The US FDA has approved a new drug to treat moderate to severe hot flashes associated with menopause. Fezolinetant, is a neurokinin 3 (NK3) receptor antagonist and is the first in this class of drugs.¹ The NK3 receptor is involved in the regulation of the body temperature by the brain. By binding to the receptor, fezolinetant binds to this receptor and inhibits its action.

Contraindications: Coadministration with CYP1A2 inhibitors (such as carbamazepine, fluvoxamine, ciprofloxacin), patients with known cirrhosis, severe renal damage or end-stage renal disease (ESRD)

Dose: 45 mg once daily orally; may be taken with meals or without meals. However, there is a caveat regarding administration. The drug has to be taken at the same time every day. If the dose is missed or delayed, it should be taken at the earliest. However, the same schedule should be followed the next day.

Side effects: Abdominal pain, diarrhea, back pain, insomnia, hot flush and raised hepatic enzymes

Warning and precautions: Liver function tests should be done before starting the treatment and every 3 months for the initial nine months of the treatment. Treatment should be discontinued if signs of liver damage such as nausea, vomiting, jaundice appear.

Reference

1. FDA news release. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-novel-drug-treat-moderate-severe-hot-flashes-caused-menopause. May 12, 2023. Accessed on May 13, 2023.