Brand name: Humira
Drug class: Disease-modifying Antirheumatic Drugs
- DMARDs
ATC class: L04AA17
VA class: MS190
Chemical name: Immunoglobulin G1, anti-(human tumor necrosis factor) (human monoclonal D2E7 heavy chain), disulfide with human monoclonal D2E7 light chain, dimer
CAS number: 331731-18-1.

Medically reviewed by Drugs.com on Mar 18, 2024. Written by ASHP.

Introduction

Tumor necrosis factor (TNF) inhibitor and biologic disease-modifying antirheumatic drug (DMARD); a recombinant DNA-derived human immunoglobulin G₁ (IgG₁) monoclonal antibody.

Rheumatoid Arthritis

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 in adults with moderate to severe disease. Use alone or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Disease-modifying treatments for rheumatoid arthritis include conventional DMARDs (e.g., hydroxychloroquine, leflunomide, methotrexate, sulfasalazine), biologic DMARDs (e.g., TNF blocking agents, abatacept, tocilizumab, sarilumab, rituximab), and/or targeted synthetic DMARDs (e.g., Janus kinase inhibitors).

Guidelines generally support use of TNF blocking agents as add-on therapy to methotrexate in patients who do not meet treatment goals with methotrexate alone.

Specific agents for rheumatoid arthritis are selected according to current disease activity, prior therapies used, and presence of comorbidities.

Juvenile Idiopathic Arthritis

Used to manage signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients ≥2 years of age. Use with or without methotrexate.

Drugs used to treat juvenile idiopathic arthritis include NSAIAs, systemic and intra-articular corticosteroids, conventional DMARDs (e.g., methotrexate, sulfasalazine, hydroxychloroquine, leflunomide), and biologic DMARDs (e.g., TNF blocking agents, abatacept, tocilizumab, rituximab).

Guidelines generally support use of TNF blocking agents, as add-on therapy in patients with moderate to high disease activity despite the use of methotrexate.

Specific agents for juvenile idiopathic arthritis treatment are selected according to presence of certain risk factors (e.g., positive anti-cyclic citrullinated peptide antibodies, positive rheumatoid factor, joint damage), level of disease activity, involvement of specific joints, presence of certain comorbidities (e.g., uveitis), and prior therapies.

Psoriatic Arthritis

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

Disease-modifying treatments for psoriatic arthritis include oral small molecules (OSMs; e.g., methotrexate, sulfasalazine, cyclosporine, leflunomide, apremilast), biologic DMARDs (e.g., TNF blocking agents, secukinumab, ixekizumab, ustekinumab, brodalumab, abatacept), and/or targeted synthetic DMARDs (e.g., tofacitinib).

Guidelines generally support use of TNF blocking agents as first-line treatment in patients with active psoriatic arthritis.

Recommendations for the use and selection of disease-modifying therapies in psoriatic arthritis vary based on the presence of certain disease characteristics (e.g., psoriatic spondylitis/axial disease, enthesitis) and comorbidities (e.g., inflammatory bowel disease, diabetes).

Ankylosing Spondylitis

Used to manage the signs and symptoms of active ankylosing spondylitis in adults.

Treatments for ankylosing spondylitis include NSAIAs, conventional DMARDs (e.g., methotrexate, sulfasalazine), biologic DMARDs (e.g., TNF blocking agents, secukinumab, ixekizumab), and/or targeted synthetic DMARDs (e.g., tofacitinib).

Guidelines generally support use of TNF blocking agents for treatment of ankylosing spondylitis in patients with active disease despite treatment with NSAIAs.

Recommendations for treatment selection in ankylosing spondylitis vary based the presence of certain comorbidities (e.g., iritis, inflammatory bowel disease).

Crohn Disease

Used to treat moderately to severely active Crohn disease in adults and pediatric patients ≥6 years of age.

Guidelines generally support use of TNF blocking agents for use as induction and maintenance therapy in adults with moderate to severe Crohn disease. Specific treatments are selected according to the patient’s risk profile and disease severity.

