Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing email@example.com or calling +44 (0)1707 367554.
Have confidence with RoACTEMRA® – a therapy used to treat more than 1.6 million patients worldwide across all of the licensed indications1
The safety profile of RoACTEMRA® has been examined across numerous clinical trials, including longitudinal studies of patients using RoACTEMRA® over a 5-year period2
Overall rate of adverse events / 100 patient years from a pooled analysis of 9 studies*2
Withdrawals due to AEs
5.2 / 100 patient years
4.4/100 patient years
Serious GI disorders
1.2/100 patient years
Serious adverse events
14.1/100 patient years
5.2/100 patient years
14.1 / 100 patient years
4.4 / 100 patient years
Serious cardiac disorders
1.2 / 100 patient years
For full details on dose adjustments in response to monitoring results and for further information on safety, please refer to the RoACTEMRA® SmPC:
*Safety outcomes in patients who received ≥1 RoACTEMRA® dose in 1 of 5 placebo-controlled studies (OPTION, TOWARD, RADIATE, AMBITION, LITHE), a clinical pharmacology study, long-term extension studies or a Phase 4 RoACTEMRA® monotherapy study (ADACTA)2. Exposed population = 4,009 patients.
AE, adverse event; GI, gastrointestinal; RA, rheumatoid arthritis; SAE, serious adverse event.
- Roche Data on File: M-GB-00001098, July 2020;
- Genovese MC et al. J Rheumatol. 2013;40:768–780;
- RoACTEMRA® 20 mg/ml Concentrate for Solution for Infusion Summary of Product Characteristics.
Date of preparation: September 2021