Acalabrutinib Capsules

What is this medication?

ACALABRUTINIB (a KAL a BROO ti nib) treats leukemia and lymphoma. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CALQUENCE

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Having or recent surgery
• Heart disease
• High blood pressure
• Infection
• Irregular heartbeat or rhythm
• Liver disease
• Take medications that treat or prevent blood clots
• An unusual or allergic reaction to acalabrutinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. Swallow capsules whole. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication with grapefruit juice. Avoid taking H2-blockers and antacids within 2 hours of taking this medication.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 3 hours late. If it is more than 3 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

• Antacids, vitamins, or other products that contain calcium
• Certain antibiotics, such as chloramphenicol, clarithromycin, rifampin, rifapentine, telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for cancer, such as apalutamide, ceritinib, enzalutamide, idelalisib, methotrexate, mitotane, ribociclib, tucatinib
• Certain medications for fungal infections, such as fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Certain medications for stomach problems, such as cimetidine, famotidine, lansoprazole, omeprazole, pantoprazole
• Diltiazem
• Grapefruit juice
• Lonafarnib
• Lumacaftor; ivacaftor
• Metformin
• Mifepristone
• Nefazodone
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need blood work done while you are taking this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

Tell your dentist and dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen.

Do not become pregnant while taking this medication or for at least 1 week after stopping it. Talk to your care team if you or your partner wish to become pregnant or think they might be pregnant. This medication can cause serious birth defects. Do not breast-feed while taking this medication or for 2 weeks after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Fatigue
• Muscle pain
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.