The effect of hepatic impairment on the pharmacokinetics of UCERIS rectal foam has not been studied. In a study in patients with mild to moderate hepatic impairment (Child-Pugh Class A and Child-Pugh Class B) dosed with budesonide 4 mg oral capsules, systemic exposure was similar between patients with mild hepatic impairment (Child-Pugh Class A; n=4) and healthy subjects (n=8), and -fold higher in patients with moderate hepatic impairment (Child-Pugh Class B; n=4) than in healthy subjects. For the intravenous dose, no significant differences in CL or VSS are observed. Patients with severe liver dysfunction (Child-Pugh Class C ) were not studied [see Use in Specific Population ].
The aftereffects of surgery for Crohn's disease varies, depending upon the location of the inflammation. Patients whose Crohn's is limited to the large intestine (colon and rectum) often do not redevelop the illness (and therefore don't require maintenance medications) if their entire colon and rectum are removed, and they are left with an ileostomy. However, if only part of the colon is removed, then there is a very high likelihood of recurrence of Crohn's disease. At some point, the disease also may recur in patients who have Crohn's of the small intestine, because complete removal of the small intestine is not possible. Patients with Crohn's fistulas often suffer recurrences after surgery, as well.