- Side Effects
- Drug Interactions
- Pregnancy & Breastfeeding
- What Else to Know
Generic Name: dapagliflozin/saxagliptin
Brand Name: Qtern
What is dapagliflozin/saxagliptin, and what is it used for?
Dapagliflozin/saxagliptin is a combination medication used to improve glycemic control in adults with diabetes mellitus type 2, in addition to diet and exercise. Dapagliflozin reduces blood glucose levels by inhibiting the reabsorption of glucose in the kidneys. Saxagliptin alters the activity of insulin and glucagon, two pancreatic hormones that regulate blood glucose levels. The combination drug is not recommended for type 1 diabetes mellitus, because it can increase the risk of ketoacidosis, a serious complication of diabetes.
Insulin stimulates the uptake of glucose from the blood by the organs, while glucagon increases blood sugar levels and prevents it from dropping too low. Diabetes mellitus is a chronic metabolic disorder caused by inadequate production or improper functioning of insulin which impairs the body’s ability to convert glucose into the form of energy that cells use. With the result, blood glucose levels remain excessively high which can damage all organ systems. Diabetes mellitus type 2 generally develops in adults, usually due to lifestyle factors.
The combination drug dapagliflozin/saxagliptin helps reduce blood glucose levels in the following ways:
- Dapagliflozin: Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor drug. SGLT2 is a protein molecule that is responsible for majority of glucose reabsorption in the kidneys. Dapagliflozin inhibits SGLT2, reduces reabsorption of glucose and promotes its excretion in the urine.
- Saxagliptin: The intestines release incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), after a meal. Incretin hormones stimulate insulin release from the pancreas, reduce glucagon secretion and glucose production in the liver. Dipeptidyl peptidase-4 (DPP-4) enzyme, present in many tissues, inactivates the incretin hormones within minutes. Saxagliptin inhibits DPP-4 enzyme and slows down the inactivation of the incretin hormones.
- Do not use dapagliflozin/saxagliptin in patients with a history of hypersensitivity to dapagliflozin, saxagliptin or any component of the formulation.
- Do not use dapagliflozin/saxagliptin to treat patients with moderate-to-severe impairment of kidney function, end-stage renal disease (ESRD) or patients on dialysis.
- There are reports of acute pancreatitis in patients treated with saxagliptin. Monitor patients for signs and symptoms of pancreatitis, and if pancreatitis is suspected, discontinue dapagliflozin/saxagliptin immediately and treat appropriately.
- Clinical trials in patients with established atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD showed that saxagliptin may increase the risk for hospitalization for heart failure, and the risk is higher in patients with a history of heart failure or renal impairment.
- Consider risks and benefits of treatment in patients at higher risk for heart failure.
- Monitor patients for signs and symptoms of heart failure during treatment.
- Educate patients on symptoms of heart failure and advise them to report such symptoms immediately.
- Evaluate patients who develop heart failure symptoms, treat appropriately and consider discontinuing dapagliflozin/saxagliptin.
- Treatment with SGLT2 inhibitors, including dapagliflozin, has been reported to lead to ketoacidosis, a life-threatening and sometimes, fatal complication of diabetes that requires immediate hospitalization.
- Consider patient’s risk for developing ketoacidosis before initiation dapagliflozin/saxagliptin.
- Monitor patients for symptoms of ketoacidosis and consider discontinuing in patients with clinical conditions that predispose to ketoacidosis and restarting after the conditions resolve.
- In patients undergoing elective surgery, consider temporary discontinuation of dapagliflozin/saxagliptin for at least 3 days before surgery.
- Educate patients on symptoms of ketoacidosis and advise them to report such symptoms immediately.
- Dapagliflozin can deplete blood volume leading to hypotension and kidney injury.
- Elderly patients, patients taking loop diuretics, and patients with impaired kidney function are at a higher risk.
- Assess patient’s blood volume status and kidney function before starting dapagliflozin/saxagliptin therapy.
