CLEARLY BRUKINSA to help you take control of your CLL/SLL

BRUKINSA is a BTK inhibitor that was designed to block BTK

  • BRUKINSA has been shown to block 100% of BTK in blood cells and 94% to 100% of BTK in lymph nodes when taken at the recommended total daily dose of 320 mg. The significance of blocking up to 100% of BTK on treatment responses has not been established

Why is a BTK inhibitor important for CLL/SLL treatment?

  • Bruton’s tyrosine kinase (BTK) is a protein that signals within cancerous B cells (like those that cause CLL or SLL), helping them to grow and spread
  • Blocking BTK can help stop this signaling

In 2 trials directly comparing BRUKINSA to other approved CLL/SLL treatment options, significantly more patients taking BRUKINSA achieved better results

BRUKINSA is the only BTKi proven to be superior to both another BTKi and to chemotherapy

In the BRUKINSA trials, 2 types of responses were studied. Progression-free survival (PFS), or the amount of time patients live without their disease worsening, was 1 response and the main purpose of this study. The other response, and a secondary purpose of this study, was overall response rate (ORR), or the percentage of patients in which treatment is working.

Talking to your doctor about these responses can help you find the treatment option that may be right for you.

In a trial comparing BRUKINSA to a combination therapy known as BR, more patients taking BRUKINSA continued responding to treatment with no sign of CLL/SLL worsening

The trial included 589 patients who had never received treatment for their CLL/SLL. 479 patients in the trial who did not have a genetic mutation known as del(17p) received either BRUKINSA or BR, which is a combination of bendamustine (a type of chemotherapy) and rituximab (a targeted therapy). There were also 110 patients with the del(17p) mutation who received BRUKINSA in a separate treatment arm.

PROGRESSION-FREE SURVIVAL

At 2 years, more patients taking BRUKINSA continued responding to treatment with no sign of their CLL/SLL worsening

PFS data for patients taking BRUKINSA® (zanubrutinib) vs BR

Patients with the del(17p) mutation responded to treatment with BRUKINSA

Certain people with CLL/SLL have a genetic mutation called del(17p). Because these patients don’t usually respond well to chemoimmunotherapy, they were studied separately to see how they’d respond to just BRUKINSA.

2-Year Progression-Free Survival: with del(17p)

89Estimated
(110 BRUKINSA patients)

Individual results may vary.

OVERALL RESPONSE RATE

At 2 years, more patients taking BRUKINSA saw an improvement* in their CLL/SLL when compared to those taking BR

ORR data for patients taking BRUKINSA® (zanubrutinib) vs BR

*When patients improved, tests showed that their cancer got smaller in size and did not spread.

Fewer patients stopped treatment with BRUKINSA
because of side effects than those taking BR

8% of patients stopped treatment with BRUKINSA for side effects vs 14% with BR

Patients who took BRUKINSA reported low rates of
atrial fibrillation or flutter (an irregular or rapid heart rhythm)

3.3% of patients who took BRUKINSA reported low rates of afib or flutter vs 2.6% with BR

More patients taking BRUKINSA continued to live without their CLL/SLL worsening than those taking BR

In the BRUKINSA trials, 2 types of responses were studied. Overall response rate (ORR), or the percentage of patients in which treatment is working, was the main purpose of this study. The other response and a secondary purpose of this study was progression-free survival (PFS), or the amount of time patients live without their disease worsening.

Talking to your doctor about these responses can help you find the treatment option that may be right for you.

In a trial comparing BRUKINSA to ibrutinib, significantly more patients responded to BRUKINSA

The trial included 652 patients who had received at least 1 prior treatment for their CLL/SLL. Patients in the trial received either BRUKINSA or ibrutinib, another BTK-targeted treatment.

OVERALL RESPONSE RATE

At 2 years, more patients taking BRUKINSA saw an improvement* in their CLL/SLL when compared to those taking ibrutinib

ORR data for patients taking BRUKINSA® (zanubrutinib) vs ibrutinib

*When patients improved, tests showed that their cancer got smaller in size and did not spread.

PROGRESSION-FREE SURVIVAL

At 2 years, more patients taking BRUKINSA continued responding to treatment with no sign of their CLL/SLL worsening, compared to those taking ibrutinib

PFS data for patients taking BRUKINSA® (zanubrutinib) vs ibrutinib

These results presented are consistent with, but not included in, the FDA-approved prescribing information.

Patients with the del(17p) mutation responded to treatment with BRUKINSA

2-Year Progression-Free Survival:
with del(17p)

2 year PFS with del(17p): 73% (75 BRUKINSA patients) vs 55% (75 ibrutinib patients)

These results presented are consistent with, but not included in, the FDA-approved prescribing information.

