Dosing Tolerability
Dosing tolerability in clinical trials
Low rate of injection site reactions from PRECiSE 1 and PRECiSE 2 (<3%)1,2
- <1% injection site stinging
- <1% injection site burning
Low incidence of allergic reactions (<1%)2
- No anaphylactic shock observed3
- Other hypersensitivity reactions observed in clinical trials included angioedema and serum sickness
Serious and sometimes fatal side effects have been reported with CIMZIA. These include tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Lymphoma and other malignancies also have been reported in children and adolescents. CIMZIA is not indicated for use in pediatric patients.
References:
- Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007;357:239-250.
- Schreiber S, Feagan BG, Hanauer SB, Rutgeerts P, Sandborn WJ. Subcutaneous certolizumab pegol is well tolerated by patients with active Crohn's disease: results from two phase III studies (PRECiSE 1 and 2). Poster presented at: Digestive Disease Week; May 20-25, 2006; Los Angeles, CA.
- CIMZIA [prescribing information]. Smyrna, GA: UCB, Inc.; 2009.