Advise the patient to read FDA-approved patient labeling (Medication Guide).

Medication Guide: Healthcare providers should instruct their patients to read the Medication Guide before starting saxagliptin and metformin hydrochloride extended-release tablet therapy and to reread it each time the prescription is renewed. Patients should be instructed to inform their healthcare provider if they develop any unusual symptom or if any existing symptom persists or worsens.

Patients should be informed of the potential risks and benefits of saxagliptin and metformin hydrochloride extended-release tablets and of alternative modes of therapy. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.

Lactic Acidosis: The risks of lactic acidosis due to the metformin component, its symptoms and conditions that predispose to its development, as noted in Warnings and Precautions (5.1), should be explained to patients. Patients should be advised to discontinue saxagliptin and metformin hydrochloride extended-release tablets immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgia, malaise, unusual somnolence, dizziness, slow or irregular heartbeat, sensation of feeling cold (especially in the extremities), or other nonspecific symptoms occur. Gastrointestinal symptoms are common during initiation of metformin treatment and may occur during initiation of saxagliptin and metformin hydrochloride extended-release tablet therapy; however, patients should consult their physician if they develop unexplained symptoms. Although gastrointestinal symptoms that occur after stabilization are unlikely to be drug related, such an occurrence of symptoms should be evaluated to determine if it may be due to lactic acidosis or other serious disease.

Patients should be counseled against excessive alcohol intake while receiving saxagliptin and metformin hydrochloride extended-release tablets.

Patients should be informed about the importance of regular testing of renal function and hematological parameters when receiving treatment with saxagliptin and metformin hydrochloride extended-release tablets.

Instruct patients to inform their doctor that they are taking saxagliptin and metformin hydrochloride extended-release tablets prior to any surgical or radiological procedure, as temporary discontinuation of saxagliptin and metformin hydrochloride extended-release tablets may be required until renal function has been confirmed to be normal [see Warnings and Precautions (5.1)].

Pancreatitis: Patients should be informed that acute pancreatitis has been reported during post-marketing use of saxagliptin. Before initiating saxagliptin and metformin hydrochloride extended-release tablets, patients should be questioned about other risk factors for pancreatitis, such as a history of pancreatitis, alcoholism, gallstones, or hypertriglyceridemia. Patients should also be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue saxagliptin and metformin hydrochloride extended-release tablets and contact their healthcare provider if persistent severe abdominal pain occurs [see Warnings and Precautions (5.2)].

Heart Failure: Patients should be informed of the signs and symptoms of heart failure. Before initiating saxagliptin and metformin hydrochloride extended-release tablets, patients should be asked about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Patients should be instructed to contact their healthcare provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet [see Warnings and Precautions (5.3)].

Hypoglycemia: Patients should be informed that the incidence of hypoglycemia may be increased when saxagliptin and metformin hydrochloride extended-release tablets are added to an insulin secretagogue (e.g., sulfonylurea) or insulin.

Hypersensitivity Reactions: Patients should be informed that serious allergic (hypersensitivity) reactions, such as angioedema, anaphylaxis, and exfoliative skin conditions, have been reported during post-marketing use of saxagliptin. If symptoms of these allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking saxagliptin and metformin hydrochloride extended-release tablets and seek medical advice promptly.

Severe and Disabling Arthralgia: Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs [see Warnings and Precautions (5.8)].

Bullous Pemphigoid: Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur [see Warnings and Precautions (5.9)].

Administration Instructions: Patients should be informed that saxagliptin and metformin hydrochloride extended-release tablets must be swallowed whole and not crushed or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.

Missed Dose: Patients should be informed that if they miss a dose of saxagliptin and metformin hydrochloride extended-release tablets, they should take the next dose as prescribed, unless otherwise instructed by their healthcare provider. Patients should be instructed not to take an extra dose the next day.