Tumor Necrosis Factor Blocker

Tumor Necrosis Factor Receptor Blocking Activity

Juvenile Arthritis

Rheumatoid Arthritis

Ulcerative Colitis

Crohn Disease

Ankylosing Spondylitis

Uveitis

Psoriatic Arthritis

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-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody 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>CYLTEZO (adalimumab-adbm) injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (CYLTEZO Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of CYLTEZO is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5.</p><p>Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP.</p><p>Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of CYLTEZO contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP.</p><p>Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of CYLTEZO contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP.</p><p>Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of CYLTEZO contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</p></section>

Cyltezo

0.2 ML adalimumab-adbm 50 MG/ML Prefilled Syringe

0.2 ML adalimumab-adbm 50 MG/ML Prefilled Syringe [Cyltezo]

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

0.4 ML adalimumab-adbm 100 MG/ML Auto-Injector [Cyltezo]

0.4 ML adalimumab-adbm 100 MG/ML Prefilled Syringe

0.4 ML adalimumab-adbm 100 MG/ML Prefilled Syringe [Cyltezo]

0.4 ML adalimumab-adbm 50 MG/ML Prefilled Syringe

0.4 ML adalimumab-adbm 50 MG/ML Prefilled Syringe [Cyltezo]

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

0.8 ML adalimumab-adbm 50 MG/ML Auto-Injector [Cyltezo]

0.8 ML adalimumab-adbm 50 MG/ML Prefilled Syringe

0.8 ML adalimumab-adbm 50 MG/ML Prefilled Syringe [Cyltezo]

adalimumab

adalimumab-adbm

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Rheumatoid Arthritis (RA) Dosing Guide

Juvenile Idiopathic Arthritis (JIA) Dosing Guide

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Ankylosing Spondylitis (AS) Dosing Guide

Crohn’s Disease (CD) Dosing Guide

Ulcerative Colitis (UC) Dosing Guide

Plaque Psoriasis (PsO) Dosing Guide

Hidradenitis Suppurativa (HS) Dosing Guide

Adult Uveitis (UV) Dosing Guide

Instructions For Use: Rheumatoid Arthritis (RA)

Instructions For Use: Juvenile Idiopathic Arthritis (JIA)

Instructions For Use: Psoriatic Arthritis (PsA)

Instructions For Use: Ankylosing Spondylitis (AS)

Instructions For Use: Crohn’s Disease (CD)

Instructions For Use: Ulcerative Colitis (UC)

Instructions For Use: Hidradenitis Suppurativa (HS)

Instructions For Use: Adult Uveitis (UV) 

Instructions For Use: Plaque Psoriasis (PsO)

Cyltezo prior authorization forms by payer