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Important Safety Information

Sitagliptin should not be used in people with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Adverse events

Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported. Hypoglycaemia has been reported in combination with sulphonylurea and insulin.

The frequency of the adverse reactions listed below are: very common (≥1/10); common (≥1/100 to <1/10).

Sitagliptin monotherapy: Common: upper respiratory tract infection, nasopharyngitis, osteoarthritis, pain in extremity, hypoglycaemia, headache.

Combination with metformin: Common: hypoglycaemia, nausea, flatulence, vomiting.

Combination with a sulphonylurea: Common: hypoglycaemia.

Combination with metformin and a sulphonylurea: Very common: hypoglycaemia; Common: constipation.

Combination with a PPARy agonist (pioglitazone): Common: hypoglycaemia, flatulence, peripheral oedema, blood glucose decrease.

Combination with a PPARy agonist (pioglitazone) and metformin: Common: hypoglycaemia, peripheral oedema.

Combination with insulin with/without metformin: Common: headache hypoglycaemia, influenza.

Adverse events with sitagliptin during post-approval use alone and/or with other diabetes medicines where frequency is not known: hypersensitivity reactions including anaphylactic responses (see precautions), interstitial lung disease, acute pancreatitis, fatal and non-fatal haemorrhage and necrotising pancreatitis, angioedema, rash, urticaria, cutaneous vasculitis, exfoliative skin conditions including Stevens-Johnson syndrome, arthralgia, myalgia, back pain, impaired renal function, acute renal failure.

Clinical considerations

Acute pancreatitis: Use of DPP-4 inhibitors has been associated with a risk of developing 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 necrotising or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Januvia should not be restarted. Caution should be exercised in patients with a history of pancreatitis.

Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products: In clinical trials of Januvia as monotherapy and as part of combination therapy with medicinal products 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. Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea. Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered (see section 4.2).

Renal impairment: Sitagliptin is renally excreted. To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2). When considering the use of sitagliptin in combination with another anti-diabetic medicinal product, its conditions for use in patients with renal impairment should be checked.

Hypersensitivity reactions: Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin 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 some reports occurring after the first dose. If a hypersensitivity reaction is suspected, Januvia should be discontinued. Other potential causes for the event should be assessed, and alternative treatment for diabetes initiated.

Bullous pemphigoid: There have been post-marketing reports of bullous pemphigoid in patients taking DPP-4 inhibitors including sitagliptin. If bullous pemphigoid is suspected, Januvia should be discontinued.

Elderly: No dose adjustment is necessary based on age

Supporting documentation

100 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

50 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

25 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

DIAB-1247350-0004 | Date of Preparation: March 2018