Sarilumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL6R), 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 Tand B cells, lymphocytes, monocytes, and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. 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 is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

• adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). 
• adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. 
• patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). 

General Considerations for Administration

• KEVZARA initiation is not recommended in patients with ANC less than 2,000/mm , platelets less than 150,000/mm or liver transaminases above 1.5 times ULN. See Full Prescribing Information (FPI) for complete information. 

Recommended Dosage in RA

• The recommended dosage is 200 mg subcutaneously, once every 2 weeks. 
• For RA, KEVZARA may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs. 

Recommended Dosage in PMR

• The recommended dosage is 200 mg subcutaneously, once every two weeks in combination with a tapering course of corticosteroids. 
• For PMR, KEVZARA can be used as monotherapy following discontinuation of corticosteroids.

Recommended Dosage in pJIA

• The recommended dosage is 200 mg given subcutaneously once every 2 weeks for pJIA patients who weigh 63 kg or greater using the 200 mg/1.14 mL pre-filled syringe. 
• For pJIA, KEVZARA can be used as monotherapy or in combination with conventional DMARDs. 
• Dosage Modifications for Cytopenias, Abnormal Liver Enzymes, Infections

Most common adverse reactions are:

• Rheumatoid Arthritis (incidence ≥3 %): neutropenia, increased ALT, injection site erythema, upper respiratory infections and urinary tract infections. 
• Polymyalgia Rheumatica (incidence ≥ 5%): neutropenia, leukopenia and injection site pruritus. 
• Polyarticular Juvenile Idiopathic Arthritis: nasopharyngitis, neutropenia, upper respiratory tract infection and injection site erythema. 

KEVZARA is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients.

Serious Infections:

• Avoid KEVZARA use during an active infection.
• Neutropenia, Thrombocytopenia, Elevated Liver Enzymes, Lipid Abnormalities: Monitor laboratory parameters. 
• Gastrointestinal (GI) Perforation: Risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids. Promptly evaluate acute abdominal signs or symptoms. 
• Hypersensitivity reactions. 
• Live vaccines: Avoid use with KEVZARA.