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

HIV Protease Inhibitors

Protease Inhibitor

Acquired Immunodeficiency Syndrome

HIV Infections

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>PREZCOBIX ®is a fixed-dose combination tablet containing darunavir and cobicistat. Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family. PREZCOBIX tablets are for oral administration. Each tablet contains darunavir ethanolate equivalent to 800 mg of darunavir and 150 mg of cobicistat. The tablets include the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and silicified microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.<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="prezcobix-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 776.0. It has the following structural formula: <div class="Figure"><img alt="Chemical Structure" src="prezcobix-02.jpg"/></div></div></section>

PREZCOBIX

cobicistat

cobicistat / darunavir

cobicistat 150 MG / darunavir 800 MG Oral Tablet

Prezcobix

cobicistat 150 MG / darunavir 800 MG Oral Tablet [Prezcobix]

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 

Pharmacy List 

Formulary Information

Benefits Investigation Form 

Business Associate Agreement [Mandatory For HCP Office]

Janssen Patient Support Program Patient Authorization Form

Coverage Authorization Request 

Coverage Authorization Appeals 

Formulary Exception Checklist 

Formulary Exception Checklist - Spanish 

Letter of Medical Necessity 

Janssen Care Path - HCP Office Portal

Enroll in Patient Savings Program 

J & J Patient Assistance Foundation Eligibility Check 

Instructions for Use: HIV 

Submit MSL Request 