Adalimumab

Active ingredient: Adalimumab, a recombinant fully humanized tumor necrosis factor alpha monoclonal antibody expressed in Chinese hamster ovary cells. Molecular weight: 148,108plusmn;8Da Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide, water for injection.

This product has been studied as a monotherapy and in combination with methotrexate in patients with rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. Compared with monotherapy, this product produces lower antibodies when used with methotrexate. Not using methotrexate will increase antibody formation, accelerate clearance, and reduce the efficacy of adalimumab (see [Pharmacology and Toxicology] section). Combination of this product with anakinra is not recommended (see [Precautions] section for combination of this product with anakinra). Combination of this product with abatacept is not recommended (see [Precautions] section for combination of this product with abatacept). Drug compatibility Since drug compatibility studies have not been conducted, this product should not be used in combination with other drugs.

Active ingredient: Adalimumab, a recombinant fully humanized tumor necrosis factor α monoclonal antibody expressed in Chinese hamster ovary cells. Molecular weight: 148080.4±7.4Da Excipients: Glacial acetate, hydrochloric acid, histidine, methionine, hydrochloric acid, arginine, polysorbate 80, sodium hydroxide, water for injection

Methotrexate Adalimumab has been studied as a monotherapy and in combination with methotrexate in patients with rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. Adalimumab produces less antibodies when used concomitantly with methotrexate than as monotherapy. Not taking methotrexate can result in increased antibody formation, more rapid clearance, and reduced efficacy of adalimumab. Although methotrexate decreases the apparent clearance of adalimumab, based on current evidence, no dose adjustment of adalimumab or methotrexate is recommended. Biologics Combination therapy with adalimumab and anakinra is not recommended (see Precautions). Combination therapy with abatacept is not recommended (see Precautions). A higher incidence of serious infections has been observed in RA patients who were treated with rituximab and subsequently with a TNF antagonist. There is insufficient information on the concomitant use of adalimumab and other biologics in patients with RA, PsA, AS, CD, UC, Ps, HS, and UV. It is not recommended to use this product in combination with other biological anti-rheumatic drugs or other TNF antagonists because this may increase the risk of infection and other potential drug interactions. Live vaccines Avoid using this product with live vaccines at the same time (see the [Precautions] section). Cytochrome P450 substrates Elevated levels of cytokines (such as TNFα, IL-6) during chronic inflammation may inhibit the production of CYP450 enzymes. Molecules that antagonize cytokine activity, such as adalimumab, may affect the production of CYP450 enzymes. Patients who are being treated with CYP450 substrates with a narrow therapeutic index are advised to monitor the treatment effect (such as warfarin) or drug concentration (such as cyclosporine or theophylline) since starting or stopping treatment with this product, and the individual dose of the drug can be adjusted as needed. Drug compatibility Since drug compatibility studies have not been conducted, this product cannot be mixed with other drugs.

Active ingredient: Adalimumab, a recombinant fully humanized tumor necrosis factor α monoclonal antibody expressed in Chinese hamster ovary cells. Molecular weight: about 148kDa Excipients: citric acid, sodium citrate, disodium hydrogen phosphate dihydrate, sodium chloride, sorbitol, polysorbate 80, phosphoric acid

Methotrexate Adalimumab has been studied as a monotherapy and in combination with methotrexate in patients with rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. Adalimumab produces less antibodies when used concomitantly with methotrexate than as monotherapy. Not using methotrexate can result in increased antibody formation, more rapid clearance, and reduced efficacy of adalimumab. Although methotrexate decreases the apparent clearance of adalimumab, based on current evidence, no dose adjustment of adalimumab or methotrexate is recommended. Biologics are not recommended for co-administration of adalimumab and anakinra (see the Precautions section). Co-administration of adalimumab and abatacept is not recommended (see the Precautions section). A higher incidence of serious infections has been observed in RA patients who were treated with rituximab and subsequently received a TNF antagonist. There is insufficient information regarding the concomitant use of adalimumab and other biologics in patients with RA, PsA, AS, CD, UC, Ps, HS, and UV. Coadministration of adalimumab with other biologic antirheumatic drugs or other TNF antagonists is not recommended because of the increased risk of infection and other potential drug interactions. Live vaccines Avoid the concomitant use of adalimumab with live vaccines (see Precautions). Cytochrome P450 substrates Elevated levels of cytokines (e.g., TNFα, IL-6) during chronic inflammation may inhibit the production of CYP450 enzymes. Molecules that antagonize cytokine activity, such as adalimumab, may affect the production of CYP450 enzymes. Patients who are being treated with CYP450 substrates with a narrow therapeutic index are advised to monitor the effect of treatment (e.g., warfarin) or drug concentrations (e.g., cyclosporine or theophylline) since starting or stopping adalimumab therapy, and individual doses of the drug may be adjusted as needed. Drug compatibility Adalimumab should not be used in combination with other drugs because drug compatibility studies have not been performed.