Calquence Connections

CALQUENCE Overview

Understanding Chronic Lymphocytic Leukemia (CLL)

A Patient’s View on Navigating the Healthcare System

Find a Treatment for CLL

Expectations and Outcomes from Treatment

Communication with your Care Team

Q&A

More Information on CALQUENCE


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.

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.

Please see full Prescribing Information, including Patient Information.

Please see full Prescribing Information, including Patient Information.

Meet the Speakers

Transcript:

Marsena Pelton, MSN, RN, OCN: Dr Sharman, what is chronic lymphocytic leukemia [CLL] and how does it affect patients?

Jeff Sharman, MD: Chronic lymphocytic leukemia is a cancer of the immune system. Specifically, it’s a cancer of what we call B cells. Within the immune system, you have the primitive immune system and the adaptive immune system. The primitive immune system just sort of jumps on the bacteria and gobbles it up.

The adaptive immune system is what helps you learn and adapt. It’s why we get vaccinations — to get our immune system prepared for the next time we encounter something. B cells are specifically the cells that make antibodies. B cells are also the cells that can go ahead and create chronic lymphocytic leukemia. It tends to be a slow-growing cancer for most patients. It is an accumulation of these cells in places where they don’t belong. Frequently, we’ll identify patients with blood count abnormalities. Their white blood cell count will be too high.

Alternatively, sometimes we see that those (cells) can collect in lymph nodes and patients can end up with enlarged lymph nodes, or they can collect and accumulate in the spleen, so patients get an enlarged spleen, or the bone marrow where they may impact the production of other cells, so patients may have low red blood cells or low platelets. Overall, it’s a cancer that accumulates in those places and then at some point in most patients, may need to be treated.

Marsena Pelton, MSN, RN, OCN: Dr Sharman, what are the signs and symptoms of CLL?

Jeff Sharman, MD: Over time, as patients have CLL that may accumulate with time, we don’t always actually jump into treatment right away. It’s kind of an unusual cancer in that simply having the diagnosis doesn’t mean that you need to jump into therapy. Consequently, you can watch it and over time, the symptoms that evolve can be abnormal lymph nodes, swollen lymph nodes in the neck or armpits or groin. They can also be within the chest or the back of the abdomen where patients may be less aware of them, but sometimes we follow those with CT [computerized tomography] scans.

It can cause low blood counts in the other cells, so patients can have low red blood cells and be anemic or they can develop low platelets and be more at risk of bleeding. Beyond those, sometimes we see patients at increased risk of infection. This is a cancer of the immune system, so maybe we shouldn’t be surprised that the immune system doesn’t work perfectly well. It can also be associated with this sort of difficult-to-characterize fatigue. Fatigue unfortunately is a common symptom and sometimes it’s a little bit difficult to tell what’s causing the fatigue, whether it’s caused by the leukemia or other things going on in the patient’s life. But those are the symptoms that are probably the most common to patients with CLL.

Chronic lymphocytic leukemia for many patients is a slow cancer and not one that requires therapy right away. In fact, in probably the majority of cases we’ll simply observe a patient over time. This idea of watch and wait, or treat when you need to treat, rather than treat just because it’s there is something that takes a little bit of time to explain to a patient as to why that can be the case.

Marsena Pelton, MSN, RN, OCN: Dr Sharman, how are patients typically diagnosed with CLL?

Jeff Sharman, MD: For a patient who is diagnosed with CLL, oftentimes they may be referred to a medical oncologist just because they have abnormal blood counts or it’s common that they may have had a test performed called flow cytometry, which is a test oftentimes just on bloodwork that’s able to tell us the diagnosis.

In terms of talking to patients about what to expect, the reality is many patients are going to live asymptomatically with their disease and their disease is going to be followed by bloodwork alone. We’ll be following them over the future to sort of try to understand their particular disease, how quickly it is or isn’t growing. Then that’s going to lead into when and whether or not a therapeutic intervention is going to be necessary.

And so, for many patients who were asymptomatic to begin with, where this was incidentally discovered and it’s really just learning to live with a new diagnosis of cancer that you’re not necessarily jumping into therapy, it can be some of the more awkward emotional complexities to overcome for these patients. Hopefully over time, if in fact their disease isn’t needing therapy, and probably when most patients are diagnosed, we might estimate that one-third of patients may not ever need therapy. One-third of patients might not need therapy now, but quite possibly will need therapy over the next few years. Then there is a group of patients who might need therapy up front.

Amongst those patients who are able to watch and wait for a number of years, we can hopefully continue to do that simply by monitoring their blood counts. They may not necessarily even have an experience of having symptoms from their disease in many cases.

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

©2021 AstraZeneca. All rights reserved. US-49150 Last Updated 5/21