LuciNiro

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.