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.