See the DrugPatentWatch profile for actemra
What are the gastrointestinal risks associated with Actemra?
Actemra, a medication used to treat rheumatoid arthritis and other autoimmune diseases, has been linked to gastrointestinal side effects, including bowel perforation, a potentially life-threatening condition.
How common is bowel perforation as a side effect of Actemra?
According to the FDA [1] and the manufacturer's prescribing information, the incidence of bowel perforation in clinical trials was low, occurring in less than 1% of patients. However, the exact incidence rate and risk factors for bowel perforation associated with Actemra are not well established.
What are the symptoms and warning signs of bowel perforation?
Patients taking Actemra are advised to seek medical attention immediately if they experience symptoms such as abdominal pain, vomiting, fever, chills, and bloody stools or blood in their stool [2]. If left untreated, bowel perforation can lead to peritonitis, a serious infection, and even death.
Why is bowel perforation a risk associated with Actemra?
Bowel perforation is a possible side effect of Actemra due to its mechanism of action as an interleukin-6 (IL-6) receptor inhibitor. IL-6 plays a role in the inflammatory response, and blocking it can lead to gastrointestinal side effects, including bleeding and perforation.
Can biosimilars like CT-P13 (Biosimilar to Actemra) also cause bowel perforation?
The risk of bowel perforation associated with biosimilars like CT-P13 is similar to that of the reference product, Actemra. Biosimilars are highly similar to the originator biologic and must meet the same safety and efficacy standards.
What measures can be taken to minimize the risk of bowel perforation with Actemra?
To reduce the risk of bowel perforation, patients taking Actemra should follow their treatment plan, report any gastrointestinal side effects to their healthcare provider promptly, and receive regular monitoring and follow-up care.
When does the patent for Actemra expire?
According to DrugPatentWatch.com [3], the Actemra (tocilizumab) patent expired in 2023.
References:
[1] FDA. (2010). tocilizumab (marketed as ACTEMRA) Injection
[2] Pfizer. (2021). ACTEMRA Prescribing Information.
[3] DrugPatentWatch.com. Tocilizumab 2023 Patent Expiration Date.