- Monitor for signs and symptoms of hypotension and impairment of renal function during treatment.
- Dapagliflozin increases the risk for serious urinary tract infections including urosepsis and pyelonephritis. Monitor patients for signs and symptoms of urinary tract infections and treat promptly.
- Dapagliflozin/saxagliptin can cause hypoglycemia and the risk is higher when used in combination with insulin or insulin secretagogue medications such as sulfonylureas. Adjust the dosage of insulin or insulin secretagogue appropriately.
- There have been reports of a rare but life-threatening bacterial genital infection, necrotizing fasciitis of the perineum (Fournier’s gangrene), associated with dapagliflozin, that have required surgical intervention.
- Educate patients of symptoms of necrotizing fasciitis and advise them to report symptoms immediately.
- If necrotizing fasciitis is suspected, institute appropriate treatment immediately, discontinue dapagliflozin/saxagliptin, monitor glucose levels closely and provide alternate treatment for glycemic control.
- There have been serious hypersensitivity reactions in some patients, including angioedema, anaphylaxis and exfoliative skin conditions, generally within the first 3 months of treatment initiation with saxagliptin.
- Use dapagliflozin/saxagliptin with caution in patients with a history of angioedema to any other dipeptidyl peptidase-4 (DPP-4) inhibitor.
- Advise patient to report hypersensitivity reactions immediately, provide appropriate treatment and monitor until symptoms resolve.
- Provide alternate treatment for diabetes if no other cause for the hypersensitivity reactions is found.
- Dapagliflozin increases the risk for genital fungal infections, particularly in patients with a history. Monitor patient and treat appropriately.
- DPP-4 inhibitors, including saxagliptin can cause severe and disabling arthralgia, that may occur immediately after initiation of therapy or even after years. Consider saxagliptin as a possible cause if patient develops arthralgia, and discontinue if appropriate.
- A rare skin disorder, bullous pemphigoid, has been reported in some patients taking DPP-4 inhibitors. Advise patients to report development of blisters and erosions. If bullous pemphigoid is suspected, discontinue dapagliflozin/saxagliptin and refer to a dermatologist for appropriate treatment.
What are the side effects of dapagliflozin/saxagliptin?
Common side effects of dapagliflozin/saxagliptin include:
- Upper respiratory tract infection
- Urinary tract infection
- Imbalance of blood fat levels (dyslipidemia)
- Increase in low-density lipoprotein (LDL) cholesterol
- Back pain
- Joint pain (arthralgia)
- Genital fungal (mycotic) infections
- Low blood glucose levels (hypoglycemia)
- Depletion of blood volume and associated events including:
- Impairment of kidney function
- Increase in serum creatinine
- Reduced urine output
- Acute kidney failure
- Increase in serum inorganic phosphorous
- Increase in hematocrit
- Increase in serum creatine kinase
- Decrease in serum bicarbonate
- Decrease in lymphocyte count
Less common side effects of dapagliflozin/saxagliptin include:
- Ketoacidosis, a serious complication of diabetes
- Acute kidney injury
- Serious urinary tract infections such as:
- Life threatening bacterial genital infection (necrotizing fasciitis of the perineum known as Fournier’s gangrene)
- Hypersensitivity reactions including:
- Exfoliative skin reactions
- Swelling beneath the skin and mucous membranes (angioedema)
- Severe allergic reaction (anaphylaxis)
- Inflammation of the pancreas (pancreatitis)
- Severe and disabling arthralgia
- Bullous pemphigoid, a rare skin disorder with fluid-filled blisters
- Breakdown of muscle cells (rhabdomyolysis)
Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:
- Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
- Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
- Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
- Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
What are the dosages of dapagliflozin/saxagliptin?
