HIGHLIGHTS OF PRESCRIBING INFORMATION

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

INDICATIONS AND USAGE

LuciNiro is a gamma secretase inhibitor indicated for adult patients withprogressing desmoid tumors who require systemic treatment.

DOSAGE AND ADMINISTRATION

• The recommended dosage is 150 mg orally twice daily until disease progression or unacceptable toxicity.

• See Full Prescribing Information for dosage modifications due to adverse reactions.

DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg×90 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

• Diarrhea: Severe diarrhea can occur. Monitor and dose modify for Grade 3-4 diarrhea.

• Ovarian Toxicity: Female reproductive function and fertility may be impaired. Advise females of reproductive potential of the potential risk prior to treatment and monitor routinely.

• Hepatotoxicity: Elevated AST and ALT can occur. Monitor AST and ALT regularly and modify dose as recommended.

• Non-Melanoma Skin Cancers: Perform dermatologic examinationprior to initiation of LuciNiro and routinely during treatment.

• Electrolyte Abnormalities: Monitor phosphate and potassium regularly and modify dose as recommended.

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

ADVERSE REACTIONS

The most common (> 15 %) adverse reactions are diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea.

The most common laboratory abnormalities (≥15%) are decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium.

DRUG INTERACTIONS

• Strong or moderate CYP3A inhibitors: Avoid concomitant use.

• Strong or moderate CYP3A inducers: Avoid concomitant use.  

• Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors and H2-receptor antagonists. If concomitant use cannot be avoided, LuciNiro administration can be staggered with antacids.

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.