Role of TNF blocking agents in pediatric Crohn disease is generally induction and maintenance therapy in patients who fail an adequate trial of steroids and exclusive enteral nutrition and/or immunomodulators, unless the patient has a complex perianal fistula at diagnosis.

Has been used in a limited number of patients with fistulizing Crohn disease^{† [off-label]}. Has been used to prevent recurrence of Crohn disease after surgical treatment^{† [off-label]}, but place in therapy for this use remains to be determined.

Ulcerative Colitis

Used to treat moderately to severely active ulcerative colitis in adults and pediatric patients ≥5 years of age.

Guidelines generally support first-line use of TNF blocking agents for induction and maintenance of remission in adults with moderate to severe ulcerative colitis. Specific treatments are selected according to disease severity, disease location/extent, disease prognosis, and previous therapies used.

Role of TNF blocking agents in pediatric ulcerative colitis is generally in patients with moderate to severe disease who fail therapy with 5-aminosalicylates/azathioprine and/or who are unable to wean from corticosteroids on 5-aminosalicylate/azathioprine therapy.

Efficacy in patients who have lost response to or were intolerant to TNF blocking agents not established.

Plaque Psoriasis

Used to manage moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and in whom other systemic therapies are medically less appropriate. Use only in patients who will be closely monitored and who will have regular follow-up visits with a clinician.

Guidelines generally support use of TNF blocking agents in moderate to severe psoriasis, either as monotherapy or in combination with topical, oral, or phototherapy.

Recommendations for use and selection of psoriasis therapies vary based on patient age, disease characteristics (e.g., severity, location, presence of psoriatic arthritis), and comorbidities (e.g., inflammatory bowel disease).

Hidradenitis Suppurativa

Used to manage moderate to severe hidradenitis suppurativa in adults and pediatric patients ≥12 years of age.

Current guidelines recommend adalimumab to improve disease severity and quality of life in patients with moderate to severe hidradenitis suppurativa.

Uveitis

Management of noninfectious intermediate uveitis, posterior uveitis, and panuveitis in adults and pediatric patients ≥2 years of age.

Recommendations from an international expert panel support use of adalimumab in patients with noninfectious uveitis whose disease is inadequately controlled by corticosteroids and nonbiologic immunomodulatory therapies.

Adalimumab Dosage and Administration

General

Pretreatment Screening

• Evaluate all patients for active and inactive tuberculosis prior to initiating therapy.

• Screen at-risk patients for hepatitis B virus (HBV) infection before initiating therapy.

• Do not initiate therapy in patients with an active infection, including clinically important localized infections.

• Examine all patients for the presence of nonmelanoma skin cancer, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of psoralen and ultraviolet A radiation (PUVA) treatment.

Patient Monitoring

• Monitor patients closely for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock) during and after treatment; monitor for possible development of tuberculosis in patients who tested negative for latent tuberculosis prior to initiating therapy.

• Perform periodic dermatologic evaluations in all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment.

• Evaluate and monitor chronic carriers of HBV during treatment and for up to several months following treatment.

Dispensing and Administration Precautions

• To avoid medication errors, the Institute for Safe Medication Practices (ISMP) recommends that prescribers communicate both the brand and generic names for adalimumab on the prescription order form.

Other General Considerations

• Methotrexate, other nonbiologic disease-modifying antirheumatic drugs (DMARDs), corticosteroids, nonsteroidal anti-inflammatory agents (NSAIAs), and/or analgesics may be continued in adults receiving adalimumab for the management of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.

• Methotrexate, corticosteroids, NSAIAs, and/or analgesics may be continued in pediatric patients receiving adalimumab for the management of juvenile idiopathic arthritis.

• Aminosalicylates and/or corticosteroids may be continued in adults receiving adalimumab for the treatment of Crohn disease or ulcerative colitis. Azathioprine, mercaptopurine, or methotrexate may be continued, if necessary, in adults receiving adalimumab for the treatment of Crohn disease. Azathioprine and mercaptopurine may be continued, if necessary, in adults receiving adalimumab for the treatment of ulcerative colitis.

