Calquence is a kinase inhibitor indicated for adults with mantle cell lymphoma and chronic lymphocytic leukemia or small lymphocytic lymphoma. Calquence was initially approved by the U.S. Food and Drug Administration in October 2017 for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy, and it has received numerous approvals since. The most recent approval being a February 2026 approval wherein Calquence, in combination with venetoclax, was approved as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
Read on to learn more about Calquence, including its dosage and administration information, warnings and precautions, and more.
Medication Overview:
- Brand Name: Calquence
- Generic Name: acalabrutinib
- Treatment for: Mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
- Manufacturer(s): AstraZeneca
- Initial FDA Approval: October 2017
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
| Mantle Cell Lymphoma | For the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). For the treatment of adult patients with MCL who have received at least one prior therapy. | Adults | October 2017 |
| Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma | For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | Adults | November 2019 |
Warnings and Precautions:
- Serious and Opportunistic Infections: Monitor for signs and symptoms of infection and treat promptly.
- Hemorrhage: Monitor for bleeding and manager appropriately.
- Cytopenias: Monitor complete blood counts regularly.
- Second Primary Malignancies: Other malignancies have occurred, including skin cancers and other solid tumors. Advise patients to use sun protection.
- Cardiac Arrhythmias: Monitor for symptoms of arrhythmias and manage.
- Hepatotoxicity, Including Drug-Induced Liver Injury: Monitor hepatic function throughout treatment.
Dosage and Administration:
Recommend dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food.
Advise patients not to chew, crush, dissolve, or cut tablets.
Manage toxicities using treatment interruption, dose reduction, or discontinuation.
Avoid Calquence in patients with severe hepatic impairment.
Contraindications:
None listed.
Drug Interactions:
- Strong CYP3A Inhibitors: Avoid co-administration with Calquence.
- Moderate CYP3A Inhibitors: Reduce the dosage of Calquence.
- Strong CYP3A Inducers: Avoid co-administration with Calquence. If co-administration is unavoidable, increase the dosage of Calquence.
Adverse Reactions:
The most common adverse reactions (≥30%), excluding laboratory abnormalities, are upper respiratory tract infection, diarrhea, headache, and musculoskeletal pain. The most common Grade 3 or 4 laboratory abnormalities (≥10%) are absolute neutrophil count decreased, uric acid increased, absolute lymphocyte count decreased, and platelets decreased.
Examples of Acalabrutinib in Guidelines
- Targeted Therapies in the First-Line and At Relapse of Chronic Lymphocytic Leukaemia
- European Society for Medical Oncology (ESMO), July 2024
- Diagnosis and Management of Mantle Cell Lymphoma
- British Society for Haematology (BSH), October 2023
- Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
- Lymphoma Canada, August 2023
Please note: This article is current as of April 28, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
Sign up for alerts to keep up with the latest clinical guidelines and guideline updates.