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This safety information outlines important considerations for the use of Qtern (dapagliflozin/saxagliptin). Please read these warnings carefully and discuss any concerns with your healthcare provider.

• Pancreatitis Risk: Although rare, saxagliptin has been associated with inflammation of the pancreas. Symptoms include upper abdominal pain, fever, nausea, and vomiting. If you experience these, contact your healthcare provider immediately, as you may need to discontinue Qtern.

• Ketoacidosis Warning: Dapagliflozin may lead to diabetic ketoacidosis (DKA), a serious condition where acidic ketones accumulate in the blood. Symptoms include difficulty breathing, vomiting, abdominal pain, dry skin, fatigue, and fruity-smelling breath. Seek prompt medical attention if these occur. Increased risk factors include prolonged fasting, recent surgery, fever, pancreatic issues, insulin dose reduction, and excessive alcohol consumption.

• Dehydration and Kidney Concerns: Qtern may cause increased urination leading to dehydration, low blood pressure, or kidney injury, potentially necessitating hospitalization or dialysis. Individuals with kidney issues, those taking loop diuretics, or older adults are at higher risk. Monitor for dizziness, confusion, chest pain, or reduced urination, and consult your provider.

• Infection Risks: Qtern may increase the likelihood of genital and urinary tract infections, including serious cases requiring hospitalization. Symptoms to watch for include genital itching, painful urination, cloudy urine, and back pain. Seek immediate medical help for severe infection signs like genital pain, swelling, redness, fever, and weakness.

• Allergic Reactions: Rarely, Qtern can trigger severe allergic reactions, including skin rash, swelling, breathing difficulties, and dizziness. These are more common in the first three months or if there's a history of reactions to DPP-4 or SGLT2 inhibitors. Inform your provider of any past allergies.

• Joint Pain: Severe joint pain has been reported with DPP-4 inhibitors like saxagliptin. If you experience joint discomfort, consult your healthcare provider.

• Heart Failure Concerns: There may be an increased risk of heart failure with DPP-4 inhibitors, especially in individuals with recent heart or kidney problems. Report symptoms like shortness of breath, fatigue, swelling, or sudden weight gain to your provider promptly.

• Hypoglycemia Risk: Qtern can increase the risk of low blood sugar when combined with other diabetes medications. Symptoms include shakiness, anxiety, confusion, sweating, rapid heartbeat, and hunger. Be familiar with blood sugar monitoring and management strategies. Changes in diet, exercise, or alcohol intake can also affect blood sugar levels.

• Contraindications: Do not use Qtern if you have moderate to severe kidney problems, end-stage renal disease, or are undergoing dialysis. Consult your healthcare provider if these conditions apply to you.

This medication may cause some common side effects, which are typically mild. These include frequent urination, dizziness, or lightheadedness, and sore throat or cough associated with upper respiratory tract infections. Headaches, diarrhea, and high cholesterol levels have also been reported. If these effects persist or worsen, it is advisable to consult a healthcare provider. To reduce dizziness or lightheadedness, it's helpful to rise slowly from sitting or lying down positions.

More serious side effects, although rare, require immediate medical attention. These include signs of a urinary tract infection, such as pain or discomfort while urinating, as well as symptoms indicative of kidney issues, heart failure, or pancreas inflammation. It's important to watch for joint pain, unusual skin blisters, and symptoms of ketoacidosis like difficulty breathing, vomiting, or fruity-smelling breath. Low blood pressure can also occur, with symptoms like dizziness and confusion.

This medication may lead to genital infections, including yeast infections, and in rare cases, a serious bacterial infection known as Fournier's gangrene. Seek urgent medical help if you notice pain, redness, or swelling in the genital area, accompanied by fever or a general feeling of unwellness.

In rare instances, severe allergic reactions may occur, characterized by rash, swelling, severe dizziness, and trouble breathing. Dehydration is another risk, potentially leading to serious kidney damage, so maintaining adequate fluid intake is crucial. If experiencing signs of dehydration, such as a dry mouth, fast heartbeat, or reduced urination, contact a healthcare provider promptly. Always communicate with your healthcare provider about any side effects experienced while taking this medication.

Saxagliptin may interact with other medications in a way that affects its removal from your body, potentially altering its effectiveness. Medications such as azole antifungals (including itraconazole and ketoconazole), nefazodone, telithromycin, and ritonavir are examples of drugs that could have this effect. Additionally, beta blockers like metoprolol, propranolol, and certain glaucoma eye drops such as timolol might mask the typical rapid or strong heartbeat that signals low blood sugar levels (hypoglycemia). However, they do not affect other signs of low blood sugar, such as dizziness, hunger, or sweating.

It's important to note that numerous drugs can influence your blood sugar levels, complicating their management. Before starting, stopping, or altering any medication, consult with your doctor or pharmacist to understand its impact on your blood sugar. Regular blood sugar monitoring is essential, and you should communicate your readings with your doctor. Notify your doctor immediately if you experience symptoms of high or low blood sugar, as adjustments to your diabetes medication, exercise routine, or diet might be necessary.

Furthermore, saxagliptin might interfere with certain laboratory tests, such as urine glucose tests, leading to inaccurate results. Be sure to inform lab personnel and all healthcare providers that you are taking this medication.