HOW EFFECTIVE IS CALQUENCE?

CALQUENCE is approved for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who are either new to treatment or have received at least one prior treatment for their cancer.

Based on clinical trials, the FDA has determined that CALQUENCE is safe and effective as a first-line CLL/SLL treatment (or second-line or beyond).

FOR THOSE WHO’VE NEVER BEEN ON TREATMENT, CALQUENCE REDUCED THE
RISK OF DISEASE PROGRESSION

In one clinical trial, 535 people with previously untreated CLL were either given CALQUENCE alone (179 people), CALQUENCE plus an immunotherapy (179 people),* or chemoimmunotherapy (177 people)† instead of CALQUENCE. Interim results were reported after a median follow-up of 28.3 months. Longer-term results were reported after a median follow-up of nearly 6 years (74.5 months).‡

IN A CLINICAL TRIAL AFTER 28.3 MONTHS

90%

lower chance of their disease progressing with CALQUENCE plus an immunotherapy*

80%

lower chance of their disease progressing with CALQUENCE alone

IN FOLLOW-UP RESULTS AFTER 6 YEARS

86%

lower chance of their disease progressing with CALQUENCE plus an immunotherapy* compared to people taking chemoimmunotherapy†

76%

lower chance of their disease progressing with CALQUENCE alone compared to people taking chemoimmunotherapy†

CALQUENCE AFTER A PREVIOUS TREATMENT SLOWED DISEASE PROGRESSION

In a different clinical trial, 310 people who had been previously treated for CLL were either given CALQUENCE (155 people) as their only therapy or an alternative combination treatment (155 people).§ Interim results were reported after a median follow-up of 16.1 months (interim analysis). Longer-term results were reported after a median follow-up of nearly 4 years (46.5 months; long-term analysis).‡

IN FOLLOW-UP RESULTS AFTER 16.1 MONTHS

69%

lower chance of their disease progressing with CALQUENCE alone compared to people taking an alternative combination treatment§

IN FOLLOW-UP RESULTS AFTER 4 YEARS

72%

lower chance of their disease progressing with CALQUENCE alone compared to people taking an alternative combination treatment§

IN THE CLINICAL TRIAL, AFTER A MEDIAN FOLLOW-UP OF 4 YEARS

83% of people (128 out of 155) achieved a response|| when taking CALQUENCE as a stand-alone therapy (only CALQUENCE 100 mg approximately every 12 hours) compared to 84% of people (130 out of 155) on an alternative treatment.§


After a median follow-up of 16.1 months, 81% of people (126 out of 155) achieved a response|| when taking CALQUENCE alone compared to 75% of people (117 out of 155) who took an alternative treatment.§


After a median follow-up of 4 years, patients on CALQUENCE alone were 72% less likely to have their disease worsen or to die than patients on an alternative treatment.§

These results presented are consistent with, but not included in, the FDA-approved prescribing information for CALQUENCE.

CALQUENCE STUDY POPULATION WAS DIVERSE, INCLUDING THOSE WITH HIGH-RISK FEATURES

CALQUENCE was studied in adults with previously untreated CLL, including:

65+

People aged 65 or older

People aged 18-65 with
certain comorbidities

People whose CLL had
high-risk features, such as
del(17p) or TP53 mutations

*CALQUENCE plus obinutuzumab.

†Obinutuzumab plus chlorambucil.

‡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).

§Rituximab plus either idelalisib or bendamustine.

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

Creatinine clearance of 30-69 mL/min calculated by use of the Cockcroft-Gault equation or Cumulative Illness Rating Scale for Geriatrics score >6.

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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This product information is for US residents only.
CALQUENCE is a registered trademark, and CALQUENCE Cares, AstraZeneca Access 360, and AZ&Me are trademarks of the AstraZeneca group of companies.
AstraZeneca Access 360 does not guarantee reimbursement.
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