Safety evaluated in 624 patients through 144 weeks with a long-term study of up to 5 years ongoing (EXTEND)2
*Adverse reactions occurring in ≥2% of patients administered KEVZARA 200 mg or KEVZARA 150 mg + DMARD and greater than observed in patients on placebo + DMARD.1
†Pre-rescue, placebo-controlled population.
Medically relevant adverse reactions occurring at an incidence less than 2% in patients with rheumatoid arthritis treated with KEVZARA in controlled studies was oral herpes1
Decrease in absolute neutrophil count (ANC) was not associated with higher incidence of infections, including serious infections1
In the long-term safety population, the overall rate of serious infections, gastrointestinal perforations, neutrophil counts, platelet counts, and lipid parameters were consistent with what was observed in the placebo-controlled trials1
Reduce to 150 mg in case of neutropenia, thrombocytopenia, and elevated liver enzymes1
If a patient develops a serious infection, hold treatment with KEVZARA until the infection is controlled1
KEVZARA initiation is not recommended in patients with an absolute neutrophil count (ANC) less than 2000/mm3, platelet count less than 150,000/mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).
ALT=alanine aminotransferase; AST=aspartate aminotransferase.Study Design
References: 1. KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc; 2. Data on file, Sanofi/Regeneron. Integrated summary. April 1, 2017