LuciSora

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.