Initial US Approval:
2017
Key Clinical Studies:
ECHO (NCT02972840)
Drug Class/Description:
Kinase inhibitor
Indications and Usage:
- In combination with bendamustine and rituximab 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.
- For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Dosage Administration:
- Recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food.
- Advise patients not to break, open, or chew capsules.
- Manage toxicities using treatment interruption, dose reduction, or discontinuation.
- Avoid Calquence in patients with severe hepatic impairment
Dosage Forms and Strengths:
Capsules: 100 mg.
Contraindications:
None.
Warnings and Precautions:
- Serious and Opportunistic Infections: Monitor for signs and symptoms of infection and treat promptly.
- Hemorrhage: Monitor for bleeding and manage appropriately. (5.2) • 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.
Adverse Reactions:
The most common adverse reactions (≥ 30%), excluding laboratory abnormalities, are diarrhea, upper respiratory tract infection, headache, musculoskeletal pain, lower respiratory tract infection, and fatigue. The most common Grade 3 or 4 laboratory abnormalities (≥ 10%) are absolute neutrophil count decreased, absolute lymphocyte count decreased, platelets decreased, and hemoglobin decreased
Drug Interactions:
- CYP3A Inhibitors: Avoid co-administration with strong CYP3A inhibitors. Dose adjustments may be recommended.
- CYP3A Inducers: Avoid co-administration with strong CYP3A inducers. Dose adjustments may be recommended.
- Gastric Acid Reducing Agents: Avoid co-administration with proton pump inhibitors (PPIs). Stagger dosing with H2-receptor antagonists and antacids.
Use in Specific Populations:
- Pregnancy: May cause fetal harm and dystocia
- Lactation: Advise not to breastfeed.
Adapted from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210259s011lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
