HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciBelu is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

DOSAGE AND ADMINISTRATION

Recommended Dosage: 200 mg taken orally once daily with food.

DOSAGE FORMS AND STRENGTHS

Tablets: 200 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• 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 (≥20%) adverse reactions, including laboratory abnormalities, are infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.

DRUG INTERACTIONS

• Strong CYP3A Inducers: Increase LuciBelu dosage to 200 mg twice daily.

• Proton Pump Inhibitors: Increase LuciBelu dosage to 200 mg twice daily.

USE IN SPECIFIC POPULATIONS

• Lactation: Advise not to breastfeed.

• Moderate or Severe Hepatic Impairment: Avoid use of LuciBelu in patients with moderate or severe hepatic impairment.

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.