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Venclyxto (venetoclax) – Package leaflet - L01XX52

Updated on site: 10-Oct-2017

Medication nameVenclyxto
ATC CodeL01XX52
Substancevenetoclax
ManufacturerAbbVie Ltd

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.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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) with or without certain changes called “17p deletion” or “TP53 mutation” in their genes.

For CLL with “17p deletion” or “TP53 mutation”, this medicine is used to treat patients who are unsuitable for or have been treated with one or more other types of medicines for their disease.

For CLL without “17p deletion” or “TP53 mutation”, this medicine is used to treat patients who have been treated with two or more other types of medicines for their disease.

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:

-you are allergic to the active substance venetoclax or any of the other ingredients of this medicine (listed in section 6).

-you are taking any of the medicines listed below when you start your treatment and while your dose is gradually being increased (usually over 5 weeks). This is because serious and life-threatening effects can occur when Venclyxto is taken with these medicines:

ketoconazole, voriconazole, posaconazole, or itraconazole for fungal infections

clarithromycin for bacterial infections

ritonavir for HIV infection.

When your Venclyxto dose has been increased to the full standard dose, check with your doctor 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 not sure about this, talk to your doctor, pharmacist or nurse before taking Venclyxto.

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:

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

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 TLS (tumour lysis syndrome). 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 Venclyxto in your blood:

-medicines for fungal infections – ketoconazole, itraconazole, fluconazole, posaconazole, or voriconazole

-antibiotics to treat bacterial infections – clarithromycin, ciprofloxacin, 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 – verapamil, diltiazem

-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), 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 Venclyxto 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.

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.

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. You will stay on the 400 mg daily dose, which is the standard dose, for as long as necessary.

Your dose may need to be adjusted for side effects. Your doctor will advise what your dose should be.

How to take Venclyxto

Take the tablets with a meal at around 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 5 weeks of treatment, you should take the tablets in the morning to help you follow-up with blood tests, if needed.

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

If it is less than 8 hours since the time you usually take your dose, take it as soon as possible.

If it is more than 8 hours since the time you usually take your dose, do not take the dose that day. Return to your normal dose schedule the next day.

Do not take a double dose to make up for a forgotten 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 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 (TLS) (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:

fever or chills

feeling or being sick (nausea or vomiting)

feeling confused

feeling short of breath

irregular heart beat

dark or cloudy urine

feeling unusually tired

muscle pain or uncomfortable joints

fits or seizures

abdominal pain and distension

Low white blood cell count (neutropenia) (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

upper respiratory tract infection – signs include runny nose, sore throat or cough

diarrhoea

feeling or being sick (nausea or vomiting)

constipation

feeling tired

Blood tests may also show

lower number of red blood cells

higher level of a body salt (electrolyte) called phosphate

Common (may affect up to 1 in 10 people)

pneumonia

urinary tract infection

low number of white blood cells with fever (febrile neutropenia)

Blood tests may also show:

higher level of creatinine

higher level of urea

higher level of potassium

lower level of calcium

lower number of white blood cells called lymphocytes

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 via the national reporting system listed in Appendix 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 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.

Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg venetoclax. Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg venetoclax. Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg venetoclax.

The other ingredients in the tablet core are copovidone (K value 28), polysorbate 80 (E433), colloidal anhydrous silica (E551), anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.

The 10 mg tablet pale yellow film coating contains: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

The 50 mg tablet beige film coating contains: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)

The 100 mg tablet pale yellow film coating contains :iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

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 inblisters which are packed in cartons as follows:

5 or 7 blisters each with 2 tablets of 10 mg (10 or 14 tablets)

5 or 7 blisters each with 1 tablet of 50 mg (5 or 7 tablets)

7 blisters each with 1 tablet of 100 mg (7 tablets)

7 blisters each with 2 tablets of 100 mg (14 tablets)

7 blisters (4 tablets of 100 mg). Four cartons are supplied in a multipack containing a total of 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AbbVie Ltd

Vanwall Road

Maidenhead

SL6 4UB

United Kingdom

Manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

AbbVie SA

AbbVie UAB

Tél/Tel: +32 10 477811

Tel: +370 5 205 3023

България

Luxembourg/Luxemburg

АбВи ЕООД

AbbVie SA

Тел:+359 2 90 30 430

Belgique/Belgien

 

Tél/Tel: +32 10 477811

Česká republika

Magyarország

AbbVie s.r.o.

AbbVie Kft.

Tel: +420 233 098 111

Tel:+36 1 455 8600

Danmark

Malta

AbbVie A/S

V.J.Salomone Pharma Limited

Tlf: +45 72 30-20-28

Tel: +356 22983201

Deutschland

Nederland

AbbVie Deutschland GmbH & Co. KG

AbbVie B.V.

Tel: 00800 222843 33 (gebührenfrei)

Tel: +31 (0)88 322 2843

 

Eesti

Norge

AbbVie Biopharmaceuticals GmbH Eesti filiaal

AbbVie AS

Tel: +372 623 1011

Tlf: +47 67 81 80 00

Ελλάδα

Österreich

AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.

AbbVie GmbH

Τηλ: +30 214 4165 555

España

Polska

AbbVie Spain, S.L.U.

AbbVie Polska Sp. z o.o.

Tel: +34 91 384 09 10

Tel: +48 22 372 78 00

France

Portugal

AbbVie

AbbVie, Lda.

Tél: +33 (0) 1 45 60 13 00

Tel: +351 (0)21 1908400

Hrvatska

România

AbbVie d.o.o.

AbbVie S.R.L.

Tel: + 385 (0)1 5625 501

Tel: +40 21 529 30 35

Ireland

Slovenija

AbbVie Limited

AbbVie Biofarmacevtska družba d.o.o.

Tel: +353 (0)1 4287900

Tel: +386 (1)32 08 060

Ísland

Slovenská republika

Vistor hf.

AbbVie s.r.o.

Tel: +354 535 7000

Tel: +421 2 5050 0777

Italia

Suomi/Finland

AbbVie S.r.l.

AbbVie Oy

Tel: +39 06 928921

Puh/Tel: +358 (0)10 2411 200

Κύπρος

Sverige

Lifepharma (Z.A.M.) Ltd

AbbVie AB

Τηλ: +357 22 34 74 40

Tel: +46 (0)8 684 44 600

Latvija

United Kingdom

AbbVie SIA

AbbVie Ltd

Tel: +371 67605000

Tel: +44 (0)1628 561090

This leaflet was last revised in

 

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

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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