If a dose of Januvia is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.

Special populations

Renal impairment

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

Clinical study experience with Januvia in patients with moderate or severe renal impairment is limited. Therefore, use of Januvia is not recommended in this patient population (see section 5.2).

Hepatic impairment

No dose adjustment is necessary for patients with mild to moderate hepatic impairment. Januvia has not been studied in patients with severe hepatic impairment.

Elderly

No dose adjustment is necessary based on age. Limited safety data is available in patients  75 years of age and care should be exercised.

Paediatric population

Januvia is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy.

Method of administration

Januvia can be taken with or without food.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).

4.4 Special warnings and precautions for use

General

Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis

In post-marketing experience there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotizing or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued.

Hypoglycaemia when used in combination with other anti-hyperglycaemic agents

In clinical trials of Januvia as monotherapy and as part of combination therapy with agents not known to cause hypoglycaemia (i.e. metformin and/or a PPARγ agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo. When sitagliptin was added to a sulphonylurea or to insulin, the incidence of hypoglycaemia was increased over that of placebo (see section 4.8). Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered (see section 4.2).

Renal impairment

As the experience is limited, patients with moderate to severe renal impairment should not be treated with Januvia (see section 5.2).

Hypersensitivity Reactions

Postmarketing reports of serious hypersensitivity reactions in patients treated with Januvia have been reported. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with Januvia, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue Januvia, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
4.5 Interaction with other medicinal products and othe