FDA Approves Juvisync

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The U.S. Food and Drug Administration has 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.

Important information about Juvisync

Serious side effects can happen in people taking Juvisync, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.

Before you start taking Juvisync:

Tell your doctor if you have ever had

• pancreatitis
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels
• kidney problems

Stop taking Juvisync and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

What is Juvisync?

• Juvisync is a prescription medicine that contains two medicines, sitagliptin and simvastatin, in one pill. Juvisync can be used in adults who need both sitagliptin and simvastatin.
• Sitagliptin can be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
• Simvastatin can be used with diet and exercise in adults at high risk for heart attack or stroke to lower your chance of:
  • death from heart problems
  • having a heart attack or stroke
  • needing certain blood vessel procedures
• Simvastatin can be used in adults with certain cholesterol problems to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty substances called triglycerides in the blood. In addition, simvastatin raises levels of HDL (good) cholesterol. Simvastatin is for people who cannot control their cholesterol levels by diet and exercise alone. You should stay on a cholesterol-lowering diet while taking this medicine.
• Sitagliptin is not for people with type 1 diabetes.
• Sitagliptin is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).
• If you have had inflammation of your pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take sitagliptin.
• Juvisync has not been studied in people who have an increase of chylomicrons (Fredrickson types I and V).
• Juvisync is not for people with certain kidney problems.
• It is not known if Juvisync is safe and effective when used in children under 18 years of age.

For more information, see the sections called What is type 2 diabetes? and What should I know about high cholesterol?.