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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.
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This is John’s CLL story. Individual results may vary.
JOHN: I’m John, 59 years old. I’m a very active person. I bike. I hunt and I fish.
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John CLL patient
JOHN: We do all the work around here. We built the place, we train the dogs, we clean the place up.
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Laura Spouse
LAURA: The nature of our business doesn’t let us have downtime. Pulling the wagon as he calls it.
JOHN: We’re a team, right?
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CLL Symptoms
JOHN: I started to develop a lot of fatigue.
LAURA: He was needing more downtime than I was.
JOHN: I’d go out and I’d have to just turn around, go back, and sit in the chair. If you can’t do life, something needs to be done.
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CLL Diagnosis
JOHN: Well my GP found this CLL with a routine checkup. He played it down. He was really vague about it. I needed to know something. I was just told I had cancer. That’s where everything kinda came to a screeching halt.
LAURA: You don’t know what to do, very scary.
JOHN: I was trying to wrap my head around a lot of this. You know, how is this going to affect me? You know, how am I going to pay for my treatment? My greatest concern, which is, of course, my wife would have to pull the wagon by herself.
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John was told his only option was chemotherapy, even though several other treatment options were available at the time.
JOHN: What I was told was is that there was only one therapy for CLL and that therapy was a chemotherapy. I didn’t really like the sound of it.
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John switched to a CLL specialist.
JOHN: I ah, got on the computer and that’s how I found Dr. Sharman.
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Jeff Sharman, MD, John’s Oncologist
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Dr. Sharman is a paid consultant for AbbVie and Genentech.
DR. SHARMAN: John had gotten to the point where he was experiencing a tremendous amount of disability, and fatigue and unable to really do a lot of the things that he was accustomed to.
JOHN: I needed to make the right first choice with treatment for me.
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CLL Treatment Choice
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Talk to your doctor to see if VENCLEXTA is right for you.
JOHN: Dr. Sharman suggested that I look into a treatment called VENCLEXTA, so I went home, and I researched it and I said VENCLEXTA is right for me.
DR. SHARMAN: John was hesitant about any treatment he would have to stay on indefinitely. And that's why we selected VENCLEXTA in combination with obinutuzumab.
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VENCLEXTA + GAZYVA® (obinutuzumab) effectively fights CLL without chemotherapy.
JOHN: VENCLEXTA is not chemotherapy. Not having to take VENCLEXTA or any drug every day is going to provide me with freedom.
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For previously untreated CLL, VENCLEXTA + GAZYVA is completed in 12 months.
DR. SHARMAN: When you take a pill every day, it's sort of like a constant reminder that you have the disease. To have a fixed-duration therapy, really to me represents freedom.
JOHN: It really appealed to me with VENCLEXTA there is an end date to treatment.
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There are no out-of-pocket costs for VENCLEXTA + GAZYVA after completing treatment at the recommended dose. You may still incur out-of-pocket costs for other treatments or tests as directed by your healthcare provider.
DR. SHARMAN: We're not only treating the disease, but we're also giving the patient a treatment that has a fixed timeframe and cost.
JOHN: I went from this place of being concerned to being hopeful.
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Treatment Efficacy
John has completed VENCLEXTA+GAZYVA treatment and is progression free.
In a clinical study of 432 people with previously untreated CLL, the primary measurement of the study showed the chance of disease worsening or death was 67% lower with VENCLEXTA+GAZYVA (216 people) than with the chemotherapy antibody regimen (216 people). The study has not yet been able to determine the median time that patients lived without their disease worsening because more than half of patients were both alive and had not yet experienced worsening of their disease. Other secondary measurements of the study include complete remissions and minimal residual disease. Complete remission means that all signs and symptoms of cancer have disappeared for a period of time, but cancer may still be in the body. Complete remission with incomplete marrow recovery means all signs and symptoms of cancer have disappeared for a period of time, except that platelet, white blood cell, or red blood cell counts remained low.
JOHN: On the bone marrow biopsy, I was told that I was clear.
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Achieving Undetectable MRD with VENCLEXTA+GAZYVA is possible.
- 50% of people (107 of 216) achieved complete remission or complete remission with incomplete marrow recovery with VENCLEXTA+GAZYVA compared to 23% (50 of 216 people) with the chemotherapy antibody regimen.
- 57% of people (123 of 216) had no detectable cancer in their bone marrow and 76% of people (163 of 216) had no detectable cancer in their blood 3 months after treatment completion compared to 17% of people (37 of 216) and 35% (76 of 216) respectively with the chemotherapy antibody regimen.
DR. SHARMAN: MRD stands for minimal residual disease, it's our ability to detect very small quantities of CLL in a patient. With John, we've done MRD testing and that testing is negative.
After completing VENCLEXTA treatment, some people had such a low level of CLL cells (fewer than 1 cancer cell per 10,000 white blood cells) that the cells were not detectable by the usual clinical tests. This is known as undetectable minimal residual disease. MRD measurements do not necessarily predict likelihood of experiencing progression-free survival, complete remission or other outcomes.
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The most common side effects of VENCLEXTA+GAZYVA were low white blood cell counts, diarrhea, tiredness, nausea, low red blood cell counts, and upper respiratory tract infection.
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Individual results may vary.
JOHN: With VENCLEXTA it's accomplished what it was supposed to do for me. I'm grateful for VENCLEXTA.
LAURA: It's an incredible gift. It's given our granddaughter a grandpa, our son has a dad.
JOHN: When you have something like this, it a makes you not want to waste a moment, yeah.
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As of April 2020, John is progression free, living his life.
JOHN: I’m looking forward to living my life to the fullest.
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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
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