questions - calquence

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FOR MCL MCL=mantle cell lymphoma. What is CALQUENCE? CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer. It is not known if CALQUENCE is safe and effective in children. Important Safety Information About CALQUENCE® (acalabrutinib) capsules Before taking CALQUENCE, tell your healthcare provider about all of your medical conditions, including if you: • have had recent surgery or plan to have surgery. Your healthcare provider may stop CALQUENCE for any planned medical, surgical, or dental procedure. • have bleeding problems. • have or had heart rhythm problems. • have an infection. • have or had liver problems, including hepatitis B virus (HBV) infection. • are pregnant or plan to become pregnant. CALQUENCE may harm your unborn baby and cause problems during childbirth (dystocia). o If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with CALQUENCE o Females who are able to become pregnant should use effective birth control (contraception) during treatment with CALQUENCE and for at least 1 week after the last dose of CALQUENCE • are breastfeeding or plan to breastfeed. It is not known if CALQUENCE passes into your breast milk. Do not breastfeed during treatment with CALQUENCE and for at least 2 weeks after your final dose of CALQUENCE. Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information. Fre q uentl y Asked Learn more about taking CALQUENCE for previously treated MCL QUESTIONS

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Page 1: QUESTIONS - CALQUENCE

FOR MCL

MCL=mantle cell lymphoma.

What is CALQUENCE?CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.It is not known if CALQUENCE is safe and effective in children.Important Safety Information About CALQUENCE® (acalabrutinib) capsules

Before taking CALQUENCE, tell your healthcare provider about all of your medical conditions, including if you:

• have had recent surgery or plan to have surgery. Your healthcare provider may stop CALQUENCE for any planned medical, surgical, or dental procedure.

• have bleeding problems.• have or had heart rhythm problems.• have an infection.

• have or had liver problems, including hepatitis B virus (HBV) infection.

• are pregnant or plan to become pregnant. CALQUENCE may harm your unborn baby and cause problems during childbirth (dystocia).o If you are able to become pregnant, your healthcare provider may

do a pregnancy test before you start treatment with CALQUENCEo Females who are able to become pregnant should use effective

birth control (contraception) during treatment with CALQUENCE and for at least 1 week after the last dose of CALQUENCE

• are breastfeeding or plan to breastfeed. It is not known if CALQUENCE passes into your breast milk. Do not breastfeed during treatment with CALQUENCE and for at least 2 weeks after your final dose of CALQUENCE.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

Frequently Asked

Learn more about taking CALQUENCE for previously treated MCL

QUESTIONS

Page 2: QUESTIONS - CALQUENCE

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About MCL......................................................3

What is mantle cell lymphoma (MCL)?What kind of cancer is MCL?How does MCL affect the body?What are the symptoms of MCL?Is MCL curable?What causes MCL?Is MCL rare?How is MCL diagnosed?What tests are used to diagnose MCL? What is the difference between B-cell lymphoma and mantle cell lymphoma?

About CALQUENCE.........................................6

What is CALQUENCE used for?How does CALQUENCE work?How do you take CALQUENCE?For how long do you take CALQUENCE?How quickly does CALQUENCE work?Is CALQUENCE a chemotherapy drug?What is a BTKi?Who makes CALQUENCE?

CALQUENCE Safety............................................8

Is CALQUENCE safe?What are the possible side effects of CALQUENCE?

CALQUENCE Dosing.........................................10

Why do I need to take my dose as prescribed?What should I do if I forget to take a dose?How can I better remember to take my dose as prescribed?

Support and Other Resources.............................11

How much does CALQUENCE cost?What financial assistance is available?What other support resources are available?Living with MCL sometimes makes me feel like I'm alone. Where can I find resources to help me?

Glossary...........................................................13

Important Safety Information..............................14

Click on a question below to go directly to the answer.

TableOF CONTENTS

Page 3: QUESTIONS - CALQUENCE

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Important Safety Information (Cont’d)

What is mantle cell lymphoma (MCL)?MCL is a cancer that starts in B cells—a type of white blood cell that forms in the bone marrow. MCL is named for where abnormal B cells came from in the body: the mantle zone of a lymph node. The mantle zone is located on the outer edge of a lymph node follicle.

