Venclyxto 10 mg comprimidos recubiertos con pelicula

Product Information for the Patient

Venclyxto 10 mg Film-Coated Tablets

Venclyxto 50 mg Film-Coated Tablets

Venclyxto 100 mg Film-Coated Tablets

venetoclax

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information. See section 4.

1.What is Venclyxto and for what it is used

2.What you need to know before starting to take Venclyxto

3.How to take Venclyxto

4.Possible side effects

5.Storage of Venclyxto

6.Contents of the pack and additional information

What is Venclyxto

Venclyxtois a cancer medicationthatcontains the active ingredient venetoclax. It belongs to a group of medications called “BCL-2 inhibitors”.

What is Venclyxto used for

Venclyxto is used to treat adults with:

• chronic lymphocytic leukemia (CLL). You may receive Venclyxto as a single treatment or in combination with other medications.
• acute myeloid leukemia (AML). You will receive Venclyxto in combination with other medications.

CLL is a type of cancer that affects a type of white blood cells called lymphocytes, and 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 very quickly in the bone marrow and blood, resulting in too many of them and not enough red blood cells in the blood.

How Venclyxto works

Venclyxto acts 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 to survive. Blocking this protein facilitates the destruction of cancer cells and reduces their number. It also delays the worsening of the disease

Do not take Venclyxto if:

• You are allergic to the active ingredient venetoclax or to any of the other components of this medicine (listed in section 6).

• You have Chronic Lymphocytic Leukemia (CLL) and are taking any of the following medicines when starting treatment and during the gradual increase in dose (usually over 5 weeks). Do not take them because they can cause severe and potentially life-threatening effects when taken with Venclyxto:
• • Itraconazole, ketoconazole, posaconazole, or voriconazole for fungal infections.
  • Clarithromycin for bacterial infections.
  • Ritonavir for HIV infection.

Once the Venclyxto dose has been increased to the standard full dose, consult 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 unsure, speak with your doctor, pharmacist, or nurse before taking Venclyxto.

It is essential to inform your doctor, pharmacist, or nurse about all the medicines you are taking, including those available over-the-counter, prescription medicines, vitamins, and herbal supplements. Your doctor may ask you to stop taking certain medicines when starting Venclyxto and during the first few days or weeks, during the dose increase to the standard full dose.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting Venclyxto if:

• You have any kidney problems, as it may increase the risk of a condition called Tumor Lysis Syndrome (TLS).
• You have liver problems, as it may increase the risk of adverse effects. Your doctor may need to reduce your Venclyxto dose.
• You think you may have an infection or have had a long-term or recurrent infection.
• You have a scheduled vaccination.

If you are in any of the above circumstances, or are unsure, consult your doctor, pharmacist, or nurse before taking this medicine.

Tumor Lysis Syndrome (TLS)

Some people may experience an unusual amount of certain salts in the blood (such as potassium and uric acid) due to the rapid breakdown of cancer cells during treatment. This situation can cause kidney function abnormalities, abnormal heart rhythms, or seizures. The condition is called Tumor Lysis Syndrome (TLS). The risk of TLS occurs in the first few 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 detect the presence of TLS.

Before starting treatment with Venclyxto, your doctor will administer medicines to help prevent the accumulation of uric acid in the body.

Drinking plenty of water, at least 1.5 to 2 liters per day, helps to 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 the hospital to administer intravenous fluids if necessary, perform more frequent blood tests, and monitor for adverse effects. This precaution is taken to ensure you can safely continue taking this medicine.

If you have Lymphoma

You may receive treatment in the hospital, and your doctor or nurse will ensure you have enough water or fluids, administer medicines to prevent uric acid accumulation in your body, and perform blood tests before starting Venclyxto, during dose increases, and when starting the full dose.

Children and Adolescents

Venclyxto should 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 the blood:

• Fungal infection medicines - fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole.
• Bacterial infection antibiotics - ciprofloxacin, clarithromycin, erythromycin, nafcillin, or rifampicin.
• Medicines for preventing seizures or treating epilepsy - carbamazepine, phenytoin.
• HIV infection medicines - efavirenz, etravirine, ritonavir.
• Medicines for high 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 hypertension - bosentan.
• A medicine for a sleep disorder (narcolepsy) called modafinil.
• A herbal medicine known as St. John's Wort.

