Printed From:

Proven Safety Profile

Studied in approximately 3000 TNF-IR and MTX-IR patients and for more than 4400 patient-years of exposure1,2

  • 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

Dosing Considerations for Patient Management

Recommended dosage modifications

  • 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

General considerations for administration

  • 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