Sub-Q Injection

Available in prefilled syringes and prefilled injection pens; all are preservative free for single use only. Various packaging configurations of the prefilled syringes and prefilled injection pens are available, including single- or multiple-strength starter packages.

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

Adalimumab injection may sit outside of refrigeration for 15–30 minutes prior to administration to allow liquid to reach room temperature; do not remove the syringe needle cover or injection pen cap while the drug is warming to room temperature.

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

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. Administer the initial self-administered dose under the supervision of a health-care professional.

Dosage

Pediatric Patients

Juvenile Arthritis

Sub-Q

Pediatric patients ≥2 years of age weighing 10 to <15 kg: 10 mg once every other week.

Pediatric patients ≥2 years of age weighing 15 to <30 kg: 20 mg once every other week.

Pediatric patients ≥2 years of age weighing ≥30 kg: 40 mg once every other week.

Not studied for this use in patients <2 years of age or weighing <10 kg.

Crohn Disease

Sub-Q

Pediatric patients ≥6 years of age weighing 17 to <40 kg: 80 mg on day 1, followed by 40 mg once 2 weeks later (on day 15). Start maintenance dosage of 20 mg once every other week on day 29 (2 weeks after the 40-mg dose).

Pediatric patients ≥6 years of age weighing ≥40 kg: 160 mg on day 1 (given in one day or divided over 2 consecutive days), followed by 80 mg once 2 weeks later (on day 15). Start maintenance dosage of 40 mg once every other week on day 29 (2 weeks after the 80-mg dose).

Ulcerative Colitis

Sub-Q

Pediatric patients ≥5 years of age weighing 20 to <40 kg: 80 mg on day 1, followed by 40 mg once on day 8 (1 week after the 80-mg dose) and 40 mg once on day 15 (1 week after the first 40-mg dose). Start maintenance dosage of 40 mg once every other week or 20 mg once every week on day 29 (2 weeks after the second 40-mg dose).

Pediatric patients ≥5 years of age weighing ≥40 kg: 160 mg on day 1 (given in one day or divided over 2 consecutive days), followed by 80 mg once on day 8 (1 week after the 160-mg dose) and 80 mg once on day 15 (1 week after the first 80-mg dose). Start maintenance dosage of 80 mg once every other week or 40 mg once every week on day 29 (2 weeks after the second 80-mg dose).

Recommended pediatric dosage should be continued in patients who turn 18 years of age and who are well-controlled on their adalimumab regimen.

Hidradenitis Suppurativa

Sub-Q

Adolescents ≥12 years of age weighing 30 to <60 kg: 80 mg on day 1, followed by 40 mg once on day 8, then 40 mg once every other week.

Adolescents ≥12 years of age weighing ≥60 kg: 160 mg on day 1 (given in one day or divided over 2 consecutive days), followed by 80 mg once 2 weeks later (on day 15). Start dosage of 40 mg once every week or 80 mg once every other week on day 29 (2 weeks after the 80-mg dose).

Uveitis

Sub-Q

Pediatric patients ≥2 years of age weighing 10 to <15 kg: 10 mg once every other week.

Pediatric patients ≥2 years of age weighing 15 to <30 kg: 20 mg once every other week.

Pediatric patients ≥2 years of age weighing ≥30 kg: 40 mg once every other week.

Not been studied for this use in patients <2 years of age or weighing <10 kg.

Adults

Rheumatoid Arthritis

Sub-Q

40 mg once every other week.

Patients not receiving methotrexate may obtain additional benefit from 40 mg once every week or 80 mg once every other week.

Psoriatic Arthritis

Sub-Q

40 mg once every other week.

Ankylosing Spondylitis

Sub-Q

40 mg once every other week.

Crohn Disease

Sub-Q

160 mg once on day 1 (given in one day or divided over 2 consecutive days), followed by 80 mg once 2 weeks later (on day 15). Start maintenance dosage of 40 mg once every other week on day 29 (2 weeks after the 80-mg dose).

