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VENCLEXTA + decitabine was studied in 13 adults with newly diagnosed AML who were age 75 years or older, or who had other medical conditions that prevented the use of standard chemotherapy. The clinical study did not include patients on decitabine alone.
Many people achieved some level of remission with VENCLEXTA + decitabine.
VENCLEXTA may not work for everyone.
Patients in the study were followed for a median of 11 months, with a range of 0.7 month to up to 38.8 months. The median length of time spent in complete remission (CR) was 13 months and in complete remission (CR) + complete remission with partial hematologic recovery (CRh) was 13 months.
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. Talk to your healthcare provider for more information about the risks and side effects of VENCLEXTA. Please see additional important safety information below.
Median means the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers 1 to 13, 7 is the median.
Remission means a decrease in or disappearance of signs and symptoms of cancer.
CR, or complete remission, means the blood count is normal, fewer than 5% of bone marrow cells are leukemia cells, and there are no signs or symptoms of leukemia elsewhere in the body. When there is CR:
CRh, or complete remission with partial hematologic recovery, means that some remission has occurred. When there is CRh, no signs of cancer are seen, but some blood counts have not returned to normal levels.
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In the clinical study, the median time for patients to achieve some level of remission for either CR or CRh was 2 months (with a range of 0.8 to 4.2 months). Remember, VENCLEXTA works differently for everyone. The time it takes to work and how long the effects last may vary from person to person.
Median means the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers 1 to 13, 7 is the median.
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:
It is not known if VENCLEXTA is safe and effective in children.
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.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:
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:
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 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.
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