What tests are used to diagnose MCL?

There are signs and symptoms that might suggest a person has mantle cell lymphoma (MCL), but tests are needed to be certain of an MCL diagnosis. They may include:

	1. Blood tests. MCL can cause abnormal blood counts. Doctors test blood to look for signs of disease. Blood tests are also used to learn if cancer treatment is needed now.
	2. Biopsies. MCL can spread outside the lymph system. The only way to know if you have cancer is with a biopsy, a procedure that removes samples of fluid or tissue for testing. There are many types of biopsies; for B-cell lymphomas, NCCN experts advise getting an incisional or excisional biopsy.
	3. Imaging tests. These tests make pictures of the insides of your body and can show you which body parts have cancer. The radiologist, a doctor who is an expert in reading images, will convey the test results to your doctor.
	4. Protein test. This test is used to identify cell proteins with a process called immunophenotyping (IM-you-noh-FEE-noh-typing). MCL has common patterns of proteins in its cells. Immunophenotyping helps confirm a diagnosis of MCL by identifying these proteins.
	5. Genetic tests. Testing for abnormal changes in genetic material can be important for both diagnosis and prognosis (the expected outcome of the cancer). MCL has common abnormal changes in chromosomes and genes, such as translocations—which are a switching of parts between chromosomes. In MCL, a translocation between chromosomes 11 and 14 is often found. Genetic testing for this translocation can help confirm a diagnosis of MCL.
	6. Molecular testing/next-generation sequencing (NGS). Each cancer has a unique set of changes in the DNA (deoxyribonucleic acid) of the cancer cells. Doctors use molecular testing/NGS to examine the DNA and genes of your cancer cells for these changes. The test is used to look for mutations and other critical changes in the genes of cancer cells. Doctors can use this information to decide whether one treatment may work better than another for you.

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).
- 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 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.

You may report side effects related to AstraZeneca products.

What tests are used to diagnose MCL?

Related Questions

Important Safety Information About CALQUENCE® (acalabrutinib)

How should I take CALQUENCE?

What are the possible side effects of CALQUENCE?

What is CALQUENCE?

Important Safety Information About CALQUENCE^® (acalabrutinib)