Ulcerative Colitis

Sub-Q

160 mg on day 1 (given in one day or divided over 2 consecutive days), followed by 80 mg once 2 weeks later (on day 15). Start maintenance dosage of 40 mg once every other week on day 29 (2 weeks after the 80-mg dose). If clinical remission is not achieved by 8 weeks (day 57), discontinue adalimumab.

Plaque Psoriasis

Sub-Q

80 mg on day 1, followed by 40 mg once every other week (maintenance dosage) starting 1 week after the initial dose.

Hidradenitis Suppurativa

Sub-Q

160 mg on day 1 (given in one day or divided over 2 consecutive days), followed by 80 mg once 2 weeks later (on day 15). Start dosage of 40 mg once every week or 80 mg once every other week on day 29 (2 weeks after the 80-mg dose).

Uveitis

Sub-Q

80 mg on day 1, followed by 40 mg once every other week starting 1 week after the initial dose.

Prescribing Limits

Adults

Plaque Psoriasis

Manufacturer states safety and efficacy of continuing adalimumab beyond 1 year have not been evaluated in clinical studies.

Special Populations

No special population dosage recommendations at this time.

Cautions for Adalimumab

Contraindications

• None.

Warnings/Precautions

Warnings

Infectious Complications

Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death. Opportunistic infections caused by bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens (e.g., aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, tuberculosis) reported, particularly in patients receiving concomitant therapy with immunosuppressive agents (e.g., methotrexate, corticosteroids). Infections frequently are disseminated. (See Boxed Warning.)

Increased incidence of serious infections observed with concomitant use of a TNF blocking agent and anakinra or abatacept. Use of adalimumab in combination with other biologic DMARDs, including abatacept and anakinra, not recommended.

Patients >65 years of age, with comorbid conditions, and/or receiving concomitant therapy with immunosuppressive agents (e.g., corticosteroids, methotrexate) may be at increased risk of infection.

Do not initiate adalimumab in patients with active infections, including localized infections. Consider potential risks and benefits of the drug prior to initiating therapy in patients with a history of chronic, recurring, or opportunistic infections; patients with underlying conditions that may predispose them to infections; and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, and blastomycosis are endemic.

Closely monitor patients during and after adalimumab therapy for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock), including the possible development of tuberculosis in patients who tested negative for latent tuberculosis prior to initiating therapy.

If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient. Discontinue adalimumab if serious infection or sepsis develops.

Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy. When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to adalimumab therapy. Also consider antimycobacterial therapy prior to adalimumab therapy for individuals with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed and for individuals with a negative tuberculin skin test who have risk factors for tuberculosis. Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.

Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis. Strongly consider tuberculosis in patients who develop new infections while receiving adalimumab, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.

Failure to recognize invasive fungal infections has led to delays in appropriate treatment. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.

When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic. Whenever feasible, consult specialist in fungal infections.

Malignancies and Lymphoproliferative Disorders

Cases of lymphoma and other malignancies (some fatal) reported in children, adolescents, and adults receiving TNF blocking agents; patients receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly may be at increased risk. Malignancies included lymphomas (e.g., Hodgkin disease, non-Hodgkin lymphoma, hepatosplenic T-cell lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers, leiomyosarcoma, hepatic malignancies, renal cell carcinoma). (See Boxed Warning.)

FDA has concluded that there is an increased risk of malignancy with TNF blocking agents; however, the strength of the association is not fully characterized.

Consider possibility of and monitor for occurrence of malignancies during and following treatment with TNF blocking agents.

Consider risks and benefits of TNF blocking agents prior to initiating therapy in patients with a known malignancy (other than successfully treated nonmelanoma skin cancer) or when deciding whether to continue therapy in patients who develop a malignancy. Carefully consider risks and benefits of these agents, especially in adolescents and young adults and especially in the treatment of Crohn disease or ulcerative colitis.

Examine all patients, but particularly those with a history of prior prolonged immunosuppressive therapy or a history of psoralen and UVA light (PUVA) therapy, for nonmelanoma skin cancer before and during adalimumab therapy.

