Relugolix/estradiol/norethisterone acetate
| Combination of | |
|---|---|
| Relugolix | GnRH antagonist |
| Estradiol (medication) | Estrogen |
| Norethisterone acetate | Progestogen |
| Clinical data | |
| Trade names | Myfembree |
| Other names | RGX/E2/NETA; MVT-601 |
| License data | |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| 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 2 3 4 5 6 7 8 9 https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214846s000lbl.pdf
- 1 2 3 4 "Ryeqo: Pending EC decision". European Medicines Agency (EMA). 20 May 2021. Retrieved 25 May 2021.
- 1 2 "Myfembree: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 26 May 2021.
- ↑ "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
- Al-Hendy A, Lukes AS, Poindexter AN, Venturella R, Villarroel C, Critchley HO, et al. (February 2021). "Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy". N Engl J Med. 384 (7): 630–42. doi:10.1056/NEJMoa2008283. PMC 8262231. PMID 33596357.
External links
- "Relugolix". Drug Information Portal. U.S. National Library of Medicine.
- "Estradiol". Drug Information Portal. U.S. National Library of Medicine.
- "Norethindrone acetate". Drug Information Portal. U.S. National Library of Medicine.
- Relugolix Combination Therapy - Myovant Sciences
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