HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciPirto is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhbitor.

DOSAGE AND ADMINISTRATION

• Recommended dosage: 200 mg orally once daily; swallow whole with water, with or without food. Do not cut, crush, or chew tablets.

• Manage toxicity using treatment interruption, dosage reduction, or discontinuation.

• Reduce dose in patients with severe renal impairment.

DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Infections: Monitor for signs and symptoms of infection, evaluate promptly, and treat.

• Hemorrhage: Monitor for bleeding and manage appropriately.

• Cytopenias: Monitor complete blood counts during treatment.

• Atrial Fibrillation and Atrial Flutter: Monitor for symptoms of arrhythmias and manage appropriately.

• Second Primary Malignancies: Other malignancies have developed, including skin cancers and other carcinomas. Monitor and advise patients to use sun protection.

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

ADVERSE REACTIONS

Most common adverse reactions (≥15%) in patients with MCL are fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. Grade 3 or 4 laboratory abnormalities (≥ 10%) are neutrophil count decreased, lymphocyte count decreased, and platelet count decreased.

DRUG INTERACTIONS

• Strong CYP3A Inhibitors: Avoid concomitant use. If concomitant use is unavoidable, reduce the LuciPirto dose.

• Strong or Moderate CYP3A Inducers: Avoid concomitant use. If concomitant use of moderate CYP3A inducers is unavoidable, increase the LuciPirto dose.

• Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: For substrates where minimal concentration changes may increase the risk of adverse reactions, follow recommendations for coadministration with CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP inhibitors provided in their approved product labeling.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

Storage

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