HOW CALQUENCE WORKS

CALQUENCE is a targeted alternative to traditional chemotherapy.

CALQUENCE is a 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.

RESULTS WITH CALQUENCE

In a clinical trial, the majority of patients with previously treated MCL responded to CALQUENCE, which means that most patients in the clinical trial saw their cancer reduce in size and not spread. When the results of CALQUENCE were initially assessed, 80% of patients (99 out of 124) achieved a response after approximately 15 months of follow-up.*

81% Percent

When doctors followed up with patients approximately a year later, 81% of patients (100 out of 124) had achieved a response after approximately 26 months of follow-up.*

*Radiographic and other tests showed that their cancer reduced in size and did not spread.

A majority of patients who responded
to CALQUENCE continued to respond for (26 months) over 2 years

Individual results may vary.

TREATMENT WITH CALQUENCE

It’s important that patients partner with their doctor to create a treatment plan that works for them.

Before taking CALQUENCE, patients should tell their healthcare provider about all of their medical conditions, including if they:

  • have had recent surgery or plan to have surgery. Their healthcare provider may stop CALQUENCE treatment 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 their unborn baby and cause problems during childbirth (dystocia)
    • If patients are able to become pregnant, their healthcare provider may do a pregnancy test before they start treatment with CALQUENCE
    • 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 their breast milk. Patients should not breastfeed during treatment with CALQUENCE and for at least 2 weeks after their final dose of CALQUENCE
Treatment with CALQUENCE

Patients should also tell their healthcare provider about all the medicines they 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. Patients should especially tell their healthcare provider if they take a blood thinner medicine.

Physical exams and occasional blood tests help doctors determine if CALQUENCE is working. It’s very important for patients to keep these appointments with their doctor—it’s the only way to monitor how they are responding to treatment.

If the disease isn’t growing, spreading, or getting worse, doctors may still want patients to stay on CALQUENCE. The best way to continuously block the target, BTK, is by taking CALQUENCE as recommended.

DOSING WITH CALQUENCE

CALQUENCE is easy to take (even on the go). But before we get into how to take CALQUENCE, remember that it’s important to take CALQUENCE exactly as prescribed.

Calquence Dosing

Patients should speak with their doctor about recommended dosing.

KEEP THE TREATMENT GOING

The best way to continuously 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.

And, of course, patients should talk with their doctor before doing or changing anything.

  • If a dose of CALQUENCE is missed, patients should take it as soon as remembered
    • If it's more than 3 hours past the usual dosing time, patients should skip the missed dose and take the next dose at its regularly scheduled time
    • Patients should not take an extra dose to make up for a missed dose, even if it seems like the right thing to do
    • If patients take too much CALQUENCE, they should call their healthcare provider or go to the nearest hospital or emergency room right away
  • Never change doses or stop taking CALQUENCE unless instructed by a doctor
  • Doctors may decrease dosing, stop treatment temporarily, or take patients off CALQUENCE completely if certain side effects develop
  • If patients need to take certain other medicines called acid reducers (H2-receptor blockers), they should take CALQUENCE 2 hours before the acid reducer
  • If patients need to take an antacid, they should take it either 2 hours before or 2 hours after they take CALQUENCE

SIDE EFFECTS WITH CALQUENCE

Patients taking CALQUENCE may experience side effects, and it’s important to know what they might be and how patients may be able to manage some of them.

Remember that everyone’s treatment experience is different, so patients should speak with their doctor immediately about any side effects they experience. Preventing and managing side effects may help patients stay on treatment.

FEW PATIENTS IN THE CLINICAL TRIAL STOPPED TREATMENT DUE TO SIDE EFFECTS

Initially,* adverse reactions led only 7% of patients (8 out of 124) to discontinue treatment and 2% (2 out of 124) to have their dose reduced in the clinical trial.

When these patients were followed up with approximately a year later,† 8% of patients (10 out of 124) had discontinued treatment due to adverse reactions and 2% (2 out of 124) had their dose reduced.

*After approximately 15 months of follow-up.

†After approximately 26 months of follow-up.

COMMON SIDE EFFECTS

Some side effects are more common than others. The most common side effects of CALQUENCE include:

Headache Icon headache
Diarrhea Icondiarrhea
Muscle and Joint Pain Iconmuscle and joint pain
Upper Respiratory Tract Infection Iconupper respiratory tract infection
Bruising Iconbruising
These are not all of the possible side effects of CALQUENCE.

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. Patients’ healthcare provider may prescribe certain medicines if they have an increased risk of getting infections. Patients should tell their healthcare provider right away if they 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. Patients’ risk of bleeding may increase if they are also taking a blood thinner medicine. Patients should tell their healthcare provider if they 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. Patients’ healthcare provider should do blood tests to check their 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. Patients’ healthcare provider will check them for skin cancers during treatment with CALQUENCE. Patients should use sun protection when outside in sunlight
  • Heart rhythm problems (atrial fibrillation and atrial flutter) have happened in people treated with CALQUENCE. Patients should tell their healthcare provider if they 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. Patients should call their doctor for medical advice about side effects. Side effects may be reported to FDA at 1-800-FDA-1088.

Important Safety Information

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).
    • 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 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.

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).
    • 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 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.

You may report side effects related to AstraZeneca products by clicking here.

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.

Please see full Prescribing Information, including Patient Information.