AMJEVITA
AMJEVITA (adalimumab-atto) is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory and autoimmune conditions in adult and pediatric populations. It is used to reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in joint-related diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The drug is also approved for gastrointestinal disorders like Crohn’s disease and ulcerative colitis, as well as specific dermatological and ophthalmic conditions. Its effectiveness has not been established in patients who have lost response to or were intolerant to other TNF blockers.
How AMJEVITA Works
AMJEVITA binds specifically to TNF-alpha, a naturally occurring cytokine involved in inflammatory and immune responses, and blocks its interaction with p55 and p75 cell surface receptors. By neutralizing TNF-alpha, the drug reduces the elevated cytokine concentrations that drive pathologic inflammation and joint destruction in diseases like rheumatoid arthritis and psoriasis. Additionally, the medication modulates biological responses regulated by TNF, such as the levels of adhesion molecules responsible for leukocyte migration. It also demonstrates the ability to lyse surface TNF-expressing cells in vitro in the presence of complement.
Details
- Status
- Prescription
- First Approved
- 2016-09-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AMJEVITA Approval History
What AMJEVITA Treats
9 indicationsAMJEVITA is approved for 9 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Crohn's Disease
- Ulcerative Colitis
- Chronic Plaque Psoriasis
- Hidradenitis Suppurativa
AMJEVITA Boxed Warning
SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue AMJEVITA if a patient develops a serious infection or sepsis during treatment. Perform te...
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue AMJEVITA if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting AMJEVITA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. 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 adalimumab products. SERIOUS INFECTIONS Patients treated with adalimumab products, including AMJEVITA, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue AMJEVITA 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 AMJEVITA use and during therapy. Initiate treatment for latent TB prior to AMJEVITA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other inva
AMJEVITA Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
Pharmacists can substitute AMJEVITA for Humira without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMJEVITA FDA Label Details
ProIndications & Usage
FDA Label (PDF)AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 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 . Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . Reducing s...
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.