- 10 mg/5 mg
Type 2 Diabetes Mellitus
- Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin
- 1 tablet (i.e., 10 mg/5 mg) orally once daily in the morning with or without food
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m²: Do not initiate
- Discontinue if eGFR persistently falls to below 60 mL/min/1.73 m²
- eGFR below 45 mL/min/1.73 m²: Contraindicated
- May be administered with hepatic impairment
- Severe hepatic impairment: Individually assess benefit-risk
Coadministration with strong CYP3A4/5 inhibitors
- Do not co-administer with strong CYP3A4/5 inhibitors
- Examples include ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin
- In patients with volume depletion, correct this condition prior to initiating drug
- Assess renal function before initiating and periodically thereafter
Limitations of use
- Not indicated for type 1 diabetes mellitus or diabetic ketoacidosis
- Should only be used in patients who tolerate dapagliflozin 10 mg
- Safety and efficacy not established
Dapagliflozin/saxagliptin overdose can lower blood glucose levels excessively and lead to hypoglycemia. Overdose may be treated with symptomatic and supportive care. Saxagliptin can be removed from the blood by hemodialysis, however, there are no studies on the removal of dapagliflozin by hemodialysis.
What drugs interact with dapagliflozin/saxagliptin?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
- Dapagliflozin/saxagliptin has no known severe interactions with other drugs.
- Serious interactions of dapagliflozin/saxagliptin include:
- Dapagliflozin/saxagliptin has moderate interactions with at least 116 different drugs.
- Dapagliflozin/saxagliptin has mild interactions with at least 88 different drugs.
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
Pregnancy and breastfeeding
- There are no adequate and well-controlled studies of dapagliflozin/saxagliptin use in pregnant women, however, animal reproductive studies show dapagliflozin can affect the fetal kidneys if used during second and third trimesters of pregnancy.
- Dapagliflozin/saxagliptin is not recommended for use in pregnant women in the second and third trimesters.
- Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications, and fetal risks for birth defects and abnormally large growth (macrosomia).
- There is no information on the presence of dapagliflozin or saxagliptin in breastmilk, or its effects on milk production and the breastfed infant. Dapagliflozin and saxagliptin are present in rat’s milk.
- Dapagliflozin/saxagliptin is not recommended for use in nursing mothers because of the potential for serious adverse reactions in the breastfed infant, including injury to the developing kidneys.
What else should I know about dapagliflozin/saxagliptin?
- Take dapagliflozin/saxagliptin exactly as instructed. Swallow tablets whole, do not chew or crush.
- You may need regular checkups, follow up with your physician and do not miss your appointments. You will test positive for glucose in urine because of the way dapagliflozin/saxagliptin works.
- Discontinue dapagliflozin/saxagliptin and contact your physician immediately if you develop:
- Symptoms of pancreatitis, which include severe abdominal pain and vomiting
- Symptoms of diabetic ketoacidosis, including nausea, vomiting, abdominal pain, tiredness and labored breathing, even if your blood sugar is not elevated.
- Severe allergic reactions such as rash, hives, peeling or flaking skin, swelling of skin, swelling of face, tongue, lips and throat, and swallowing and/or breathing difficulties.
- Report to your physician immediately if you develop:
- Symptoms of heart failure such as rapid weight gain, swelling of feet and increasing shortness of breath
- Low blood pressure symptoms; drink adequate fluids because dehydration increases the risk for reduced blood volume and associated hypotension
- Symptoms of urinary tract infection
- Pain, swelling, redness or tenderness of genitals or in the area between the genitals and rectum, along with malaise and/or fever above 100.4 F
- Symptoms of genital fungal infection
- Severe joint pain
- Blisters or erosions in the skin
- Store dapagliflozin/saxagliptin safely out of reach of children.
- In case of overdose, seek medical help or contact Poison Control.
Dapagliflozin/saxagliptin is a combination medication used to improve glycemic control in adults with diabetes mellitus type 2, in addition to diet and exercise. Dapagliflozin reduces blood glucose levels by inhibiting reabsorption of glucose in the kidneys. Common side effects of dapagliflozin/saxagliptin include upper respiratory tract infection, urinary tract infection, imbalance of blood fat levels (dyslipidemia), increase in low-density lipoprotein (LDL) cholesterol, diarrhea, headache, back pain, joint pain (arthralgia), genital fungal (mycotic) infections, low blood glucose levels (hypoglycemia), and others.
