WHAT ARE THE SIDE EFFECTS?

SIDE EFFECTS MAY HAPPEN

Side effects may occur with CALQUENCE, but learning about them early may help you identify and manage some of them at home. Preventing and managing side effects from treatment may help you stay on treatment. Remember to always tell your doctor about any side effects you experience, especially if side effects are severe, or if they don't go away or get worse.

The most common side effects of CALQUENCE (and tips on how to manage them) include:

Headache Icon

Headache

  • Can usually occur within 30 minutes of dosing and typically can be managed with acetaminophen (like Tylenol®) or caffeine
  • Can be managed and typically resolves over a period of 4 weeks
Diarrhea Icon

Diarrhea

  • Drink more fluids, eat smaller, more frequent, and easier-to-digest meals, and avoid spicy foods
  • Your doctor may recommend taking an anti-diarrheal medication (like Imodium®)
Muscle and Joint Pain

Muscle and joint pain (myalgia)

  • Take the time to stretch in order to relax and ease aches (for example, consider mild stretching while positioned on hands and knees)
  • Use over-the-counter medications, like acetaminophen, and apply heat or cold on the affected area
  • Take pain medication as prescribed
Upper Respiratory Tract Infection

Upper respiratory tract infection

  • Minimize the chance of catching or spreading an infection by washing your hands with soap and water thoroughly and often
  • Tell your doctor right away if you have any signs or symptoms of an infection, including fever, chills, or flu-like symptoms
Bruising Icon

Bruising

  • Elevate and ice the affected area to reduce swelling and ease tenderness
Fatigue Icon

Fatigue

  • Ensure adequate nighttime sleep and take short naps early in the day if needed
  • Meditate, read, or listen to music to help relieve stress
  • Engage in moderate exercise, such as walking or stretching (consult your doctor before starting any exercise plan)

Always tell your doctor about any side effects you experience, especially if side effects are severe, or if they don't go away or get worse.

SERIOUS SIDE EFFECTS

There are also more serious side effects that can occur:

  • Serious infections can happen during treatment with CALQUENCE and may lead to death. Your doctor may prescribe certain medicines if you have an increased risk of getting infections. You should tell your doctor 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. You should tell your doctor if you have any signs or symptoms of bleeding, including:
    • blood in the stools or black stools (looks like tar)
    • pink or brown urine
    • unexpected bleeding, or bleeding that is severe or cannot be controlled
    • vomit blood or vomit that looks like coffee grounds
    • cough up blood or blood clots
    • dizziness
    • weakness
    • confusion
    • changes in speech
    • headache that lasts a long time
    • 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 doctor should do blood tests to check your blood counts regularly during treatment with CALQUENCE
  • Second primary cancers. New cancers have happened during treatment with CALQUENCE, including cancers of the skin or other organs. Your doctor will check for skin cancers during treatment with CALQUENCE. You should use sun protection when outside in sunlight
  • Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in treatment with CALQUENCE. You should tell your doctor if you have any of the following signs or symptoms:
    • fast or irregular heartbeat
    • dizziness
    • feeling faint
    • chest discomfort
    • shortness of breath

These are not all of the possible side effects of CALQUENCE. You should call your doctor for medical advice about side effects. Side effects may be reported to FDA at 1-800-FDA-1088.1-800-FDA-1088.

HOW MANY PEOPLE STOP TREATMENT DUE TO SIDE EFFECTS?

In an interim analysis from a clinical trial of previously untreated patients with CLL, after approximately 28 months of median* follow-up, only 10% of patients treated with CALQUENCE alone (17 out of 179) had to stop treatment due to side effects.

In the same clinical trial, after approximately 58 months of median* follow-up, only 16% of patients (28 out of 179) had to stop treatment due to side effects.

In patients treated with the combination of CALQUENCE plus an immunotherapy, after approximately 28 months of median* follow-up, only 11% of patients (19 out of 178) had to stop treatment due to side effects.

In the same clinical trial, after approximately 58 months of median* follow-up, only 17% of patients (31 out of 179) had to stop treatment due to side effects.

ARE THERE ANY SIDE EFFECTS ASSOCIATED WITH HEART HEALTH?

Information collected from 4 clinical trials in CLL patients who had received at least 1 dose of CALQUENCE alone showed there were low rates of hypertension (9%, or 67 out of 762 patients) and heart rhythm issues, such as atrial fibrillation/flutter (5%, or 38 out of 762 patients). Overall, 129 out of 762 patients in the clinical trials had cardiac adverse events; 117 of these 129 patients had prior cardiovascular risk factors.

Adults with CLL/SLL should talk to their doctor about the right therapy for them. High blood pressure, or hypertension, is a condition where over time the force of your blood against the artery walls is hard enough that it may cause health problems, such as heart disease. Adults over 65 are more likely to have cardiovascular disease (problems with the heart, blood vessels, or both).

*Median is the middle number in a group of numbers that are arranged from lowest to highest (e.g., 29 is the median of 20, 22, 29, 33, 38).

Important Safety Information About CALQUENCE® (acalabrutinib)bottom to top button

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).
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with CALQUENCE
    • Females who are able to become pregnant should 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 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 (cardiac arrhythmias) have happened in people treated with CALQUENCE, which may be serious or lead to death. 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.
  • Liver problems. Liver problems can happen during treatment with CALQUENCE, which may be severe or life-threatening, or lead to death. Contact your healthcare provider 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 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.

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.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products. (Opens in new window)

Important Safety Information About CALQUENCE® (acalabrutinib)bottom to top button

EXPAND COLLAPSE

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).
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with CALQUENCE
    • Females who are able to become pregnant should 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 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 (cardiac arrhythmias) have happened in people treated with CALQUENCE, which may be serious or lead to death. 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.
  • Liver problems. Liver problems can happen during treatment with CALQUENCE, which may be severe or life-threatening, or lead to death. Contact your healthcare provider 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 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.

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.

Please see full Prescribing Information, including Patient Information.

You may report side effects related to AstraZeneca products. (Opens in new window)

Important Safety Information About CALQUENCE® (acalabrutinib)

 EXPAND

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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.
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