Lucius Version of Fezolinetant: Dosage and Administration, Indications, Precautions

Lucius Version of Fezolinetant: Dosage and Administration, Indications, Precautions

Indications

Fezolinetant is the first non-hormonal therapy for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause. By blocking neurokinin B in the brain's temperature control center, it restores the balance between estrogen and neurokinin B, thereby reducing the frequency and intensity of hot flashes.

Dosage and Administration

Before initiating Fezolinetant, perform baseline blood tests to assess liver function and injury.Conduct follow-up blood tests 3 months, 6 months, and 9 months after starting Fezolinetant treatment, as well as when there are obvious symptoms of liver injury.Take 45mg orally once daily, either on an empty stomach or with food.

Use in Specific Populations

Pregnancy

There are no data on the use of VEOZAH in pregnant women to evaluate the drug-related risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Lactation

There are no data on whether fezolinetant is secreted into human milk, its effects on breastfed infants, or its impact on milk production. It is unknown whether fezolinetant is present in human milk.

Pediatric Use

The efficacy and safety of VEOZAH in individuals under 18 years of age have not been established.

Geriatric Use

A sufficient number of elderly women have not participated in clinical trials of VEOZAH to determine whether the response to VEOZAH in women over 65 years of age differs from that in younger women.

Renal Impairment

VEOZAH is contraindicated in patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m²) or end-stage renal disease (eGFR < 15 mL/min/1.73 m²) [see Clinical Pharmacology (12.3)]. No dosage adjustment of VEOZAH is recommended for patients with mild (eGFR 60 to < 90 mL/min/1.73 m²) or moderate (eGFR 30 to < 60 mL/min/1.73 m²) renal impairment.

Hepatic Impairment

Hepatic impairment of Child-Pugh Class A or B increases VEOZAH exposure. VEOZAH has not been studied in patients with Child-Pugh Class C hepatic impairment. VEOZAH is contraindicated in patients with cirrhosis.

Warnings and Precautions

Elevated Liver Transaminases: In clinical trials, serum transaminase concentrations increased to more than three times the upper limit of normal (ULN). Perform blood tests before initiating Fezolinetant to assess liver function and injury. Do not start treatment if serum transaminase concentrations are equal to or exceed twice the ULN.Conduct follow-up assessments of liver transaminase concentrations 3 months, 6 months, and 9 months after starting treatment.

Drug Interactions

Effects of Other Drugs on VEOZAHCYP1A2 Inhibitors: VEOZAH is a substrate of CYP1A2. Concomitant use of VEOZAH with weak, moderate, or strong CYP1A2 inhibitors can increase the plasma Cmax and AUC of VEOZAH. VEOZAH is contraindicated in individuals taking CYP1A2 inhibitors.

Adverse Reactions

The most common adverse reactions (occurring in at least 2% of the Fezolinetant 45 mg group and higher than the placebo group) are: abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver transaminases.

Contraindications

Fezolinetant is contraindicated in women with any of the following conditions:

Known cirrhosis.

Severe renal impairment or end-stage renal disease.

Concomitant use with CYP1A2 inhibitors.

Dosage Form

Tablets.

Storage Method

Store at 20°C to 25°C (68°F to 77°F); short-term transportation is permitted at temperatures ranging from 15°C to 30°C (59°F to 86°F).