Januvia Special Precautions

General: JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: There have been reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis (see SIDE EFFECTS), in patients taking sitagliptin. 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. If pancreatitis is suspected, JANUVIA and other potentially suspect medicinal products should be discontinued.
Use in Patients with Renal Impairment: JANUVIA is renally excreted. To achieve plasma concentrations of JANUVIA similar to those in patients with normal renal function, lower dosages are recommended in patients with eGFR < 45 mL/min/1.73 m², as well as in ESRD patients requiring hemodialysis or peritoneal dialysis. (See Patients with Renal Impairment under DOSAGE & ADMINISTRATION.)
Hypoglycemia in Combination with a Sulfonylurea or with Insulin: In Clinical trials of JANUVIA as monotherapy and as part of combination therapy with agents not known to cause hypoglycemia (i.e. metformin or a PPARγ agonist (thiazolidinediones)), rates of hypoglycemia reported with JANUVIA were similar to rates in patients taking placebo. As is typical with other antihyperglycemic agents, hypoglycemia has been observed when JANUVIA was used in combination with insulin or a sulfonylurea (see SIDE EFFECTS). Therefore, to reduce the risk of sulfonylurea- or insulin-induced hypoglycemia, a lower dose of sulfonylurea or insulin may be considered (see DOSAGE & ADMINISTRATION).
Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 CONTRAINDICATIONS and Postmarketing Experience under SIDE EFFECTS.)
Bullous Pemphigoid: Postmarketing 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. Tell patients to report development of blisters or erosions while receiving JANUVIA. If bullous pemphigoid is suspected, JANUVIA should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.
Use in Children: A 54-week, double-blind study was conducted to evaluate the efficacy and safety of JANUVIA in pediatric patients (10 to 17 years of age) with type 2 diabetes who were not on anti-hyperglycaemic therapy for at least 12 weeks or were on a stable dose of insulin for at least 12 weeks. Patients were randomized and treated with JANUVIA 100 mg (N=95) or placebo (N=95) once daily for 20 weeks.
Treatment with JANUVIA 100 mg did not provide significant improvement in HbA_1c at 20 weeks.
In pediatric patients aged 10 to 17 years with type 2 diabetes, the profile of side effects was comparable to that observed in adults.
JANUVIA has not been studied in pediatric patients under 10 years of age.
Use in the Elderly: In clinical studies, the safety and effectiveness of JANUVIA in the elderly (≥65 years) were comparable to those seen in younger patients (<65 years). No dosage adjustment is required based on age. Elderly patients are more likely to have renal impairment; as with other patients, dosage adjustment may be required in the presence of significant renal impairment (see Patients with Renal Impairment under DOSAGE & ADMINISTRATION).