Acute Myeloid Leukemia

VENCLEXTA + AZACITIDINE WAS PROVEN TO HELP SOME ADULTS WITH AML LIVE LONGER

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Learn about treatment with VENCLEXTA + azacitidine 

In a clinical study, VENCLEXTA + azacitidine was found to help some adults with AML live longer than those treated with azacitidine alone.

VENCLEXTA + azacitidine was studied in 431 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. In the study, 286 patients received VENCLEXTA + azacitidine and 145 patients received azacitidine + placebo (an inactive medication), also considered as azacitidine alone.

Median overall survival

Half of patients treated with VENCLEXTA + azacitidine were still alive at 14.7 months vs 9.6 months for those receiving treatment with azacitidine alone.

Median overal survival was 14.7 months on VENCLEXTA + azacitidine alone versus 9.6 months on azacitidine alone Median overal survival was 14.7 months on VENCLEXTA + azacitidine alone versus 9.6 months on azacitidine alone Median overal survival was 14.7 months on VENCLEXTA + azacitidine alone versus 9.6 months on azacitidine alone
The study showed that there was a 34% REDUCTION in the risk of death in patients treated with VENCLEXTA + azacitidine compared with those treated with azacitidine alone The study showed that there was a 34% REDUCTION in the risk of death in patients treated with VENCLEXTA + azacitidine compared with those treated with azacitidine alone The study showed that there was a 34% REDUCTION in the risk of death in patients treated with VENCLEXTA + azacitidine compared with those treated with azacitidine alone

VENCLEXTA may not work for everyone.

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 overall survival refers to the length of time from the start of treatment in a clinical trial that half of the patients are still alive.

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.

 

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Remission may be possible with VENCLEXTA + azacitidine

More patients treated with VENCLEXTA + azacitidine achieved remissions than with azacitidine alone.

Percentage of patients achieving complete remission (CR) and complete remission with partial hematologic recovery (CRh)

Remission rates graph showing study data for VENCLEXTA + azacitidine (37% achieved complete remission, an additional 28% achieved complete remission with partial hematologic recovery, 65% achieved some level of remission (CR+CRh))

VENCLEXTA may not work for everyone.

When treated with VENCLEXTA + azacitidine

  • 37% (105 of 286 people) achieved complete remission (CR)
  • 28% (80 of 286 people) achieved complete remission with partial hematologic recovery (CRh)
  • 65% (185 of 286 people) achieved complete remission (CR) or complete remission with partial hematologic recovery (CRh)

Percentage of patients achieving complete remission (CR) and complete remission with partial hematologic recovery (CRh)

Remission rates graph showing study data for Azacitidine alone (18% achieved complete remission, an additional 5% achieved complete remission with partial hematologic recovery, 23% achieved some level of remission (CR+CRh))

When treated with azacitidine alone

  • 18% (26 of 145 people) achieved complete remission (CR)
  • 5% (7 of 145 people) achieved complete remission with partial hematologic recovery (CRh)
  • 23% (33 of 145 people) achieved complete remission (CR) or complete remission with partial hematologic recovery (CRh)

How long does remission last?

For patients treated with VENCLEXTA + azacitidine, the median length of time spent in:

  • complete remission (CR) was 18.0 months compared to 13.4 months for patients treated with azacitidine alone
  • complete remission (CR) + complete remission with partial hematologic recovery (CRh) was 17.8 months compared to 13.9 months for patients treated with azacitidine alone

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:

  • Patients do not need to receive red blood cell transfusions
  • Patients may not need to receive platelet transfusions based on their platelet levels and no signs of bleeding

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.

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.

Side effects may occur with VENCLEXTA + azacitidine.

How long does it take for patients to respond to treatment? 

In the clinical study, the median time for patients to achieve some level of remission for either CR or CRh was 1 month (with a range of 0.6 to 14.3 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.

Remissions with VENCLEXTA + azacitidine were achieved within 1 month (range: 0.6 to 14.3 months) median length of time after starting treatment

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.

Learn more about treating AML with VENCLEXTA

Use

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.

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 

 or call 1‑800‑FDA‑1088.

If you cannot afford your medication, contact 

 for assistance.

US-VENA-200272

Please see full 

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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

Uses

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.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side

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

Uses

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.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side

Use

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.

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 

 or call 1‑800‑FDA‑1088.

If you cannot afford your medication, contact 

 for assistance.

US-VENA-200272