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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Rheumatoid Arthritis in Adults

Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis. Use alone or in combination with methotrexate or other DMARDs.

Psoriatic Arthritis

Used to manage the signs and symptoms of active arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with psoriatic arthritis. Use alone or in combination with other DMARDs.

Ankylosing Spondylitis

Management of the signs and symptoms of active ankylosing spondylitis.

Dosage and Administration

General

• Methotrexate, other DMARDs, corticosteroids, salicylates, NSAIAs, and analgesics may be continued.

Administration

Sub-Q Injection

Administer by sub-Q injection every other week or every week.

Administer sub-Q injections into thighs or abdomen; do not make abdominal injections within 5.18 cm (2 inches) of the umbilicus. Rotate injection sites. Give new injections ≥2.54 cm (1 inch) from an old site; do not make injections into areas where the skin is tender, bruised, red, or hard, or into scars or stretch marks.

Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up as necessary. The initial self-administered dose should be made under the supervision of a health-care professional.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Adults

Rheumatoid Arthritis

Sub-Q

40 mg once every other week.

Patients not receiving methotrexate may obtain additional benefit from once weekly doses of 40 mg.

Psoriatic Arthritis

Sub-Q

40 mg once every other week.

Ankylosing Spondylitis

Sub-Q

40 mg once every other week.

Cautions

Contraindications

• Known hypersensitivity to adalimumab or any ingredient in the formulation.

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Infectious Complications

Serious, sometimes fatal infections (including sepsis, tuberculosis, and opportunistic infections) reported, particularly in patients receiving concomitant therapy with immunosuppressive agents that, in addition to rheumatoid arthritis, could have predisposed them to infections. Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) and invasive opportunistic fungal infections reported in patients receiving adalimumab or other TNF blocking agents.

Do not initiate adalimumab in patients with active infections, including chronic or localized infections. Exercise caution when considering adalimumab therapy in patients with a history of recurring infections or with underlying conditions that may predispose to infections.

Discontinue adalimumab if serious infection develops. Closely monitor any patient who develops a new infection.

Caution advised if adalimumab therapy is considered in patients who reside in regions where tuberculosis or histoplasmosis is endemic.

Evaluate all patients for active or latent tuberculosis prior to initiation of therapy. When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to adalimumab therapy. Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.

Increased incidence of serious infection observed with concomitant use of etanercept (another agent that blocks TNF) and anakinra (a human interleukin-1 receptor antagonist). Similar toxicities expected with use of anakinra and other agents that block TNF, including adalimumab. (See Specific Drugs under Interactions.)

Increased incidence of infection and serious infection reported with concomitant use of a TNF blocking agent and abatacept. (See Specific Drugs under Interactions.)

Hepatitis B Virus (HBV) Reactivation

Reactivation of HBV infection reported in patients who are chronic carriers of the virus (i.e., hepatitis B surface antigen-positive [HBsAg-positive]). Death reported in a few individuals. Use of multiple immunosuppressive agents may contribute to HBV reactivation.

Screen patients at risk prior to initiation of therapy. Evaluate and monitor HBV carriers before, during, and for up to several months after therapy. Safety and efficacy of antiviral therapy for prevention of HBV reactivation not established. Discontinue adalimumab and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs. Not known whether adalimumab can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.

Nervous System Effects

Exacerbation of clinical manifestations and/or radiographic evidence of demyelinating disorders, including multiple sclerosis, reported rarely in patients receiving adalimumab or other TNF blocking agents.

Exercise caution when considering adalimumab therapy in patients with preexisting or recent-onset CNS demyelinating disorders.

Malignancies and Lymphoproliferative Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Lymphoma reported more frequently in patients receiving adalimumab or other TNF blocking agents than in control patients. Patients with rheumatoid arthritis, especially those with highly active disease, may be at increased risk of lymphoma; role of TNF blocking agents in the development of malignancies not fully determined.

Other malignancies (e.g., breast, colorectal, lung, prostate, melanoma, and nonmelanoma skin cancer) have occurred.

Hematologic Effects

Possible pancytopenia (including aplastic anemia), leukopenia, or thrombocytopenia. Consider discontinuance in patients with confirmed hematologic abnormalities.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis reported rarely. Other allergic reactions (e.g., allergic rash, anaphylactoid reactions, fixed drug eruption, nonspecified drug reaction, urticaria) also observed.

If serious allergic reaction or anaphylaxis occurs, immediately discontinue adalimumab and initiate appropriate therapy.

Latex Sensitivity

The needle cover of prefilled syringes of adalimumab contains dry natural rubber (latex) and should not be handled by individuals sensitive to latex.

General Precautions

Cardiovascular Effects

Worsening CHF and new-onset CHF reported in patients receiving adalimumab or other TNF blocking agents. Use with caution and carefully monitor patients with heart failure.

Immunologic Reactions and Antibody Formation

Possible formation of autoimmune antibodies. Lupus-like syndrome reported. If manifestations suggestive of lupus-like syndrome develop, discontinue adalimumab.

Antibodies to adalimumab may develop. Long-term immunogenicity remains to be determined.

Immunosuppression

No evidence of depression of delayed-type hypersensitivity, decrease in immunoglobulin concentrations, or change in the enumeration of effector cell populations, monocytes/macrophages, or neutrophils observed.

Safety and efficacy in patients with immunosuppression not evaluated.

Specific Populations

Pregnancy

Category B.

Pregnancy registry at 877-311-8972.

Lactation

Not known whether adalimumab is distributed into milk or is absorbed systemically following ingestion. Discontinue nursing or the drug.

Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Safety and efficacy not established in children <18 years of age.

Geriatric Use

No substantial differences in efficacy relative to younger adults.

The incidence of serious infection and malignancy in adalimumab-treated patients >65 years of age is higher than the incidence in younger adults. The overall incidence of infection and malignancy is higher in the geriatric population in general than in younger adults; use with caution.

Common Adverse Effects

Upper respiratory tract infection, injection site pain, headache, rash, sinusitis.