BRUKINSA is a BTK inhibitor that
was designed to completely block BTK
Why is a BTK inhibitor important for
mantle cell lymphoma (MCL) treatment?
MCL is caused by rapid growth and spread of cancerous B cells.
- Bruton’s tyrosine kinase (BTK) is a protein that signals to cancerous B cells, helping them to grow and spread
- Blocking BTK can help stop this signaling
The significance of completely blocking BTK on treatment responses has not been established.
Treatment that is complete and consistent.
How well does BRUKINSA work?
In 2 clinical studies,
118 patients with MCL received BRUKINSA
after at least 1 prior therapy. In both clinical studies:
The effectiveness of BRUKINSA may vary for different people.
What are the possible side effects of BRUKINSA?
BRUKINSA may cause serious side effects, including:
Bleeding problems (hemorrhage) that 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
- change in speech
- headache that lasts a long time
Infections that can be serious and may lead to death. Tell your healthcare provider right awayif you have fever, chills, or flu-like symptoms.
Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with BRUKINSA, but can also be severe. 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 and atrial flutter). 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
What are the most common side effects?
The most common side effects of BRUKINSA include:
Decreased white blood cells
Upper respiratory tract infection
Decreased platelet count
Muscle or joint pain
7% of patients discontinued treatment due to side effects in the trials.
Most side effects occurred during the early stages of treatment. When evaluated after about 3 years, side effects remained mostly consistent.
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.
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.
About 18 months was the median duration of treatment for patients in the clinical studies. The median marks the midpoint where half of the patients were still taking BRUKINSA, while half were no longer on treatment.
Remember, everyone responds differently to treatment, so the length of time that you take BRUKINSA could be
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