Venclexta - Jan 7 - story 1

Managing Chronic Lymphocytic Leukemia With Informed Decisions

Chronic lymphocytic leukemia (CLL) is a type of cancer that primarily affects older adults around the age of 70, impacting both the bone marrow and the blood. It is one of the most common leukemias in adults in the United States, with an estimated 23,000 new cases in 2025. CLL often develops slowly, with up to 90% of patients having no symptoms at the time of diagnosis. When symptoms do appear, they can include enlarged but painless lymph nodes, fatigue, fevers, night sweats, weight loss and abdominal pain caused by an enlarged spleen. In addition, CLL weakens the immune system, increasing the risk of infections and contributing to a higher risk of other types of cancer, including skin cancers. A CLL diagnosis is a shock to the patient and their loved ones. It is crucial for those diagnosed to work closely with their healthcare team to understand the disease, its implications, and the range of available treatment options. In addition, there are a number of disease advocacy organizations, such as the CLL Society, that offer education and peer support. Dr. Edward Ratner, an internist, geriatrician, and associate professor of medicine at the University of Minnesota, was diagnosed with CLL in January 2015. “CLL Society support group members’ stories and my personal experience taught me the importance of being well informed about self-care and CLL treatment options,” he said.

balancing observation and Treatment

For more information about CLL and VENCLEXTA, visit www.venclexta.com.

The information in this story is specific to one patient’s experience and is not a substitute for consulting your own doctor. If you have CLL, talk to your doctor about your individual symptoms and potential treatment options.

Contrary to the common belief that cancer treatment should begin immediately after diagnosis, this is rarely the case with CLL. Because CLL is a slow-growing cancer, and many people with early-stage CLL do not experience significant symptoms, doctors may recommend closely monitoring disease progression but not starting treatment immediately to avoid unnecessary side effects. The time between diagnosis and start of treatment, often many years, has been called “watch and wait,” but Dr. Ratner says it is more accurately “watch and worry” or “active surveillance,” with close monitoring by an oncologist. Blood tests at the time of diagnosis may offer guidance on how long until treatment is needed, but rate of progression for an individual is unpredictable. Over the seven years after his diagnosis, Dr. Ratner developed symptoms as his CLL progressed, which led to worsening blood test results. About a year before actually starting treatment, his oncologist recommended a chemotherapy-free treatment regimen of oral VENCLEXTA® (venetoclax) plus GAZYVA® (obinutuzumab) infusion. VENCLEXTA is a targeted medicine designed to selectively bind and inhibit the BCL-2 protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venetoclax is designed to block the BCL-2 protein and work to help restore the process of apoptosis. The combination of VENCLEXTA and GAZYVA, approved by the FDA for adults with previously untreated CLL, is taken for a fixed duration of time (12 months), unlike some other cancer medicines that are taken until unacceptable toxicity or until they are no longer effective in controlling the CLL. Dr. Ratner also mentioned that both treatment strategies may be effective for many years, but it is common for CLL to eventually return, requiring additional or new treatment. VENCLEXTA may cause serious side effects, including tumor lysis syndrome, low white blood cell counts, and infections. In the clinical trial of VENCLEXTA plus GAZYVA, the most common adverse reactions were low white blood cell count, diarrhea, fatigue, nausea, low red blood cell count and upper respiratory tract infection. 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. Individual results may vary. Learn more about the approved use and safety information for VENCLEXTA (venetoclax tablets; 10mg, 50mg, 100mg) at the end of this article. “Initially, I was apprehensive about stopping treatment after the time-limited course, but once completed, I experienced a sense of relief. The thought of no longer being bound to continuous treatment lifted a weight off my shoulders, and my mind was freed up to focus on other aspects of my life,” said Dr. Ratner. “I have been progression-free since 2023 and cherish every day I spend with family and friends and doing the activities I love.”

VENCLEXTA USE 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. 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 genentechaccess.com/patient/brands/venclexta for assistance. Please see full Prescribing Information, including Medication Guide at https://www.rxabbvie.com/pdf/venclexta.pdf.

References

1. 2. 3. 4. 5.

American Cancer Society. (2024). Key statistics for chronic lymphocytic leukemia. Accessed November 20, 2024. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html American Cancer Society (2024). What is chronic lymphocytic leukemia? Accessed November 20, 2024. https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html CLL Society. CLL symptoms. Accessed November 20, 2024. https://cllsociety.org/cll-sll-patient-education-toolkit/cll-symptoms/ Cleveland Clinic (2024). Chronic lymphocytic leukemia. Accessed November 20, 2024. https://my.clevelandclinic.org/health/diseases/6210-chronic-lymphocytic-leukemia Leukemia & Lymphoma Society. Watch and wait. Accessed November 20, 2024. https://www.lls.org/leukemia/chronic-lymphocytic-leukemia/treatment/watch-and-wait