HIGHLIGHTS OF PRESCRIBING INFORMATION 

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

INDICATIONS AND USAGE

LuciFezo is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

DOSAGE AND ADMINISTRATION 

Perform baseline bloodwork to evaluate for hepatic function and injury before beginning LuciFezo. While using LuciFezo, perform follow-up bloodwork at 3 months, 6 months, and 9 months after initiation of therapy and when symptoms suggest liver injury. 

One 45 mg tablet orally once daily with or without food.

DOSAGE FORMS AND STRENGTHS 

Tablets: 45 mg×30 tablets

CONTRAINDICATIONS 

• Known cirrhosis.

• Severe renal impairment or end-stage renal disease.

• Concomitant use with CYP1A2 inhibitors.

WARNINGS AND PRECAUTIONS 

Hepatic transaminase elevation: Elevations in serum transaminase concentrations greater than three times the upper limit of normal (ULN) occurred in the clinical trials. Perform bloodwork prior to initiation of LuciFezo to evaluate for hepatic function and injury. Do not start therapy if 

serum transaminase concentration is equal to or exceeds two times the ULN. Perform follow-up evaluations of hepatic transaminase concentration at 3 months, 6 months, and 9 months after initiation of therapy.

ADVERSE REACTIONS 

The most common adverse reactions with LuciFezo [at least 2% in LuciFezo 45 mg and greater than placebo] are: abdominal pain, diarrhea, insomnia, back pain, hot flush, and hepatic transaminase elevation. 

DRUG INTERACTIONS 

LuciFezo is a substrate of CYP1A2. Concomitant use of LuciFezo with drugs that are weak, moderate, or strong CYP1A2 inhibitors, increase the plasma Cmax and AUC of LuciFezo.

LuciFezo is contraindicated in individuals using CYP1A2 inhibitors.

USE IN SPECIFIC POPULATIONS 

Renal Impairment 

LuciFezo is contraindicated in individuals with severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2). No dose adjustment of LuciFezo is recommended for individuals with mild (eGFR 60 to less than 90 mL/min/1.73 m2) or moderate (eGFR 30 to less than 60 mL/min/1.73 m2) renal impairment. 

Hepatic Impairment 

Child-Pugh Class A or B hepatic impairment increased the exposure of LuciFezo. LuciFezo has not been studied in individuals with Child-Pugh Class C hepatic impairment. 

LuciFezo is contraindicated in individuals with cirrhosis.

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.