Januvia

From: Merck

1 INDICATIONS AND USAGE

1.1 Monotherapy and Combination Therapy
JANUVIA1 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

1.2 Important Limitations of Use
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic
ketoacidosis, as it would not be effective in these settings.
JANUVIA has not been studied in combination with insulin.

2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.
2.2 Patients with Renal Insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women), no dosage adjustment for JANUVIA is required.
For patients with moderate renal insufficiency (CrCl ≥30 to <50>1.7 to ≤3.0 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily.
For patients with severe renal insufficiency (CrCl <30>3.0 mg/dL in men and >2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of hemodialysis.

Because there is a need for dosage adjustment based upon renal function, assessment of renal
function is recommended prior to initiation of JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [See Clinical Pharmacology(12.3).]

2.3 Concomitant Use with a Sulfonylurea
When JANUVIA is used in combination with a sulfonylurea, a lower dose of sulfonylurea may be
required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.2).]
3 DOSAGE FORMS AND STRENGTHS
• 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.

4 CONTRAINDICATIONS
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.3) and Adverse Reactions (6.2).]

5 WARNINGS AND PRECAUTIONS
5.1 Use in Patients with Renal Insufficiency
A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis. [See Dosage and Administration (2.2);
Clinical Pharmacology (12.3).]

5.2 Use with Medications Known to Cause Hypoglycemia
As is typical with other antihyperglycemic agents used in combination with a sulfonylurea, when
JANUVIA was used in combination with a sulfonylurea, a class of medications known to cause
JANUVIA™ (sitagliptin) Tablets 9762707
3 hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. [See Adverse
Reactions (6.1).] Therefore, a lower dose of sulfonylurea may be required to reduce the risk of
hypoglycemia. [See Dosage and Administration (2.3).]

5.3 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 Adverse Reactions (6.2).]

5.4 Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or any other anti-diabetic drug.

From: FDA
Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis
Audience: Diabetes healthcare professionals, patients [Posted 09/25/2009] FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.