Calquence (acalabrutinib) is a targeted cancer treatment used for chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL), in certain patients.

Calquence is a Bruton tyrosine kinase (BTK) inhibitor that works by blocking BTK, a protein that plays a key role in cancer cell growth and division. By inhibiting BTK, Calquence helps to slow the progression of cancer and helps extend patients’ lives

Calquence capsules and tablets are taken twice daily.

Calquence FDA approval was granted on October 31, 2017, for treating MCL. Its approval was later expanded to include CLL and SLL. Calquence is manufactured by AstraZeneca Pharmaceuticals.

How does Calquence work? 

Some cancer cells get signals to grow and divide from a protein called Bruton tyrosine kinase (BTK). The Calquence mechanism of action is by blocking Bruton tyrosine kinase (BTK), which helps to stop cancer cells from growing and multiplying, to help reduce cancer growth. The Calquence class of medications is called BTK inhibitors and is a targeted therapy.

Is Calquence chemotherapy?

No, Calquence is not chemotherapy; it is a targeted therapy, specifically a Bruton’s tyrosine kinase (BTK) inhibitor.

What is Calquence used for?

Calquence is used for adult patients with:

• chronic lymphocytic leukemia (CLL)
• small lymphocytic lymphoma (SLL) 
• mantle cell lymphoma (MCL)  in patients
  • who have received at least one prior therapy, or
  • who are previously untreated, and
    • are ineligible for autologous hematopoietic stem cell transplantation (HSCT), and
    • used in combination with bendamustine and rituximab.

Calquence side effects

Common Calquence side effects

Common Calquence side effects include:

• Infection (65%)
• Upper respiratory tract infection – URTI (35%)
• Lower respiratory tract infection – LRTI (18%)
• Urinary tract infection – UTI (15%)
• Headache (39%)
• Dizziness (20%)
• Diarrhea (35%)
• Nausea (22%)
• Musculoskeletal pain (32%)
• Joint pain (16%)
• Tiredness (23%)
• Bruising (21%)
• Rash (25%)
• Hemorrhage (20%).

There were also changes in blood test levels neutropenia 23% (low white blood cells), anemia 53% (low red blood cells), thrombocytopenia 32% (low platelet levels, and lymphocytosis 16% (high white blood cells).

The above common side effects occurred in patients being treated with Calquence CLL as monotherapy and occurred in 15% or more of patients.

Serious side effects

Calquence may cause serious side effects. Call your doctor at once if you have:

• unusual bleeding – nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop
• bleeding inside your body – weakness, dizziness, confusion; problems with speech, prolonged headache, bloody or tarry stools, pink or brown urine; coughing up blood or vomit that looks like coffee grounds
• heart rhythm disorders – dizziness, chest pain, shortness of breath, fast or irregular heart rate, or feeling light-headed. Serious cardiac arrhythmias have occurred in patients treated with Calquence
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath
• signs of infection – fever, chills, tiredness, flu-like symptoms, cough with mucus, chest pain, trouble breathing.

Get emergency medical help if you have signs of an allergic reaction to Calquence hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

This medicine may cause a brain infection that can lead to disability or death. Tell your doctor if you have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.

Liver toxicity, which may be severe or fatal, has been reported with Bruton tyrosine kinase inhibitors, including this medicine. Your healthcare provider will monitor your liver function tests before starting treatment with this medicine and while you are taking it. Tell your healthcare provider immediately if you experience abdominal discomfort, dark urine, or yellowing of the skin.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

Bleeding problems. Calquence can make it easier for you to bleed. Contact your doctor or seek emergency medical attention if you have any bleeding that will not stop.

Call your doctor at once if you have signs of bleeding inside your body, such as: dizziness, weakness, confusion, headache, speech problems, black or bloody stools, pink or brown urine, or coughing up blood or vomit that looks like coffee grounds.

Your healthcare provider may stop this medicine for any planned medical, surgical, or dental procedure

Infections: Monitor for signs and symptoms of infection and treat promptly. 

Change in blood tests. It may cause low levels of red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia). You will have complete blood counts regularly.

Second Primary Cancer: Other cancers have occurred, including skin cancers and other solid tumors. Always use sun protection. 

Heart rhythm changes: You will be monitored for symptoms of problems with the rate or rhythm of your heart (arrhythmias).

Severe hepatic impairment. This medicine should be avoided in patients with severe liver impairment and liver problems that have occurred in patients taking this medicine. If you have symptoms of stomach pain, dark-colored urine of dark color, or yellowing of your skin, you should contact your healthcare provider, who will monitor your liver function.

Before taking this medicine

To make sure Calquence is safe for you, tell your doctor if you have ever had:

• an active or chronic infection, including hepatitis B;
• a heart rhythm disorder;
• bleeding problems;
• recent surgery or plan to have surgery, medical or dental procedure; or
• liver problems

Taking Calquence may increase your risk of developing other cancers. Ask your doctor about this risk.

