Low white blood
cell count
Possible side effects of VENCLEXTA
Actor portrayals.
Serious side effects previously untreated CLL/SLL patients need to be aware of
Side effects can be managed with your healthcare provider. Each person responds differently to VENCLEXTA. Side effects are a real possibility, and some can be very serious. These include:
Tumor lysis syndrome (TLS)
TLS is a serious side effect caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. So tell your doctor right away if you experience symptoms associated with TLS, including:
- Fever
- Chills
- Nausea
- Vomiting
- Confusion
- Shortness of breath
- Seizures
- Irregular heartbeat
- Dark or cloudy urine
- Unusual tiredness
- Muscle or joint pain
In the clinical trial, 1% (3 of 212 people) treated with VENCLEXTA + GAZYVA® (obinutuzumab) had TLS. All events of TLS resolved and did not lead to withdrawal from the study.
In the clinical trial, 0.3% of people (1 out of 291) treated with VENCLEXTA + acalabrutinib had TLS.*
*TLS information from the clinical trial does not appear in the prescribing information.
Tips to help prevent TLS
The risk of TLS can vary for different people. To determine your risk of getting TLS, your healthcare provider will do blood tests before you start VENCLEXTA.
Drink plenty of water
It is very important to drink 6-8 glasses (~56 oz) of water every day, starting 2 days before your first dose, on the day of your first dose, and each time your dose is increased.
Take medications your doctor gives you
Your healthcare provider will give you medications—sometimes including IV fluids—before starting and during treatment to help reduce your risk of TLS.
Take VENCLEXTA as prescribed
Your healthcare provider may delay your dose, decrease your dose, or stop treatment with VENCLEXTA if you get side effects.
Go to your blood test appointments
Your healthcare provider will do blood tests in your first 5 weeks of treatment to check for TLS during treatment with VENCLEXTA. It is important to keep your appointments for blood tests.
Low white blood cell counts (neutropenia)
Your healthcare provider will do blood tests to check your blood counts 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.
Some people may experience other side effects.
Common side effects of VENCLEXTA
Common side effects that occurred with VENCLEXTA when used in combination with acalabrutinib in an all-oral regimen include:
Headache
Diarrhea
Muscle and bone pain
Infections including COVID-19
Common side effects that occurred with VENCLEXTA when used in combination with GAZYVA or rituximab or alone include:
|
Low white blood cell count |
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Low platelet count |
 |
Low red blood cell count |
|
Diarrhea |
 |
Nausea |
 |
Upper respiratory tract infection |
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Cough |
|
Muscle and bone pain |
 |
Tiredness |
 |
Swelling of arms, legs, hands, and feet |
Your healthcare provider may delay or decrease your dose or stop treatment if you get side effects. Don’t stop or change your dose unless directed by your healthcare provider.
Common side effects that occurred with VENCLEXTA when used in combination with acalabrutinib in an all-oral regimen include:
|
Low white blood cell counts |
|
Headache |
|
Diarrhea |
|
Muscle and bone pain |
|
COVID-19 |
Common side effects that occurred with VENCLEXTA when used in combination with GAZYVA or rituximab or alone include:
|
Low white blood cell counts |
|
Low platelet counts |
|
Low red blood cell counts |
|
Diarrhea |
|
Nausea |
|
Upper respiratory tract infection |
|
Cough |
|
Muscle and joint pain |
|
Tiredness |
|
Swelling of arms, legs, hands, and feet |
Your healthcare provider may delay or decrease your dose or stop treatment if you have side effects. Don’t stop or change your dose unless directed by your healthcare provider.
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. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA.
Helpful tips
It's important to take care of yourself while on treatment. The activities below can help you practice a healthy lifestyle:
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Exercise |
 |
Meditation |
 |
Acupuncture |
 |
Therapeutic massage |
 |
Yoga |
Check with your healthcare provider before practicing any of the above activities.
Because the VENCLEXTA regimens are taken for a fixed amount of time, there is no additional VENCLEXTA regimen exposure after completing treatment.
Prepare to have a more open and informed conversation with your doctor.
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