What is this medicine?

ACALABRUTINIB (a kal a broo ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat mantle cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma.

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 health care provider before I take this medicine?

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

  • bleeding disorders
  • high blood pressure
  • history of irregular heartbeat
  • infection including hepatitis B virus infection
  • liver disease
  • recent surgery
  • take medicines that treat or prevent blood clots
  • an unusual or allergic reaction to acalabrutinib, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush or chew this medicine. Do not take with grapefruit juice. Avoid taking H2-blockers and antacids within 2 hours of taking this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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. If your next dose is to be taken in less than 9 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

  • antiviral medications for HIV or AIDS
  • aprepitant
  • boceprevir
  • calcium channel blockers like diltiazem and verapamil
  • certain antibiotics like clarithromycin, erythromycin, and troleandomycin
  • certain medicines for fungal infections like fluconazole, ketoconazole, itraconazole, posaconazole, and voriconazole
  • certain medicines for seizures like carbamazepine and phenytoin
  • certain medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole
  • ciprofloxacin
  • clotrimazole
  • conivaptan
  • crizotinib
  • cyclosporine
  • dronedarone
  • enzalutamide
  • fluvoxamine
  • grapefruit juice
  • idelalisib
  • imatinib
  • methotrexate
  • mitotane
  • nefazodone
  • rifampin
  • 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 medicine?

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

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

If you are going to have surgery or any other procedures, tell your doctor you are taking this medicine. Tell your dentist and dental surgeon that you are taking this medicine. You should not have major dental surgery while on this medicine. See your dentist to have a dental exam and fix any dental problems before starting this medicine.

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.

Do not become pregnant while taking this medicine or for at least 1 week after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
  • signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls
  • signs or symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose; confusion; trouble speaking or understanding; severe headaches; weakness; or dizziness
  • signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
  • signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

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

  • constipation
  • diarrhea
  • headache
  • muscle aches
  • stomach pain
  • tiredness

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 medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

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.

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