Relugolix/estradiol/norethisterone acetate

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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
  • US: ℞-only [1]
Identifiers
KEGG

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]

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[]

Legal status[]

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. ^ a b c d e f g h i https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214846s000lbl.pdf
  2. ^ a b c d "Ryeqo: Pending EC decision". European Medicines Agency (EMA). 20 May 2021. Retrieved 25 May 2021.
  3. ^ a b "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[]

External links[]



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