Januvia (sitagliptin)

JANUVIA (sitagliptin) – 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. DPP-4 inhibitors, are believed to exert their actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones. By increasing and prolonging active incretin levels, JANUVIA increases insulin release and decreases glucagon levels in the circulation in a glucose-dependent manner.

FDA approved uses: Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis.

Available dosage forms: Tablets: 25, 50, and 100 mg.

Usual dosage: The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. Dosage should be adjusted to 50 mg daily in moderate ESRD and 25 mg daily in severe ESRD.

Contraindications: History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

Adverse reactions (side effects) of these medications: The most common side effects of Januvia include 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. Other adverse reactions seen in clinical trials or post-marketing include: anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis, Stevens-Johnson syndrome, hepatic enzyme elevations, acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis, worsening renal function, constipation, vomiting, headache, myalgia, pain in extremity, and back pain.

Common drug interactions: There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100 mg sitagliptin for 10 days. Patients receiving digoxin should be monitored appropriately. No dosage adjustment of digoxin or JANUVIA is recommended.

Special instructions for patients: It is important to adhere to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.

Acute pancreatitis has been reported during postmarketing use of JANUVIA. Persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Promptly discontinue JANUVIA and contact physician if persistent severe abdominal pain occurs.

The incidence of hypoglycemia is increased when JANUVIA is added to a sulfonylurea or insulin and that a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Allergic reactions have been reported during postmarketing use of JANUVIA. If symptoms of allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JANUVIA and seek medical advice promptly.

Tablets must be swallowed whole and never split, crushed or chewed.

Full prescribing information may be found at the manufacturer‘s official website Januvia.com or at the U.S. Food and Drug Administration’s website at Januvia Info at Drugs@FDA

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