What is the generic name?

RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE

What is the Trade Name for RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE?

Myfembree

What are the Indications for RELUGOLIX, ESTRADIOL HEMIHYDRATE, AND NORETHINDRONE ACETATE?

• 1. INDICATIONS AND USAGE MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. MYFEMBREE is a combination of relugolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. ( 1 ) Limitations of Use Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible . ( 1 , 5.2 , 6 ) Limitations of Use Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible [see Warnings and Precautions (5.2) ].

References: https://open.fda.gov/