Venetoclax

The most important thing to know

VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA.

You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests.

Tell your healthcare provider right away if you get any symptoms of TLS during treatment with VENCLEXTA, including: ○ fever ○ chills ○ nausea ○ vomiting ○ confusion ○ shortness of breath ○ seizures ○ irregular heartbeat ○ dark or cloudy urine ○ unusual tiredness ○ muscle or joint pain Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS.

Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you get symptoms of TLS. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

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How to take it

Take VENCLEXTA exactly as your healthcare provider tells you to take it. Do not change your dose of VENCLEXTA or stop taking VENCLEXTA unless your healthcare provider tells you to. When you first take VENCLEXTA: ○ You may need to take VENCLEXTA at a hospital or clinic to be monitored for TLS. ○ If you take VENCLEXTA for CLL or SLL, your healthcare provider will start VENCLEXTA at a low dose.

Your dose will be slowly increased weekly over 5 weeks up to the full dose. Read the Quick Start Guide that comes with VENCLEXTA before your first dose. ○ If you take VENCLEXTA for AML, your healthcare provider will start VENCLEXTA at a low dose. Your dose will be slowly increased daily over 3 or 4 days up to the full dose.

Follow your healthcare provider’s instructions carefully while increasing to the full dose. Follow the instructions about drinking water described in the section of this Medication Guide about TLS called “What is the most important information I should know about VENCLEXTA?” and also in the Quick Start Guide. Take VENCLEXTA 1 time a day with a meal and water at about the same time each day.

Swallow VENCLEXTA tablets whole. Do not chew or break the tablets. Tell your healthcare provider if you have trouble swallowing VENCLEXTA tablets. Your healthcare provider may prescribe your dose in smaller sized tablets. If you are unable to swallow VENCLEXTA tablets whole, the tablets can be crushed: ○ Crush the number of tablets needed for your prescribed dose and mix with ½ cup (4 ounces) of water, apple juice, apple sauce, or yogurt.

○ Take the entire mixture right away with a meal and water. ○ Do not crush more than 1 VENCLEXTA dose at a time. ○ Crushed tablets may cause yellow staining, including of the skin. Consider using disposable gloves when handling crushed tablets. If you miss a dose of VENCLEXTA and it has been less than 8 hours, take your dose as soon as possible.

If you miss a dose of VENCLEXTA and it has been more than 8 hours, skip the missed dose and take the next dose at your usual time. If you vomit after taking VENCLEXTA, do not take an extra dose. Take the next dose at your usual time the next day.

Side effects, and when to stop

" for more information about side effects. What is VENCLEXTA? VENCLEXTA is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who: ○ are 75 years of age or older, or ○ have other medical conditions that prevent the use of standard chemotherapy.

It is not known if VENCLEXTA is safe and effective in children.

Who should not take it

People taking certain medicines during the beginning of VENCLEXTA treatment (when the dose is being slowly increased) are at increased risk of TLS. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.

Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider. Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems have liver problems have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium have a history of high uric acid levels in your blood or gout are scheduled to receive a vaccine.

You should not receive a “live vaccine” before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.

are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA. Use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.

are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of VENCLEXTA. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

VENCLEXTA and other medicines may affect each other causing serious side effects. See “Who should not take VENCLEXTA?”

What to avoid

You should not drink grapefruit juice, eat grapefruit, Seville oranges (often used in marmalades), or starfruit during treatment with VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood. What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including: Low white blood cell count (neutropenia).

Your healthcare provider will do blood tests to check your blood count during treatment with VENCLEXTA and may pause dosing of VENCLEXTA or give you medicines to help treat your neutropenia if it is severe. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA.

Your healthcare provider will closely monitor and treat you right away if you get a fever or any signs of infection during treatment with VENCLEXTA. Tell your healthcare provider right away if you get a fever or any signs of an infection during treatment with VENCLEXTA. The most common side effects of VENCLEXTA when used in combination with obinutuzumab, or rituximab, or alone in people with CLL or SLL include: low white blood cell count low platelet count low red blood cell count diarrhea nausea upper respiratory tract infection cough muscle and joint pain tiredness swelling of your arms, legs, hands, and feet The most common side effects of VENCLEXTA when used in combination with acalabrutinib in people with CLL or SLL include: low white blood cell count headache diarrhea muscle and bone pain COVID-19 The most common side effects of VENCLEXTA in combination with azacitidine, or decitabine, or low-dose cytarabine in people with AML include: nausea diarrhea low platelet count constipation low white blood cell count fever with low white blood cell count tiredness vomiting swelling of arms, legs, hands, or feet fever infection in lungs shortness of breath bleeding low red blood cell count rash stomach (abdominal) pain infection in your blood muscle and joint pain dizziness cough sore throat low blood pressure Your healthcare provider may temporarily stop VENCLEXTA treatment, decrease your dose, or completely stop treatment if you get severe side effects.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Storing it

Store VENCLEXTA at or below 86°F (30°C). Keep VENCLEXTA in its original packaging or container to protect from moisture. Keep VENCLEXTA and all medicines out of reach of children.