Xiglip Special Precautions

General: Sitagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
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 hemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, sitagliptin and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, sitagliptin should not be restarted.
Caution should be exercised in patients with a history of pancreatitis.
Hypoglycemia with Concomitant Use with Other Anti-Hyperglycemic Medicinal Products: In clinical trials of sitagliptin as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycemia (i.e. metformin and/or a PPARγ agonist), rates of hypoglycemia reported with sitagliptin were similar to rates in patients taking placebo. Hypoglycemia has been observed when sitagliptin was used in combination with insulin or a sulphonylureas. Therefore, to reduce the risk of hypoglycemia, a lower dose of sulphonylureas or insulin may be considered.
Heart Failure: Consider the risks and benefits of sitagliptin prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and observe these patients for signs and symptoms of heart failure during therapy.
Advise patients to immediately report such symptoms. If heart failure develops, evaluate and manage the case according to current procedures and standards of care and consider discontinuation of sitagliptin.
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 moderate and severe renal impairment, as well as in ESRD patients requiring hemodialysis or peritoneal dialysis. 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, sitagliptin should be discontinued. Other potential causes for the event should be assessed, and alternative treatment for diabetes initiated.
Severe and Disabling Arthralgia: There have been post-marketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain.
Bullous Pemphigoid: Post-marketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Patient should report development of blisters or erosions while receiving Sitagliptin. If bullous pemphigoid is suspected, sitagliptin should be discontinued and refer the patient to a dermatologist for diagnosis and appropriate treatment.