Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - venclyxto

Document Subject

Generated Narrative: MedicinalProductDefinition mp03819170889474c02f91ff032bd7d943

identifier: http://ema.europa.eu/identifier/EU/1/16/1138/001 (10 mg, 10 tablets)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Venclyxto 10 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-03819170889474c02f91ff032bd7d943

identifier: http://ema.europa.eu/identifier/EU/1/16/1138/001 (10 mg, 10 tablets)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - venclyxto

Attesters

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

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 leukaemia (CLL). Venclyxto may be given to you in combination with other medicines or alone.

acute myeloid leukaemia (AML). Venclyxto will be given in combination with other medicines. 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. AML is a type of cancer affecting white blood cells called myeloid cells. In AML, myeloid blood cells multiply and grow very quickly in bone marrow and blood, so that there are too many of them and not enough 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 some cancer cells and 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.

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 have CLL and 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:

itraconazole ketoconazole, posaconazole, or voriconazole 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 days or weeks when 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 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. Your doctor may need to reduce your dose of Venclyxto

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 tumour lysis syndrome (TLS). The risk for TLS is in the first days or weeks of treatment with Venclyxto, as you increase your dose. If you have CLL Your doctor, pharmacist or nurse will do blood tests to check for TLS. Your doctor will 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. If you have AML You may be treated in hospital and your doctor or nurse will make sure that you have enough water/fluids, give you medicines to prevent the build-up of uric acid in your body and do blood tests before you start to take Venclyxto, while they increase your dose and when you start to take the full dose. 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:

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 raised blood pressure or angina diltiazem, verapamil

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, often used in marmalades), 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

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 or dizzy after taking Venclyxto, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines. Venclyxto contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium free .

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 If you have CLL 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 for 7 days.

When you are receiving Venclyxto therapy alone, you will stay on the 400 mg daily dose, which is the standard dose, for as long as necessary.

When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.

When you are receiving Venclyxto therapy in combination with obinutuzumab, you will receive the 400 mg daily dose for approximately 10 months. Your dose may need to be adjusted for side effects. Your doctor will advise what your dose should be. If you have AML You will begin treatment with Venclyxto on 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) is taken once a day. Doses are listed in the table below Day Venclyxto daily dose 1 100 mg (One 100 mg tablet) 2 200 mg (Two 100 mg tablets) 3 and after 400 mg (Four 100 mg tablets) Your doctor will give you Venclyxto in combination with another medicine (azacitidine or decitabine). You will keep taking Venclyxto at the full dose until either your AML gets worse or you cannot take Venclyxto as it is causing serious side effects. 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 days or weeks of treatment as you increase the dose, 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 If you have CLL 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 have AML It is very important you drink plenty of water when taking Venclyxto especially when you start treatment and increase your dose. Drinking water will help to remove cancer cell breakdown products from your blood through your urine. Your doctor or nurse will give you fluids into the vein if needed if you are in hospital to make sure this happens. 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.

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:

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) 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 such as pneumonia or blood infection (sepsis) 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: 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 or being sick (nausea or vomiting)

constipation

feeling tired Blood tests may also show

lower number of red blood cells

lower number of white blood cells called lymphocytes

higher level of potassium

higher level of a body salt (electrolyte) called phosphate

lower level of calcium Common (may affect up to 1 in 10 people)

severe infection in the blood (sepsis)

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

feeling or being sick (nausea or vomiting)

diarrhoea

mouth sores

feeling tired or weak

infection of lung or blood

decreased appetite

joint pain

dizziness or fainting

headache

shortness of breath

bleeding

low blood pressure

urinary tract infection

weight loss

pain in belly (abdominal pain) Blood tests may also show

lower number of platelets (thrombocytopenia)

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

lower number of red blood cells (anaemia)

higher level of total bilirubin

low level of potassium in the blood Common (may affect up to 1 in 10 people)

gall stones or gall bladder infection 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.

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.

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 are:

In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551), anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
In the film-coating:

Venclyxto 10 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

Venclyxto 50 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)

Venclyxto 100 mg film-coated tablets: 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 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 on the other. Venclyxto tablets are provided in blisters which are packed in cartons as follows: Venclyxto 10 mg film-coated tablets:

10 tablets (5 blisters each with 2 tablets)

14 tablets (7 blisters each with 2 tablets) Venclyxto 50 mg film-coated tablets:

5 tablets (5 blisters each with 1 tablet)

7 tablets (7 blisters each with 1 tablet) Venclyxto 100 mg film-coated tablets:

7 tablets (7 blisters each with 1 tablet)

14 tablets (7 blisters each with 2 tablets)

112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets). Not all pack sizes may be marketed. Marketing Authorisation Holder and 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: Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: +370 5 205 3

: +359 2 90 30 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel: +420 233 098 Magyarorsz g AbbVie Kft. Tel: +36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30-20-Malta V.J.Salomone Pharma Limited Tel: +356 22983Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (geb hrenfrei) Tel: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel: +372 623 1Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 91 384 09 Polska AbbVie Sp. z o.o. Tel: +48 22 372 78 France AbbVie T l: +33 (0) 1 45 60 13 Portugal AbbVie, Lda. Tel: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel: + 385 (0)1 5625 Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Ireland AbbVie Limited Tel: +353 (0)1 4287Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. Tel: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd : +357 22 34 74 Sverige AbbVie AB Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: