HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciPem is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

DOSAGE AND ADMINISTRATION

· Confirm the presence of an FGFR2 fusion or rearrangement prior to initiation of treatment with LuciPem.

· Recommended dose is 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs.

· Swallow tablet whole, with or without food.

DOSAGE FORMS AND STRENGTHS

Tablets: 4.5 mg×14 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

· LuciPem can cause retinal pigment epithelial detachment. Perform ophthalmological examination including optical coherence tomography (OCT) prior to initiation of therapy, every 2 months for the first 6 months of treatment and every 3 months thereafter, and urgently at any time for visual symptoms.

· Hyperphosphatemia: Increases in phosphate levels are a pharmacodynamic effect of LuciPem. Monitor for hyperphosphatemia and withhold, reduce the dose, or permanently discontinue based on duration and severity of hyperphosphatemia.

· Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to the fetus and use effective contraception.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 20%) are hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, and dry skin.

DRUG INTERACTIONS

· Strong and moderate CYP3A Inducers: Avoid concomitant use of LuciPem.

· Strong and moderate-CYP3A inhibitors:Reduce the dose of LuciPem, if concomitant use cannot be avoided.

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.