Acalabrutinib

Acalabrutinib is used to treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) who have already been treated with at least one other chemotherapy medication. It is also used alone or with obinutuzumab (Gazyva) to treat chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL: a type of cancer that begins in the white blood cells). Acalabrutinib 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.

Acalabrutinib comes as a capsule to take by mouth. It is usually taken with or without food every 12 hours (twice a day) for as long as your doctor recommends that you receive treatment. Take acalabrutinib at around the same times 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 acalabrutinib 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 break them.

Your doctor may temporarily or permanently stop your treatment or decrease your dose of acalabrutinib depending on the side effects that you experience. Be sure to talk to your doctor about how you are feeling during your treatment. Do not stop taking acalabrutinib 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 acalabrutinib,

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

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulant medications ('blood thinners') such as warfarin (Coumadin); antiplatelet medications ('blood thinners') such as aspirin, cilostazol, clopidogrel (Plavix), dipyridamole (Persantine, in Aggrenox), prasugrel (Effient), ticagrelor (Brilinta), and ticlodipine; diltiazem (Cardizem, Cartia, Diltzac, others); erythromycin (E.E.S., Eryc, Erythrocin, others); fluconazole (Diflucan); itraconazole (Onmel, Sporanox); proton pump inhibitors such as dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, in Yosprala, Zegerid), pantoprazole (Protonix), and rabeprazole (Aciphex); and rifampin (Rifadin, Rimactane, in Rifater, Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with acalabrutinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• if you are taking cimetidine (Tagamet), famotidine (Pepcid, in Duexis), nizatidine (Axid), or ranitidine (Zantac) take acalabrutinib at least 2 hours before taking these medications.

• if you are taking antacids (Maalox, Mylanta, Tums, others) take acalabrutinib at least 2 hours before or after taking these medications.

• tell your doctor if you have an infection or have had surgery recently, or if you have or have ever had liver disease including hepatitis B, problems with your heart rhythm, or bleeding problems.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking acalabrutinib. You should not start taking acalabrutinib until a pregnancy test has shown that you are not pregnant and you should use birth control to prevent pregnancy during your treatment and for at least 1 week after your final dose. Acalabrutinib may harm your unborn baby. If you become pregnant while taking acalabrutinib, call your doctor immediately.

• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment 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 acalabrutinib. Your doctor may tell you to stop taking acalabrutinib 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. Acalabrutinib 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.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if more than three hours have already passed since the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

  • headache

  • nausea

  • vomiting

  • constipation

  • diarrhea

  • abdominal pain

  • rash

  • light bruising or small red or purple spots on skin

  • joint or muscle pain

  • extreme tiredness

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

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

  • cough, shortness of breath, chest pain when you breathe or cough, fever

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

  • unusual or severe bleeding or bruising

  • 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

• Acalabrutinib may increase your risk of developing other cancers. Talk to your doctor about the risks of taking this medication.

• Acalabrutinib 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 will order certain lab tests to check your body's response to acalabrutinib.

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.