Tumor Necrosis Factor Receptor Blocking Activity

Tumor Necrosis Factor Blocker

Arthritis, Juvenile

Arthritis, Rheumatoid

Colitis, Ulcerative

Crohn Disease

Spondylitis, Ankylosing

Uveitis

Arthritis, Psoriatic

Hidradenitis Suppurativa

<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">Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. </p><p>AMJEVITA™ (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2.</p><p>Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2.</p><p>Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. </p><p>Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. </p><p>Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2.</p><p>Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2.</p><p>Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</p></section>

AMJEVITA

adalimumab-atto

0.4 ML adalimumab-atto 50 MG/ML Prefilled Syringe

Amjevita

0.4 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]

0.8 ML adalimumab-atto 50 MG/ML Auto-Injector

0.8 ML adalimumab-atto 50 MG/ML Auto-Injector [Amjevita]

0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe

0.8 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]

0.2 ML adalimumab-atto 50 MG/ML Prefilled Syringe

0.2 ML adalimumab-atto 50 MG/ML Prefilled Syringe [Amjevita]

0.2 ML adalimumab-atto 100 MG/ML Prefilled Syringe

0.2 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]

0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe

0.4 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]

0.4 ML adalimumab-atto 100 MG/ML Auto-Injector

0.4 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]

0.8 ML adalimumab-atto 100 MG/ML Prefilled Syringe

0.8 ML adalimumab-atto 100 MG/ML Prefilled Syringe [Amjevita]

0.8 ML adalimumab-atto 100 MG/ML Auto-Injector

0.8 ML adalimumab-atto 100 MG/ML Auto-Injector [Amjevita]

adalimumab

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

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 

Instructions For Use (Pre-filled Syringe): All Indications 

Pharmacy List 

Coverage Authorization Request 

Coverage Authorization Appeals 

Amgen Support Plus HCP Request Form 

Reimbursement Information

Amjevita Access Guide 

Enroll in Patient Savings Program 

Amgen Support Plus Program - Online 

Amgen Support Plus Program - (HCP office can sign patient up by faxing form in)

Other HCP Resources 

Amjevita Patient Brochure 

My Injection Journey 

About Amjevita 

Taking Amjevita 

Instructions For Use (SureClick Auto Injector): Rheumatoid Arthritis 

Instructions For Use (SureClick Auto Injector): Psoriatic Arthritis 

Instructions For Use (SureClick Auto Injector): Plaque Psoriasis

Instructions For Use (SureClick Auto Injector): Ankylosing Spondylitis (AS)

Instructions For Use (SureClick Auto Injector): Crohn's Disease

Instructions For Use (SureClick Auto Injector): Ulcerative Colitis 

Instructions For Use (SureClick Auto Injector):  Polyarticular Juvenile Idiopathic Arthritis (JIA)