Brynovin Side Effects

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Pancreatitis [ see Warnings and Precautions ( 5.1 ) ] • Heart Failure [ see Warnings and Precautions ( 5.2 ) ] • Acute Renal Failure [ see Warnings and Precautions ( 5.3 ) ] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [ see Warnings and Precautions ( 5.4 ) ] • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.5 ) ] • Severe and Disabling Arthralgia [ see Warnings and Precautions ( 5.6 ) ] • Bullous Pemphigoid [ see Warnings and Precautions ( 5.7 ) ] Most common adverse reactions (incidence ≥5%) are: upper respiratory tract infection, nasopharyngitis and headache.

In the add-on to sulfonylurea and add-on to insulin trials, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of BRYNOVIN has been established for glycemic control in patients with type 2 diabetes mellitus based in adequate and well-controlled trials of sitagliptin tablets, referenced below as “sitagliptin” [see Clinical Studies ( 14 )] .

Common Adverse Reactions In controlled clinical trials as both monotherapy and combination therapy with metformin, pioglitazone, or rosiglitazone and metformin, the overall incidence of adverse reactions, hypoglycemia, and discontinuation of therapy due to clinical adverse reactions with sitagliptin were similar to placebo.

In combination with glimepiride, with or without metformin, the overall incidence of clinical adverse reactions with sitagliptin was higher than with placebo, in part related to a higher incidence of hypoglycemia (see Table 3);

the incidence of discontinuation due to clinical adverse reactions was similar to placebo.

Two placebo-controlled monotherapy trials, one of 18- and one of 24-week duration, included patients treated with sitagliptin 100 mg daily, sitagliptin 200 mg daily, and placebo.

Five placebo-controlled add-on combination therapy trials were also conducted: one with metformin;