Cytochrome P450 2D6 Inhibitors

P-Glycoprotein Inhibitors

Organic Anion Transporting Polypeptide 1B1 Inhibitors

Organic Anion Transporting Polypeptide 1B3 Inhibitors

Breast Cancer Resistance Protein Inhibitors

Cytochrome P450 3A Inhibitors

Cytochrome P450 3A Inhibitor

Multidrug and Toxin Extrusion Transporter 1 Inhibitors

Nucleoside Reverse Transcriptase Inhibitors

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor

HIV Protease Inhibitors

Protease Inhibitor

Acquired Immunodeficiency Syndrome

HIV Infections

Hepatitis B, Chronic

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11. DESCRIPTION</h1>SYMTUZA ®(darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) is a fixed-dose combination tablet. <ul class="Disc"><li>Darunavir is an inhibitor of the HIV-1 protease.</li><li>Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.</li><li>Emtricitabine, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI).</li><li>Tenofovir alafenamide, an HIV NRTI, is converted in vivoto tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. </li></ul>SYMTUZA tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine, and 11.2 mg of tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide. The tablets include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and yellow ferric oxide.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>Darunavir: Darunavir, in the form of darunavir ethanolate, has the following chemical name: [(1 S,2 R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-carbamic acid (3 R,3a S,6a R)-hexahydrofuro[2,3- b]furan-3-yl ester monoethanolate. Its molecular formula is C 27H 37N 3O 7S ∙ C 2H 5OH and its molecular weight is 593.73. Darunavir ethanolate has the following structural formula: <div class="Figure"><img alt="Chemical Structure" src="symtuza-01.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Cobicistat: Cobicistat is adsorbed onto silicon dioxide. The chemical name for cobicistat is 1,3-thiazol-5-ylmethyl[(2 R,5 R)-5-{[(2 S)-2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)amino]-4-(morpholin-4yl)butanoyl]amino}-1,6-diphenylhexan-2-yl]carbamate. It has a molecular formula of C 40H 53N 7O 5S 2and a molecular weight of 776.02. It has the following structural formula: <div class="Figure"><img alt="Chemical Structure" src="symtuza-02.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>Emtricitabine: The chemical name of emtricitabine is 4-amino-5-fluoro-1-(2 R-hydroxymethyl-[1,3]-oxathiolan-5 S-yl)-(1H)-pyrimidin-2-one. Emtricitabine is the (-)enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5 position. Emtricitabine has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.24. It has the following structural formula: <div class="Figure"><img alt="Chemical Structure" src="symtuza-03.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.4"></a>Tenofovir alafenamide: The chemical name of tenofovir alafenamide fumarate drug substance is L-alanine, N-[( S)-[[(1 R)-2-(6-amino-9 H-purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-,1-methylethyl ester, (2 E)-2-butenedioate (2:1). Tenofovir alafenamide fumarate has a molecular formula of C 21H 29O 5N 6P∙½(C 4H 4O 4) and a formula weight of 534.50. It has the following structural formula: <div class="Figure"><img alt="Chemical Structure" src="symtuza-04.jpg"/></div></div></section>

Symtuza

cobicistat

tenofovir alafenamide

cobicistat / darunavir / emtricitabine / tenofovir alafenamide

cobicistat 150 MG / darunavir 800 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet

cobicistat 150 MG / darunavir 800 MG / emtricitabine 200 MG / tenofovir alafenamide 10 MG Oral Tablet [Symtuza]

emtricitabine

darunavir

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

Online Sample Form 

Benefits Investigation Form 

Business Associate Agreement [Mandatory For HCP Office]

Janssen Patient Support Program Patient Authorization Form

Coverage Authorization Request 

Coverage Authorization Appeals 

Letter of Medical Necessity 

Appeals Considerations Checklist

Appeals Considerations Checklist - Spanish

Formulary Exception Request Letter 

Formulary Exception Request Letter - Spanish

PA Checklist 

Janssen Care Path - HCP Office Portal

Enroll in Patient Savings Program 

J & J Patient Assistance Foundation Eligibility Check 

Symply Start Program 

Other HCP Resources

About Symtuza 

Patient Stories 

Symtuza Support Source Program

Doctor Discussion Guide: Newly Diagnosed 

Doctor Discussion Guide: Patients Switching 

Patient Brochure: Newly Diagnosed

Patient Brochure: Patients Switching

Instructions For Use: HIV