Last year, it was estimated that nearly 20,000 people in the United States would be diagnosed with acute myeloid leukemia (AML), a very fast-progressing type of blood cancer that can be devastating if not treated quickly.1,2
How does AML start? It begins in the bone marrow – the spongy tissues inside of bones where red blood cells, white blood cells and platelets are developed. Over time, cancer cells build up in the bone marrow and eventually crowd out these normal healthy cells, causing symptoms such as fever, shortness of breath and weakness.3
While people of any age can be diagnosed with AML, the average age is 68. Some older patients with AML tend to have poorer outcomes than younger patients because often, they are not able to tolerate the intensive chemotherapy that has traditionally been a standard treatment for AML.1 For AML patients who are unable to receive intensive chemotherapy, the average survival is only five to 10 months.4
Targeted treatment options have emerged to treat AML patients that can’t tolerate intensive chemotherapy, including VENCLEXTA® (venetoclax tablets) – a prescription medicine used in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) to treat adults with newly diagnosed AML patients who are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. It is not known if VENCLEXTA is safe and effective in children.5
The FDA approval of VENCLEXTA for newly diagnosed AML patients who are 75 years or older or ineligible for intensive chemotherapy is supported by data from a series of studies including two phase 3 studies – VIALE-A and VIALE-C. Data from the VIALE-A study showed that this population lived longer following treatment with VENCLEXTA and azacitidine (286 adults) than patients treated with azacitidine plus placebo (an inactive medication), also considered azacitidine alone (145 adults). Half of patients treated with VENCLEXTA and azacitidine were still alive at 14.7 months versus 9.6 months for those receiving treatment with azacitidine alone. The study showed that there was a 34% reduction in the risk of death in patients treated with VENCLEXTA and azacitidine compared with those treated with azacitidine alone. VENCLEXTA may not work for everyone.5
In the VIALE-C study, the primary analysis of efficacy was based on overall survival at 12 months with VENCLEXTA plus LDAC. At that time, VENCLEXTA plus LDAC did not show a significant reduction in the risk of death in comparison to patients who received LDAC plus placebo.5
VENCLEXTA 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.5 Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA. Please see additional important safety information below. VENCLEXTA may not work for everyone.
VENCLEXTA is a pill that works differently than other treatments. It targets a specific protein in the body called BCL‑2, helping restore apoptosis, a process of natural cell death that is disrupted when someone has cancer. Through apoptosis, the body kills cancer cells. With fewer cancer cells in the bone marrow, there is sufficient room for healthy cells to grow in the bone marrow.6
If you or someone you know has been recently diagnosed with AML, it is important to consult with a doctor as soon as possible to develop a treatment plan. Treatment for AML varies and is often unique to the individual, and your doctor will recommend a treatment plan that is right for you.
For more information about AML and VENCLEXTA, visit https://www.venclexta.com/aml.
The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.
Uses and Important VENCLEXTA® (venetoclax) U.S. Safety Information5
VENCLEXTA is a prescription medicine used in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
• are 75 years of age or older, or
• have other medical conditions that prevent the use of standard chemotherapy.
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 at least 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 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 in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.
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. Call your doctor for medical advice about side effects.
You are encouraged to report side effects of prescription drugs to the FDA. Visit http://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.
1) National Cancer Institute, Surveillance, Epidemiology, and End Results Program. Cancer stat facts: leukemia—acute myeloid leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html. Accessed March 2021.
2) Ofran, Yishai et al. “How I treat acute myeloid leukemia presenting with preexisting comorbidities.” Blood vol. 128,4 (2016): 488-96.
3) American Cancer Society (2019). If You Have Acute Myeloid Leukemia (AML). https://www.cancer.org/cancer/acute-myeloid-leukemia/if-you-have-acute-myeloid-leukemia.html. Accessed March 2021.
4) Döhner H, Weisdorf DJ, Bloomfield CD. Acute myeloid leukemia. N Engl J Med. 2015;373(12):1136-1152.
5) VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc.
6) Plati J, Bucur O, Khosravi-Far R. Apoptotic cell signaling in cancer progression and therapy. Integr Biol (Camb). 2011;3(4):279-296.