Description

Each 0.4 mL pre-filled syringe contains: Adalimumab 40 mg.
Each 0.4 mL pre-filled pen contains: Adalimumab 40 mg.
Humira (adalimumab) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. Humira was created using phage display technology resulting in fully human heavy and light chain variable regions, which confer specificity to human tumor necrosis factor (TNF), and human IgG1 heavy chain and kappa light chain sequences. Humira binds with high affinity and specificity to soluble tumor necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system. 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 1 mL pre-filled glass syringe, 1 mL single-use glass vial or as a single-use pre-filled Pen (Humira Pen). Enclosed within the Pen is a single-use, 1 mL pre-filled glass syringe. The solution of Humira is clear and colorless, with a pH of about 5.2.
Inactive ingredients for Humira 40 mg per 0.8 mL (50 mg/mL) include: 4.93 mg sodium chloride, 0.69 mg monobasic sodium phosphate dihydrate, 1.22 mg dibasic sodium phosphate dihydrate, 0.24 mg sodium citrate, 1.04 mg citric acid monohydrate, 9.6 mg mannitol, 0.8 mg polysorbate 80, sodium hydroxide, as needed (for pH adjustment) and water for injection.
Inactive ingredients for Humira 40 mg per 0.4 mL (100 mg/mL) include: 16.8 mg mannitol, 0.4 mg polysorbate 80, and water for injection.
Inactive ingredients for Humira 80 mg per 0.8 mL (100 mg/mL) include: 33.6 mg mannitol, 0.8 mg polysorbate 80, and water for injection.