What kind of cancer is MCL?MCL is a type of blood cancer. Most blood cancers start in the bone marrow, which is where blood is produced. Lymphoma is the most common blood cancer. Mantle cell lymphoma is one of the many types of B-cell non-Hodgkin lymphomas.

How does MCL affect the body?One of the first signs of MCL may be a swelling of the lymph nodes. These lymph nodes may be in your neck, armpit, or groin area. MCL cells can grow through lymph nodes and into nearby tissues and organs, such as the bone marrow, liver, and gastrointestinal tract. MCL cells that enter the bone marrow can crowd out normal blood cells and cause low blood cell counts (including red blood cells, white blood cells, and platelets). Other areas of the body that may be affected by MCL include the skin, the glands that produce tears, the lungs, and the central nervous system.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking CALQUENCE with certain other medications

may affect how CALQUENCE works and can cause side effects. Especially tell your healthcare provider if you take a blood thinner medicine.

AboutMCL

Click on any underlined word to link to the Glossary for its definition.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

Page 4: QUESTIONS - CALQUENCE

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What are the symptoms of MCL?Symptoms of MCL vary from person to person but may include:

• Swollen lymph nodes• Fever• Night sweats• Weight loss• Feeling very tired (fatigue)Many people with MCL may not have any symptoms for a long time.

Is MCL rare?MCL is an uncommon form of non-Hodgkin lymphoma. In the United States, MCL makes up about 6% of all non-Hodgkin lymphomas.

How is MCL diagnosed?MCL is diagnosed by looking at tissue taken from a lymph node, called a biopsy. MCL cells have common patterns of proteins. A hematopathologist (him-AT-uh-path-AHL-uh-jist), who is an expert at diagnosing cancers of blood and immune cells, will look for these patterns in the tissue sample. MCL can also be diagnosed (or ruled out) with genetic testing.

About MCL (cont'd)

What causes MCL?The exact cause of MCL is unknown. Most types of lymphoma, including MCL, are thought to be caused by damage to the DNA in the genes of a cell. Some risk factors for MCL include older age, being male, environmental factors (such as exposure to chemicals), having an autoimmune condition or suppressed immune system, being on medications that suppress the immune system, and certain genetic disorders.

Is MCL curable?The prognosis for MCL is better with response to treatment, but may not be curable.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

Click on any underlined word to link to the Glossary for its definition.

Important Safety Information (Cont’d)

How should I take CALQUENCE?

• Take CALQUENCE exactly as your healthcare provider tells you to take it.

• Do not change your dose or stop taking CALQUENCE unless your healthcare provider tells you to.

• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking CALQUENCE if you develop certain side effects.

• Take CALQUENCE 2 times a day (about 12 hours apart).• Take CALQUENCE with or without food.

• Swallow CALQUENCE capsules whole with a glass of water. Do not open, break, or chew capsules.

• If you need to take an antacid medicine, take it either 2 hours before or 2 hours after you take CALQUENCE.

• If you need to take certain other medicines called acid reducers (H2-receptor blockers), take CALQUENCE 2 hours before the acid reducer medicine.

• If you miss a dose of CALQUENCE, take it as soon as you remember. If it is more than 3 hours past your usual dosing time, skip the missed dose and take your next dose of CALQUENCE at your regularly scheduled time. Do not take an extra dose to make up for a missed dose.

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Important Safety Information (Cont’d)

What are the possible side effects of CALQUENCE?

CALQUENCE may cause serious side effects, including:

• Serious infections can happen during treatment with CALQUENCE and may lead to death. Your healthcare provider may prescribe certain

medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms.

About MCL (cont'd)

What tests are used to diagnose MCL? 1. Protein tests. To get the right diagnosis, the

hematopathologist tests for many cell proteins with a process called immunophenotyping (IM-you-noh-FEE-noh-typing). MCL has common patterns of proteins in its cells. Immunophenotyping helps confirm a diagnosis of MCL by identifying these proteins.

2. Genetic tests. Testing for abnormal changes in genetic material can be important for both diagnosis and prognosis (the expected outcome of the cancer). MCL has common abnormal changes in chromosomes and genes, such as translocations. A translocation is a switching of parts between chromosomes. In MCL, a translocation between chromosomes 11 and 14 is often found. Genetic testing for this translocation can help confirm a diagnosis of MCL. Mutations are another type of abnormal change genetic tests look for. Certain mutations are known to affect prognosis.