Pregnancy

Tell your healthcare professional if you are pregnant or plan to become pregnant, as Calquence may harm your unborn baby and problems during childbirth (dystocia). Your healthcare provider may do a pregnancy test before you start treatment, if you are able to become pregnant.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with this medicine and for at least 1 week after the last dose.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Calquence passes into your breast milk. Do not breastfeed during treatment with this medicine and for at least 2 weeks after your final dose.

How should I take Calquence?

Calquence directions

• Calquence tablet and capsules is usually taken twice per day (about 12 hours apart) with or without food, with a glass of water. Swallow the tablet and capsule whole, and do not crush, chew, break, open, or dissolve it.
• 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 (H-2 receptor blockers), take Calquence 2 hours before the acid reducer medicine.
• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking this medicine if you develop certain side effects. 
• Take this medicine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
• If you need surgery, tell the surgeon beforehand that you are using this medication. You may need to stop using the medicine for a short time.
• While taking this medicine, you may need frequent blood tests.
• If you’ve had hepatitis B, it may come back. You may need liver function tests while using this medicine.

Calquence dosing information

Usual monotherapy adult dose of Calquence for CLL,  SLL, or MCL

Dose: Calquence 100 mg capsule or tablet orally every 12 hours until the cancer progresses or there is unacceptable toxicity.

Usual adult dose in combination with obinutuzumab 

For patients with previously untreated CLL or SLL. The recommended dose of Calquence 100 mg taken orally approximately every 12 hours. Start Calquence at Cycle 1 (each cycle is 28 days). Start obinutuzumab (Gazyva) at Cycle 2 for a total of 6 cycles and refer to the obinutuzumab prescribing information for recommended dosing. 

Administer Calquence prior to obinutuzumab when given on the same day. 

Usual adult Calquence dose in combination with bendamustine and rituximab 

For patients with previously untreated MCL. The recommended dosage of 100 mg taken orally approximately every 12 hours until disease progression or unacceptable toxicity

Start Calquence on Day 1 of Cycle 1 (each cycle is 28 days) 

Administer bendamustine 90 mg/m2 on Days 1 and 2 and rituximab 375 mg/m2 on Day 1 of Cycle 1 and continue for a total of 6 cycles. 

Patients achieving a response (PR or CR) after the first 6 cycles may receive maintenance rituximab on Day 1 of every other cycle for a maximum of 12 additional doses, starting on Cycle 8 up to Cycle 30 

General dose information

How long do you take Calquence? Calquence treatment should be continued until the cancer progresses or there is unacceptable toxicity.

Formulations available: 

• Calquence 100mg capsules.
• Calquence 100mg tablets.

Hepatic Impairment. You should not take this medicine if you have severe hepatic impairment. Dose modifications are not required for patients with mild or moderate hepatic impairment.

Dose modifications for drug interactions. See detailed dosing information for dose modifications required for drug interactions.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 3 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Calquence?

Avoid taking an antacid such as Tums or calcium carbonate within 2 hours before or after you take Calquence.

Calquence could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect Calquence?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Drug interactions with groups:

• Strong CYP3A Inhibitors: Avoid co-administration of strong CYP3A Inhibitors with Calquence.
• Moderate CYP3A Inhibitors: Reduce the dosage of Calquence if these medicines are used together.
• Strong CYP3A Inducers: Avoid co-administration of strong CYP3A Inducers with Calquence. If co-administration is unavoidable, then the dosage of Calquence should be increased.

If you use a stomach acid reducer such as cimetidine, ranitidine, Tagamet, Pepcid, or Zantac, take the Calquence dose 2 hours before taking any of these other medicines.

Tell your doctor about all your current medicines. Many drugs can affect acalabrutinib, especially:

• a blood thinner (warfarin, Coumadin, Jantoven);
• an antibiotic or antifungal medicine (itraconazole, fluconazole, erythromycin, rifampin);
• antiviral medicine to treat hepatitis C or HIV/AIDS;
• heart medication (diltiazem) ; or
• a proton pump inhibitor stomach acid medicine – such as omeprazole, lansoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

This list is not complete and many other drugs may interact with acalabrutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Calquence Copay Card and Calquence Cares

The Calquence Copay Card can help you pay as little as $0 per month for out-of-pocket costs if you have commercial insurance plans.

AstraZeneca has a support program called AstraZeneca Access 360, which can help with questions about insurance, costs, affordability options, and other patient resources.

For patients with Medicare or no insurance facing affordability challenges, there is also an AstraZeneca Prescriptions Savings plan called AZ&ME.

Calquence Package Insert 

Review the Calquence Package Insert (PI) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Breyanzi is used to treat 5 types of non-Hodgkin lymphoma, including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), with relapsed or refractory (R/R) marginal zone lymphoma (MZL) in specific patients.

Breyanzi is a one-time infusion of CAR T cell therapy that may help you have complete and lasting remission. 

