Calquence 100 mg acalabrutinib film ‑ 60 coated Tablets

Product Overview

Brand Name: Calquence®

Generic Name: Acalabrutinib

Form: Film-coated tablets

Strength: 100 mg

Route: Oral use

Initial U.S. FDA Approval: 2017

Indications and Usage

Mantle Cell Lymphoma (MCL):

For adults who have received at least one prior therapy.

Approved under accelerated approval based on overall response rate.

Continued approval may depend on confirmatory clinical trial outcomes.

Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL):

Indicated for adult patients.

Dosage and Administration

Recommended Dose: 100 mg orally every 12 hours.

Administration: Swallow whole with water, with or without food.

Do Not: Chew, crush, dissolve, or cut the tablets.

Toxicity Management: Use treatment interruption, dose reduction, or discontinuation.

Hepatic Impairment: Avoid use in severe hepatic impairment.

Dosage Forms and Strengths

Tablet: 100 mg

Contraindications

None

Warnings and Precautions

Infections: Risk of serious and opportunistic infections; monitor and treat promptly.

Cytopenias: Regular monitoring of blood counts is required.

Second Primary Malignancies: Includes skin cancers and solid tumors; advise sun protection.

Atrial Fibrillation and Flutter: Monitor for arrhythmia symptoms and manage accordingly.

Adverse Reactions

Most common (≥30%):

Anemia

Neutropenia

Upper respiratory tract infection

Thrombocytopenia

Headache

Diarrhea

Musculoskeletal pain

Drug Interactions

Strong CYP3A Inhibitors: Avoid use.

Moderate CYP3A Inhibitors: Dose reduction required.

Strong CYP3A Inducers: Avoid or increase dose if unavoidable.

Use in Specific Populations

Pregnancy: May cause fetal harm and dystocia.

Lactation: Breastfeeding not recommended.

Severe Hepatic Impairment: Avoid use.