LuciMomel

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciMomel is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

DOSAGE AND ADMINISTRATION

• Recommended dosage: 200 mg orally once daily with or without food.

• Severe hepatic impairment (Child-Pugh Class C): Reduce the starting dose to 150 mg orally once daily.

DOSAGE FORMS AND STRENGTHS

Tablets: 100 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Risk of Infections: Do not initiate LuciMomel in patients with an active infection. Monitor for signs and symptoms of infection, including reactivation of hepatitis B, and initiate appropriate treatment promptly.

• Thrombocytopenia and Neutropenia: Manage by dose reduction or interruption.

• Hepatotoxicity: Obtain liver tests before initiation of and periodically throughout treatment with LuciMomel.

• Major Adverse Cardiovascular Events (MACE): Monitor for symptoms, evaluate and treat promptly.

• Thrombosis: Evaluate and treat symptoms of thrombosis promptly.

• Malignancies: Monitor for development of secondary malignancies, particularly in current or past smokers.

ADVERSE REACTIONS

The most common adverse reactions (≥20% in either study) are thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.

DRUG INTERACTIONS

• Organic Anion Transporting Polypeptide (OATP)1B1/B3 inhibitors: Monitor for adverse reactions.

• Breast Cancer Resistance Protein (BCRP) substrates: Reduce rosuvastatin (BCRP substrate) dosage. Follow approved product information recommendations for other BCRP substrates.

USE IN SPECIFIC POPULATIONS

• Pregnancy: May cause fetal harm.

• 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.