Related Disease Conditions
Normal Blood Sugar Levels In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Is a Glucose Level of 101 Bad?
It means that you should control your blood sugar level through your diet. Otherwise, you may develop diabetes. This is a warning sign that you should stop ingesting extra glucose through your diet.
Diabetes Symptoms in Women
Diabetes symptoms in women include vaginal itching, pain, or discharge, loss of interest or pain after having sex, polycystic ovarian syndrome (POS), and urinary tract infections or UTIs (which are more common in women. Symptoms of diabetes that are the same in women and men are excessive thirst and hunger, bad breath, and skin infections, darkening of skin in areas of body creases (acanthosis nigricans), breath odor that is fruity, sweet, or acetone, and tingling or numbness in the hands or feet, blurred vision, fatigue, tingling or numbness in the hands or feet, wounds that heal slowly, irritability, and weight loss or gain. Complications of type 1 and type 2 diabetes are the same, for example, skin, eye, and circulation problems, low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), ketoacidosis, and amputation. If diabetes is not managed a person may not survive.
Type 2 Diabetes Diet Plan
A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
Which is Worse - Type 1 or Type 2 Diabetes?
Learn about the similarities and differences between Type 1 and Type 2 Diabetes.
Type 1 vs. Type 2 Diabetes: Differences
Diabetes mellitus is a metabolic condition in which a person's blood sugar (glucose) levels are too high. Over 29.1 million children and adults in the US have diabetes. Of that, 8.1 million people have diabetes and don't even know it. Type 1 diabetes (insulin-dependent, juvenile) is caused by a problem with insulin production by the pancreas. Type 2 diabetes (non-insulin dependent) is caused by: Eating a lot of foods and drinking beverages with simple carbohydrates (pizza, white breads, pastas, cereals, pastries, etc.) and simple sugars (donuts, candy, etc.) Consuming too many products with artificial sweeteners (We found out that they are bad for us!) Lack of activity Exercise Stress Genetics While the signs and symptoms of both types of diabetes are the same, which include: Increased urination Increased hunger Increased thirst Unexplained weight loss. However, the treatments are different. Type 1 diabetes is insulin dependent, which means a person with this type of diabetes requires treatment with insulin. People with type 2 diabetes require medication, lifestyle changes like eating a healthy diet, and getting regular exercise.
Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
Diabetes Treatment: Medication, Diet, and Insulin
The major goal in treating diabetes is controlling elevated blood sugar without causing abnormally low levels of blood sugar. Type 1 diabetes is treated with: insulin, exercise, and a diabetic diet. Type 2 diabetes is first treated with: weight reduction, a diabetic diet, and exercise. When these measures fail to control the elevated blood sugar, oral medications are used. If oral medications are still insufficient, insulin medications are considered.
How to Prevent Diabetes Naturally
Prediabetes is a condition in which a person has early symptoms of diabetes, but has not yet fully developed the condition. If prediabetes is not treated with lifestyle changes, the person could develop type 2 diabetes. Type 2 diabetes and prediabetes can be prevented with lifestyle changes, for example, eating a healthy diet, getting more exercise, reducing stress, quitting smoking, reducing or managing blood pressure and cholesterol, and managing any other health conditions or risk factors that you may have for developing type 2 diabetes.
What Should I Eat the Day Before My 3-Hour Glucose Test?
For three days before your glucose test, you can consume about 150 grams or 10 servings of carbohydrates.
What Are the Early Signs of Diabetes?
The early signs of diabetes depend on if one has type 1 or type 2 diabetes. Type 1 diabetes usually occurs in children, whereas type 2 diabetes is prevalent in adults.
