Fraizeron Special Precautions

Infections: Fraizeron has the potential to increase the risk of infections. In clinical studies, infections have been observed in patients receiving Fraizeron (see Adverse Reactions). Most of these were mild or moderate.
Caution should be exercised when considering the use of Fraizeron in patients with a chronic infection or a history of recurrent infection.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and Fraizeron should not be administered until the infection resolves.
No increased susceptibility to tuberculosis was reported from clinical studies. However, Fraizeron should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be considered prior to initiation of Fraizeron in patients with latent tuberculosis.
Inflammatory Bowel Disease (IBD): Caution should be exercised, when prescribing Fraizeron to patients with inflammatory bowel disease (e.g. Crohn's disease and ulcerative colitis) as exacerbations of IBD, in some cases serious, were observed in clinical studies in both Fraizeron and placebo groups.
In addition, cases of new onset IBD have been reported with post-marketing use.
Patients who are treated with Fraizeron and have IBD should be followed closely.
Hypersensitivity reactions: In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving Fraizeron. If an anaphylactic or other serious allergic reaction occurs, administration of Fraizeron should be discontinued immediately and appropriate therapy initiated.
Latex-sensitive individuals – 1 mL pre-filled pen: The removable caps of the Fraizeron 1 mL pre-filled pen, contain a derivative of natural rubber latex. Although no natural rubber latex is detected in the cap, the safe use of Fraizeron pre-filled pen in latex-sensitive individuals has not been studied.
Vaccinations: Live vaccines should not be given concurrently with Fraizeron (see also Interactions).
Patients receiving Fraizeron may receive concurrent inactivated or non-live vaccinations.
In a study, after meningococcal and inactivated influenza vaccinations, a similar proportion of patients treated with Fraizeron and patients treated with placebo were able to mount an adequate immune response of at least a 4-fold increase in antibody titers to meningococcal and influenza vaccines. The data suggest that Fraizeron does not suppress the humoral immune response to the meningococcal or influenza vaccines.
Prior to initiating therapy with Fraizeron, it is recommended that pediatric patients receive all age-appropriate immunizations as per current immunization guidelines.