HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciAcal safely and effectively. See full prescribing information for LuciAcal.

INDICATIONS AND USAGE

LuciAcal is a kinase inhibitor indicated for the treatment of adult patients with:

• Mantle cell lymphoma (MCL) who have received at least one prior therapy.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• 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 withor without food.

· Advise patients not to break, open, or chew capsules.

· Manage toxicities using treatment interruption, dose reduction, or discontinuation.

· Avoid LuciAcal in patients with severe hepatic impairment.

DOSAGE FORMS AND STRENGTHS

Capsules: 100 mg×60 capsules

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

Most common adverse reactions (incidence ≥ 30%) were: anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.

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.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.