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis, angioedema, and other allergic reactions (e.g., allergic rash, anaphylactoid reactions, fixed drug reaction, nonspecified drug reaction, urticaria) observed. If serious allergic reaction or anaphylaxis occurs, immediately discontinue adalimumab and initiate appropriate therapy.

Latex Sensitivity

In certain packaging configurations (injection pen and prefilled syringes containing 40 mg in 0.8 mL), the needle cover may contain dry natural rubber (latex) and should not be handled by individuals sensitive to latex.

Other Warnings/Precautions

HBV Reactivation

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

Screen at-risk patients 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

New onset or exacerbation of central or peripheral nervous system demyelinating disorders (e.g., multiple sclerosis, optic neuritis, Guillain-Barré syndrome) reported rarely in patients receiving adalimumab or other TNF blocking agents.

Exercise caution when considering adalimumab therapy in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders. Consider discontinuing adalimumab if any such disorders develop during therapy.

Intermediate uveitis is known to be associated with central demyelinating disorders.

Hematologic Effects

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

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.

In adults with rheumatoid arthritis, incidence of antibodies to adalimumab is lower in patients receiving adalimumab with methotrexate compared with those receiving adalimumab monotherapy. Incidence also may be lower with weekly compared with every-other-week monotherapy. In patients receiving every-other-week monotherapy, clinical response achieved in fewer antibody-positive patients than antibody-negative patients.

In pediatric patients with juvenile idiopathic arthritis, incidence of antibodies to adalimumab is lower in those receiving adalimumab with methotrexate compared with those receiving adalimumab monotherapy.

In adults with noninfectious uveitis, no association observed between antibody development and adalimumab safety or efficacy.

In pediatric patients with ulcerative colitis, development of antibodies to adalimumab associated with reduced serum adalimumab concentrations; no association between antibody development and adalimumab safety observed. Association between antibody development and efficacy not assessed.

In patients with hidradenitis suppurativa, development of antibodies to adalimumab associated with reduced serum adalimumab concentrations (magnitude of reduction generally greater with increasing antibody titers); no apparent association between antibody development and adalimumab safety.

Immunization

Patients may receive inactivated vaccines. No data available on secondary transmission of infection by live vaccines in adalimumab-treated patients. Avoid live vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, smallpox vaccine, typhoid vaccine live oral, varicella virus vaccine live, yellow fever vaccine).

When considering adalimumab for pediatric patients, review vaccination status of child and administer all age-appropriate vaccines included in current immunization guidelines.

In utero exposure to adalimumab may affect immune response of infants. Consider risks and benefits of administering live vaccines to infants exposed to the drug in utero; safety of live vaccines in such infants is unknown.

Psoriasis

New-onset psoriasis, including pustular and palmoplantar psoriasis, and exacerbation of existing psoriasis reported with TNF blocking agents, including adalimumab. Most patients experienced improvement following discontinuance of the TNF blocking agent.

Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.

Hepatic Effects

Severe hepatic reactions, including acute liver failure, reported in patients receiving TNF blocking agents. Serum ALT elevations of ≥3 times the ULN observed in patients receiving adalimumab; causal relationship not clear because many patients received concomitant therapy with drugs known to increase liver enzyme concentrations (e.g., methotrexate, NSAIAs).

Specific Populations

Pregnancy

Available studies do not reliably establish an association between adalimumab and major birth defects. In a pregnancy registry cohort study, a higher incidence of major birth defects observed in women exposed to adalimumab; however, methodologic limitations preclude definitive conclusions.

No fetal harm or malformations observed in animal studies.

Data suggest increased disease activity in women with rheumatoid arthritis or inflammatory bowel disease is associated with increased risk of adverse pregnancy outcomes (e.g., preterm delivery, low birth weight, small size for gestational age at birth).

As pregnancy progresses, monoclonal antibodies are increasingly transported across the placenta. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy. Some data suggest adalimumab may be detectable in serum of infants exposed to the drug in utero for ≥3 months following birth.

In utero exposure to adalimumab may affect immune response of infants. Consider risks and benefits of administering live vaccines to infants exposed to the drug in utero; safety of live vaccines in such infants is unknown.

