Acalabrutinib

What is acalabrutinib used for?

• Acalabrutinib is used to treat types of leukemia and lymphoma.

Before taking acalabrutinib, tell your doctor:

• If you are allergic to acalabrutinib; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with acalabrutinib, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with acalabrutinib.
• If you are breast-feeding. Do not breast-feed while you take acalabrutinib and for 2 weeks after your last dose.

This is not a list of all drugs or health problems that interact with acalabrutinib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take acalabrutinib with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take acalabrutinib?

• Tell all of your health care providers that you take acalabrutinib. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If acalabrutinib is stopped, your doctor will tell you when to start taking acalabrutinib again after your surgery or procedure.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. Rarely, some bleeding problems have been deadly.
• This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
• The chance of skin cancer may be raised. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with acalabrutinib. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
• If you have had hepatitis B before or carry the virus, talk with your doctor. This medicine can cause the virus to become active again.
• If you are 65 or older, use acalabrutinib with care. You could have more side effects.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start acalabrutinib to show that you are NOT pregnant.
• This medicine may also cause problems during childbirth.
• Women must use birth control while taking acalabrutinib and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

How is acalabrutinib best taken?

Use acalabrutinib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take with a full glass of water.
• Swallow whole. Do not chew, open, or crush.
• Keep taking acalabrutinib as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take antacids within 2 hours before or 2 hours after taking acalabrutinib.
• If you also take cimetidine, famotidine, nizatidine, or ranitidine, take it at least 2 hours after you take acalabrutinib.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it has been more than 3 hours since the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of acalabrutinib that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Dizziness or passing out.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• Shortness of breath.
• Change in color or size of a mole.
• A skin lump or growth.

What are some other side effects of acalabrutinib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling tired or weak.
• Back, bone, joint, muscle, or neck pain.
• Stomach pain.
• Signs of a common cold.
• Constipation, diarrhea, throwing up, and upset stomach are common with acalabrutinib. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out acalabrutinib?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about acalabrutinib, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take acalabrutinib or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to acalabrutinib. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.