For people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Possible Side Effects

Common Side Effects

Some side effects may be managed at home. Below are some of the most common side effects and tips on how to manage them.

Upper and Lower Respiratory Tract Infection Icon

Upper respiratory tract infections

Talk to your doctor right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms
Wash hands with soap and water
Wear a mask when in crowds

Diarrhea

Avoid caffeine, alcohol, dairy, fat, fiber, and spicy foods
Eat low-fiber foods
Talk to your doctor about taking anti-diarrheal medication (like Imodium^®)

Headache

Take acetaminophen (Tylenol^®)
Get 7-9 hours of sleep
Caffeine (coffee or tea)

Muscle and joint pain

Take acetaminophen (Tylenol^®)
Discuss therapeutic massage or physical therapy with your doctor
Apply heat or cold to the affected area

Serious side effects may occur

Serious infections have happened in people treated 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) have happened in people treated 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 right away 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
bruising or red or purple skin marks

Decrease in blood cell counts. Decreased white blood cell counts, red blood cell counts, and platelet counts can be severe during treatment with CALQUENCE. 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 (cardiac arrhythmias) have happened in people treated with CALQUENCE, and can be serious or lead to death. Tell your healthcare provider right away if you have any of the following signs or symptoms:

fast or irregular heartbeat
dizziness
feeling faint
chest discomfort
shortness of breath

Liver problems have happened in people treated with CALQUENCE, and can be severe or life-threatening, or lead to death. Tell your healthcare provider right away if you experience stomach pain or discomfort, urine of dark color or yellowing of your skin. Your healthcare provider will request tests to monitor your liver function during treatment with CALQUENCE.

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.

Your doctor may tell you to decrease your dose, temporarily stop, or completely stop taking CALQUENCE if you develop certain side effects. Take CALQUENCE exactly as your doctor tells you to take it.

Tolerability and Select Cardiovascular Results

LOW RATES OF DISCONTINUATION

In an interim analysis from a clinical trial of previously untreated patients with CLL taking CALQUENCE, only 10% of patients had to stop CALQUENCE due to side effects after approximately 28 months of median* follow-up.

Low rates of high blood pressure and heart rhythm issues

Based on information collected from 4 clinical trials:

9% (67 of 762 patients)
had increased blood pressure (hypertension)

5% (38 of 762 patients)
had heart rhythm issues,
such as
atrial fibrillation or flutter

Overall, 129 of 762 patients in the clinical trials had cardiac adverse events of any severity; 117 of these 129 patients had prior cardiovascular risk factors.

Heart rhythm problems (cardiac arrhythmias) experienced during treatment with CALQUENCE may be serious or lead to death. Tell your doctor right away if you have signs or symptoms of heart rhythm problems, including fast or irregular heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath.

CALQUENCE may interact with prescription or over-the-counter medications, vitamins, and herbal supplements.

*Median is the middle number in a group of numbers arranged from lowest to highest.

Important Safety Information About CALQUENCE^® (acalabrutinib)

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).
Females who are able to become pregnant:
- Your healthcare provider may do a pregnancy test before you start treatment with CALQUENCE
- Use effective birth control (contraception) during treatment with CALQUENCE and for 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 2 weeks after your last 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 tablets whole with a glass of water. Do not chew, crush, dissolve, or cut tablets.
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 can cause serious side effects, including:

Serious infections have happened 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) have happened in people treated 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 right away 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 white blood cell counts, red blood cell counts, and platelet counts can be severe during treatment with CALQUENCE. 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 (cardiac arrhythmias) have happened in people treated with CALQUENCE, and can be serious or lead to death. Tell your healthcare provider right away if you have any of the following signs or symptoms: fast or irregular heartbeat, dizziness, feeling faint, chest discomfort, or shortness of breath.
Liver problems. Liver problems have happened in people treated with CALQUENCE, and can be severe or life-threatening, or lead to death. Tell your healthcare provider right away if you experience stomach pain or discomfort, urine of dark color or yellowing of your skin. Your healthcare provider will request tests to monitor your liver function during treatment with CALQUENCE.

The most common side effects of CALQUENCE include upper respiratory infection, diarrhea, headache, muscle and joint pain, decreased white blood cell counts, and decreased platelet counts.

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.

What is CALQUENCE?

CALQUENCE is a prescription medicine used to treat adults with:

Mantle cell lymphoma (MCL) in combination with bendamustine and rituximab in people who have not had prior treatment for MCL and who cannot receive a type of stem cell transplant that uses their own blood stem cells (autologous hematopoietic stem cell transplantation [HSCT]).
Mantle cell lymphoma (MCL) who have received at least one prior therapy.
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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

Please see full Prescribing Information, including Patient Information .

You may report side effects related to AstraZeneca
products.