HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciEncor is a kinase inhibitor indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastaticmelanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.

Limitations of Use:

LuciEncor is not indicated for treatment of patients with wild-type BRAF melanoma.

DOSAGE AND ADMINISTRATION

· Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to the initiation of LuciEncor.

· The recommended dose is 450 mg orally once daily in combination with binimetinib. Take LuciEncor with or without food.

DOSAGE FORMS AND STRENGTHS

Capsules: 75 mg×90 Capsules

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

· New Primary Malignancies, cutaneous and non-cutaneous: Can occur. Monitor for malignancies and perform dermatologic evaluations prior to, while on therapy, and following discontinuation of treatment.

· Tumor Promotion in BRAF Wild-Type Tumors: Increased cell proliferation can occur with BRAF inhibitors.

· Hemorrhage: Major hemorrhagic events can occur.

· Uveitis: Perform ophthalmologic evaluation at regular intervals and for any visual disturbances.

· QTProlongation: Monitor electrolytes before and during treatment. Correct electrolyte abnormalities and control for cardiac risk factors for QT prolongation. Withhold LuciEncor for QTc of 500 ms or greater.

· Embryo-Fetal Toxicity: Can cause fetal harm. Advise females with reproductive potential of potential risk to the fetus and to use effective non-hormonal method of contraception.

ADVERSE REACTIONS

Most common adverse reactions (>25%) for LuciEncor, in combination with binimetinib, are fatigue, nausea, vomiting, abdominal pain, and arthralgia.

DRUG INTERACTIONS

· Strong or moderate CYP3A4 inhibitors: Concomitant use may increase encorafenib plasma concentration. If concomitant use cannot be avoided, modify LuciEncor dose.

· Strong or moderate CYP3A4 inducers: Concomitant use may decrease encorafenib plasma concentrations. Avoid concomitant use.

· Sensitive CYP3A4 substrates: Concomitant use with LuciEncor may increase toxicity or decrease efficacy of these agents. Avoid hormonal contraceptives.

USE IN SPECIFIC POPULATIONS

· Lactation: Advise not to breastfeed.

· Males of Reproductive Potential: LuciEncor may impair fertility.

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.