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

FAQs

Frequently Asked Questions

No, CALQUENCE is not chemotherapy. It is an oral, targeted therapy designed to block Bruton tyrosine kinase (BTK), a protein that contributes to the survival, growth, and spread of CLL/SLL cancer cells. CALQUENCE may also affect healthy cells.

It is important to note that there are no head-to-head studies that compared CALQUENCE and Brukinsa. Therefore, no comparisons or conclusions can be made about any difference between CALQUENCE and Brukinsa.

Please speak to your doctor about any additional questions.

In recent years, a great deal of progress has been made in understanding CLL and how to best treat it. In some cases, chemotherapy may not be the best course of treatment. Certain genetic markers can point to which treatments may work best for you, which is why your doctor may have you take a genetic or biomarker test before you start treatment.

The results of the test can help to determine your outlook, or how quickly the disease will progress, and what treatment options may be appropriate. For example, adults with a del(17p) mutation are more likely to have CLL that is harder to treat, and traditional chemotherapy may not work as well for them.

In a clinical study of 535 patients with previously untreated CLL after a median^† follow-up of 28.3 months, 92% (165 of 179) on CALQUENCE + immunotherapy,^‡ 85% (153 of 179) on CALQUENCE alone, and 47% (84 of 177) on chemoimmunotherapy^§ had no cancer growth or spread. In this study, CALQUENCE + immunotherapy was compared with chemoimmunotherapy and CALQUENCE alone was compared with chemoimmunotherapy.

Another clinical study included 2 groups of patients with previously untreated CLL. There were 291 patients who received CALQUENCE + venetoclax and 291 patients who received chemoimmunotherapy. After a median^† follow-up of 42.6 months, 69% (202 of 291) of patients receiving CALQUENCE + venetoclax had no cancer growth or spread vs 67% (195 of 290) of patients receiving chemoimmunotherapy.^¶

In another clinical study, 310 patients with previously treated CLL, after a median^† follow-up of 16.1 months, 83% (128 of 155) on CALQUENCE alone vs 56% (87 of 155) on chemoimmunotherapy^‖ had no cancer growth or spread.

CALQUENCE can cause serious side effects including: serious infections, bleeding problems, decrease in blood cell counts, new cancers, heart rhythm problems, and liver problems. Some may lead to death. 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.

For more information on the efficacy of CALQUENCE, click here.

For more information on side effects of CALQUENCE, click here.

*Fixed duration treatment with CALQUENCE alone, or continuous treatment with CALQUENCE + venetoclax.

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

^‡CALQUENCE plus obinutuzumab.

^§Obinutuzumab plus chlorambucil.

^¶FCR (fludarabine + cyclophosphamyde + rituximab) or BR (bendamustine + rituximab).

^||Rituximab plus either idelalisib or bendamustine.

You and your doctor will decide which treatment regimen is most appropriate for you. This may be either CALQUENCE alone or CALQUENCE plus venetoclax.

HOW TO TAKE CALQUENCE ALONE*^†

CONTINUOUS TREATMENT^† FOR PREVIOUSLY UNTREATED AND PREVIOUSLY TREATED CLL/SLL*

CALQUENCE is a 100-mg tablet taken at home or on the go. Take one tablet by mouth twice daily, approximately 12 hours apart. CALQUENCE tablets can be taken with or without food. Swallow the tablet whole with a glass of water. Do not chew, crush, dissolve, or cut tablets. It's important to take CALQUENCE exactly as your doctor tells you to take it.

How to take CALQUENCE + venetoclax^‡

FIXED-DURATION TREATMENT FOR PREVIOUSLY UNTREATED CLL/SLL

For patients with newly diagnosed CLL or SLL, twice-daily oral CALQUENCE for 14 cycles^II is taken in combination with 12 cycles^II of venetoclax.

Treatment cycles (each cycle is 28 days, or 4 weeks)

*Take each tablet by mouth.

^†Take CALQUENCE continuously and stop treatment if your disease progresses or if you develop certain side effects.

^‡Stop treatment after cycle 14 unless your doctor tells you to stop earlier because your disease progresses or you develop certain side effects.

^§About 12 hours apart as prescribed by your doctor.

^II1 cycle is 28 days.

Some common side effects with CALQUENCE may be managed at home. It’s important to have an open dialogue with your doctor about side effects since they are the most familiar with your medical history and are best positioned to help manage side effects.

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

Interactions may affect how CALQUENCE works or may cause side effects. Depending on the medication, your doctor may need to adjust your therapy. Do not change your dose or stop taking CALQUENCE unless your healthcare provider tells you to. It is important to give your doctor a complete list of medications that you are taking, including all nutritional supplements, vitamins, or over-the-counter medications. Especially tell your healthcare provider if you take a blood thinner medicine.

Common medications, vitamins, or herbal supplements that may interact with CALQUENCE*

*Does not represent all possible examples. Please ask your doctor if you have any questions.

^†Ritonavir and cobicistat are medications usually given in combination with other drugs for conditions including HIV and hepatitis C virus (HCV).

You will receive your CALQUENCE prescription from a specialty pharmacy. This will be coordinated by your care team, and you will receive your prescription from either the pharmacy of your doctor’s office or from one of AstraZeneca’s in-network Specialty Pharmacy Providers.

Once your doctor sends your prescription to a selected specialty pharmacy, you or your caregiver will receive a phone call (or text) from the pharmacy to arrange pickup at your doctor’s office or delivery from a pharmacy. The pharmacy will also contact you to make sure you understand how to take your medication, what to expect, and possible side effects before you get started. If a copay is required, the pharmacy will discuss payment options with you.

CALQUENCE is covered by most commercial, Medicare, and government insurance plans. The AstraZeneca Access 360™ program can help you understand your benefits and help obtain coverage. To learn more, please call 1-844-ASK-A360 (1-844-275-2360), Monday through Friday, 8 _AM – 6 _PM ET, or visit www.MyAccess360.com.

Yes, the CALQUENCE Copay Savings Program can help eligible commercially insured patients with their out-of-pocket costs. Patients may pay as little as $0* per month for CALQUENCE. There are no income requirements to participate in this program.

Talk to your doctor or pharmacist, who can help you enroll in the program and file claims on your behalf. For more information about eligibility requirements, please call 1-844-ASK-A360 (1-844-275-2360), Monday through Friday, 8 _AM – 6 _PM ET or visit www.AZPatientSupport.com.

If you are facing affordability challenges, CALQUENCE is supported by the AZ&Me™ Prescription Savings Program, a free drug program for qualified patients with Medicare or no insurance. To learn more about this program, please visit www.AZandMe.com.

*Terms and conditions apply. See www.AZPatientSupport.com for full eligibility and terms of use.

You can join CALQUENCE™ Connections Facebook to connect and share online. You can also reach out to these support organizations for additional help:

• Blood Cancer United: https://bloodcancerunited.org/resources

• Lymphoma Research Foundation: https://lymphoma.org/resources/supportservices/

• Leukemia Research Foundation: https://leukemiarf.org/patients/

• CLL Society: https://cllsociety.org/programs-and-support/cll-specific-patient-support-groups/

In addition, our real patient stories feature stories and voices of others who understand what you’re going through.

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.