Acalabrutinib is used to treat mantle cell lymphoma in adults who have received at least one prior treatment for this condition.

Acalabrutinib is also used to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Acalabrutinib may also be used for purposes not listed in this medication guide.

You may get infections or bleed more easily. Call your doctor if you have unusual bleeding or signs of infection (fever, cough, skin sores, painful urination).

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Take the medicine exactly as directed.

Do not switch brand forms without your doctor's advice.

Acalabrutinib is usually taken twice per day (about 12 hours apart) with or without food, with a glass of water.

Swallow the medicine whole and do not crush, chew, break, or dissolve it.

If you need surgery, tell the surgeon ahead of time that you are using acalabrutinib. You may need to stop using the medicine for a short time.

While using acalabrutinib, you may need frequent blood tests.

If you've had hepatitis B, it may come back. You may need liver function tests while using this medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Lymphoma:

100 mg orally every 12 hours

Comments:
-Start treatment at cycle 1 (each cycle is 28 days) when use concomitantly with obinutuzumab.
-Start obinutuzumab at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing; administer this drug prior to obinutuzumab when given on the same day.
-Treatment should be continued until disease progression or unacceptable toxicity.

Use:
-As monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
-As monotherapy or in combination with obinutuzumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Tell your doctor if you have or have ever had:

• an active or chronic infection, including hepatitis B;

• a heart rhythm disorder;

• bleeding problems;

• recent surgery or plan to have surgery, medical or dental procedure; or

• liver disease.

Taking acalabrutinib may increase your risk of developing other cancers. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

May cause birth defects. Do not use if you are pregnant. You must use effective birth control while using acalabrutinib and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using acalabrutinib, and for at least 2 weeks after your last dose.

Take the medicine as soon as you can, but skip the missed dose if you are more than 3 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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.

Avoid taking an antacid such as Tums or calcium carbonate within 2 hours before or after you take acalabrutinib.

Acalabrutinib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Acalabrutinib may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Acalabrutinib may cause serious side effects. Call your doctor at once if you have:

• unusual bleeding--nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;

• bleeding inside your body--weakness, dizziness, confusion; problems with speech, prolonged headache, bloody or tarry stools, pink or brown urine; coughing up blood or vomit that looks like coffee grounds;

• heart rhythm disorders--dizziness, chest pain, shortness of breath, fast or irregular heart rate, feeling light-headed;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of infection--fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of acalabrutinib may include:

• bruising;

• headache, feeling tired;

• muscle or joint pain;

• low blood cell counts;

• diarrhea; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

If you use a stomach acid reducer such as cimetidine, ranitidine, Tagamet, Pepcid, or Zantac, take acalabrutinib dose 2 hours before taking any of these other medicines.

Tell your doctor about all your current medicines. Many drugs can affect acalabrutinib, especially:

• a blood thinner (warfarin, Coumadin, Jantoven);

• an antibiotic or antifungal medicine (itraconazole, fluconazole, erythromycin, rifampin);

• antiviral medicine to treat hepatitis C or HIV/AIDS;

• heart medication (diltiazem) ; or

• a proton pump inhibitor stomach acid medicine--such as omeprazole, lansoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs may affect acalabrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.