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:
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:
In the clinical trial, 1% (3 of 212 people) treated with VENCLEXTA + GAZYVA® (obinutuzumab) and 3% (6 of 194 people) treated with VENCLEXTA + rituximab had TLS. All events of TLS resolved and did not lead to withdrawal from the study.
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 have side effects.
Low white blood cell counts are common with VENCLEXTA but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA.
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 have fever or any signs of infection during treatment with VENCLEXTA. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.
Some people may experience other side effects.
Common side effects
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|
|Upper respiratory tract infection|
|Muscle and joint pain|
|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.