Januvia (Sitagliptin Phosphate)

JANUVIA belongs to a new breakthrough class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors that improves blood sugar control in patients with type 2 diabetes. JANUVIA enhances a natural body system called the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, JANUVIA works only when blood sugar is elevated to address diminished insulin due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction.

JANUVIA is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications. It is important to use this medication regularly to get the most benefit.

Directions

Take JANUVIA as exactly as prescribed by your doctor. Your doctor may occasionally change your dose to make sure you get the best results. Patients can take JANUVIA with or without food.

Ask your doctor how to adjust your JANUVIA dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Cautions

JANUVIA is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in adults with type 2 diabetes. Before taking JANUVIA, tell your doctor if you have:

• kidney disease
• are on dialysis
• have a history of pancreatitis
• are pregnant or planning on becoming pregnant
• breastfeeding a newborn
• are allergic to JANUVIA
• are in a state of diabetic ketoacidosis

Patients may have to visit their doctor regularly to check their blood sugar checked often. It is important to know the signs of low blood sugar (hypoglycemia) and how to recognize them. Common signs and symptoms of low blood sugar include: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

JANUVIA should not be used in patients with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine). If you have had pancreatitis (inflammation of the pancreas), it is not known if you have a higher chance of getting it while taking JANUVIA.

Talk with your doctor about additional risks and benefits of using JANUVIA.

Side Effects

Serious side effects can occur in patients taking JANUVIA, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death or serious allergic reactions. Contact your doctor immediately.

The most common side effects of JANUVIA include:

• upper respiratory infection
• stuffy or runny nose and sore throat
• headache

JANUVIA may have other side effects, including:

• stomach upset and diarrhea
• swelling of the hands or legs, when JANUVIA is used with the combination of metformin & rosiglitazone (other types of diabetes medicines)
• elevated liver enzymes

Patient must ensure they do not allow their blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about additional side effects or any side effect that bothers you or that do not go away.