Sponsored Content: CALQUENCE® (acalabrutinib) for Patients with Chronic Lymphocytic Leukemia (CLL)

Sponsored Content by AstraZeneca

What is CLL

Chronic lymphocytic leukemia is different from other blood cancers in that it typically is a slow-growing disease. “It’s really more like a chronic condition, and it can be managed over a long period of time,” says Dr. Jennifer Lue, an assistant professor of Medicine with Columbia University Irving Medical Center in New York. “With recent advances in treatment, 5-year overall survival is 85%, which speaks to the chronicity of this
disease and howwell current treatments work.”

CLL affects white blood cells, specifically the B lymphocytes. Essentially, B lymphocytes are healthy white blood cells that change to become abnormal and slowly grow out of control. They also do not die when they should, so over time, these abnormal cells crowd the bone marrow, preventing healthy cells from growing.

“I think when anyone receives a cancer diagnosis, their first thought is fear,” says Lue. However, with CLL, “the conversation is more about living with the disease, often for many years, and planning a lifelong relationship with your oncologist.”

What areBTKis and how do they work?

B lymphocytescontain an enzyme called “Bruton tyrosine kinase,” or BTK, which helps them grow and live properly. In CLL, these abnormal B cells have too much BTK, which allows them to overproduce, preventing space for healthy cells.

“A BTKi or BTKinhibitor is a medicine that targets the enzyme that is overstimulated in CLL,” says Lue. Essentially, BTKis limit the BTK to keep the abnormal B cells from growing uncontrollably.

“BTKis are well-studied, and we know they have a very durable (prolonged) response with some cancer patients,” says Lue.

Most BTKis are what doctors call “oral agents,” or medicines you can take by mouth at home, unlike some other CLL medicines that are given by infusion into a vein.

“That’s why a lot of patients may prefertaking BTK inhibitors,” says Lue, “especially during the time of Coronavirus so they can avoid the hospital setting. This type of medicine can also be more accommodating to their schedules.”

Can you describe your experience with CALQUENCE® (acalabrutinib) in treating CLL patients?

For the most part, Dr. Lue uses the BTK inhibitor CALQUENCE when treating her CLL patients, both in patients receiving medication for the first time (first-line treatment) as well as those who have taken a previous treatment (relapsed or refractory disease).

“A lot of my patients have been on CALQUENCE for a while now,” she says.

“In the ELEVATE-TNand ASCEND clinical trials, the majority of patients with CLL responded to CALQUENCE, which means that their cancer reduced in size and did not spread,” Dr. Lue added. In the ELEVATE TN clinical trial of patients new to CLL treatment, 86% responded to CALQUENCE compared to 79% who received another treatment (chlorambucil plus obinutuzumab). In the ASCEND clinical trial of patients with previously-treated CLL, 81% responded to CALQUENCE compared to 75% who received another treatment (rituximab plus either idelalisib or bendamustine).

Like most BTKis, CALQUENCE may cause some side effects. “Some issues I’ve noticed with my patients are headache, and sometimes muscle pain, known as myalgia. For some patients, these are usually managed with over-the-counter medicines, if anything at all, because they are generally temporary and go away in time.” Individual results may vary. See Important Safety Information below.

With COVID, we can now offer telemedicine visits and send patients for local blood work close to home, so they can avoid having to go to a hospital,” says Lue. “I monitor my patients very closely with office visits and blood tests.”

Dr. Lue reinforces how important it is that patients tell her when they are not feeling right. “Even if it’s trivial, it’s so important for patients to call the office with any concerns, so we can help manage it and keep patients on their CLL treatment.”

Over time, as patients get used to taking CALQUENCE, they can expect to have fewer office visits, says Lue. “Sometimes the toughest part is just remembering to take their CALQUENCE.” Dr. Lue recommends people set a reminder on their phone twice a day, especially in the evening if they aren’t taking other medications before bed.

To hear from real people with chronic lymphocytic leukemia taking CALQUENCE, visit Youtube.com/CALQUENCEpatientvideos.

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 related to AstraZeneca products by clicking here.

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.

CALQUENCE is a registered trademark of the AstraZeneca group of companies.

©2020 AstraZeneca. All rights reserved. US-44575 Last Updated 12/20