What is the difference between B-cell lymphoma and mantle cell lymphoma? There are many different types of B-cell lymphomas. Mantle cell lymphoma is one type of B-cell non-Hodgkin lymphoma. MCL is different from other B-cell lymphomas in the following ways:

• How the lymphoma cell looks under the microscope

• The chromosome features of the lymphoma cell:o For example, MCL can be differentiated from

other types of B-cell lymphomas because it has a translocation between chromosomes 11 and 14

• The pattern of certain proteins on the surface of the cancer cells

• How MCL is treated

Click on any underlined word to link to the Glossary for its definition.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

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AboutCALQUENCE

Important Safety Information (Cont’d)

• Bleeding problems (hemorrhage) can happen during treatment with CALQUENCE and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including blood in your stools or black stools (looks like tar), pink or brown

urine, unexpected bleeding or bleeding that is severe or you cannot control, vomit blood or vomit that looks like coffee grounds, cough up blood or blood clots, dizziness, weakness, confusion, changes in your speech, headache that lasts a long time, or bruising or red or purple skin marks

What is CALQUENCE used for?CALQUENCE is used to treat adults with a type of blood cancer called mantle cell lymphoma (MCL) who have received at least 1 prior treatment for their cancer.

How does CALQUENCE work?CALQUENCE is a type of kinase inhibitor that affects the growth of MCL cancer cells. Kinases are part of the chemical pathways within cells, some of which can start the growth of new cells. Kinase inhibitors help stop growth signals and reduce the number of new cancer cells being made.CALQUENCE works by blocking a protein called Bruton tyrosine kinase (BROO-tuhn TY-ruh-seen KY-nays), or BTK, in B cells.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

Click on any underlined word to link to the Glossary for its definition.

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About CALQUENCE (cont'd)

• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with CALQUENCE, but can also be severe. Your healthcare provider should do blood tests to check your blood counts regularly during treatment with CALQUENCE.

Important Safety Information (Cont’d)

How do you take CALQUENCE?CALQUENCE is a 100-mg capsule taken by mouth, twice a day, about every 12 hours. CALQUENCE can be taken with or without food. Swallow CALQUENCE capsules whole with a glass of water. Do not open, break, or chew capsules.It’s important to take CALQUENCE exactly as your doctor tells you to take it.Do not change your dose or stop taking CALQUENCE unless your doctor tells you to. Your doctor may tell you to decrease your dose, temporarily stop, or completely stop taking CALQUENCE if you develop certain side effects.Be sure to talk to your doctor about recommended dosing.

Is CALQUENCE a chemotherapy drug?CALQUENCE is an oral targeted therapy. Targeted therapies are different from traditional chemotherapy. CALQUENCE targets and interferes with the growth of cancer cells in a way that harms healthy cells less than chemotherapy.

What is a BTKi?BTKi stands for Bruton tyrosine kinase inhibitor. CALQUENCE is a BTKi—a targeted therapy that helps stop the growth and survival of cancer cells.

Who makes CALQUENCE?CALQUENCE is made by the pharmaceutical company AstraZeneca. AstraZeneca is a global, science-led company whose innovative medicines are used by millions of patients around the world.

For how long do you take CALQUENCE?CALQUENCE is a long-term therapy and should be taken every day. Remember that your doctor knows you and your treatment goals, which is why it’s important to take CALQUENCE exactly as prescribed.

How quickly does CALQUENCE work?CALQUENCE starts to work to block Bruton tyrosine kinase (BTK) soon after it is taken—and keeps working over the entire 12-hour dosing period. BTK is a protein found in B cells that contributes to the growth and survival of MCL cancer cells.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

Click on any underlined word to link to the Glossary for its definition.

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Is CALQUENCE safe?All medications, including over-the-counter, have a risk of side effects. You may experience side effects from taking CALQUENCE.In clinical trials that included over 1000 people with hematologic malignancies who took CALQUENCE, there were some commonly occurring side effects. Of the patients who experienced side effects, most did not have to stop taking CALQUENCE. Some people also experienced more serious side effects.

What are the possible side effects of CALQUENCE?Not everyone has the same response to CALQUENCE, but some side effects are more commonly experienced than others. The most common side effects of CALQUENCE include headache, diarrhea, muscle and joint pain, upper respiratory tract infection, and bruising.

