Gonadotropin Releasing Hormone Receptor Antagonists

Gonadotropin Releasing Hormone Receptor Antagonist

Cytochrome P450 2C19 Inhibitors

P-Glycoprotein Inhibitors

Cytochrome P450 3A Inducers

Abdominal Pain

<section class="Section" data-sectioncode="34089-3"><a name="section-10"></a><h1>11 DESCRIPTION</h1>ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium is a nonpeptide small molecule, GnRH receptor antagonist. Elagolix sodium is chemically described as sodium 4-({(1R)-2-[5-(2-fluoro-3-methoxyphenyl)-3-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-4-methyl-2,6-dioxo-3,6-dihydropyrimidin-1(2H)-yl]-1-phenylethyl}amino)butanoate. Elagolix sodium has a molecular formula of C32H29F5N3O5Na and a molecular weight of 653.58. Elagolix free acid has a molecular weight of 631.60. Elagolix sodium has the following structural formula: <img alt="Elagolix sodium has the following structural formula" src="orilissa-elagolix-tablets-for-oral-use-03.jpg"/>Elagolix sodium is a white to off white to light yellow powder and is freely soluble in water. ORILISSA 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium (equivalent to 150 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and carmine high tint. ORILISSA 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium (equivalent to 200 mg of elagolix) as the active ingredient and the following inactive ingredients: mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red. </section>

Orilissa

elagolix

elagolix 150 MG Oral Tablet

elagolix 150 MG Oral Tablet [Orilissa]

elagolix 200 MG Oral Tablet

elagolix 200 MG Oral Tablet [Orilissa]

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Instructions For Use: Moderate to Severe Pain due to Endometriosis

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