CLEARLY BRUKINSA to help you take
control of your FL

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 follicular lymphoma (FL) treatment?

FL is caused by the rapid growth and spread of cancerous B cells.

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

How well does BRUKINSA work?

BRUKINSA was shown to be effective with obinutuzumab in the ROSEWOOD study. Obinutuzumab is a type of treatment called a monoclonal antibody (mAB) that is used to treat different types of lymphomas. The aim of the study was to see if BRUKINSA + obinutuzumab was more effective than obinutuzumab alone.

The study included 217 patients with FL who had received at least 2 prior treatments. In the ROSEWOOD study, different types of responses were studied. Overall response rate (ORR), or the percentage of patients in which treatment is working, was the main purpose of the study. Additional responses studied were duration of response (DOR), or the amount of time before treatment stopped working, and progression-free survival (PFS), or the length of time which patients lived without their disease worsening.

BRUKINSA is the first and only BTK inhibitor approved for the treatment of FL

In the ROSEWOOD study, significantly more patients were proven to respond to BRUKINSA + obinutuzumab than obinutuzumab alone.

OVERALL RESPONSE RATE

At 20 months, more patients taking BRUKINSA + obinutuzumab saw an improvement* in their FL compared to patients taking obinutuzumab alone

Overall response rate data for patients taking BRUKINSA® (zanubrutinib) + obinutuzumab vs obinutuzumab alone

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

DURATION OF RESPONSE

At 18 months, treatment continued working for more patients taking BRUKINSA + obinutuzumab than obinutuzumab alone

Duration of response data for patients taking BRUKINSA® (zanubrutinib) + obinutuzumab vs obinutuzumab alone
PROGRESSION-FREE SURVIVAL

The amount of time in which the median, or 50% of patients in each treatment group, continued to see no worsening of their FL

Progression-free survival data for patients taking BRUKINSA® (zanubrutinib) + obinutuzumab vs obinutuzumab alone

This suggests that the combination of BRUKINSA + obinutuzumab may delay worsening of FL by as much as 18 months.

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

Individual results may vary.

Side effects for BRUKINSA + obinutuzumab were similar to those seen for BRUKINSA and obinutuzumab separately

Patients taking BRUKINSA may experience side effects.

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 healthcare team 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. 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.

17% of patients discontinued BRUKINSA treatment due to side effects in the ROSEWOOD study.

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.

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.