Initial US Approval:
2017
Key Clinical Studies:
AMPLIFY (NCT03836261)
Drug Class/Description:
Kinase inhibitor
Indications and Usage:
CALQUENCE is a kinase inhibitor indicated:
- 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 and Administration:
- Recommended 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.
Dosage Forms and Strengths:
Tablets: 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.
- 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 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.
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.
Use in Specific Populations:
- Pregnancy: May cause fetal harm and dystocia.
- Lactation: Advise not to breastfeed.
- Severe Hepatic Impairment: Avoid use of CALQUENCE.
Adapted From:
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.
