There have been significant updates to several sections of the SPC, including the following:

Change to section 4.2 - Posology and method of administration

A change has been made to the dosage regimen for renally impaired patients which necessitates lower tablet strengths of 25mg and 50 mg which will become available.

When considering the use of sitagliptin in combination with another anti-diabetic product, its conditions for use in patients with renal impairment should be checked.

For patients with mild renal impairment (creatinine clearance [CrCl] 50 ml/min), no dose adjustment for Januvia is required.

For patients with moderate renal impairment (CrCl 30 to <50 mL/min), the dose of Januvia is 50 mg once daily.

For patients with severe renal impairment (CrCl <30 mL/min) or with end-stage renal disease (ESRD) requiring haemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily. Januvia may be administered without regard to the timing of dialysis.

Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.

Please refer to SPC link below for full information on all changes.