Can people with prior stroke, DVT, blood clots take fezolinetant?

Published

Prescribing Information including BOXED WARNING

There is no contraindication for the use of fezolinetant in women with a clinical history of deep vein thrombosis (DVT), pulmonary embolism (PE) or stroke/cerebrovascular accident (CVA), although the numbers of such individuals in the Phase 3 trial program were small (≤1%) and no subgroup analyses were performed

In the Phase 3 trials, SKYLIGHT 1, 2 and 4, a medical condition or chronic disease (including history of neurological, cardiovascular, pulmonary) that could confound interpretation of the study outcome in the opinion of the investigator was an exclusion criterion.¹
In SKYLIGHT 2 and 4, a small number of participants (≤1% across all treatment groups) reported a history of DVT, PE or CVA.¹
In SKYLIGHT 4, there was one (0.2%) treatment-emergent adverse event (TEAE) of DVT in the placebo group and one (0.2%) of PE in the fezolinetant 45 mg group, neither of which were considered related to the study drug. No TEAEs of DVT, PE or CVA were reported in SKYLIGHT 1 or 2.¹

Table 1: Medical history of DVT / PE / CVA in SKYLIGHT 2 (52-week study period) in the safety analysis set (all participants who were randomized and received at least one dose of fezolinetant during either the 12-week double-blind or the 40-week active treatment extension periods)¹

Preferred term

Fezolinetant

30 mg

(n = 166)

Fezolinetant 45 mg

(n = 167)

Placebo / Fezolinetant

30 mg

(n = 76)

Placebo / Fezolinetant

45 mg

(n = 75)

DVT

1 (0.6%)

Post procedural PE

1 (1.3%)

CVA

1 (1.3%)

Table 2: Medical history of DVT / PE / CVA in SKYLIGHT 4 in the safety analysis set (all randomized participants who took at least one dose of study intervention)¹