Generic name: zanubrutinib (ZAN ue BROO ti nib)
Brand name: Brukinsa
Drug class: BTK inhibitors
Brukinsa (zanubrutinib) is used to treat mantle cell lymphoma in adults who have received at least one prior treatment for this condition.
Brukinsa was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.
It is not known if Brukinsa is safe and effective in children.
Warnings
Using Brukinsa may increase your risk of developing other cancers, such as skin cancer. Ask your doctor about this risk and what skin symptoms to watch for. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Tell your doctor if you have ever had liver disease.
You may need to have a negative pregnancy test before you start using Brukinsa.
Before taking this medicine
Before you start treatment with 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. Zanubrutinib can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with this medicine.
- Females should not become pregnant during treatment and for at least 1 week after the last dose. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose.
- Males should avoid getting female partners pregnant during treatment and for at least 1 week after the last dose of Brukinsa. You should use effective birth control (contraception) during treatment and for at least 1 week after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if zanubrutinib passes into your breast milk. Do not breastfeed during treatment with Brukinsa and for at least 2 weeks after your last dose.
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 zanubrutinib works and can cause side effects.
How should I take Brukinsa?
Take Brukinsa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take this medicine with a full glass of water.
You may take Brukinsa with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Brukinsa affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.
Store at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Lymphoma:
160 mg orally 2 times a day until disease progression or unacceptable toxicity
OR
320 mg orally once a day until disease progression or unacceptable toxicity
Use: For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
What happens if I miss a dose?
Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Brukinsa side effects
Get emergency medical help if you have signs of an allergic reaction to Brukinsa: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Zanubrutinib can cause serious or life-threatening side effects. Call your doctor at once if you have:
- pounding heartbeats or fluttering in your chest;
- chest discomfort;
- a light-headed feeling, like you might pass out;
- liver problems - right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;
- low platelets in your blood - easy bruising, unusual bleeding, purple or red spots under your skin;
- low red blood cells - pale skin, weakness, unusual tiredness, feeling light-headed or short of breath, cold hands and feet, fast or irregular heartbeat;
- low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
- signs of bleeding inside your body - red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds, severe headache, vision problems, numbness or weakness on one side, trouble speaking or understanding what is said to you; or
- signs of infection - fever, chills, redness or swelling, cough with mucus, feeling short of breath.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common Brukinsa side effects may include:
- diarrhea;
- low platelet or other blood cell counts;
- easy bruising or bleeding;
- rash; or
- cold symptoms such as stuffy nose, sneezing, sore throat or cough.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Brukinsa?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may interact with zanubrutinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.