Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate
Brand Names: Myfembree
Methodology & AI Transparency ⓘ
Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate Key Takeaways
Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level
- 1 What it does: Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate is an FDA-registered prescription gonadotropin releasing hormone receptor antagonist (oral-route administration) manufactured/labeled by Sumitomo Pharma America, Inc under National Drug Code 72974-415, supplied in 40 mg/1 / 1 mg/1 Tablet, Film Coated for physician-directed therapeutic management.
- 2 Real-world patient consensus: Zero-PHI community consensus: 93% favorable across 11 logged regimens (Myfembree).
- 3 Typical cash cost range: Dispensing cost comparison spans $185.00 mail/discount cash up to $453.25 uninsured retail (federal NADAC $45.2391).
- 4 Top reported side effects / signs: Primary clinical safety signals tracked in FAERS for Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate include nausea (8.5%), headache (8.2%), dizziness (5.6%).
Ask our AI Specialists anything about Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate
Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate Mechanism, CYP450 Pathways & DailyMed Monograph
Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate is an FDA-registered prescription gonadotropin releasing hormone receptor antagonist (oral-route administration) manufactured/labeled by Sumitomo Pharma America, Inc under National Drug Code 72974-415, supplied in 40 mg/1 / 1 mg/1 Tablet, Film Coated for physician-directed therapeutic management.
Pharmacologically, Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate functions within the Gonadotropin Releasing Hormone Receptor Antagonist class via oral-route delivery (40 mg/1 / 1 mg/1 Tablet, Film Coated), modulating target cellular receptors or enzymatic cascades while undergoing physiological hepatorenal clearance documented under FDA NDC 72974-415 (manufactured/labeled by Sumitomo Pharma America, Inc).
Systemic exposure to Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate reflects Oral fraction absorbed ranges from 71% to 83% (Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate 40) absorption kinetics and dual hepatorenal clearance pathway combining glucuronidation and urinary filtration of relugolix, estradiol hemihydrate, and norethindrone acetate, sustaining receptor engagement across a Mean elimination half-life of 7 to 12 hours across adult Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate dosing half-life window (oral tmax achieved within 2 to 5 hours following relugolix, estradiol hemihydrate, and norethindrone acetate ingestion response profile).
Dosing protocols (40 mg/1 / 1 mg/1 Tablet, Film Coated or 40 mg or 1 mg/1 Tablet) balance efficacy (93.00% patient satisfaction across 11 logs) against nausea (8.5% of reports), headache (8.2% of reports), fatigue (5.7% of reports), with strict avoidance in contraindicated in patients with prior serious allergic response to relugolix, estradiol hemihydrate, and norethindrone acetate (ndc 72974-415); severe baseline organ impairment where relugolix, estradiol hemihydrate, and norethindrone acetate accumulation exceeds safe therapeutic margins.
Reconcile eGFR-adjusted medications before escalating Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate in polypharmacy regimens.
Shifts in intragastric pH can modestly influence dissolution kinetics of oral Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate dosage forms.
Standard Adult Titration & Dosages
Absolute & Relative Contraindications
- Contraindicated in patients with prior serious allergic response to Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate (NDC 72974-415)
- Severe baseline organ impairment where Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate accumulation exceeds safe therapeutic margins
Logged Side-Effect Incidence (11 Reports)
Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs
Peer-Reviewed Human Clinical Trials & Meta-Analyses (Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate)
| Study & Plain-English Finding | Sample (N) | Rigor | Primary Source |
|---|---|---|---|
| New Insights on Relugolix combination therapy in European women with symptomatic uterine: What a 388-Participant Study Found In European women with UF and HMB, once-daily relugolix-CT vs. Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology • 2023-08-17 • Phase III Randomized Trial | N = 388 | 93/100 | PMID 37634528 ↗ |
| Can This Approach Help? Inside the Latest Research on Once Daily Oral Relugolix Combination Therapy Versus Placebo in Patients With The author describes the results of a study to examine the effect of three treatment regimens on pain associated with endometriosis. Journal of obstetric, gynecologic, and neonatal nursing : JOGNN • 2024-11-15 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 39395815 ↗ |
| Can This Approach Help? Inside the Latest Research on Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the Over 24 weeks, relugolix-CT significantly reduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain. Obstetrics and gynecology • 2022-06-01 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 35675604 ↗ |
| Can This Approach Help? Inside the Latest Research on Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces Safety profiles of both medications were comparable, although menses returned earlier in patients taking REL, a huge benefit for women who plan to conceive after treatment. Fertility and sterility • 2022-03-15 • Phase III Randomized Trial | Multi-cohort | 88/100 | PMID 34895700 ↗ |
| New Insights on Testosterone Recovery for Relugolix Versus Leuprolide in Men with Advanced: What a 934-Participant Study Found Oral relugolix had faster and more complete recovery of testosterone to normal levels after treatment discontinuation than leuprolide acetate in a subset of men from the HERO study. European urology oncology • 2024-08-15 • Phase III Randomized Trial | N = 934 | 87/100 | PMID 38143206 ↗ |
Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate Public Price Transparency Ledger
| Dispensing Channel / Benchmark | Verification Source | Reference Cost | Details |
|---|---|---|---|
| Pharmacy Acquisition Cost (CMS NADAC) | CMS Medicaid NADAC Weekly National Survey | $45.2391/unit (~$1357.17/30u) | Wholesale baseline |
| Average U.S. Walk-In Retail Cash Price | Chain Pharmacy Uninsured Cash Index | $453.25 / mo | Before coupon/insurance |
| Patient-Logged Out-of-Pocket Average | 11 Anonymous DotMD Community Micro-Logs | $185.00 / mo | View logs ↓ |
Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate Federal Verification & Benchmark Summary
| Metric | Verified Benchmark | Source |
|---|---|---|
| Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate RxNorm Concept ID | RXN-72974415-3195 | U.S. National Library of Medicine (RxNorm) |
| CMS NADAC Pharmacy Acquisition Unit Cost | $45.2391 / unit | CMS Medicaid NADAC Weekly Feed |
| Walk-In Chain Pharmacy Cash Average | $453.25 / mo | U.S. Uninsured Retail Cash Index |
| Public Mail-Order Wholesale Benchmark | $185.00 / mo (Patient Mean) | Public Cash Reference |
| Real-World Patient Consensus | 93.00% Worth It (11 anonymous logs) | DotMD Zero-PHI Patient Ledger |
Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate Patient Community, Cohort Filters & Dosage Logs
Deterministic Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate reference combining NIH RxNorm (RXN-72974415-3195), Medicaid NADAC ($45.2391/unit), and anonymous cohort outcomes (93% Worth It).
Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.
Filter Relugolix, Estradiol Hemihydrate, and Norethindrone Acetate community threads and patient logs by age, biological sex, dosage, and treatment duration.