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Matched label
JANUVIA
SITAGLIPTIN - Cardinal Health 107, LLC
® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Label facts
- Application
- NDA021995
- Route
- ORAL
- Label updated
- November 5, 2025
Indication
® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dose and administration
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.
Side effects
The following adverse reactions are also discussed elsewhere in the labeling: • Pancreatitis • Heart Failure • Acute Renal Failure • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues • Hypersensitivity Reactions • Severe and Disabling Arthralgia • Bullous Pemphigoid Adverse reactions reported in ≥5% of patients treated with JANUVIA and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with JANUVIA compared to placebo.
Safety flags
Pancreatitis
Heart failure
Acute Renal Failure
Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues
Hypersensitivity Reactions
Severe and Disabling Arthralgia
Contraindication: History of a serious hypersensitivity reaction to sitagliptin
Contraindication: such as anaphylaxis
Contraindication: angioedema.
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