Kevzara Generic Name & Formulations
Mechanism of Action
Sarilumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to ≥1 DMARDs. Polymyalgia rheumatica (PMR) in adults who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
Kevzara Dosage and Administration
Rotate inj sites; do not inj into tender, damaged, bruised, or scarred skin. Give 200mg SC inj once every 2 weeks. RA: may use as monotherapy or in combination with methotrexate or other conventional DMARDs. PMR: use in combination with a tapering course of systemic corticosteroids (can use as monotherapy after discontinuation of corticosteroids). Do not initiate if ANC <2000/mm3, platelets <150000/mm3, or ALT/AST >1.5xULN. Dose modifications for neutropenia, thrombocytopenia, and elevated liver enzymes: see full labeling.
Kevzara Boxed Warnings
Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections). Active infections: do not give therapy. Consider risks/benefits prior to initiating: chronic or recurrent, or history of opportunistic infections, exposed to TB, travel to, or residence in, areas with endemic TB or mycoses, conditions that predispose to infection. Monitor closely for infection during and after therapy; interrupt therapy if a serious or opportunistic infection develops until controlled. Test for and treat latent TB prior to starting therapy. Monitor neutrophils, platelets, ALT/AST prior to initiation, 4–8 weeks after initiation, then every 3 months. Monitor lipids at baseline, 4–8 weeks after initiation, then every 6 months. Increased risk of GI perforation with concurrent diverticulitis. Active hepatic disease or impairment: not recommended. Severe renal impairment: not studied. Immunosuppression. Malignancies. Discontinue immediately if anaphylaxis or other hypersensitivity reactions occur. Elderly. Pregnancy. Nursing mothers.
- Median Tmax: 2 to 4 days. Steady state was reached in 14–16 weeks. Estimated mean (± SD) steady-state AUC: 395 ± 207 mg.day/L. Estimated mean Cmin: 16.5 ± 14.1 mg/L. Estimated mean Cmax: 35.6 ± 15.2 mg/L.
- Median time to steady state was estimated to be 28 weeks. Estimated mean (± SD) steady-state AUC: 551 ± 321 mg.day/L. Estimated mean Cmin: 27.0 ± 21.5 mg/L. Estimated mean Cmax: 46.5 ± 23.0 mg/L.
Apparent volume of distribution at steady state: 7.3 L.
Half-life: ~8 days (150 mg), ~10 days (200 mg).
Kevzara Adverse Reactions
Kevzara Clinical Trials
Kevzara Patient Counseling