Adalimumab-adazdrug info

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

What it is used for

HYRIMOZ 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 rheumatoid 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 psoriatic 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 HYRIMOZ 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. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

1.2 Juvenile

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

1.3 Psoriatic

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

1.4 Ankylosing

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

1.5 Crohn’s

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

1.8 Hidradenitis

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

1.6 Ulcerative

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

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 17, 2025. 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-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell 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. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary 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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