Annotation of FDA Label for relugolix / estradiol / norethindrone acetate and F5, PROC, PROS1, SERPINC1
PharmGKB ID
Summary
The FDA-approved drug label for relugolix/estradiol/norethindrone acetate (MYFEMBREE) states that women who are known to have inherited or acquired hypercoagulopathies should not use the drug. Specific inherited hypercoagulophathies were not mentioned on the label, but include protein C (PROC) deficiency, protein S (PROS1) deficiency, antithrombin-III (SERPINC1) deficiency, or Factor V Leiden (F5).
Prescribing
MYFEMBREE is contraindicated in women:
- With a high risk of arterial, venous thrombotic, or thromboembolic disorders [...]. Examples include [...] women who are known to have [...] inherited or acquired hypercoagulopathies
Annotation
Excerpt from the relugolix/estradiol/norethindrone acetate (MYFEMBREE) label:
MYFEMBREE is contraindicated in women:
- With a high risk of arterial, venous thrombotic, or thromboembolic disorders [see Boxed Warning and Warnings and Precautions (5.1)]. Examples include women over 35 years of age who smoke and women who are known to have [...] inherited or acquired hypercoagulopathies
Specific inherited hypercoagulophathies were not mentioned on the label, but include protein C (PROC) deficiency, protein S (PROS1) deficiency, antithrombin-III (SERPINC1) deficiency, or Factor V Leiden (F5).
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the relugolix/estradiol/norethindrone acetate drug label.
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Variants Discussed on Label
Evidence for Clinical Annotations
This annotation has not been used as evidence for any clinical annotations.
History
No history available.