Annotation of FDA Label for relugolix / estradiol / norethindrone acetate and F5, PROC, PROS1, SERPINC1

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PharmGKB ID

PA166397721

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.