Saxagliptin and metformin

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take saxagliptin and metformin. Blood and urine tests may be needed to check for unwanted effects.

Let your doctor or dentist know you are taking saxagliptin and metformin. Your doctor may advise you to temporarily stop taking saxagliptin and metformin before you have major surgery or diagnostic tests, including procedures that use contrast dye.

Under certain conditions, too much metformin can cause a condition called lactic acidosis. The symptoms of lactic acidosis are severe, appear quickly, and usually occur when other health problems are present, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If symptoms of lactic acidosis occur, you should get immediate emergency medical help.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using saxagliptin and metformin. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

If you are rapidly gaining weight, having shortness of breath, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem.

saxagliptin and metformin may cause serious types of allergic reactions, including anaphylaxis and angioedema. These conditions may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest tightness.

saxagliptin and metformin may cause hypoglycemia (low blood sugar). This is more common when saxagliptin and metformin is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

saxagliptin and metformin may cause severe joint pain. Call your doctor right away if you have severe joint pain with saxagliptin and metformin.

saxagliptin and metformin may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using saxagliptin and metformin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• If you have an allergy to saxagliptin, metformin, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Acidic blood problem, kidney disease, liver disease, or type 1 diabetes.
• If you have had a recent heart attack or stroke.
• If you are not able to eat or drink like normal, including before certain procedures or surgery.

This is not a list of all drugs or health problems that interact with saxagliptin and metformin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

(sax a GLIP tin & met FOR min)

• Antidiabetic Agent, Biguanide
• Antidiabetic Agent, Dipeptidyl Peptidase 4 (DPP-4) Inhibitor

Saxagliptin inhibits dipeptidyl peptidase IV (DPP-IV) enzyme resulting in prolonged active incretin levels. Incretin hormones (eg, glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]) regulate glucose homeostasis by increasing insulin synthesis and release from pancreatic beta cells and decreasing glucagon secretion from pancreatic alpha cells. Decreased glucagon secretion results in decreased hepatic glucose production. Under normal physiologic circumstances, incretin hormones are released by the intestine throughout the day and levels are increased in response to a meal; incretin hormones are rapidly inactivated by the DPP-IV enzyme.

Metformin decreases hepatic glucose production, decreasing intestinal absorption of glucose and improves insulin sensitivity (increases peripheral glucose uptake and utilization).

Diabetes mellitus, type 2: Management of adults with type 2 diabetes mellitus (noninsulin dependent, NIDDM) as an adjunct to diet and exercise when treatment with both saxagliptin and metformin is appropriate.

US labeling: History of serious hypersensitivity reaction (eg, anaphylaxis, angioedema, exfoliative skin conditions) to saxagliptin, metformin, or any component of the formulation; severe renal impairment (eGFR <30 mL/minute/1.73 m2); acute or chronic metabolic acidosis including diabetic ketoacidosis

Canadian labeling: Hypersensitivity to saxagliptin, another dipeptidyl peptidase-4 inhibitor, metformin, or any component of the formulation; unstable and/or insulin-dependent (Type 1) diabetes mellitus; acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, history of ketoacidosis with or without coma; history of lactic acidosis (regardless of precipitating factors); presence of renal disease or impairment and patients with serum creatinine levels above the upper limit of normal range or abnormal creatinine clearance (<60 mL/minute), which may also result from conditions such as cardiovascular collapse, acute myocardial infarction, and septicemia or when renal function is unknown; excessive ethanol intake (acute or chronic); moderate and severe hepatic impairment; cases of cardiovascular collapse and disease states associated with hypoxemia such as cardiorespiratory insufficiency which are often associated with hyperlactacidemia; during stress conditions (eg, severe infection, trauma, surgery and postoperative recovery phase); severe dehydration; pregnancy; breast-feeding

Refer to adult dosing. The initial and maintenance dosing should be conservative, due to the potential for decreased renal function (monitor).

Adverse events were not observed in animal reproduction studies conducted with this combination. Refer to individual monographs.