HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciBru 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 a confirmatory trial(s).

• Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) .

• Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.

• Adult patients with Waldenström’s macroglobulinemia (WM) .

• Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based 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 a confirmatory trial(s).

• Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy .

DOSAGE AND ADMINISTRATION

• MCL and MZL: 560 mg taken orally once daily.

• CLL/SLL and WM: 420 mg taken orally once daily.

• cGVHD:

o Patients 12 years and older: 420 mg taken orally once daily.

o Patients 1 to less than 12 years of age: 240 mg/m2 taken orally once daily (up to a dose of 420 mg).

Tablets should be taken orally with a glass of water. Do not cut, crush, or chew the tablets.

DOSAGE FORMS AND STRENGTHS

Tablets: 140 mg×120 tablets

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

• Hemorrhage: Monitor for bleeding and manage.

• Infections: Monitor patients for fever and infections, evaluate promptly, and treat.

• Cardiac Arrhythmias, Cardiac Failure, and Sudden Death: Monitor for symptoms of arrhythmias and cardiac failure and manage.

• Hypertension: Monitor blood pressure and treat.

• Cytopenias: Check complete blood counts monthly.

• Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas.

• Tumor Lysis Syndrome (TLS): Assess baseline risk and take precautions. Monitor and treat for TLS.

• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

• The most common (≥30%) adverse reactions in patients with B-cell malignancies (MCL, CLL/SLL, WM and MZL) are thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, and bruising.

• The most common (≥20%) adverse reactions in adult or pediatric patients with cGVHD are fatigue, anemia, bruising, diarrhea, thrombocytopenia, musculoskeletal pain, pyrexia, muscle spasms, stomatitis, hemorrhage, nausea, abdominal pain, pneumonia, and headache.

DRUG INTERACTIONS

• CYP3A Inhibitors: Modify LuciBru dose as described.

• CYP3A Inducers: Avoid coadministration with strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed. 

• Hepatic Impairment: Avoid use of LuciBru in patients with severe hepatic impairment. In patients with mild or moderate impairment, reduce LuciBru dose.

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.