Onglyza (Saxagliptin)

What is saxagliptin?

Saxagliptin is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin your body produces after eating. Saxagliptin is for people with type 2 diabetes. Saxagliptin is sometimes used in combination with other diabetes medications, but is not for treating type 1 diabetes. Saxagliptin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about saxagliptin?

You should not use this medicine if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Saxagliptin is not for treating type 1 diabetes.

What should I discuss with my healthcare provider before taking saxagliptin?

You should not use this medication if you have ever had a severe allergic reaction to saxagliptin, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). To make sure you can safely take saxagliptin, tell your doctor if you have: kidney disease (or if you are on dialysis); pancreatitis; gallstones; high triglycerides (a type of fat in the blood); or a history of alcoholism. This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether saxagliptin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Saxagliptin is not approved for use by anyone younger than 18 years old.

How should I take saxagliptin?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended. You may take this medicine with or without food. Follow your doctor's instructions. Do not crush, chew, or break a saxagliptin tablet. Swallow it whole. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice. Your doctor may want you to stop taking saxagliptin for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Saxagliptin 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 medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Store at room temperature away from moisture and heat

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food if your doctor has instructed you to). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I avoid while taking saxagliptin?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Saxagliptin side effects

Get emergency medical help if you have signs of an allergic reaction: hives, a purple or red skin rash that spreads and causes blistering and peeling; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking saxagliptin and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats. Call your doctor at once if you have: severe or ongoing pain in your joints;  pain or burning when you urinate; or swelling in your hands, ankles, or feet. Common side effects may include: runny or stuffy nose, sore throat, cough; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Saxagliptin dosing information

Usual Adult Dose for Diabetes Type 2: 2.5 or 5 mg orally once a day, regardless of meals, Coadministration with strong CYP450 3A4/5 inhibitors: 2.5 mg orally once a day Use: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings

What other drugs will affect saxagliptin?

Other drugs may increase or decrease the effects of saxagliptin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.