Generic Name and Formulations:
Sarilumab 150mg/1.14mL, 200mg/1.14mL; soln for SC inj; preservative-free.
Sanofi US and Regeneron
Indications for KEVZARA:
Moderately-to-severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to ≥1 DMARDs; may be used as monotherapy or in combination with methotrexate or other DMARDs.
Rotate inj sites; do not inj into tender, damaged, bruised, or scarred skin. Give 200mg SC inj once every 2 weeks. 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.
Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections); if develop, interrupt until controlled. 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 signs/symptoms of infection during and after therapy; interrupt if serious or opportunistic infection develops. Test for and treat latent TB prior to starting therapy. Monitor neutrophils, platelets, ALT/AST 4–8 weeks after initiation, then every 3 months. Monitor lipids 4–8 weeks after initiation, then every 6 months. Increased risk of GI perforation with concurrent diverticulitis. Active hepatic disease or impairment: not recommended. Immunosuppression. Malignancies. Discontinue immediately if anaphylaxis or other hypersensitivity reactions occur. Elderly. Pregnancy. Nursing mothers.
Avoid concomitant live vaccines. Increased risk of infection and immunosuppression with concomitant biological DMARDs (eg, TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies, selective co-stimulation modulators); avoid. Increased risk of GI perforation with concomitant NSAIDs, corticosteroids. Monitor warfarin, cyclosporine, theophylline, other drugs that are CYP450 substrates with narrow therapeutic indices. Caution with CYP3A4 substrate drugs (eg, oral contraceptives, lovastatin, atorvastatin, others).
Neutropenia, increased ALT, inj site erythema, upper respiratory infections, urinary tract infections; hypersensitivity reactions (may be severe), thrombocytopenia, GI perforation, increased lipids, immunosuppression.
Enroll pregnant patients in the pregnancy exposure registry by calling (877) 311-8972.
Single-dose prefilled syringes—2