Lactation

Distributes into human milk in small amounts (0.1–1% of maternal serum concentrations); systemic exposure in nursing infants is likely to be low because drug is degraded in GI tract. However, effects of local GI tract exposure are unknown. No reports of adverse effects on breast-fed infants or effects on milk production.

Consider developmental and health benefits of breast-feeding along with the mother's clinical need for adalimumab and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.

Pediatric Use

Safety and efficacy for uses other than polyarticular juvenile idiopathic arthritis, Crohn disease, ulcerative colitis, and noninfectious uveitis not established in pediatric patients. Clinical trials in adults support use for management of hidradenitis suppurativa in adolescents.

Use for management of polyarticular juvenile idiopathic arthritis in pediatric patients ≥2 years of age supported by a safety and efficacy study in pediatric patients 4–17 years of age and a safety study in children 2 to <4 years of age; adverse effects generally similar to those observed in adults. Safety and efficacy for this indication not established in pediatric patients <2 years of age or weighing <10 kg.

Use for management of Crohn disease in pediatric patients ≥6 years of age supported by adequate, well-controlled studies in adults and a randomized, double-blind, clinical study of 2 adalimumab dosages in 192 pediatric patients 6–17 years of age. Safety and efficacy for this indication not established in pediatric patients <6 years of age.

Use for management of ulcerative colitis in pediatric patients ≥5 years of age supported by adequate, well-controlled studies in adults and a randomized, controlled study in 93 pediatric patients 5–17 years of age. Recommended dosage of adalimumab in pediatric patients with ulcerative colitis based on modeled dose/exposure-efficacy relationships and pharmacokinetic data; clinically relevant differences between the studied higher dosage administered in the clinical trial and the recommended dosage not anticipated. Safety and efficacy for this indication not established in pediatric patients <5 years of age.

Use for management of noninfectious uveitis in pediatric patients ≥2 years of age supported by adequate, well-controlled studies in adults and a randomized controlled study in 90 pediatric patients. Safety and efficacy for this indication not established in pediatric patients <2 years of age.

Use for management of hidradenitis suppurativa in adolescents ≥12 years of age supported by adequate, well-controlled studies in adults. Similarity of the disease course allows extrapolation of data from adults to adolescents. Population pharmacokinetic modeling and simulation data suggest exposure resulting from weight-based dosing in adolescents is generally similar to exposure in adults. Safety and efficacy for this indication not established in pediatric patients <12 years of age.

Review vaccination status of the child and administer all age-appropriate vaccines, if possible, prior to initiation of adalimumab.

Malignancies, some fatal, reported in children and adolescents who received TNF blocking agents, including adalimumab.

Neonates and infants exposed to adalimumab in utero may have impaired immune responses. Adalimumab crosses the placenta; clinical importance of elevated concentrations in infants is unknown. Consider risks and benefits of administering live vaccines to infants exposed to adalimumab in utero; safety of live vaccines in these infants is unknown.

Geriatric Use

In geriatric patients with rheumatoid arthritis, 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 than in younger adults; consider risks and benefits of adalimumab in geriatric patients and closely monitor for development of infection or malignancy.

Common Adverse Effects

Common adverse effects (≥10%) include infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

Drug Interactions

Administered concomitantly with aminosalicylates, methotrexate, other DMARDs, corticosteroids, other immunomodulatory agents (e.g., azathioprine, mercaptopurine), and/or NSAIAs in clinical studies.

Drugs Metabolized by Hepatic Microsomal Enzymes

Because increased levels of TNF during chronic inflammation may suppress formation of CYP isoenzymes, antagonism of TNF activity by adalimumab may normalize formation of CYP enzymes.

Drugs metabolized by CYP isoenzymes that have a low therapeutic index: Monitor therapeutic effect and/or serum concentrations following initiation or discontinuance of adalimumab; adjust dosage as needed.

Biologic Antirheumatic Agents

For other biologic agents used in the management of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, noninfectious uveitis, or hidradenitis suppurativa, manufacturer states data regarding concomitant use with adalimumab are insufficient.

