HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciSora is a kinase inhibitor indicated for the treatment of

· Unresectable hepatocellular carcinoma.

· Advanced renal cell carcinoma.

· Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

DOSAGE AND ADMINISTRATION

· 400 mg (2 tablets) orally twice daily without food.

· Treatment interruption and/or dose reduction may be needed to manage adverse reactions.

DOSAGE FORMS AND STRENGTHS

Tablets: 200 mg×120 tablets

CONTRAINDICATIONS

· LuciSora is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of LuciSora.

· LuciSora in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.

WARNINGS AND PRECAUTIONS

· Cardiovascular Events: Consider temporary or permanent discontinuation of LuciSora.

· Bleeding: Discontinue LuciSora if needed.

· Hypertension: Monitor blood pressure weekly during the first 6 weeks and periodically thereafter.

· Dermatologic Toxicities: Interrupt and/or decrease dose. Discontinue for severe or persistent reactions, or if Stevens-Johnson syndrome and toxic epidermal necrolysis is suspected.

· Gastrointestinal Perforation: Discontinue LuciSora.

· QT Prolongation: Monitor electrocardiograms and electrolytes in patients at increased risk for ventricular arrhythmias.

· Drug-Induced Liver Injury: Monitor liver function tests regularly; discontinue for unexplained transaminase elevations.

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

· Impairment of TSH suppression in DTC: Monitor TSH monthly and adjust thyroid replacement therapy in patients with thyroid cancer.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) for LuciSora are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.

DRUG INTERACTIONS

· Avoid strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

· Lactation: Advise women not to breastfeed.

· Females and Males of Reproductive Potential: Verify pregnancy status prior to initiation of LuciSora.

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.