What Is Humira®?(adalimumab) | HealthInfi

What is Humira?

Humira (adalimumab) is a tumor necrosis factor (TNF) blocker that reduces the effects of a substance in the body that can cause inflammation.

Humira is used to reduce the signs and symptoms of moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and and a chronic skin condition called hidradenitis suppurativa. It is also used reduce the signs and symptoms of moderately to severely active Crohn’s disease or moderately to severely active ulcerative colitis, after other drugs have been tried without successful treatment of symptoms.

Humira is also used to treat non-infectious intermediate, posterior and panuveitis in adult patients.

HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). HUMIRA was 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 is produced by recombinant DNA technology in a mammalian 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.

HUMIRA is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use, prefilled pen (HUMIRA Pen), as a single-use, 1 mL prefilled glass syringe, or as a single-use institutional use vial. Enclosed within the pen is a single-use, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2.

Each 80 mg/0.8 mL prefilled syringe delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab 80 mg, mannitol 33.6 mg, polysorbate 80 0.8 mg, and Water for Injection, USP.

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 HUMIRA contains adalimumab 40 mg, mannitol 16.8 mg, polysorbate 80 0.4 mg, and Water for Injection, USP.

Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-use institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab 40 mg, citric acid monohydrate 1.04 mg, dibasic sodium phosphate dihydrate 1.22 mg, mannitol 9.6 mg, monobasic sodium phosphate dihydrate 0.69 mg, polysorbate 80 0.8 mg, sodium chloride 4.93 mg, sodium citrate 0.24 mg and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.

Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab 20 mg, citric acid monohydrate 0.52 mg, dibasic sodium phosphate dihydrate 0.61 mg, mannitol 4.8 mg, monobasic sodium phosphate dihydrate 0.34 mg, polysorbate 80 0.4 mg, sodium chloride 2.47 mg, sodium citrate 0.12 mg and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.

Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab 10 mg, citric acid monohydrate 0.26 mg, dibasic sodium phosphate dihydrate 0.31 mg, mannitol 2.4 mg, monobasic sodium phosphate dihydrate 0.17 mg, polysorbate 80 0.2 mg, sodium chloride 1.23 mg, sodium citrate 0.06 mg and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.

Important information

Some people using Humira have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. Humira can also lower blood cells that help your body fight infections and help your blood to clot. Serious and sometimes fatal infections may occur during treatment with Humira.

Call your doctor at once if you have symptoms such as fever, night sweats, weight loss, feeling full after eating only a small amount, pain in your upper stomach, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes).

Humira can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with Humira. Tell your doctor at once if you develop signs of infection.Read More