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

Published

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

0

1 (0.6%)

0

0

Post procedural PE

0

0

1 (1.3%)

0

CVA

0

0

1 (1.3%)

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

Preferred term

Placebo

(n = 610)

Fezolinetant

30 mg

(n = 611)

Fezolinetant

45 mg

(n = 609)

DVT

3 (0.5%)

2 (0.3%)

3 (0.5%)

DVT post operative

0

0

1 (0.2%)

PE

1 (0.2%)

1 (0.2%)

4 (0.7%)

CVA

0

1 (0.2%)

2 (0.3%)

  1. Data on file.

find-my-msl

Find My MSL

Medical Science Liaisons are available to help answer your scientific questions.

submit

Submit an Inquiry

For any medical inquiries, please submit your question online to Astellas Medical Information or call or fax your inquiry.

Astellas Phone: 1-800-727-7003

Fax: 1-877-829-7942

adverse

Report an Adverse Event or Product Complaint

Report adverse events and product complaints to Astellas or FDA MedWatch.

Astellas Phone: 1-800-727-7003

FDA MedWatch: 1-800-FDA-1088

Hours: M–F, 8 AM–4:30 PM (CT)