Previously Untreated CLL/SLL

VENCLEXTA + GAZYVA®
(OBINUTUZUMAB)
OFFERS A CHANCE
FOR A TREATMENT-FREE
PERIOD AFTER 12 MONTHS

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VENCLEXTA + GAZYVA was studied in a clinical trial

A significantly lowered chance of disease progression or death

In a clinical study of 432 people who had not been treated for CLL, VENCLEXTA was studied with an antibody treatment called GAZYVA. This regimen is not a chemotherapy and was studied against a commonly used chemotherapy-containing regimen. Half of the patients (216) received VENCLEXTA + GAZYVA and the other half received the chemotherapy-containing regimen (chlorambucil and GAZYVA). The VENCLEXTA-containing regimen was proven to be more effective than the chemotherapy-containing regimen.

The chance of disease worsening or death was 67% lower with the VENCLEXTA regimen (216 people) than with the chemotherapy-containing regimen (216 people). Doctors generally call this progression-free survival or PFS.

Please take note that the median PFS was not reached for either regimen in the study. This was based on median follow-up of 28 months. A definition of median is the “middle” value of a sorted list of numbers. The study was not yet able to determine the median* time that patients lived without their disease worsening because more than half of patients were both alive and had not yet experienced a worsening of their disease.

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 click here for additional Important Safety Information.

*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers [1, 5, 6, 8, 9], 6 is the median.

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Download helpful questions to discuss with your doctor about VENCLEXTA treatment

Individual results may vary

Individual results may vary

  

Remission defined

Remission means that the signs of cancer have lessened or are no longer detectable, although cancer may still be in the body.

Complete remission means that all signs and symptoms of cancer have disappeared for a period of time, but cancer may still be in the body.

Complete remission with incomplete marrow recovery means that most signs and symptoms of cancer disappeared for a period of time except that platelet, white blood cell, or red blood cell counts remained low.

Partial remission means that there are still signs of cancer, but your treatment regimen is working because the number of cancer cells in your body has greatly decreased.

Remission with the confidence to stop treatment

The remission rates people in the clinical trial experienced are:

  • 85% of people achieved some level of remission (183 of 216 people) with VENCLEXTA + GAZYVA compared to 71% (154 of 216 people) of people with chlorambucil and GAZYVA
  • 50% of people achieved complete remission or complete remission without incomplete marrow recovery (107 of 216 people) with VENCLEXTA + GAZYVA compared to 23% (50 of 216 people) with chlorambucil and GAZYVA
  • 35% of people achieved a partial remission (76 of 216 people) with VENCLEXTA + GAZYVA compared to 48% (104 of 216 people) of people with chlorambucil and GAZYVA

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You can be free of detectable disease in your blood

After completing VENCLEXTA treatment, some people had such a low level of CLL cells (fewer than 1 cancer cell per 10,000 white blood cells) that the cells were not detectable using sensitive clinical tests. This is known as undetectable minimal residual disease (MRD) or MRD negativity.

  • 76% of people (163 of 216) had no detectable cancer in their blood 3 months after treatment with VENCLEXTA + GAZYVA compared to 35% of people (76 of 216) had no detectable cancer in their blood 3 months after treatment with VENCLEXTA + GAZYVA

Please take note that undetectable MRD or MRD negativity does not necessarily equal successful treatment due to limitations with MRD testing. For instance, it is possible for patients to have a partial response to treatment while still testing as MRD negative and patients can have a complete response and be MRD positive.

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PATIENT BROCHURE

Get more information about treatment with VENCLEXTA

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Learn more about how VENCLEXTA can help

In a clinical study of 432 people who had not been treated for CLL, VENCLEXTA was studied with an antibody treatment called GAZYVA. This regimen is not a chemotherapy and was studied against a commonly used chemotherapy containing regimen. Half of the patients (216) received VENCLEXTA + GAZYVA and the other half received the chemotherapy containing regimen (chlorambucil and GAZYVA). The VENCLEXTA containing regimen was proven to be more effective than the chemotherapy containing regimen.

The chance of disease worsening or death was 67% lower with the VENCLEXTA regimen (216 people) than with the chemotherapy containing regimen (216 people). Doctors generally call this progression free survival or PFS.

Please take note that the median PFS was not reached for either regimen in the study. A definition of median is the “middle” value of a sorted list of numbers. The study was not yet able to determine the median* time that patients lived without their disease worsening because more that half of patients were both alive and had not yet experienced a worsening of their disease. Click here to learn about possible side effects of VENCLEXTA.

*Median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers [1,5,6,8,9}, 6 is the median.

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.

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.

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.
  • 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 negative 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-VENC-190384

Please see full 

, including 

.

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

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.

Use

VENCLEXTA is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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

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.

Use

VENCLEXTA is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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.

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.

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.
  • 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 negative 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-VENC-190384