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-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

adalimumab-adbm

0.8 ML adalimumab-adbm 50 MG/ML Prefilled Syringe

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

0.4 ML adalimumab-adbm 100 MG/ML Prefilled Syringe

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

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

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

adalimumab

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Psoriasis (PsO)

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Taltz

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