What is the most important information I should know about zanubrutinib?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
What is zanubrutinib?
Zanubrutinib is used to treat mantle cell lymphoma in adults who have received at least one prior treatment for this condition.
Zanubrutinib 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.
Zanubrutinib may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking zanubrutinib?
Tell your doctor if you have ever had liver disease.
Using zanubrutinib 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.
You may need to have a negative pregnancy test before you start using zanubrutinib.
Both men and women using this medicine should use effective birth control to prevent pregnancy. Zanubrutinib can harm an unborn baby if the mother or father is using this medicine. Keep using birth control for at least 1 week after your last dose.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using zanubrutinib.
Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.
How should I take zanubrutinib?
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 zanubrutinib with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Zanubrutinib 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.
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 should I avoid while taking zanubrutinib?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of zanubrutinib?
Get emergency medical help if you have signs of an allergic reaction: 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 side effects may include:
- 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 zanubrutinib?
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 affect 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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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