Indications for: KEVZARA
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.
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 >1.5×ULN. 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). 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.
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.
Half-life: ~8 days (150 mg), ~10 days (200 mg).
Generic Drug Availability:
Single-dose prefilled syringes—2