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

Published

Prescribing Information including BOXED WARNING

A history of deep vein thrombosis (DVT), pulmonary embolism (PE), or stroke is not a contraindication for fezolinetant, but the numbers of such patients in the Phase 3 trials 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 1, 2 and 4, a small number of participants (≤ 1% for each treatment groups) reported a history of DVT, PE, cerebrovascular accident (CVA), or transient ischaemic attack (TIA).¹
Across the three SKYLIGHT studies, there was one (0.1%) treatment-emergent adverse event (TEAE) of DVT in the placebo group, one (0.1%) TEAE of PE in the fezolinetant 45 mg group, and two TEAEs of TIA, one (0.1%) in the placebo group and one (0.1%) in the fezolinetant 45 mg group.¹ None of these TEAEs were considered drug-related.

Table 1: Medical history of DVT / PE / CVA / TIA in SKYLIGHT 1 (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 = 173)

Fezolinetant 45 mg

(n = 174)

Placebo / Fezolinetant

30 mg

(n = 76)

Placebo / Fezolinetant

45 mg

(n = 76)

TIA

1 (0.6%)

Table 2: Medical history of DVT / PE / CVA / TIA 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	0	1 (0.6%)	0	0
Post procedural PE	0	0	1 (1.3%)	0
CVA	0	0	1 (1.3%)	1 (1.3%)
TIA	1 (0.6%)	1 (0.6%)	0	1 (1.3%)

Table 3: Medical history of DVT / PE / CVA / TIA in SKYLIGHT 4 in the safety analysis set (all randomized participants who took at least one dose of study intervention)¹