LuciPirto

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.