Your doctor may change your Venclyxto dose.

Inform your doctor if you are taking any of the following medicines, as Venclyxto may affect their functioning:

• Blood thinners - warfarin, dabigatran.
• A medicine for heart problems, called digoxin.
• A cancer medicine called everolimus.
• A medicine to prevent organ rejection, known as sirolimus.
• Cholesterol-lowering medicines, known as statins.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This includes over-the-counter medicines, herbal supplements, and vitamins. You should do this because Venclyxto may affect how some medicines work. Additionally, other medicines may affect how Venclyxto works.

Taking Venclyxto with Food and Drinks

Do not take products containing grapefruit, Seville oranges (bitter oranges, often used in marmalades), or starfruit while taking Venclyxto - do not eat them, drink their juice, or take supplements that may contain them. This is because they may increase the amount of venetoclax in the blood.

Pregnancy

• Do not become pregnant while taking this medicine. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, pharmacist, or nurse before using this medicine.
• Venclyxto should not be used during pregnancy. There is no information on the safety of venetoclax in pregnant women.

Contraception

• Women of childbearing age should use a highly effective contraceptive method during treatment and for at least 30 days after receiving Venclyxto to avoid becoming pregnant. If you are using birth control pills or hormone-based devices, you should also use a barrier method (such as a condom) because the effect of hormone-based birth control may be affected by Venclyxto.
• Inform your doctor immediately if you become pregnant while taking this medicine.

Breastfeeding

Do not breastfeed your child while taking this medicine. The active ingredient of Venclyxto may pass into breast milk.

Fertility

Based on animal studies, Venclyxto may cause male infertility (low or no sperm count). This may affect your ability to have children. Consult your doctor about sperm storage before starting treatment with Venclyxto.

Driving and Using Machines

After taking Venclyxto, you may feel tired or dizzy, which may affect your ability to drive and 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 of sodium (23 mg) per dose; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication indicated by your doctor, pharmacist or nurse. In case of doubt, consult your doctor, pharmacist or nurse again.

Amount 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 standard full dose. During the first 4 weeks, you will receive a new package every week.

• The initial 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.
• • If you are receiving Venclyxto as a single treatment, you will continue to take the daily dose of 400 mg, which is the recommended daily dose, 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.

You may need a dose adjustment due to adverse effects. Your doctor will indicate what dose you should take.

If you have LMA

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 standard full dose. The dose (tablets) is taken once a day.

Doses are indicated in the following table

Your doctor will administer Venclyxto in combination with another medication (azacitidine or decitabine).

You will continue to take the full dose of Venclyxto until your LMA worsens or you cannot take Venclyxto because it is causing severe adverse effects.

How to take Venclyxto

• Take the tablets with a meal approximately at the same time every 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 when the dose is increased, take the tablets in the morning to facilitate monitoring through blood tests, if necessary.

If you vomit after taking Venclyxto, do not take an additional dose that day. Take the next dose at the usual time the next day. If you have trouble taking this medication, inform your doctor.

Drink plenty of water

If you have CLL

It is very important that you drink plenty of water while taking Venclyxto during the first 5 weeks of treatment. This will help eliminate the waste products of cancer cells from the blood through urine.

You should start drinking at least 1.5 to 2 liters of water per day, two days before starting Venclyxto. You can also include non-caffeinated and non-alcoholic beverages in this amount, but do not drink grapefruit, bitter orange or starfruit juice. You should continue to drink at least 1.5 to 2 liters of water per day two days before the dose increase and on that day.

If your doctor considers that you are at risk of developing TLS, you may receive treatment in the hospital to administer additional intravenous fluids, if necessary, perform more frequent blood tests and check for adverse effects. This precaution is taken to determine if you can safely continue taking this medication.

If you have LMA

It is very important that you drink plenty of water while taking Venclyxto, especially when starting treatment and when increasing the dose. Drinking water will help eliminate the waste products of cancer cells from the blood through 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. Bring the tablets and this leaflet with you.

If you forget to take Venclyxto

• If less than 8 hours have passed since the time you usually take your dose, take it as soon as possible.
• If more than 8 hours have passed since the time you usually take your dose, do not take it that day. Return to your usual dosing schedule the next day.
• Do not take a double dose to compensate for the missed doses.
• Consult your doctor, pharmacist or nurse if you are unsure.