There are also more serious side effects that can occur,* including:

• Serious infections• Bleeding problems (hemorrhage)• Decrease in blood cell counts• Second primary cancers• Heart rhythm problems (atrial fibrillation and

atrial flutter)

• Second primary cancers. New cancers have happened in people during treatment with CALQUENCE, including cancers of the skin or other organs. Your healthcare provider will check you for skin cancers during treatment with CALQUENCE. Use sun protection when you are outside in sunlight.

Important Safety Information (Cont’d)

These are not all of the possible side effects of CALQUENCE. Your doctor may need to decrease your dose, stop treatment temporarily, or take you off CALQUENCE completely if certain side effects develop.Be sure to speak up and let your healthcare provider know about any side effects you experience. There are medicines your doctor can give you that may reduce these side effects and help you feel better.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

SafetyCALQUENCE

Click on any underlined word to link to the Glossary for its definition. *See page 14 for more details.

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Important Safety Information (Cont’d)

The suggestions below are meant to help manage and ease some of the most common side effects.

• Over-the-counter medications, like acetaminophen, can be very helpful in relieving headaches

• Caffeine has been shown to help relieve headachesHeadache

• Drink clear liquids and eat smaller meals more often throughout the day

• Consult with your doctor to see if you need medication for your diarrheaDiarrhea Muscle and

bone pain

• Take the time to stretch in order to relax and ease aches

• Use over-the-counter medication like acetaminophen to help with pain

Bruising

• Ice the bruise to reduce swelling and ease tenderness

CALQUENCE Safety (cont'd)

Nausea

• Choose bland foods, such as dry toast or crackers

• Make sure not to skip meals if possible• Eating food cold or at room

temperature can be helpful

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

• Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Tell your healthcare provider if you have any of the following signs or symptoms: fast or irregular heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath

Click on any underlined word to link to the Glossary for its definition.

Page 10: QUESTIONS - CALQUENCE

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Why do I need to take my dose as prescribed?The best way to block the target, BTK, is by taking CALQUENCE as recommended by a doctor: twice a day, approximately every 12 hours. Missing doses may negatively impact treatment goals.Never change doses or stop taking CALQUENCE unless instructed by your healthcare provider. Your healthcare provider may decrease dosing, stop treatment temporarily, or take you off CALQUENCE completely if certain side effects develop.

What should I do if I forget to take a dose?If you forget to take a dose of CALQUENCE, take it as soon as you remember. If it's more than 3 hours past the usual dosing time, skip the missed dose and take the next dose at its regularly scheduled time.Do not take an extra dose to make up for a missed dose, even if it seems like the right thing to do. If you take too much CALQUENCE, call your healthcare provider or go to the nearest hospital or emergency room right away.

• Set 2 separate alarms—for example, 8 am and 8 pm—for the times when you’re supposed to take CALQUENCE

• Keep CALQUENCE at room temperature and somewhere it will be easy to see, like the kitchen counter

• Use the AM and PM stickers in your CALQUENCE Starter Kit. Extra tip: put them where you keep your drinking glasses

Important Safety Information (Cont’d)

How can I better remember to take my dose as prescribed?Try keeping these tips in mind to help avoid accidentally missing a dose:

More tools that can help you stay on track are provided in your CALQUENCE Starter Kit.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

DosingCALQUENCE

The most common side effects of CALQUENCE include headache, diarrhea, muscle and joint pain, upper respiratory tract infection, and bruising.

These are not all the possible side effects of CALQUENCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Click on any underlined word to link to the Glossary for its definition.

Page 11: QUESTIONS - CALQUENCE

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PER MONTH

How much does CALQUENCE cost?If you have commercial insurance and are eligible, the CALQUENCE Patient Savings Program* can assist you with your out-of-pocket costs for CALQUENCE. Most eligible patients will pay $0 per month and may have access to up to $26,000 per year to assist with out-of-pocket costs related to CALQUENCE. There are no income requirements to participate in the program.The CALQUENCE Patient Savings Program covers the cost of the drug only, and does not cover costs for office visits or any other associated costs.Be sure to talk to your healthcare provider, who can help you enroll in the program and file claims on your behalf.

* For more information about the CALQUENCE Patient Savings Program including eligibility requirements, please visit astrazenecaspecialtysavings.com or download the CALQUENCE Affordability Brochure.

