Tumor Necrosis Factor Receptor Blocking Activity

Tumor Necrosis Factor Blocker

Arthritis, Rheumatoid

Colitis, Ulcerative

Crohn Disease

Spondylitis, Ankylosing

Arthritis, Psoriatic

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Infliximab-abda, the active ingredient in RENFLEXIS, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-abda is produced in a recombinant cell line and is purified by a series of steps that includes measures to inactivate and remove viruses.</p><p>RENFLEXIS (infliximab-abda) for Injection is supplied as a sterile, white, lyophilized powder for intravenous infusion. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 6. Each mL contains 10 mg infliximab-abda, dibasic sodium phosphate heptahydrate (0.12 mg), monobasic sodium phosphate monohydrate (0.63 mg), polysorbate 80 (0.05 mg), and sucrose (50 mg). No preservatives are present.</p></section>

Renflexis

infliximab

infliximab-abda

infliximab-abda 100 MG Injection

infliximab-abda 100 MG Injection [Renflexis]

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

Instructions For Use: Crohn's Disease 

Instructions For Use: Pediatric Crohn's Disease 

Instructions For Use: Ulcerative Colitis 

Instructions For Use: Pediatric Ulcerative Colitis 

Instructions For Use: Rheumatoid Arthritis 

Instructions For Use: Plaque Psoriasis 

Instructions For Use: Psoriatic Arthritis

Instructions For Use: Ankylosing Spondylitis

Prescribing Information

Medication Guide 

Pharmacy List 

PA Checklist 

Coverage Authorization Request 

Appeals Checklist 

Coverage Authorization Appeals

Organon Access Program Application 

Organon Access Program Application - Online [For pts in office]

Organon Access Program Application - Online [For pts not in office]

Enroll in Patient Savings Program 

Patient Assistance Program 

Other HCP Resources 

Patient Brochure 

Patient Brochure - Spanish

Transition Guide 

Transition Guide - Spanish

About Renflexis 

Side Effects 

Receiving Renflexis 

What Are Biosimilars?

Transition To Renflexis 

FAQs: All Indications 

Patient Resources 

Doctor Discussion Guide 

Doctor Discussion Guide - Spanish