The new regimens with Januvia described in the updated labeling include, as an adjunct to diet and exercise, initial therapy in combination with metformin; add-on therapy to a sulfonylurea (glimepiride) when the single agent alone does not provide adequate glycemic control; and, add-on therapy to the combination of a sulfonylurea (glimepiride) and metformin when dual therapy does not provide adequate glycemic control.
The expanded labeling for Januvia was also updated to include post-marketing reports of hypersensitivity reactions in patients treated with Januvia. These reactions include anaphylaxis, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome. The expanded labeling includes a contraindication for patients with history of a serious hypersensitivity reaction to sitagliptin, including anaphylaxis and angioedema.