Adalimumab-aatydrug info

0.4 ML adalimumab-aaty 100 MG/ML Auto-Injector [Yuflyma]

What it is used for

YUFLYMA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid arthritis. Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active p soriatic arthritis. Reducing signs and symptoms in adult patients with active ankylosing spondylitis. Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Treatment of moderately to severely active ulcerative colitis in adult patients.

Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

1.1 Rheumatoid

Arthritis YUFLYMA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. YUFLYMA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

1.2 Juvenile

Idiopathic Arthritis YUFLYMA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUFLYMA can be used alone or in combination with methotrexate.

1.3 Psoriatic

Arthritis YUFLYMA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUFLYMA can be used alone or in combination with non-biologic DMARDs.

1.4 Ankylosing

Spondylitis YUFLYMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

1.5 Crohn's

Disease YUFLYMA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.

1.6 Ulcerative

Colitis YUFLYMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers. 1.7 Plaque Psoriasis YUFLYMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. YUFLYMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

1.8 Hidradenitis

Suppurativa YUFLYMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis YUFLYMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 15, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Adalimumab-aaty is a tumor necrosis factor blocker. Adalimumab-aaty is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-aaty 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. YUFLYMA (adalimumab-aaty) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, auto-injector (YUFLYMA AI), as a single-dose, 1 mL prefilled syringe with safety guard, or a single-dose, 1 mL prefilled syringe. Enclosed within the auto-injector is a single-dose, 1 mL prefilled syringe. The solution of YUFLYMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of YUFLYMA contains adalimumab-aaty (80 mg), acetic acid (0.13 mg), glycine (15.02 mg), polysorbate 80 (0.8 mg), sodium acetate (0.48 mg) and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or prefilled syringe with safety guard or auto-injector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of YUFLYMA contains adalimumab-aaty (40 mg), acetic acid (0.06 mg), glycine (7.51 mg), polysorbate 80 (0.4 mg), sodium acetate (0.24 mg) and Water for Injection, USP. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of YUFLYMA contains adalimumab-aaty (20 mg), acetic acid (0.03 mg), glycine (3.75 mg), polysorbate 80 (0.2 mg), sodium acetate (0.12 mg) and Water for Injection, USP. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of YUFLYMA contains adalimumab-aaty (10 mg), acetic acid (0.02 mg), glycine (1.88 mg), polysorbate 80 (0.1 mg), sodium acetate (0.06 mg) and Water for Injection, USP.

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