HADLIMA
HADLIMA (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory and autoimmune conditions in adult and pediatric populations. Its therapeutic role involves reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function across various arthritic, gastrointestinal, and dermatologic disorders. The medication is used for patients with moderate to severe disease activity, including those with rheumatoid arthritis, Crohn’s disease, and plaque psoriasis. It may be administered as a monotherapy or in combination with methotrexate and other non-biologic disease-modifying anti-rheumatic drugs.
How HADLIMA Works
HADLIMA functions by binding specifically to TNF-alpha, a naturally occurring cytokine that drives inflammatory and immune responses. By blocking TNF-alpha from interacting with p55 and p75 cell surface receptors, the drug inhibits the pathological inflammation and joint destruction associated with elevated TNF levels. Additionally, the medication can lyse cells that express TNF on their surface and modulate biological responses, such as the concentration of adhesion molecules responsible for leukocyte migration. In conditions like plaque psoriasis, this activity may lead to reduced epidermal thickness and decreased infiltration of inflammatory cells.
Details
- Status
- Prescription
- First Approved
- 2019-07-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HADLIMA Approval History
What HADLIMA Treats
9 indicationsHADLIMA is approved for 9 conditions since its original approval in 2019. 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
HADLIMA Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HADLIMA, 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 HADLIMA if a patient develops a serious infection or sepsis. Reported infections include: • Active tubercu...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HADLIMA, 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 HADLIMA 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 HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA 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 anti-fungal 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. Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products
HADLIMA 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 HADLIMA 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.
HADLIMA FDA Label Details
ProIndications & Usage
FDA Label (PDF)HADLIMA 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 . • Re...
WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including HADLIMA, 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 infe...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.