Adalimumab-aacfdrug info

0.8 ML adalimumab-aacf 50 MG/ML Prefilled Syringe

What it is used for

Adalimumab-aacf is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): 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 RA. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. Crohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC): 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. Plaque Psoriasis (Ps): 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. Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

1.1 Rheumatoid

Arthritis Adalimumab-aacf 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. Adalimumab-aacf can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

1.2 Juvenile

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

1.3 Psoriatic

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

1.4 Ankylosing

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

1.5 Crohn's

Disease Adalimumab-aacf 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 Adalimumab-aacf 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

Adalimumab-aacf 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. Adalimumab-aacf should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

1.8 Hidradenitis

Suppurativa Adalimumab-aacf is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

1.9 Uveitis

Adalimumab-aacf is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective January 8, 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-aacf is a tumor necrosis factor blocker. Adalimumab-aacf 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-aacf 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. Adalimumab-aacf injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-aacf Pen), as a single-dose, 1 mL or prefilled glass syringe or as a single dose institutional use vial kit. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-aacf is clear and colorless to pale yellow, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled pen, or institutional use vial kit delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-aacf contains adalimumab-aacf (40 mg) and glacial acetic acid (0.5 mg), trehalose (54.8 mg), polysorbate 80 (0.8 mg), sodium chloride (2.3 mg), and Water for Injection. Sodium hydroxide is added to adjust pH.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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