Relugolix/estradiol/norethisterone acetate

Relugolix/estradiol/norethisterone acetate (RGX/E2/NETA), sold under the brand name Myfembree, is a fixed-dose combination hormonal medication which is used for the treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.[1][2] It contains relugolix, an orally active gonadotropin-releasing hormone antagonist (GnRH antagonist), estradiol (E2), an estrogen, and norethisterone acetate (NETA), a progestin.[1][2]

Relugolix/estradiol/norethisterone acetate
Combination of
RelugolixGnRH antagonist
Estradiol (medication)Estrogen
Norethisterone acetateProgestogen
Clinical data
Trade namesMyfembree
Other namesRGX/E2/NETA; MVT-601
License data
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
KEGG

The most common side effects include hot flushes, hyperhidrosis or night sweats, uterine bleeding, alopecia (hair loss or hair thinning), and decreased libido (decreased interest in sex).[1]

Relugolix/estradiol/norethisterone acetate was approved for medical use in the United States in May 2021.[1][3][4]

Medical uses

RGX/E2/NETA is used in the treatment of heavy menstrual bleeding associated with uterine fibroids.[1]

Available forms

Each tablet of Myfembree contains 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethisterone acetate.[1] It is taken at a dose of one tablet per day.[1]

Society and culture

RGX/E2/NETA was approved for medical use in the United States in May 2021.[1][3]

On 20 May 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ryeqo, intended for the treatment of symptoms of uterine fibroids.[2] The applicant for this medicinal product is Gedeon Richter Plc.[2]

References
  1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214846s000lbl.pdf
  2. "Ryeqo: Pending EC decision". European Medicines Agency (EMA). 20 May 2021. Retrieved 25 May 2021.
  3. "Myfembree: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 26 May 2021.
  4. "Myovant Sciences and Pfizer Receive FDA Approval for Myfembree, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids". Pfizer (Press release). 26 May 2021. Retrieved 26 May 2021.

Further reading



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