IMPORTANT SAFETY INFORMATION for KOMBIGLYZE XR (saxagliptin and metformin HCI extended-release) tablets

Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking KOMBIGLYZE XR and call your doctor right away if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack, severe infection, or stroke, or are 80 years of age or older and have not had your kidney function tested.

Do not take KOMBIGLYZE XR if you have kidney problems, have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine), or are allergic to metformin hydrochloride, saxagliptin, or any of the ingredients in KOMBIGLYZE XR. Serious allergic reactions can occur with KOMBIGLYZE XR and may include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking KOMBIGLYZE XR and contact your doctor right away.

Serious side effects can happen to people taking KOMBIGLYZE XR, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking KOMBIGLYZE XR, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking KOMBIGLYZE XR and contact 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.

Your doctor should do blood tests to check how well your kidneys are working before and during your treatment with KOMBIGLYZE XR.

If you take KOMBIGLYZE XR with another medicine that can cause low blood sugar (hypoglycemia), such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Symptoms of low blood sugar include, shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood. Follow your doctor's instructions for treating low blood sugar.

The most common side effects of KOMBIGLYZE XR include upper respiratory tract infection, stuffy or runny nose and sore throat, urinary tract infection, headache, diarrhea, and nausea and vomiting.

Tell your doctor if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, as your doctor may need to change your dose of KOMBIGLYZE XR.

Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

Swallow KOMBIGLYZE XR whole; do not crush, cut, or chew.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click here for Medication Guide, and click here for US Full Prescribing Information for KOMBIGLYZE XR, including Boxed WARNING about lactic acidosis.

WHAT IS KOMBIGLYZE XR?

KOMBIGLYZE XR is a prescription medicine that contains saxagliptin and metformin hydrochloride. KOMBIGLYZE XR is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes. Your doctor will decide if treatment with both saxagliptin and metformin is right for you.

KOMBIGLYZE XR should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher chance of getting pancreatitis while taking KOMBIGLYZE XR.