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Humira

Generic Name: Adalimumab
Drug Category: TNF Blocker
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 2 years old for a maximum duration of 2 years.

Approved Uses

Indicated for: 

Rheumatoid Arthritis (adults): 

• Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti rheumatic drugs (DMARDs). 

Juvenile Idiopathic Arthritis (2 to 17 years of age):

• Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate.

HUMIRA has not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.

Psoriatic Arthritis (adults):

• Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis (adults): 

• Reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease (patients 6 years of age and older and adults): 

• The treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis (patients 5 years of age and older and adults):

• The treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis (adults):

• The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa (patients 12 years of age and older and adults):

• The treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 

Uveitis (patients 2 years of age and older and adults): 

• Treatment of non-infectious intermediate, posterior and panuveitis in adults and pediatric patients 2 years of age and older.

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness
  • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA. 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.

In 52 global controlled and uncontrolled clinical trials of HUMIRA in adult patients with RA, PsA, AS, CD, UC, Ps, HS and UV, the most frequently observed malignancies, other than lymphoma and NMSC, were breast, colon, prostate, lung, and melanoma.

Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.

Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.

Use of TNF blocking agents, including HUMIRA, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.

Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., thrombocytopenia, leukopenia) have been infrequently reported with HUMIRA.

Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with HUMIRA, discontinue treatment.

Treatment with HUMIRA should not be initiated in patients with an active infection, including localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating therapy in patients:

  • with chronic or recurrent infection
  • who have been exposed to tuberculosis
  • with a history of an opportunistic infection
  • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis or
  • with underlying conditions that may predispose them to infection

The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections in patients with rheumatoid arthritis (RA); therefore, the concomitant use of HUMIRA and these biologic products is not recommended in the treatment of patients with RA.

Avoid the use of live vaccines with HUMIRA.

Upon initiation or discontinuation of HUMIRA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant. Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester.

Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum level.

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Off-label Uses

• Use in patients under 6 years of age for crohn’s disease. GoToSource

• Use in patients under 18 years of age for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,  and plaque psoriasis. GoToSource

• Use in patients under than 2 years of age or weight below 10 kg for polyarticular JIA. GoToSource

• Undifferentiated polyarthritis, undifferentiated seronegative spondyloarthropathy, sarcoidosis, myositis, behçet’s syndrome, panuveitis, adult-onset still’s disease and reactive arthritis. GoToSource

• Pyoderma gangrenosum, sweet’s syndrome, pemphigus, systemic vasculitides, multicentric reticulohistiocytosis and stomatitis. GoToSource

• Cicatricial pemphigoid, subcorneal pustular dermatosis (sneddon–wilkinson disease), SAPHO (synovitis, acne, pustulosis, hyperostosis, osteitis) syndrome, pityriasis rubra pilaris, eosinophilic fasciitis, panniculitis, necrobiosis lipoidica diabeticorum, dermatomyositis, graft-versus-host disease, toxic epidermal necrolysis, erythema annulare centrifugum and scleroderma. GoToSource

Adverse Events

Serious infections including lower respiratory tract infections, septic shock and death. GoToSource

Non-tuberculous mycobacteria, opportunistic fungal infections including pneumocystis jiroveci, candida sp, aspergillus, cryptococcus, opportunistic bacterial infections including nocardia, parasitic infections including leishmania and viral infections including cytomegalovirus and human herpes virus 8 (HHV8). GoToSource

Pulmonary and disseminated histoplasmosis, coccidioidomycosis and blastomycosis. GoToSource

Pneumocystis pneumonia (pulmonary infection). GoToSource

Reactivation of tuberculosis, congestive heart failure, lupus-like syndrome and worsening or initiation of a multiple sclerosis. GoToSource

Lymphomas (cancer of the lymph nodes). GoToSource

Liver failure. GoToSource

Sarcoid reactions. GoToSource

Demyelinating disorders (optic neuritis, guillain-barré syndrome). GoToSource

Venous and arterial thromboembolic events. GoToSource

Alopecia (hair loss). GoToSource

Malignant melanoma (skin cancer). GoToSource

Acute myelogenous leukemia (cancer of blood and bone marrow). GoToSource

Disseminated mucormycosis (fungal infection). GoToSource

Increased infectious and surgical complications in patients undergoing intestinal resection or any intra-abdominal surgery. GoToSource

Legionnaires’ disease (severe form of pneumonia). GoToSource

Hepatitis B virus reactivation. GoToSource

Pancytopenia (low levels of red cells, white cells and platelets). GoToSource

Litigation

Lawsuits filed for fungal infections, cancer, tuberculosis, new or worsening heart failure and pneumonia.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024