Breyanzi is a cancer treatment created using immune cells, called T cells, collected from the patient’s own blood. The T cells are modified to become CAR T cells and are then infused back into the patient’s body. The CART T cells can attach to the cancer cells and kill them, helping clear the cancer from the body.  Before your infusion, you will have chemotherapy to prepare your body for your treatment. 

Breyanzi FDA approval was first received on February 5, 2021, for the company Bristol Myers Squibb (BMS).  It contains lisocabtagene maraleuce. The most recent approval was for relapsed or refractory marginal zone lymphoma (MZL) on December 4, 2025.

What is Breyanzi used for?

Breyanzi is FDA-approved to treat five types of non-Hodgkin lymphoma: large B-cell lymphoma, relapsed or refractory chronic CLL/SLL, relapsed or refractory follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), and relapsed or refractory (R/R) marginal zone lymphoma (MZL)  in specific patients.

Large B-cell lymphoma

Breyanzi is used to treat large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, in adults. You can only be treated with Breyanzi if:

• your first treatment has not worked, or your cancer returned within a year of your first treatment, OR
• your first treatment has not worked, or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age, OR
• two or more kinds of treatment have not worked or stopped working.

It is not indicated for the treatment of primary central nervous system lymphoma.

Relapsed or refractory chronic CLL/SLL

Breyanzi is used to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have:

• received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. 
• This is an accelerated FDA approval.

Relapsed or refractory follicular lymphoma (FL) 

Breyanzi is used to treat relapsed or refractory follicular lymphoma (FL) in adults who have:

• received 2 or more prior lines of systemic therapy. 
• This is an accelerated FDA approval.

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

It is approved for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Relapsed or refractory (R/R) marginal zone lymphoma (MZL)

Breyanzi is approved for adult patients who have received at least two prior lines of systemic therapy.

Breyanzi side effects

Common Breyanzi side effects

Common Breyanzi side effects may include:

• headache, dizziness;
• confusion, problems with speech or thinking;
• fever, chills, shaking;
• nausea, vomiting, stomach pain;
• diarrhea, constipation;
• fast or irregular heartbeats;
• cough, trouble breathing;
• swelling; or
• pain in your bones, joint, or muscles.

Serious Bryanzi side effects

Get emergency medical help if you have signs of an allergic reaction, hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to treat CRS if it occurs.

Breyanzi may cause other serious side effects. Call your doctor at once if you have:

• problems with speech;
• confusion, trouble concentrating, memory problems;
• decreased consciousness;
• tremors, or a seizure; or
• signs of infection – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Breyanzi may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication. This medication may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online .

How will I receive Breyanzi?

Breyanzi is a one-time cancer treatment made from your own white blood cells. The process takes several weeks and involves collecting, modifying, and then infusing those cells back into your body, with close monitoring for side effects.

Breyanzi is a liquid medicine given intravenously (into a vein) by a doctor or nurse. It is usually given as two infusions over about 30 minutes total as a one-time dose.

Breyanzi treatment process

Step 1: T Cell collection

• T cells, which are a type of white blood cell, are collected using a procedure called leukapheresis (a process that removes white blood cells from the body).

Step 2: T Cell activation

• The collected T cells are sent away and modified so they can better recognize and attack cancer cells.
• This modification process takes about 3–4 weeks.

Step 3: Preparation for infusion

• You will receive chemotherapy medicines a few days before Breyanzi to prepare your body; this is called lymphodepleting chemotherapy.

Step 4: Breyanzi infusion

• The modified cells are then infused back into your body as Breyanzi. Because the treatment is made from your own cells, it must only be given to you.

Step 5: Follow-up

• Your healthcare provider will check if the treatment is working and monitor for side effects.
  You should plan to stay near the treatment center for at least 4 weeks after receiving Breyanzi.

It is very important not to miss your cell collection or treatment appointment

Before taking this medicine

Tell your doctor if you have ever had:

• hepatitis B or C; or
• if you have received a vaccine within the past 6 weeks.

Using Breyanzi may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

You may need to have a negative pregnancy test before starting this treatment.

Warnings

Breyanzi has a boxed warning for cytokine release syndrome(CRS), neurologic toxicity, and secondary hematological malignancies.

Cytokine release syndrome (CRS): This is a common but serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to treat this condition if it occurs.

Breyanzi may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with this medicine. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including this therapy.

What should I avoid after receiving Breyanzi?

 Avoid driving or operating machinery for at least 2 weeks after receiving this treatment. This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures.

Do not donate blood, organs, tissues, or cells for transplantation.

Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your Breyanzi treatment, and until your doctor tells you your immune system has recovered

What other drugs will affect Breyanzi?

Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. You should keep a written list of all the prescription and nonprescription (over-the-counter) medicines you take, along with any products such as vitamins, minerals, or other dietary supplements. Remember to bring this list with you each time you see a doctor or are hospitalized. This information is important to have on hand for emergencies.