Gonadotropin Releasing Hormone Receptor Antagonists

Gonadotropin Releasing Hormone Receptor Antagonist

P-Glycoprotein Inhibitors

Cytochrome P450 2B6 Inducers

Breast Cancer Resistance Protein Inhibitors

Cytochrome P450 3A Inducers

Estrogen Receptor Agonists

Estrogen

Progestin

Acne Vulgaris

Breast Neoplasms

Endometrial Hyperplasia

Endometriosis

Hypogonadism

Menopause, Premature

Menorrhagia

Prostatic Neoplasms

Primary Ovarian Insufficiency

Hot Flashes

<section class="Section" data-sectioncode="34089-3"><a name="s73"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">MYFEMBREE tablets for oral administration contain a fixed-dose combination of relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg as active ingredients.</p><p>Relugolix is a non-peptide small molecule, GnRH receptor antagonist. It is a white to off white to slightly yellow solid and is sparingly soluble in water. The chemical name is N-(4-{1-[(2,6-difluorophenyl)methyl]-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl}phenyl)-N-methoxyurea with the empirical formula of C<span class="Sub">29</span>H<span class="Sub">27</span>F<span class="Sub">2</span>N<span class="Sub">7</span>O<span class="Sub">5</span>S and a molecular weight of 623.63. The structural formula is:</p><div class="Figure"><a name="f01"></a><img alt="Structural Formula
" src="myf00-0000-01.jpg"/></div><p>Estradiol (E2), an estrogen, is present as the hemihydrate (C<span class="Sub">18</span>H<span class="Sub">24</span>O<span class="Sub">2</span>•½H<span class="Sub">2</span>O) which is a white or almost white crystalline powder. Its chemical name is estra-1, 3, 5 (10)-triene-3, 17β-diol with the empirical formula of C<span class="Sub">18</span>H<span class="Sub">24</span>O<span class="Sub">2</span> and a molecular weight of 272.4. The structural formula is:</p><div class="Figure"><a name="f02"></a><img alt="Structural Formula
" src="myf00-0000-02.jpg"/></div><p>Norethindrone acetate (NETA), a progestin, is a white or yellowish-white crystalline powder. Its chemical name is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate with the empirical formula of C<span class="Sub">22</span>H<span class="Sub">28</span>O<span class="Sub">3</span> and a molecular weight of 340.5. The structural formula is:</p><div class="Figure"><a name="f03"></a><img alt="Structural Formula
" src="myf00-0000-03.jpg"/></div><p>Each MYFEMBREE (relugolix, estradiol, and norethindrone acetate) film-coated tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, iron oxide yellow, lactose monohydrate, mannitol, magnesium stearate, sodium starch glycolate, titanium dioxide, and triacetin.</p></section>

Myfembree

relugolix

estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet

estradiol 1 MG / norethindrone acetate 0.5 MG / relugolix 40 MG Oral Tablet [Myfembree]

estradiol / norethindrone / relugolix

norethindrone acetate

estradiol

norethindrone

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event 

Prescribing Information 

Medication Guide 

Submit MSL Request 

Pharmacy List 

Formulary Information: Uterine Fibroids

Reimbursement Information

Coverage Authorization Request 

Coverage Authorization Appeals 

Letter of Medical Necessity 

Medical Necessity Checklist 

Myfembree Support Enrollment Form 

Enroll in Patient Savings Program 

Myovant Patient Assistance Program 

About Myfembree: Uterine Fibroids 

About Myfembree: Endometriosis 

Taking Myfembree: Uterine Fibroids 

Taking Myfembree: Endometriosis 

Doctor Discussion Guide: Uterine Fibroids 

Doctor Discussion Guide: Endometriosis

Myfembree Support Program Enrollment

Instructions For Use: Uterine Fibroids

Instructions For Use: Endometriosis 