Now Approved as Tablets: Available Early October 2025
CLEARLY BRUKINSA
to help you take controlof your WM
- 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
Waldenström’s macroglobulinemia (WM) treatment?
WM is caused by 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
The significance of blocking up to 100% of BTK on treatment responses has not been established.
BRUKINSA’s effectiveness was assessed in a clinical trial. The aim of that study was to compare BRUKINSA with ibrutinib, another FDA-approved BTK inhibitor, to see if BRUKINSA achieved better treatment responses for people with Waldenström’s macroglobulinemia.
The trial included 201 people who were either newly diagnosed with, or who had received at least one prior treatment for, WM.
Although BRUKINSA did not achieve a better combined treatment response than ibrutinib, as both BRUKINSA and ibrutinib had a 78% combined response rate—complete response (CR) + very good partial response (VGPR) + partial response (PR)—BRUKINSA did show a higher very good partial response: 16% for BRUKINSA and 7% for ibrutinib. In addition, 95% of patients on BRUKINSA continued to respond for a year or longer and 89% of patients on ibrutinib continued to respond for a year or longer, after a median follow-up of 19.4 months.
Neither treatment had a complete response in this study.
The study included people who had been previously treated for WM and those who had not, as well as people with and without certain genetic mutations: MYD88MUT, MYD88WT, CXCR4WT, and CXCR4WHIM. In the exploratory analysis of 26 MYD88WT patients who received BRUKINSA, 50% had either a very good partial response or partial response and 27% had a very good partial response.
Results were consistent across each of these groups.
It is important to know that a response, even a very good partial response, does not mean the cancer has been cured.
| Treatment Response Category | Definition |
|---|---|
| Complete response (CR) | The disease has completely responded to treatment and there are no symptoms or signs of WM |
| Very good partial response (VGPR) | A small amount of disease can be detected, and there are no new symptoms or signs of WM |
| Partial response (PR) | The disease is still detectable, but there are no new symptoms or signs of WM |
- Decreased white blood cell count
- Upper respiratory tract infection
- Decreased platelet count
- Bleeding
- Muscle, bone, or joint pain
- 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:
- blood in your stools or black stools (looks like tar)
- pink or brown urine
- unexpected bleeding, or bleeding that is severe or you cannot control
- vomit blood or vomit that looks like coffee grounds
- cough up blood or blood clots
- increased bruising
- dizziness
- weakness
- confusion
- change in speech
- 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:
- your heartbeat is fast or irregular
- feel lightheaded or dizzy
- pass out (faint)
- shortness of breath
- 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 the 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.
| How long will I be on treatment with BRUKINSA? |
|---|
You will take BRUKINSA for as long as your doctor thinks it is helping you, or for as long as side effects are manageable. Remember, everyone responds differently to treatment, so the length of time that you take BRUKINSA could be shorter or longer. |
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.
- 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.
- 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:
- blood in your stools or black stools (looks like tar)
- pink or brown urine
- unexpected bleeding, or bleeding that is severe or you cannot control
- vomit blood or vomit that looks like coffee grounds
- cough up blood or blood clots
- increased bruising
- dizziness
- weakness
- confusion
- change in speech
- 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:
- your heartbeat is fast or irregular
- feel lightheaded or dizzy
- pass out (faint)
- shortness of breath
- 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.
