Zanubrutinib

Zanubrutinib is used to treat mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) in adults who have already been treated with at least one other chemotherapy medication. Zanubrutinib is used to treat adults with Waldenstrom's macroglobulinemia (WM; a slow-growing cancer that begins in certain white blood cells in your bone marrow), It is also used to treat marginal zone lymphoma (MZL; a slow growing cancer that begins in a type of white blood cells that normally fight infection) in adults whose cancer has returned or did not respond to a certain type of medication. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Zanubrutinib comes as a capsule to take by mouth. It is usually taken once or twice daily with or without food. Take zanubrutinib at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take zanubrutinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a glass of water; do not open, chew, or crush them.

Your doctor may decrease your dose, or interrupt or discontinue your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take zanubrutinib even if you feel well. Do not stop taking zanubrutinib without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking zanubrutinib,

• tell your doctor and pharmacist if you are allergic to zanubrutinib, any other medications, or any of the ingredients in zanubrutinib capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulant medications ('blood thinners') such as warfarin (Coumadin, Jantoven); antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), or ketoconazole; aprepitant (Cinvanti, Emend); clarithromycin (Biaxin, in Prevpac); digoxin (Lanoxin); diltiazem (Cardizem, Cartia, Tiazac, others); erythromycin (E.E.S., Erythrocin, others); certain medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as efavirenz (Sustiva, in Atripla), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); nefazodone; omeprazole (Prilosec); phenobarbital; phenytoin (Dilantin, Phenytek); pioglitazone (Actos); rifampin (Rifadin, Rifamate, Rimactane, others); midazolam; and oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. John's Wort.

• tell your doctor if you have an infection or recently had surgery. Also tell your doctor if you have or have ever had hepatitis B (HBV, a virus that infects the liver and may cause severe liver damage), an irregular heartbeat, high blood pressure, bleeding problems, or heart or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. You should not become pregnant while you are taking zanubrutinib. If you are female, you will need to take a pregnancy test before you start treatment and should use birth control to prevent pregnancy during your treatment and for 1 week after your final dose. If you are male, you and your female partner should use birth control during your treatment with zanubrutinib and continue for 1 week after your final dose. If you or your partner become pregnant while taking zanubrutinib, call your doctor immediately. Zanubrutinib can cause fetal harm.

• tell your doctor if you are breast-feeding. Do not breastfeed while you are taking zanubrutinib and for 2 weeks after your final dose.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zanubrutinib. Your doctor may tell you to stop taking zanubrutinib for a period of time before and after the surgery or procedure.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Zanubrutinib may make your skin sensitive to the dangerous effects of the sunlight, and may increase your risk of developing skin cancer.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it that day and continue your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.

• Zanubrutinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • diarrhea

  • constipation

  • cough

  • muscle, joint, or back pain

  • rash

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • fever, sore throat, cough, chills, or other signs of infection

  • painful, frequent, or urgent urination

  • unusual bruising or bleeding

  • blood in your stools or black, tarry stools; pink or brown urine; vomiting blood or coffee ground vomit; coughing up blood

  • feeling dizzy, weak, or confused; changes in speech; headache that lasts a long time

  • fast or irregular heartbeat, palpitations, feeling lightheaded or dizzy, fainting, shortness of breath, chest pain

• Zanubrutinib may increase your risk of developing other cancers, including skin cancer. Talk to your doctor about the risks of taking zanubrutinib.

• Zanubrutinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to zanubrutinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.