Non-Nucleoside Reverse Transcriptase Inhibitors

Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor

HIV Integrase Inhibitors

Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor

Organic Cation Transporter 2 Inhibitors

Multidrug and Toxin Extrusion Transporter 1 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/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 402.88 g/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

rilpivirine

dolutegravir

dolutegravir / rilpivirine

dolutegravir 50 MG / rilpivirine 25 MG Oral Tablet

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

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 

Coverage Authorization Request 

Coverage Authorization Appeals 

Letter of Medical Necessity

ViiVConnect Enrollment Form 

ViiVConnect Online Portal - HCP Office 

Enroll in Patient Savings Program 

Common Patient Assistance Program Application (CPAPA)

Reimbursement Information

About Juluca

Side Effects

Doctor Discussion Guide 

Patient Stories 

Patient Resources 

Instructions For Use: HIV