Januvia
(Sitagliptin)Dosage & 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/1.73 m2.
| eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2 | eGFR less than 30 mL/min/1.73 m2 (including patients with end stage renal disease [ESRD] on dialysis) |
| 50 mg once daily | 25 mg once daily |
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Januvia Prescribing Information
JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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/1.73 m2.
| eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2 | eGFR less than 30 mL/min/1.73 m2 (including patients with end stage renal disease [ESRD] on dialysis) |
| 50 mg once daily | 25 mg once daily |
- 100 mg tablets are beige, round, film-coated tablets with "277" on one side.
- 50 mg tablets are light beige, round, film-coated tablets with "112" on one side.
- 25 mg tablets are pink, round, film-coated tablets with "221" on one side.
The limited available data with JANUVIA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a Hemoglobin A1c >7% and has been reported to be as high as 20-25% in women with a Hemoglobin A1c >10%. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
- Pancreatitis:There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA.
- Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of JANUVIA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.
- Acute Renal Failure:Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating JANUVIA and periodically thereafter.
- Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues:Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required.
- Hypersensitivity Reactions:There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with JANUVIA such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop JANUVIA, assess for other potential causes, institute appropriate monitoring and treatment.
- Severe and Disabling Arthralgia:Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
- Bullous Pemphigoid:There have been postmarketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue JANUVIA.