treatment for cll/sll and mcl | calquence® (acalabrutinib) - … · 2020. 10. 1. · what is small...

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FOR CLL/SLL CLL=chronic lymphocytic leukemia; SLL=small lymphocytic lymphoma. Please see Important Safety Information throughout, and full Prescribing Information, including Patient Information. What is CALQUENCE? CALQUENCE is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 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. Frequently Asked Learn more about taking CALQUENCE for CLL/SLL QUESTIONS

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Page 1: Treatment for CLL/SLL and MCL | CALQUENCE® (acalabrutinib) - … · 2020. 10. 1. · What is small lymphocytic lymphoma (SLL)? SLL is also a cancer of the B cells in which the bone

FOR CLL/SLL

CLL=chronic lymphocytic leukemia; SLL=small lymphocytic lymphoma.

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

What is CALQUENCE?CALQUENCE is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).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.

Frequently Asked Learn more about taking CALQUENCE for CLL/SLL

QUESTIONS

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

About CLL and SLL..............................................3

What is chronic lymphocytic leukemia (CLL)?

What is small lymphocytic lymphoma (SLL)?

What is the difference between CLL and SLL?

How does CLL affect the body?

What are the symptoms of advanced CLL?

What are the stages of CLL?

How is CLL diagnosed?

What tests are used to diagnose CLL?

Are CLL and SLL curable?

What causes CLL/SLL?

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 CLL/SLL sometimes makes me feel like I'm alone. Where can I find resources to help me?

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

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

OF CONTENTS

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AboutCLL AND SLL

Important Safety Information (Cont’d)

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.

What is chronic lymphocytic leukemia (CLL)?CLL is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). Major types of white blood cells include B cells, T cells, and natural killer cells. CLL is a cancer of the B cells.

What is small lymphocytic lymphoma (SLL)?SLL is also a cancer of the B cells in which the bone marrow makes too many lymphocytes.

What is the difference between CLL and SLL?CLL and SLL are thought to be the same cancer. The same type of abnormal B cell is seen in both CLL and SLL—the main difference is where they are found. In CLL, many abnormal B cells are found in the blood, bone marrow, spleen, and lymph nodes. In SLL, abnormal B cells are primarily found in the lymph nodes. Treatment is the same for CLL and SLL.

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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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.

About CLL and SLL (cont'd)

How does CLL affect the body?Because CLL is often a slow-growing cancer, you may not know you have CLL for years because you may have no symptoms.

Over time, CLL causes too many abnormal B cells to crowd out healthy cells. As a result, you may feel tired, lose weight, or get sick more easily. CLL may also spread to your lymph nodes, liver, and spleen, and cause these organs to enlarge.

What are the symptoms of advanced CLL?Many people with CLL don’t have any obvious physical symptoms until the disease is in a later stage. Symptoms of CLL that have progressed may include:

• Feeling very tired

• Shortness of breath during normal physical activity

• Anemia (decreased red blood cell count)

• Swollen lymph nodes (particularly in the neck)

• Feeling of fullness (due to an enlarged spleen or liver)

• Unexplained weight loss

• Night sweats

• Easy bruising or bleeding

• Low-grade fever

• Frequent infections

What are the stages of CLL?Staging helps doctors to assess how the disease is expected to progress over time and also to develop a treatment plan. CLL commonly uses the Rai staging system. It has 5 cancer stages:

• Stage 0: Defined by normal test results except for a high white blood cell count

• Stage 1: Defined by a high white blood cell count and enlarged lymph nodes

• Stage 2: Defined by a high white blood cell count and an enlarged liver, spleen, or both

• Stage 3: Defined by a high white blood cell count and a low hemoglobin level (anemia)

• Stage 4: Defined by a high white blood cell count and a low platelet count (thrombocytopenia)

How is CLL diagnosed?Doctors use many tests to find, or diagnose, CLL. When choosing a diagnostic test, your doctor may consider factors such as your age and general health, the signs and symptoms you are having, or the type of leukemia suspected. CLL may be suspected because of abnormal results from blood tests that were ordered either as part of an annual physical or a medical examination for an unrelated condition. An unexplained elevated white blood cell (lymphocyte) count is the most common finding that leads doctors to consider a diagnosis of CLL.

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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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 CLL and SLL (cont'd)

What tests are used to diagnose CLL? 1. Blood tests. The process of diagnosing CLL

usually begins with a routine blood test called a complete blood count, or CBC. A CBC measures the number of different types of cells in a sample of a person’s blood, including white blood cells. If CLL is suspected, further tests are required to confirm a diagnosis.

2. Protein test. This is an important test used to help confirm a diagnosis of CLL. CLL cells have distinctive markers, called cell surface proteins, on the outside of the cell. The pattern of these markers is called the immunophenotype (IM-yoo-noh-FEEN-oh-type). Immunophenotyping is done with an instrument called a “flow cytometer” using a sample of blood.

3. Immunoglobulin test. This test provides a measurement of the concentration of immunoglobulins in the blood. Immunoglobulins are the “antibodies” made by B cells in healthy individuals to protect the body from infection. CLL cells do not make effective antibodies and also interfere with the ability of the normal lymphocytes to make antibodies. As a result, people with CLL often have low levels of immunoglobulins.

Are CLL and SLL curable? Both CLL and SLL are slow-growing diseases. This means that many patients that respond to treatment can have a good prognosis, but may not be curable. Many people can live a long time—even decades—with CLL or SLL.

What causes CLL/SLL?Doctors don't know exactly what causes CLL and SLL. There are certain factors, however, that may slightly raise a person’s risk of developing CLL/SLL. These factors include older age, male gender, having a first-degree relative with CLL, exposure to Agent Orange (a chemical used during the Vietnam War), or having a higher than usual level of lymphocytes (called monoclonal B-cell lymphocytosis).

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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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 adult patients with types of blood cancer called chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

How does CALQUENCE work?CALQUENCE is a type of kinase inhibitor that affects the growth of CLL/SLL 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 CLL/SLL 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.

SafetyCALQUENCE

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.

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)

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

CALQUENCE Safety (cont'd)

Headache

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

• Caffeine has been shown to help relieve headaches

Diarrhea

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

• Consult with your doctor to see if you need medication for your diarrhea 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

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.

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

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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.

DosingCALQUENCE

• 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:

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.

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.

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

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Support andOTHER RESOURCES

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.

PER MONTH

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.

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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.

Living with CLL/SLL 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 lymphomas: 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 chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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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What is CALQUENCE?

CALQUENCE is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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.

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-40489 Last Updated 6/20