Class Name(s):

• 10:00 Antineoplastic Agents

Pronunciation:

• (a kal" a broo' ti nib)

Brand Name(s):

• Calquence^®

WHY is this medicine prescribed?

Acalabrutinib is used to treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system). It is also used 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.

HOW should this medicine be used?

Acalabrutinib comes as a tablet 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.

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 tablets whole with a glass of water; do not chew, crush, dissolve or cut them.

Your doctor may make changes in how you take 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.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking acalabrutinib,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and which symptoms you had.
• some medications should not be taken with acalabrutinib. Make sure you have discussed any medications you are currently taking or plan to take before starting acalabrutinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking acalabrutinib, please get the advice of your doctor or pharmacist.
• 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 sunlight and may increase your risk of developing skin cancer.

What SPECIAL DIETARY instructions should I follow?

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.

What should I do IF I FORGET to take a dose?

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.

What SIDE EFFECTS can this medicine cause?

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).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://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.

What should I know about STORAGE and DISPOSAL of this medication?

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).

Keep all medication out of sight and reach of children as many containers are not child resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to acalabrutinib.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2025.