Important Safety Information

Important Safety Information

KOMBIGLYZE XR can cause serious side effects, including lactic acidosis. Metformin, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis: feel cold in your hands or feet, feel dizzy or lightheaded, have a slow or irregular heartbeat, feel very weak or tired, unusual (not normal) muscle pain, trouble breathing, feel sleepy or drowsy, or have stomach pains, nausea or vomiting.

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with KOMBIGLYZE XR if you have severe kidney problems, your kidneys are affected by certain x-ray tests that use injectable dye, have liver problems, drink alcohol (very often or a lot of alcohol in short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have surgery, have a heart attack, severe infection, or stroke.

Do not take KOMBIGLYZE XR if you:

• have kidney problems. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with KOMBIGLYZE XR
• are allergic to saxagliptin, metformin, or any of the ingredients in KOMBIGLYZE XR. Symptoms of a serious allergic reaction 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 any of these symptoms, stop taking KOMBIGLYZE XR and contact your healthcare provider or go to the nearest hospital emergency room right away

Serious side effects can happen in people who take 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
• Heart failure. Before taking KOMBIGLYZE XR tell your doctor if you have ever had heart failure or problems with your kidneys. Contact your doctor right away if you have any of the following symptoms of heart failure: increasing shortness of breath or trouble breathing, especially when you lie down; an unusually fast increase in weight; swelling or fluid retention, especially in the feet, ankles or legs; unusual tiredness
• Low blood sugar. 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
• Joint pain. Some people who take medicines called DPP-4 inhibitors, one of the medicines in KOMBIGLYZE XR, may develop joint pain that can be severe. Call your doctor if you have severe joint pain
• Skin reaction. Some people who take medicines called DPP-4 inhibitors, like one of the active ingredients in KOMBIGLYZE XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin

Tell your healthcare provider:

• if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed
• 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

How to take KOMBIGLYZE XR:

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

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.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide for KOMBIGLYZE XR. KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) (5/500•5/1000•2.5/1000 mg tablets).

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.