HIV Integrase Inhibitors

Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor

Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor

Multidrug and Toxin Extrusion Transporter 1 Inhibitors

Non-Nucleoside Reverse Transcriptase Inhibitors

Organic Cation Transporter 2 Inhibitors

HIV Infections

<section class="Section" data-sectioncode="34089-3"><a name="ID_dbd162e9-2039-4b8c-b0a1-7b83a74c1bec"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION </h1><p class="First">JULUCA is a fixed-dose combination tablet containing dolutegravir (as dolutegravir sodium), an INSTI, and rilpivirine (as rilpivirine hydrochloride), an NNRTI. </p><p>The chemical name of dolutegravir sodium is sodium (4<span class="Italics">R</span>,12a<span class="Italics">S</span>)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2<span class="Italics">H</span>-pyrido[1',2':4,5]pyrazino[2,1-<span class="Italics">b</span>][1,3]oxazin-7-olate. The empirical formula is C<span class="Sub">20</span>H<span class="Sub">18</span>F<span class="Sub">2</span>N<span class="Sub">3</span>NaO<span class="Sub">5</span> and the molecular weight is 441.36 g per mol. It has the following structural formula:</p><div class="Figure"><a name="id645168608"></a><img alt="dolutegravir sodium chemical structure " src="juluca-spl-graphic-01.jpg"/></div><p>Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water.</p><p>The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C<span class="Sub">22</span>H<span class="Sub">18</span>N<span class="Sub">6</span> • HCl and its molecular weight is 402.88g per mol. Rilpivirine hydrochloride has the following structural formula:</p><div class="Figure"><a name="id462393071"></a><img alt="rilpivirine hydrochloride chemical structure" src="juluca-spl-graphic-02.jpg"/></div><p>Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range.</p><p>JULUCA tablets are for oral administration. Each film-coated tablet contains the active ingredients 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride) and the inactive ingredients croscarmellose sodium, D-mannitol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone K29/32 and K30, silicified microcrystalline cellulose, sodium starch glycolate, and sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients iron oxide red, iron oxide yellow, macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.</p></section>

Juluca

dolutegravir

dolutegravir / rilpivirine

dolutegravir 50 MG / rilpivirine 25 MG Oral Tablet

dolutegravir 50 MG / rilpivirine 25 MG Oral Tablet [Juluca]

rilpivirine

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