Pronunciation: a KAL a BROO ti nib

Brand: Calquence

What is the most important information I should know about acalabrutinib?

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).

What is acalabrutinib?

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.

What should I discuss with my healthcare provider before taking acalabrutinib?

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 this medicine, and for at least 2 weeks after your last dose.

How should I take acalabrutinib?

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.

What happens if I miss a 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.

What happens if I overdose?

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

What should I avoid while taking acalabrutinib?

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.

What are the possible side effects of acalabrutinib?

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.

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 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.

What other drugs will affect acalabrutinib?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about acalabrutinib.

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