What financial assistance is available?AstraZeneca offers financial assistance programs to help eligible patients afford their treatment with CALQUENCE. They include the Co-Pay Savings Program, the AZ&Me™ Patient Assistance Program, and additional independent patient assistance foundations.† Please visit astrazeneca-us.com/medicines/Affordability.html to learn more and see if you qualify.

† Financial support by independent foundations is not guaranteed. Each foundation sets their own eligibility requirements and support determinations. Your healthcare provider can help you apply for foundation support.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

Support andOTHER RESOURCES

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Support and Other Resources (cont'd)

What other support resources are available?AstraZeneca is committed to supporting you during your treatment with the following programs:

CALQUENCE Cares was created to provide you with education and support during treatment. Sign up at CALQUENCECares.com or call 1-800-236-9933.

CALQUENCETM Cares

• Information about treatment with CALQUENCE• Regular e-mails with helpful information on managing your treatment

Remember, your healthcare provider is your first source of care and information—they should always be contacted for medical advice and treatment.

AstraZeneca Access 360TM can help answer questions about:

• Insurance coverage • Patient savings and assistance programs• Pharmacies that stock or deliver your medicine • Nurse assistance and education programs

Call Access 360 at 1-844-ASK-A360 (1-844-275-2360), Monday–Friday, 8 am–8 pm ET, or visit MyAccess360.com.

Lighthouse provides personalized support during your CALQUENCE treatment from medically trained advocates who are available 24 hours a day, 7 days a week. To enroll, visit HemeLighthouseProgram.com, or call 1-855-LHOUSE1 (1-855-546-8731).

Living with MCL sometimes makes me feel like I’m alone. Where can I find resources to help me?

You are not alone. We’re here for you all day, every day (and all night too). CALQUENCE is more than a prescription—it’s a commitment from AstraZeneca to support you during your treatment, and as you manage your life with cancer.

Beyond AstraZeneca support, there are plenty of other resources that you and those you care about can tap into. National cancer organizations offer a wealth of information, such as the American Cancer Society or the Lymphoma Research Foundation. For help that’s closer to home, professionally led cancer support groups meet right in your neighborhood (digitally these days). You can find one by going to CancerSupportCommunity.org and entering your ZIP code.

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

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B cells: A type of white blood cell that makes antibodies. B cells are part of the immune system and develop from stem cells in the bone marrow. Also called B lymphocytes.

B-cell non-Hodgkin lymphoma: A type of cancer that forms from the B cells, which are a type of immune system cell. Most B-cell lymphomas are non-Hodgkin lymphomas. There are several different types of non-Hodgkin lymphomas, including mantle cell lymphoma (MCL).

Chemical pathways: A set of actions among molecules in a cell that leads to a change in the cell.

Growth signals: The messages sent between cells that control cellular growth.

Hematologic malignancies: Also called blood cancers, hematologic malignancies are cancers that begin in blood-forming tissue, such as the bone marrow, or in the cells of the immune system. Examples of hematologic malignancies are leukemia, lymphoma, and multiple myeloma.

Kinase inhibitor: A substance that blocks a type of enzyme called a kinase. Human cells have many different kinases, and they help control important functions, such as cell signaling, metabolism, division, and survival. Blocking the kinds of kinases that are more active in cancer cells may help keep the cancer cells from growing.

Lymph node: A small bean-shaped structure that is part of the body’s immune system. There are hundreds of lymph nodes found throughout the body, including in the neck, underarms, chest, abdomen, and groin. Lymph nodes contain lymphocytes (white blood cells) that help the body fight infection and disease.

Oral targeted therapy: A type of precise cancer treatment—formulated as a pill, capsule, or liquid that you swallow—that works by targeting the proteins that control how cancer cells grow, divide, and spread.

Platelet: A tiny piece of cell that is found in the blood and spleen. Platelets are pieces of very large cells in the bone marrow called megakaryocytes. They help form blood clots to slow or stop bleeding and to help wounds heal. Also called thrombocytes.

Prognosis: A doctor's judgment of the way a disease is likely to develop, or of the chances of getting better.

