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VENCLEXTA is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is not known if VENCLEXTA is safe and effective in children.
Please see Important Safety Information throughout this video.
Please see full Prescribing Information, including Medication Guide, on www.VENCLEXTA.com or at www.rxabbvie.com/pdf/venclexta.pdf
CINDY: I’m Cindy. I live in North Carolina on a horse farm with my wife, Pamela.
CINDY: I started CLL treatment with VENCLEXTA on August 13th of 2020 and my last pill was July 17th, 2021.
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CINDY
Completed VENCLEXTA
in 2021
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TIME-OFF TALKS
LORI: I was diagnosed in October of `21. When you were deciding about treatment, how difficult was that choice for you? Any advice you would give someone like me?
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LORI
Diagnosed 2021
Waiting for first treatment
CINDY: I researched my treatment options. When the doctor said, “It’s time for treatment,” it came down to VENCLEXTA and obinutuzumab. The time-limited treatment was a big plus to me.
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TIME-LIMITED TREATMENT
CINDY: One year treatment and done.
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For previously untreated CLL, VENCLEXTA + GAZYVA® (obinutuzumab) is designed to be completed in 12 months.
LORI: I’ve heard VENCLEXTA defined in different ways. What’s your understanding of what it does?
CINDY: My understanding of CLL is that the CLL cells just keep growing and growing and growing, and cause problems.
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In a clinical trial with a 28-month median follow-up, 13% of patients on VENCLEXTA + GAZYVA had disease progression or died vs 37% of patients on chemoimmunotherapy. More than half were progression-free and treatment-free after 5 years.
CINDY: And VENCLEXTA may allow those cells to die to the point that they’re undetectable by the tests they have, and that’s a wonderful place to be.
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After completing VENCLEXTA treatment, 76% of people had such a low level of CLL cells in their blood (fewer than 1 cancer cell per 10,000 white blood cells) that the cells were not detectable using a sensitive clinical test. This is known as undetectable minimal residual disease (MRD) or MRD negativity.
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Please take note that undetectable MRD or MRD negativity does not necessarily equal successful treatment due to limitations with MRD testing.
LORI: From the time that your doctor said it was time to start treatment, what was the regimen like?
CINDY: In the first month there were obinutuzumab infusions once a week and then after that it’s once a month. For the VENCLEXTA pills they have a little pack they give you that’s week 1, week 2, week 3.
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VENCLEXTA + GAZYVA IS DESIGNED TO BE COMPLETED
IN 12 MONTHS FOR PREVIOUSLY UNTREATED CLL/SLL
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GAZYVA® (obinutuzumab), an antibody infusion therapy, is started first and is given during the first 6 cycles of treatment. VENCLEXTA is a pill that’s taken once a day with a meal and water. In week 4, your doctor will start VENCLEXTA at a low dose and then slowly increase the dose over the following 5 weeks up to the full dose.
CINDY: It was twelve 28-day cycles, which is between 11 and 12 months.
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Your doctor may tell you to take VENCLEXTA differently than described here. Take VENCLEXTA exactly as prescribed. Do not start taking VENCLEXTA until you have reviewed the specific instructions with your doctor. You may be directed to take your first dose and any increase in your dose in your doctor’s office or at the hospital.
LORI: We often hear about side effects. What was your experience?
CINDY: One serious side effect that people may experience with VENCLEXTA is tumor lysis syndrome. My doctor put me on allopurinol before I started the obinutuzumab infusions to help my body to deal with getting rid of all those CLL cells.
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VENCLEXTA can cause serious side effects, including tumor lysis syndrome, low white blood cell counts, and infections. These are not all of the possible side effects of VENCLEXTA. Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA.
CINDY: Drinking lots of water was important because all those CLL cells were in your blood and needed to be washed out. So, that all helped.
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The most common side effects of VENCLEXTA + GAZYVA include low white blood cell counts, low red blood cell counts, diarrhea, nausea, upper respiratory tract infections, and tiredness.
LORI: And you were able to get off VENCLEXTA without any transition phase?
CINDY: Right. I asked, “Oh, do we wean this off like we ramped up?” And they said, “Nope, you’re just done on that last pill.” When I took that last pill—that was very liberating.
LORI: How do you feel now about the possibility of the future and potentially needing more treatments?
CINDY: I know I still have CLL cells and they will come back someday, but they hoped after you complete treatment that you will have several years off treatment.
LORI: And here you are 3 years later.
CINDY: Yeah.
LORI: Were there certain things that you really looked forward to as you were moving forward? And did you do those things?
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After completing her VENCLEXTA regimen, Cindy was treatment-free for 3.5 years.
VENCLEXTA is not a cure. Individual results may vary. You will need to continue to work with your healthcare team.
CINDY: About 10 months into treatment, Pam and I decided things were going so well—we decided to get married.
CINDY: I’m living in the present and when that next step comes along, we’ll be ready to deal with that. But right now, I’m just living for the moment.
LORI: That’s what we want.
CINDY: That’s what we want.
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After completing her VENCLEXTA regimen, Cindy was treatment-free for 3.5 years.
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IMPORTANT SAFETY INFORMATION
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Important Safety Information
What is the most important information I should know about VENCLEXTA?
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.
Who should not take VENCLEXTA?
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.
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 or 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. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should 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 with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?
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.
What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Low white blood cell counts (neutropenia). 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 and may pause dosing.
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 have a 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.
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 www.fda.gov/medwatch or call 1-800-FDA-1088.
If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.
Please see full Prescribing Information, including Medication Guide, on www.VENCLEXTA.com or at www.rxabbvie.com/pdf/venclexta.pdf
US-VENC-240056
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VENCLEXTA + GAZYVA is designed to be completed in 12 months.
Ask your doctor is it’s right for you.
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