Concomitant use of adalimumab and other biologic DMARDs not recommended.

Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase the risk of infection.

Vaccines

Patients may receive inactivated vaccines.

Avoid live vaccines. No data available on secondary transmission of infection by live vaccines in adalimumab-treated patients.

Specific Drugs

Adalimumab Pharmacokinetics

Absorption

Bioavailability

Bioavailability is approximately 64%. Peak serum concentrations achieved in 131 hours.

Distribution

Extent

Distributed into synovial fluid.

Distributed into milk in small amounts. Crosses placenta.

Elimination

Metabolism

Metabolic fate undetermined.

Elimination Route

Unknown.

Half-life

2 weeks (range: 10–20 days).

Special Populations

In patients with adalimumab antibodies, clearance of adalimumab is higher.

Clearance of adalimumab is lower with increasing age in patients 40–>75 years of age.

Stability

Storage

Parenteral

Injection

2–8°C. Do not freeze; do not use solutions that have been frozen. Protect from light; store in original carton until time of administration.

If necessary (e.g., during travel), may store at room temperature up to 25°C, protected from light, for a period of up to 14 days; discard if not used within 14 days.

Actions

• Potent antagonist of TNF biologic activity.

• Has high specificity and affinity for TNF (TNF-α); does not bind to or inactivate lymphotoxin α (TNF-β). Prevents the binding of TNF to cell surface TNF receptors, thereby blocking the biologic activity of TNF.

• An immunoglobulin G₁ (IgG₁) made by phage display technology with amino acid sequences from the human germline; does not contain nonhuman components or artificially fused human peptide sequences. Indistinguishable in structure and function from naturally occurring human IgG.

• Produced by recombinant DNA technology in a mammalian cell expression system; purified by a process that includes specific viral inactivation and removal steps.

Advice to Patients

• Importance of patients reading the manufacturer’s patient information (medication guide) prior to initiation of therapy and each time the prescription is refilled.

• Importance of instructing patient and/or caregiver regarding proper dosage and administration of adalimumab, including the use of aseptic technique, and proper disposal of needles and syringes if it is determined that the patient and/or caregiver is competent to safely administer the drug.

• Advise patients that if a dose is missed, the missed dose should be administered as soon as it is remembered and then the regular dosing schedule should be resumed.

• Increased susceptibility to infection. Importance of seeking immediate medical attention if signs and symptoms suggestive of infection (e.g., fever; fatigue; cough; warm, red, or painful skin; sores on the body; muscle aches; diarrhea; stomach pain; shortness of breath; weight loss; burning on urination; urinary frequency) develop.

• Risk of lymphoma, including hepatosplenic T-cell lymphoma, leukemia, or other malignancies with use of TNF blocking agents. Importance of informing patients and caregivers about the increased risk of cancer development in children, adolescents, and young adults, taking into account the clinical utility of TNF blocking agents, the relative risks and benefits of these and other immunosuppressive drugs, and the risks associated with untreated disease. Importance of promptly informing clinicians if signs and symptoms of malignancies (e.g., unexplained weight loss; fatigue; abdominal pain; persistent fever; night sweats; easy bruising or bleeding; swollen lymph nodes in the neck, underarm, or groin; hepatomegaly or splenomegaly) occur.

• Importance of informing clinician of any new or worsening medical conditions (e.g., neurologic conditions [e.g., demyelinating disorders], heart failure, autoimmune disorders [e.g., lupus-like syndrome], psoriasis, cytopenias).

• Importance of alerting clinician if allergy to latex exists. Advise latex-sensitive patients that the needle cover included in certain packaging configurations of adalimumab (injection pens and prefilled syringes containing 40 mg in 0.8 mL) may contain natural rubber latex.

• Importance of promptly contacting a clinician if manifestations of an allergic reaction (e.g., urticaria, facial swelling, difficulty breathing) occur.

• Importance of taking the drug as prescribed and of not altering or discontinuing therapy without first consulting with a clinician.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or any history of cancer, tuberculosis, HBV infection, or other chronic or recurring infections.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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• What is the difference between Amjevita and Humira?

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