KEVZARA Dosage & Rx Info | Uses, Side Effects

Kevzara Generic Name & Formulations

Legal Class

General Description

Sarilumab 150mg/1.14mL, 200mg/1.14mL; soln for SC inj; preservative-free.

Pharmacological Class

Interleukin-6 antagonist.

How Supplied

Single-dose prefilled syringes—2

Manufacturer

Sanofi US and Regeneron

Generic Availability

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.

Kevzara Indications

Indications

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

Adult

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.

Children

Not established.

Kevzara Contraindications

Not Applicable

Kevzara Boxed Warnings

Not Applicable

Kevzara Warnings/Precautions

Warnings/Precautions

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.

Kevzara Pharmacokinetics

Absorption

Rheumatoid Arthritis

Median T_max: 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 C_min: 16.5 ± 14.1 mg/L. Estimated mean C_max: 35.6 ± 15.2 mg/L.

Polymyalgia rheumatica

Median time to steady state was estimated to be 28 weeks. Estimated mean (± SD) steady-state AUC: 551 ± 321 mg.day/L. Estimated mean C_min: 27.0 ± 21.5 mg/L. Estimated mean C_max: 46.5 ± 23.0 mg/L.

Distribution

Apparent volume of distribution at steady state: 7.3 L.

Metabolism

Catabolic pathways.

Elimination

Half-life: ~8 days (150 mg), ~10 days (200 mg).

Kevzara Interactions

Interactions

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).

Kevzara Adverse Reactions

Adverse Reactions

Neutropenia, increased ALT, inj site erythema, upper respiratory infections, urinary tract infections; hypersensitivity reactions (may be severe), thrombocytopenia, GI perforation, increased lipids, immunosuppression.

Kevzara Clinical Trials

See Literature

Kevzara Note

Notes

Enroll pregnant patients in the pregnancy exposure registry by calling (877) 311-8972.

Kevzara Patient Counseling