Exploring Treatment Options for Patients with CLL

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Considering a Chemo-Free Future for Patients with CLL

If you turn the clock back almost 20 years, a person diagnosed with chronic lymphocytic leukemia (CLL) had one treatment option: chemotherapy as the lead treatment. Today, we are in an era where a range of targeted therapies have impacted the treatment landscape and made it possible for a chemotherapy-free treatment plan for patients.i,ii

Targeted treatments are designed to target and block certain proteins in the body that may attribute to CLL cell survival. Some patients, including elderly patients, may not tolerate chemotherapy and could benefit from targeted therapies. With many treatment options now available, physicians can incorporate broader selection criteria when deciding on a treatment plan, including considering patient preferences, to achieve the best possible treatment outcomes.

Patient Preferences in Treatment Decisions

In addition to considering a treatment option’s risks and benefits, patients and physicians can work together to personalize a treatment plan based on patient preferences and other decision criteria, including individual patient risk factors and characteristics such as age and gender.ii Financial burden, decreased adherence to therapy, treatment side effects, and the possibility of drug resistance and disease relapse can all weigh heavily on patients over time and should be considered when developing a treatment plan.iii

When considering patient preferences, it’s important to understand what treatment features matter to patients – for example, how it's administered, and whether it needs to be taken continuously. The opportunity for patients to have treatment-free periods may be a potential benefit for patients and their physicians to consider.iv

Today, there are approved therapies that offer a fixed treatment period such as VENCLEXTA® (venetoclax tablets), a prescription medicine that is used to treat adult patients with CLL or small lymphocytic leukemia (SLL). It is not known if VENCLEXTA is safe and effective in children. VENCLEXTA-based combination regimens are targeted, chemotherapy-free, fixed-duration therapies that may allow CLL patients to be free from continuous treatment.v VENCLEXTA is designed to be completed in a set amount of time – 12 months in combination with GAZYVA® (obinutuzumab) for previously untreated CLL/SLL and about 24 months in combination with rituximab for previously treated CLL/SLL.v

VENCLEXTA (venetoclax tablets) can cause serious side effects, including tumor lysis syndrome, low white blood cell count, and infections. These are not all of the possible side effects of VENCLEXTA.v Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA.

For more information on VENCLEXTA in CLL, please visit: https://www.venclexta.com.

Creating a Personalized CLL Treatment Plan

When it’s time to begin CLL treatment, patients and physicians should work together to customize a treatment plan. A first step is to align on goals of therapy based on the patient’s specific needs, preferences and the nature of their CLL. CLL treatment varies and is often unique to the individual, so understanding the potential benefits and risks of different treatment options while considering patient goals can help patients and physicians make shared decisions that may improve outcomes.vi

The full U.S. Prescribing Information, including Medication Guide, for VENCLEXTA (venetoclax tablets) can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.

Important Safety Information

What is the most important information I should know about VENCLEXTA (venetoclax tablets)?

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:

  1. have kidney or liver problems.
  2. have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
  3. have a history of high uric acid levels in your blood or gout.
  4. 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.
  5. 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.
  6. 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:

  1. 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.
  2. 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.

US-VENC-210198


i Foon KA, Hallek MJ. Changing paradigms in the treatment of chronic lymphocytic leukemia. Leukemia 24, 500-511 (2010). https://doi.org/10.1038/leu.2009.266.

ii Burger JA, O'Brien S. Evolution of CLL treatment - from chemoimmunotherapy to targeted and individualized therapy. Nat Rev Clin Oncol. 2018 Aug;15(8):510-527. doi: 10.1038/s41571-018-0037-8. PMID: 29777163.

iii Friedberg J, Williams ME. Adherence and Oral Therapies in Lymphoma and CLL. In: ; 2018.

iv Frontline CLL Treatment With Fixed-Duration Regimens. https://www.onclive.com/view/frontline-cll-treatment-with-fixed-duration-regimens

v VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc.

vi Coulter A. When should you involve patients in treatment decisions?. Br J Gen Pract. 2007;57(543):771-772.