Eye Problems and Diabetes
Diabetes and eye problems are generally caused by high blood sugar levels over an extended period of time. Types of eye problems in a person with diabetes include glaucoma, cataracts, and retinopathy. Examples of symptoms include blurred vision, headaches, eye aches, pain, halos around lights, loss of vision, watering eyes. Treatment for eye problems in people with diabetes depend on the type of eye problem. Prevention of eye problems include reducing blood pressure, cholesterol levels, quitting smoking, and maintaining proper blood glucose levels.
What Are the Early Signs of Type 2 Diabetes?
Type 2 Diabetes is a chronic disease characterized by increased blood sugar (glucose) level. Type 2 Diabetes is caused by either insufficient insulin secretion or resistance to that hormone’s action. Insulin is produced by the pancreas and helps process the glucose in the blood. Thus, with inadequate insulin, the bodies can’t burn all the blood sugar for energy in an efficient way. This means the glucose level in the blood rises, causing a variety of symptoms and when severe may even lead to death.
Diabetes Foot Problems
Diabetes related foot problems can affect your health with two problems: diabetic neuropathy, where diabetes affects the nerves, and peripheral vascular disease, where diabetes affects the flow of blood. Common foot problems for people with diabetes include athlete's foot, fungal infection of nails, calluses, corns, blisters, bunions, dry skin, foot ulcers, hammertoes, ingrown toenails, and plantar warts.
Can Diabetes Make My Legs Hurt?
Yes, diabetes, particularly a poorly controlled diabetes where the blood sugars are high, is a major cause of pain and uncomfortable sensations in the leg. Diabetic leg pain may present as a dull ache in the soles, calves, and thighs or present with pins and needles like sensation in the lower limb.
Types of Diabetes Type 2 Medications
Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
Hypoglycemia Without Diabetes: Causes and Diet
Hypoglycemia (low blood sugar level) is a condition most seen in patients with diabetes, who are on insulin or medications. Hypoglycemia is uncommon to happen in people without diabetes.
Which Glucose Meter Is the Best?
Here are the best available glucose meters to monitor your blood glucose levels and keep your diabetes under control.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
Can Type 2 Diabetes be Cured?
Type 2 diabetes is a long-term medical condition in which the body is not able to regulate blood sugar (glucose) level because of the inability of the body to properly use insulin. An individual can get type 2 diabetes because of a number of factors that reduce insulin action or quantity in the body. The goals of diabetes management are to eliminate symptoms and prevent the development of complications. Many drugs, both oral and injectable, are available for diabetes management.
What Are the 3 Most Common Symptoms of Undiagnosed Diabetes?
Diabetes mellitus has become a worldwide epidemic, thanks to changing lifestyles and increasing obesity. Type 2 diabetes affects approximately 13% of the population of the United States. Worldwide prevalence of diabetes is estimated to be around 463 million people. Type 2 diabetes accounts for over 90% of patients with diabetes.
What Happens to Your Body When You Have Diabetes?
Diabetes is an impairment in the manner in which the body manages and uses sugar (glucose) as a fuel. High blood sugar levels may cause problems with the cardiovascular system, neurological system, and immune system.
What Is the Relationship Between Diabetes and Kidney Disease?
Diabetic kidney disease is caused by multiple factors, including changes in the kidneys caused by diabetes and hypertension-related vascular changes. Having high blood sugar levels can lead to kidney damage and failure. People with diabetes may already have hypertension when they are diagnosed. Because high blood pressure damages the kidneys, it increases the risk of diabetic kidney disease.
What Are Complications of Uncontrolled Diabetes?
Uncontrolled diabetes can result in complications such as heart disease, nerve damage, eye problems, gum disease, and other health problems. Learn about the complications of diabetes and what you can do to avoid them. Check out the center below for more medical references on diabetes, including multimedia (slideshows, images, and quizzes), related diseases, treatment, diagnosis, medications, and prevention or wellness.
What Technologies Are Used for Type 2 Diabetes?
Approximately 90 percent of all diabetes cases are type 2. Over the past decade, many improvements in diabetes technology have focused on safer and more precise glucose testing and insulin delivery.
Treatment & Diagnosis
Prevention & Wellness
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.