Individual results may vary.

Fewer patients stopped treatment with BRUKINSA because of side effects than those taking ibrutinib

15% with BRUKINSA vs 22% with ibrutinib

Fewer patients reported atrial fibrillation or flutter (an irregular or rapid heart rhythm) with BRUKINSA than those taking ibrutinib

5% with BRUKINSA vs 13% with ibrutinib

More patients taking BRUKINSA saw an improvement in their CLL/SLL than those taking ibrutinib

Side effects with BRUKINSA

People taking BRUKINSA may experience side effects. In a trial for previously untreated patients with CLL/SLL, 8% of patients stopped treatment due to side effects after a median treatment duration of 26.1 months. In a trial for patients who had previously received treatment for CLL/SLL, 15% stopped treatment due to side effects after a median treatment duration of 28.4 months. It’s important to remember that everyone responds to medication differently.

Speak to your doctor about side effects of concern. Most side effects can be managed by your doctor to help you feel better and stay on treatment. Be sure to tell your doctor right away about any new or worsening side effects.

The most common side effects of BRUKINSA include:

  • Decreased white blood cell count
  • Upper respiratory tract infection
  • Decreased platelet count
  • Bleeding
  • Muscle, bone, or joint pain

BRUKINSA may cause serious side effects, including:

  • Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
    1. blood in your stools or black stools (looks like tar)
    2. pink or brown urine
    3. unexpected bleeding, or bleeding that is severe or you cannot control
    4. vomit blood or vomit that looks like coffee grounds
    5. cough up blood or blood clots
    6. increased bruising
    7. dizziness
    8. weakness
    9. confusion
    10. change in speech
    11. headache that lasts a long time
  • Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
  • Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.
  • Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Use sun protection when you are outside in sunlight.
  • Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:
    1. your heartbeat is fast or irregular
    2. feel lightheaded or dizzy
    3. pass out (faint)
    4. shortness of breath
    5. chest discomfort
  • Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with BRUKINSA. Your healthcare provider will do blood tests to check your liver before and during treatment with BRUKINSA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If side effects occur, partnering with your doctor can help you manage any symptoms you may experience and may help ensure you can continue treatment with BRUKINSA.

You will continue to take BRUKINSA for as long as your doctor thinks it is helping you, or for as long as side effects are manageable.

IMPORTANT SAFETY INFORMATION

What should I tell my healthcare provider before taking BRUKINSA?

Before taking BRUKINSA, tell your healthcare provider about all of your medical conditions, including if you:

  • have bleeding problems.
  • have had recent surgery or plan to have surgery. Your healthcare provider may stop BRUKINSA for any planned medical, surgical, or dental procedure.
  • have an infection.
  • have or had heart rhythm problems.
  • have high blood pressure.
  • have liver problems, including a history of hepatitis B virus (HBV) infection.
  • are pregnant or plan to become pregnant. BRUKINSA can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with BRUKINSA.
    1. Females should avoid getting pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
    2. Males should avoid getting female partners pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
  • are breastfeeding or plan to breastfeed. It is not known if BRUKINSA passes into your breast milk. Do not breastfeed during treatment with BRUKINSA and for 2 weeks after the last dose of BRUKINSA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.

What are the possible side effects of BRUKINSA?

BRUKINSA may cause serious side effects, including:

  • Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
    1. blood in your stools or black stools (looks like tar)
    2. pink or brown urine
    3. unexpected bleeding, or bleeding that is severe or you cannot control
    4. vomit blood or vomit that looks like coffee grounds
    5. cough up blood or blood clots
    6. increased bruising
    7. dizziness
    8. weakness
    9. confusion
    10. change in speech
    11. headache that lasts a long time
  • Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
  • Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.
  • Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with BRUKINSA. Use sun protection when you are outside in sunlight.
  • Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:
    1. your heartbeat is fast or irregular
    2. feel lightheaded or dizzy
    3. pass out (faint)
    4. shortness of breath
    5. chest discomfort
  • Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with BRUKINSA. Your healthcare provider will do blood tests to check your liver before and during treatment with BRUKINSA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

The most common side effects of BRUKINSA include:

  • decreased white blood cell count
  • decreased platelet count
  • upper respiratory tract infection
  • bleeding
  • muscle, bone, or joint pain

These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is BRUKINSA?

BRUKINSA is a prescription medicine used to treat adults with:

  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Waldenström’s macroglobulinemia (WM).
  • Mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.
  • Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of treatment.
  • Follicular lymphoma (FL), in combination with the medicine obinutuzumab, when the disease has come back or did not respond to treatment and who have received at least two prior treatments.

It is not known if BRUKINSA is safe and effective in children.

Please see full Prescribing Information including Patient Information.