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VENCLEXTA is a pill that you take once a day. Your healthcare provider may prescribe VENCLEXTA with GAZYVA, an antibody infusion therapy.
You will start taking VENCLEXTA at a low dose and gradually build up to a higher dose—this is known as a “ramp-up” period. This dose ramp-up is designed to gradually destroy your cancer cells and may help reduce your risk of tumor lysis syndrome (TLS).
Your healthcare provider may tell you to take VENCLEXTA differently than described here. Take VENCLEXTA exactly as prescribed by your healthcare provider. Do not start taking VENCLEXTA until you have reviewed the specific instructions with your healthcare provider. You may be directed to take your first dose and any increase in dose in your healthcare provider’s office or at the hospital.
How should VENCLEXTA be taken?
What is the most important information to know about VENCLEXTA?
See important information about getting started with VENCLEXTA.
Weeks 1-3: In the first month, you will receive GAZYVA on the first day of weeks 1-3; however, your very first dose of GAZYVA will be split over days 1 and 2.
Week 4: After the first 3 weeks of GAZYVA treatment, you will start taking VENCLEXTA once a day at a low dose and gradually build up to a higher dose—this is known as a ramp-up period.
Throughout the second month, you will gradually build up to a higher dose of VENCLEXTA and receive GAZYVA once during the month.
You will receive GAZYVA once per month, on the first day of the month and continue to take VENCLEXTA once daily for months 2-6.
You will continue to take VENCLEXTA once daily until the end of the 12-month treatment period. VENCLEXTA should be taken at the recommended daily dose as prescribed until your healthcare provider tells you to stop taking VENCLEXTA or changes your dose.
It is not known if VENCLEXTA is safe and effective in children.
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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 treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have 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, or 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 have side effects. 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.
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.
VENCLEXTA can cause serious side effects, including:
Tell your healthcare provider right away if you have 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 counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.
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 side effects of prescription drugs to the FDA. Visit
or call 1-800-FDA-1088.
If you cannot afford your medication, contact
for assistance.
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