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Pharmacologic class: Biological modifier

Therapeutic class: Antirheumatic (disease-modifying), immunomodulator

Pregnancy risk category B

FDA Box Warning

• There is increased risk of serious infections with drug use (including tuberculosis [TB], bacterial sepsis, invasive fungal infections [such as histoplasmosis], and infections due to other opportunistic pathogens) leading to hospitalization or death.

• Discontinue adalimumab if a serious infection or sepsis develops during treatment.

• Perform test for latent TB; if positive, start treatment for TB before starting adalimumab.

• Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

• Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers, including adalimumab.

• Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all these patients had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or before diagnosis. It's uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.


Human immunoglobulin (Ig) G1 monoclonal antibody that binds to human tumor necrosis factor (TNF), which plays a role in inflammation and immune responses. Also modulates biological responses induced or modulated by TNF.


Injection (preservative-free): 20 mg/0.4 ml in single-use prefilled glass syringe, 40 mg/0.8 ml in a single-use prefilled pen or single-use prefilled glass syringe

Indications and dosages

To reduce signs and symptoms, slow disease progression, and improve physical function of moderately to severely active rheumatoid arthritis and to reduce signs and symptoms of psoriatic arthritis

Adults: 40 mg subcutaneously every other week alone or in combination with methotrexate or other disease-modifying antirheumatic drugs

Moderate to severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate

Adults: Initially, 80 mg subcutaneously followed by 40 mg every other week starting 1 week after initial dose

To reduce signs and symptoms of ankylosing spondylitis

Adults: 40 mg subcutaneously every other week

Crohn's disease

Adults: Initially, 160 mg subcutaneously (four 40-mg injections in one day or two 40-mg injections per day for two consecutive days), followed by 80 mg subcutaneously 2 weeks later (day 15). Two weeks later (day 29), begin a maintenance dose of 40 mg subcutaneously every other week.

Moderately to severely active polyarticular juvenile idiopathic arthritis as monotherapy or concomitantly with methotrexate

Children age 4 and older weighing 15 kg (33 lb) to less than 30 kg (66 lb): 20 mg subcutaneously every other week

Children age 4 and older weighing 30 kg (66 lb) or more: 40 mg subcutaneously every other week


• Hypersensitivity to drug

• Active infection, including chronic or localized infection


Use cautiously in:

• preexisting or recent onset of demyelinating disorders, immunosuppression, or lymphoma

• elderly patients

• pregnant or breastfeeding patients

• children.


• Give subcutaneously; rotate injection sites.

• Be aware that patients not receiving methotrexate concurrently may benefit from dosage increase to 40 mg weekly.

• Store in refrigerator and protect from light.

Adverse reactions

CNS: headache, demyelinating disease

CV: hypertension, arrhythmias

EENT: sinusitis

GI: nausea, vomiting, abdominal pain

GU: urinary tract infection, hematuria

Metabolic: hyperlipidemia, hypercholesterolemia

Musculoskeletal: back pain

Respiratory: upper respiratory tract infection

Skin: rash

Other: accidental injury, pain and swelling at injection site, flulike symptoms, lupuslike syndrome, fungal infection, allergic reactions, tuberculosis reactivation, malignancies


Drug-drug. Immunosuppressants (including corticosteroids): serious infection

Live-virus vaccines: serious illness

Drug-diagnostic tests. Alkaline phosphatase: elevated level

Patient monitoring

Monitor for signs and symptoms of infection if patient is receiving concurrent corticosteroids or other immunosuppressants (because of risk that infection may progress).

• Monitor CBC.

Patient teaching

• Teach patient how to recognize and report signs and symptoms of allergic response and other adverse reactions.

• Inform patient that drug lowers resistance to infection. Instruct him to immediately report fever, cough, breathing problems, and other infection symptoms.

• Instruct patient to minimize GI upset by eating small, frequent servings of healthy food and drinking plenty of fluids.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


A human monoclonal antibody that blocks the action of tumor necrosis factor and is used to treat certain autoimmune disorders, especially rheumatoid arthritis, Crohn's disease, and psoriasis.


an antirheumatic immunomodulating agent used to treat patients older than 18 years of age with moderate to severe rheumatoid arthritis.


A recombinant human IgG1 monoclonal antibody that reacts with human TNF, which causes rapid reduction in acute phase reactants of inflammation—C-reactive protein, erythrocyte sedimentation rate, serum cytokines (e.g., IL-6)—in patients with rheumatoid arthritis. Serum matrix metalloproteinases, MMP-1 and MMP-3—which remodel tissue and cause cartilage destruction—also reduced after Humira administration.
Adverse effects Infections—primarily URIs—including tuberculosis, UTIs; increased risk of malignancies—lymphomas, including the extremely rare hepatosplenic T-cell lymphoma; neurologic events—TNF blockers may exacerbate clinical and/or radiographic evidence of demyelination.


A human tumour necrosis factor-alpha monoclonal antibody used to treat severe active RHEUMATOID ARTHRITIS in cases in which treatment with methotrexate fails to produce an adequate response. The antibody binds to TNF-alpha and blocks its interaction with cell surface TNF receptors. This reduces chronic inflammation and cartilage destruction. A brand name is Humira.
References in periodicals archive ?
The results indicate that the clinical effectiveness, safety and immunogenicity of Celltrion Healthcare's CT-P13 (biosimilar infliximab) in patients with Crohn's disease is comparable to those treated with reference infliximab as well as those treated with adalimumab.
Sandoz said on Tuesday that it has successfully filed its Biologics License Application (BLA) with the US Food and Drug Administration (FDA) under the 351 (k) pathway for its proposed biosimilar adalimumab to the reference medicine, Humira.
It is the second adalimumab biosimilar approved by the FDA; Amjevita (adalimumab-atto) was approved in 2016.
In making the recommendation, the body recognises adalimumab to be a clinically and cost effective treatment option for eligible adults with the condition who had an "inadequate" response to corticosteroids.
This randomized controlled trial demonstrated that subcutaneous adalimumab at 40 mg every other week was no different from placebo for alleviation of pain, synovitis, or bone marrow lesions in patients with erosive hand osteoarthritis presenting with MRI-detected synovitis.
The serum levels of adalimumab were lower than the cutoff in both of the partial responders and the ADAs were high, whereas the other 17 patients had adalimumab levels above the cutoff and low ADA levels.
All patients were diagnosed as ANA positive oligoarticular/ extended oligoarticular or ERA JIA subtypes, with active or previous history of uveitis for which adalimumab was prescribed if it failed to respond to standard treatment.
It is unclear what other indications Boehringer may seek for its adalimumab biosimilar, but Amjevita is indicated for several forms of arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis.
Adalimumab is a recombinant human monoclonal antibody that binds specifically to tumor necrosis factor (TNF)-alpha, blocking interaction with its cell surface receptors and thereby reducing the impact of inflammation.
Adalimumab, therapeutic alternative in the Vogt Koyanagi Harada syndrome refractory to infliximab: case report
Herein, we present a case of Chinese man with a 10-year history of RA developing crescentic immunoglobulin A (IgA) nephritis and multiple autoantibodies during adalimumab treatment.