ACTEMRA HAS AN EXTENSIVE SAFETY PROFILE ACROSS CLINICAL TRIALS AND POSTMARKETING STUDIES 2,4-6,8,10-20

All-exposure pooled pivotal and long-term, open-label data

Pooled data from patients who received at least one dose of ACTEMRA IV during the 6-month controlled period of the pivotal studies (OPTION, TOWARD, RADIATE, AMBITION, and LITHE) and pooled long-term safety data (mean duration in the study was 3.89 years leading to a total duration of 16,204.8 PY) that include the 6-month pivotal safety data, the open-label, long-term extension studies (GROWTH95 and GROWTH96), a clinical pharmacology study and 6-month data from a Phase IV monotherapy study.

This is not a complete list of the Important Safety Information for ACTEMRA. Please see full Prescribing Information, including BOXED WARNING, for additional Important Safety Information.

Serious Infections

Myocardial Infarctions

Serious Hepatic Events

Medically Confirmed Gastrointestinal Perforations

Medically Confirmed Malignancies

*Rates per 100 patient-years (95% CI) are based on 16,204.8 patient-years of observation from the latest safety data as of October 2017.

Rates per 100 patient-years (95% CI) are based on 16,204.8 patient-years of observation from the latest safety data as of May 2, 2012.

CI=confidence interval; DMARD=disease-modifying antirheumatic drug; GI=gastrointestinal; MI=myocardial infarction; PY=patient years; RA=rheumatoid arthritis; TNF=tumor necrosis factor.

ACTEMRA and Pregnancy Registry Study

The Organization of Teratology Information Specialists (OTIS) is building a study to understand the safety of treatments such as ACTEMRA on pregnant women. To enroll a patient in this study, please go to the OTIS website: Enroll Patients