Medication Monitor

Generic Name (Trade Name—Company)
October 31, 2019


Ustekinumab has new indication for treatment of adults with ulcerative colitis

On October 21, Janssen announced FDA approval of ustekinumab to treat adult patients with moderately to severely active ulcerative colitis (UC).

Approval for this new indication was based on the pivotal Phase III UNIFI clinical trial, which demonstrated that treatment with ustekinumab induced and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active UC compared with placebo.

Ystekinumab is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines, which have been shown to play an important role in inflammatory and immune responses.

The recommended dosage for UC starts with a weight-based, one-time I.V. infusion induction dose, followed by a maintenance dosing schedule of a 90-mg S.C. maintenance injection every 8 weeks.

Common adverse effects include nasal congestion, sore throat, and runny nose; upper respiratory infections; fever; headache; tiredness; itching; nausea and vomiting; redness at the injection site; vaginal yeast infections; urinary tract infections; sinus infection; stomach pain; diarrhea; and joint pain.