Side effects: Unwanted symptoms caused by cancer treatment that affect healthy tissues or organs. Side effects can range from mild conditions, such as mild headache or feeling sick (nausea), to life-threatening conditions, which are rare. The risk of getting side effects varies from person to person. All medicines can cause side effects.

White blood cell: A type of blood cell that is made in the bone marrow and found in the blood and lymph tissue. White blood cells are part of the body’s immune system. They help the body fight infection and other diseases. B cells are a type of white blood cell. Checking the number of white blood cells in the blood is used to look for many kinds of conditions, including lymphoma. White blood cells are also called lymphocytes.

Glossary

Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information.

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CALQUENCE is a registered trademark and CALQUENCE Cares, AstraZeneca Access 360 and AZ&Me are trademarks of the AstraZeneca group of companies.©2020 AstraZeneca. All rights reserved. US-40491 Last Updated 6/20

What is CALQUENCE?CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

It is not known if CALQUENCE is safe and effective in children.

Important Safety Information About CALQUENCE® (acalabrutinib) capsules

Before taking CALQUENCE, tell your healthcare provider about all of your medical conditions, including if you:

• have had recent surgery or plan to have surgery. Your healthcare provider may stop CALQUENCE for any planned medical, surgical, or dental procedure.

• have bleeding problems.• have or had heart rhythm problems.• have an infection.• have or had liver problems, including hepatitis B virus (HBV) infection.• are pregnant or plan to become pregnant. CALQUENCE may harm your

unborn baby and cause problems during childbirth (dystocia).o If you are able to become pregnant, your healthcare provider may do

a pregnancy test before you start treatment with CALQUENCEo Females who are able to become pregnant should use effective birth

control (contraception) during treatment with CALQUENCE and for at least 1 week after the last dose of CALQUENCE

• are breastfeeding or plan to breastfeed. It is not known if CALQUENCE passes into your breast milk. Do not breastfeed during treatment with CALQUENCE and for at least 2 weeks after your final dose of CALQUENCE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking CALQUENCE with certain other medications may affect how CALQUENCE works and can cause side effects. Especially tell your healthcare provider if you take a blood thinner medicine.

How should I take CALQUENCE?• Take CALQUENCE exactly as your healthcare provider tells you to take it.• Do not change your dose or stop taking CALQUENCE unless your

healthcare provider tells you to.• Your healthcare provider may tell you to decrease your dose,

temporarily stop, or completely stop taking CALQUENCE if you develop certain side effects.

• Take CALQUENCE 2 times a day (about 12 hours apart).• Take CALQUENCE with or without food.• Swallow CALQUENCE capsules whole with a glass of water. Do not

open, break, or chew capsules.

• If you need to take an antacid medicine, take it either 2 hours before or 2 hours after you take CALQUENCE.

• If you need to take certain other medicines called acid reducers (H2-receptor blockers), take CALQUENCE 2 hours before the acid reducer medicine.

• If you miss a dose of CALQUENCE, take it as soon as you remember. If it is more than 3 hours past your usual dosing time, skip the missed dose and take your next dose of CALQUENCE at your regularly scheduled time. Do not take an extra dose to make up for a missed dose.

What are the possible side effects of CALQUENCE?CALQUENCE may cause serious side effects, including:

• Serious infections can happen during treatment with CALQUENCE and may lead to death. Your healthcare provider may prescribe certain medicines if you have an increased risk of getting infections. Tell your healthcare provider right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms.

• Bleeding problems (hemorrhage) can happen during treatment with CALQUENCE and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or you cannot control, vomit blood or vomit that looks like coffee grounds, cough up blood or blood clots, dizziness, weakness, confusion, changes in your speech, headache that lasts a long time, or bruising or red or purple skin marks

• Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with CALQUENCE, but can also be severe. Your healthcare provider should do blood tests to check your blood counts regularly during treatment with CALQUENCE.

• Second primary cancers. New cancers have happened in people during treatment with CALQUENCE, including cancers of the skin or other organs. Your healthcare provider will check you for skin cancers during treatment with CALQUENCE. Use sun protection when you are outside in sunlight.

• Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Tell your healthcare provider if you have any of the following signs or symptoms: fast or irregular heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath

The most common side effects of CALQUENCE include headache, diarrhea, muscle and joint pain, upper respiratory tract infection, and bruising.

These are not all the possible side effects of CALQUENCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.Please see full Prescribing Information, including Patient Information.