Side effects and precautions of Fezonatant

Fizolinant is a non-hormonal drug targeting moderate to severe vasomotor symptoms caused by menopause, developed by Astellas Pharmaceuticals of Japan. As the first NK3 receptor antagonist approved by the FDA, it will be launched in Europe and the United States in 2023, but has not yet entered the Chinese market. This article will conduct a detailed analysis of the side effects, medication precautions, and efficacy of fezonatant to help patients better understand this drug.

Side effects of filazonatant

It has shown certain side effects in clinical trials and actual use. Patients should fully understand these potential risks before use.

Common adverse reactions

Common adverse reactions include abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver transaminases. Most of these symptoms are mild to moderate and usually appear in the early stages of medication.

Liver-related risks

Fizolinant may cause drug-induced liver injury, manifested by increased levels of ALT, AST, ALP and bilirubin. Post-marketing surveillance shows that this type of liver injury mostly occurs within 40 days of taking the drug. Some patients will experience symptoms of liver damage such as fatigue, loss of appetite, and nausea.

Patients need to regularly monitor liver function during medication, and seek medical attention promptly if abnormalities are found.

Precautions for filazonatant

Special attention should be paid to the following matters when using filazonatant.

Pre-medication tests

Liver function tests, including ALT, AST, ALP and bilirubin levels, must be performed before starting treatment. If ALT or AST is ≥2 times the upper limit of normal, or total bilirubin is ≥2 times the upper limit of normal, the drug is prohibited.

Monitoring during medication

Liver function needs to be reviewed regularly in the first 3 months, 6 months and 9 months after the start of treatment. If symptoms of liver damage occur, such as jaundice, darker urine, etc., you should stop taking the drug immediately and seek medical advice.

Contraindicated for special groups

Contraindicated for patients with severe renal impairment (eGFR<30ml/min/1.73m²) or liver cirrhosis. The safety of pregnant women, lactating women and people under 18 years of age has not been determined and should be avoided.

Efficacy of Fezonatant

As a new non-hormonal drug, Fezonatant has shown unique advantages in the treatment of menopausal symptoms.

Therapeutic Mechanism

As an NK3 receptor antagonist, fizonaitant works by regulating the hypothalamic temperature regulation center, effectively relieving vasomotor symptoms. Its mechanism of action is different from that of hormone therapy, providing a new option for patients who are unwilling or unable to use hormone therapy.

Clinical Effects

Clinical trials have shown that daily oral administration of 45 mg of fezonastat can significantly reduce the frequency and severity of moderate to severe hot flashes. The drug has a rapid onset of action, with a median peak time of 1.5 hours and a half-life of approximately 9.6 hours, making it suitable for once-daily administration.

Fezonatant provides a safe and effective non-hormonal treatment option for menopausal women, but it must be used rationally under the guidance of a doctor.