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Remicade (Infliximab-Dyyb)
Infliximab-dyyb neutralizes TNFα by binding with high affinity to soluble and transmembrane forms, inhibiting receptor binding.
Infliximab-dyyb (INFLECTRA) is a TNF-blocking monoclonal antibody indicated for multiple inflammatory conditions including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The drug has a terminal half-life of 7.7-9.5 days and is distributed primarily within the vascular compartment, with clearance increased by anti-drug antibody development. Major contraindications include doses >5 mg/kg in moderate-to-severe heart failure and prior severe hypersensitivity reactions; combination with anakinra, abatacept, or other TNF blockers increases serious infection risk. Concomitant methotrexate use may improve drug concentrations and reduce anti-drug antibody formation, supporting its use in combination therapy for appropriate indications.
At a glance
| Generic name | Infliximab-Dyyb |
|---|---|
| Sponsor | Johnson & Johnson |
| Drug class | TNF blocker |
| Target | Tumor Necrosis Factor alpha (TNFα) |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1998 |
Mechanism of action
Infliximab products neutralize the biological activity of TNFα by binding with high affinity to both soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. The drug does not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Biological activities attributed to TNFα that are inhibited include: induction of proinflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNFα bound by infliximab products can be lysed in vitro or in vivo. The drug inhibits the functional activity of TNFα in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T lymphocytes and epithelial cells.
Approved indications
- Ankylosing spondylitis
- Behcet's disease
- Crohn's disease
- Erythrodermic psoriasis
- Plaque psoriasis
- Psoriasis with arthropathy
- Pustular psoriasis
- Rheumatoid arthritis
- Ulcerative colitis
Boxed warnings
- Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and infections due to other opportunistic pathogens.
- Discontinue INFLECTRA if a patient develops a serious infection.
- Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. 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 adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products.
- Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products.
Common side effects
- infusion reaction
- nonspecific symptoms such as fever or chills
- cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea)
- pruritus, urticaria, or combined symptoms of pruritus/urticaria and cardiopulmonary reactions
- serious infusion reactions
- infusion reactions (3 mg/kg group, psoriasis studies)
- infusion reactions (5 mg/kg group, psoriasis studies)
- infusion reactions (placebo group, psoriasis studies)
- serious infusion reactions during re-treatment induction therapy
- serious infusion reactions during maintenance therapy
Drug interactions
- Anakinra or abatacept
- Tocilizumab
- Other biological products
- Methotrexate (MTX)
- Immunosuppressants
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |