 The U.S. Food and Drug Administration approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.
Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood.
Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet.It is reported that there is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.
The most common side effects of Juvisync include upper respiratory infection; stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea. |
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