If you interrupt treatment with Venclyxto

Do not interrupt treatment with this medication unless your doctor tells you to. If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. This medicine can cause the following serious side effects:

Tumour Lysis Syndrome (TLS)(frequent-can affect up to 1 in 10people)

Stop taking Venclyxto and seek medical attention immediately if you notice any of the symptoms of TLS:

• fever or chills
• nausea or vomiting
• confusion
• difficulty breathing
• irregular heart rhythm
• dark or cloudy urine
• unusual feeling of fatigue
• muscle pain or joint discomfort
• seizure or convulsions
• abdominal pain and distension

Decrease in white blood cell count (neutropenia) and infections(very frequent-can affect more than 1 in 10people)

Your doctor will check the blood cell count during treatment with Venclyxto. The decrease in white blood cells may increase the risk of infections. The signs may be fever, chills, weakness, or confusion, cough, pain, or burning sensation while urinating. Some infections such as pneumonia or blood infection (sepsis) can be severe and cause death. Inform your doctor immediately if you have signs of infection during treatment with this medicine.

Inform your doctor if you notice any of the following side effects:

If you have CLL

Very frequent(can affect more than 1 in 10 people)

• pneumonia
• upper respiratory tract infection (the signs are nasal discharge, sore throat, or cough)
• diarrhea
• nausea or vomiting
• constipation
• fatigue

The following may also be observed in the blood test:

• decrease in red blood cell count
• decrease in white blood cell count called lymphocytes
• increase in potassium level
• increase in a body electrolyte called phosphate
• decrease in calcium level

Frequent(can affect up to 1 in 10 people)

• severe blood infection (sepsis)
• urinary tract infection
• febrile neutropenia (decrease in white blood cells with fever)

The following may also be observed in the blood test:

• increase in creatinine level
• increase in urea level

If you have LMA

Very frequent(can affect more than 1 in 10people)

• feeling of dizziness (nausea or vomiting)
• diarrhea
• mouth sores
• feeling of fatigue or weakness
• lung or blood infection
• loss of appetite
• joint pain
• dizziness or fainting
• headache
• difficulty breathing
• bleeding
• low blood pressure
• urinary tract infection
• weight loss
• abdominal pain (dolor abdominal)

The blood tests may show:

• lower platelet count (thrombocytopenia)
• lower white blood cell count with fever (neutropenia febril)
• lower red blood cell count (anemia)
• higher total bilirubin level
• lower potassium level in blood

Frequent(can affect up to 1 in 10people)

• gallstones or infection of the gallbladder

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenationalnotification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on thelabelof the blister pack and the container, after CAD.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Venclyxto

The active ingredient is venetoclax.

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

The other components are:

• In the core of the tablet: copovidone (K 28), polisorbate 80 (E433), anhydrous colloidal silica (E551), anhydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.

On the film coating:

• Venclyxto 10mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
• Venclyxto 50mg 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 100mg film-coated tablets: iron oxide yellow (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 face and 10 on the other.

Venclyxto 50 mg film-coated tablet is beige, oblong, 14 mm long, marked with a V on one face 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 face and 100 on the other.

Venclyxto tablets are presented in blisters or bottles contained in the following packs:

Venclyxto 10mgfilm-coated tablets:

• 10 tablets(5 blisters each containing 2 tablets)
• 14 tablets(7 blisters each containing 2 tablets)

Venclyxto 50mg film-coated tablets:

• 5 tablets(5 blisters each containing 1 tablet)
• 7 tablets(7 blisters each containing 1 tablet)

Venclyxto 100mg film-coated tablets:

• 7 tablets (7 blisters each containing 1 tablet)
• 14 tablets (7 blisters each containing 2 tablets)
• 112 (4x28) tablets (4packs of 7 blisters each containing 4 tablets)
• 360 tablets (3 bottles of 120 tablets each)

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible manufacturer

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

AbbVieS.r.l.

S.R. 148 Pontina, km 52 SNC

04011 Campoverde di Aprilia (Latina)

Italy

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.

The website of the European Medicines Agency may be consulted for this leaflet in all languages of the European Union/European Economic Area.

To listen to this leaflet or request a copy in Braille, large print or audio, please contact the local representative of the marketing authorisation holder.