Safety Monitoring and Dosing for NK3 Antagonists in Menopause VMS

This content is sponsored by Astellas, Inc but was independently developed by MJH Life Sciences

Pauline M. Maki, PhD, explains that OPTION-VMS provided reassuring news about the safety of fezolinetant (Veozah): No new or emerging adverse events were evident in the real-world study. This matters, she says, because women enrolled in randomized trials go through extensive screening and tend to be healthier than the general population, and adverse events often emerge only when a medication is used by women with broader medical histories. Clinicians can counsel women that the real-world data so far appear reassuring, Maki notes, while recognizing that the findings are conference-based, have not yet been published, and must be confirmed through peer review.

She then walks through practical prescribing considerations. The FDA requires hepatic laboratory testing for fezolinetant, including ALT, AST, ALP, total bilirubin, and direct bilirubin, before starting therapy, monthly for the first 3 months, and again at months 6 and 9. OPTION-VMS showed no new emerging events in this category, Maki says, and these outcomes will continue to be monitored, but clinicians need to understand that the testing is necessary.

Fezolinetant has a single fixed dose of 45 mg taken orally once daily, with or without food, with no dose titration. Benefits on hot flashes can emerge as early as 1 week in some analyses, Maki explains. Although the 12-week primary outcome is the focus, OPTION-VMS data showed vasomotor symptom (VMS) benefits at 4, 8, and 12 weeks, with a similar time course for sleep and mood. Because hormone therapy can take longer to relieve VMS, she views this early onset as a benefit for women seeking relief.

In the next segment, Maki explains how an expanding nonhormonal treatment class and the boxed-warning removal for hormone therapy reshape counseling conversations.