mg Venclyxto film-coated tablet is beige in colour, oblong, with a length
of 14 mm, with V imprinted on one side and 50 on the other.
The 100 mg Venclyxto film-coated tablet is pale yellow in colour, oblong, with a
length of 17.2 mm, with V imprinted on one side and 100 on the other.
Venclyxto tablets are provided in blisters or in bottles packaged in cartons as reported
below:
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 (4x28) tablets (4 boxes containing 7 blisters with 4 tablets each)
• 360 tablets (3 bottles containing 120 tablets each)

Not all pack sizes may be marketed.

Marketing authorisation 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
For further information on this medicine, contact the local representative of the marketing
authorisation holder:
F.

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811

Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.: +359 2 90 30 430

Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111

Magyarország
AbbVie Kft.
Tel:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28

Malta
V.J.Salomone Pharma Limited
Tel: +356 22983201

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0

Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011

Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Τηλ: +30 214 4165 555

Österreich
AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10

Polska
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

Hrvatska
AbbVie d.o.o.
Tel: + 385 (0)1 5625 501

România
AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900

Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

Ísland
Vistor hf.
Tel: +354 535 7000

Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921

Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ: +357 22 34 74 40

Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu
This leaflet is available in all languages of the European Union/European Economic Area on the
European Medicines Agency website.

for large print> or
authorisation holder.