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MEDICATION GUIDE
QTERN® [CUE-turn]
(dapagliflozin and saxagliptin)
tablets, for oral use
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What is the most important information I should know about QTERN?
Serious side effects can happen to people taking QTERN, including:
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• Diabetic Ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. QTERN can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood.
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Stop taking QTERN and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.
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- nausea
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- vomiting
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- stomach area (abdominal) pain
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- tiredness
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- trouble breathing
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- ketones in your urine or blood
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Inflammation of the pancreas (pancreatitis). Saxagliptin, one of the medicines in QTERN, can cause inflammation of the pancreas, which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
Before you start taking QTERN, tell your healthcare provider if you have ever had:
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- inflammation of your pancreas (pancreatitis)
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- stones in your gallbladder (gallstones)
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- a history of alcoholism
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- high blood triglyceride levels
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- It is not known if having these medical problems will make you more likely to get pancreatitis with QTERN.
Stop taking QTERN and contact your healthcare provider 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.
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Heart failure. Heart failure means your heart does not pump blood well enough.
Before you start taking QTERN, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys.
Contact your healthcare provider right away if you have any of the following symptoms:
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- increasing shortness of breath or trouble breathing, especially when you lie down
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- swelling or fluid retention, especially in the feet, ankles, or legs
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- an unusually fast increase in weight
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- unusual tiredness
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- These may be symptoms of heart failure.
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Dehydration. QTERN can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking dapagliflozin, a component of QTERN. You may be at a higher risk of dehydration if you:
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- take medicines to lower your blood pressure, including water pills (diuretics)
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- are on a low salt diet
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- have kidney problems
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- are 65 years of age or older
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- Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.
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What is QTERN?
QTERN is a prescription medicine that contains dapagliflozin and saxagliptin. QTERN is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
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- QTERN is not for use to improve blood sugar (glucose) control in people with type 1 diabetes.
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- It is not known if QTERN is safe and effective in children younger than 18 years of age.
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Who should not take QTERN?
Do not take QTERN if you:
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- are allergic to dapagliflozin, saxagliptin, or any of the ingredients in QTERN. See the end of this Medication Guide for a list of ingredients in QTERN.
Symptoms of a serious allergic reaction to QTERN may include:
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- swelling of the face, lips, throat and other areas of your skin
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- difficulty with swallowing or breathing
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- rash, itching, flaking, or peeling
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- raised red areas on your skin (hives)
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- If you have any of these symptoms, stop taking QTERN and contact your healthcare provider or go to the nearest hospital emergency room right away.
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- have moderate to severe kidney problems or are on dialysis.
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Before taking QTERN, tell your healthcare provider about all of your medical conditions, including if you:
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- have type 1 diabetes or have had diabetic ketoacidosis (increased ketones in your blood or urine).
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- have a decrease in your insulin dose.
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- have a serious infection.
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- have a history of infection of the vagina or penis.
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- have kidney problems.
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- have liver problems.
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- have a history of urinary tract infections or problems with urination.
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- are on a low sodium (salt) diet. Your healthcare provider may ask you to change your diet.
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- are going to have surgery. Your healthcare provider may stop your QTERN before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking QTERN and when to start it again.
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- are eating less or there is a change in your diet.
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- are dehydrated.
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- have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
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- drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
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- have heart problems, including heart failure.
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- have had a history of swelling of the face, lips, tongue and throat (angioedema) when you have taken a dipeptidyl peptidase 4 (DPP-4) inhibitor like saxagliptin one of the medicines in QTERN. If you are not sure that you have taken this medicine before, ask your healthcare provider.
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- are pregnant or plan to become pregnant. QTERN may harm your unborn baby. If you are pregnant or plan to become pregnant, talk to your healthcare provider about the best way to control your blood sugar.
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- are breastfeeding or plan to breastfeed. It is not known if QTERN passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking QTERN. Breastfeeding is not recommended while taking QTERN.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
QTERN may affect the way other medicines work, and other medicines may affect how QTERN works. Contact your healthcare provider if you will be starting or stopping certain other types of medicines such as antibiotics or medicines that treat fungus or HIV/AIDS, because your dose of QTERN might need to be changed.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
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How should I take QTERN?
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- Take QTERN exactly as your healthcare provider tells you to take it.
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- Take QTERN by mouth 1 time each day in the morning with or without food.
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- Your healthcare provider will tell you how much QTERN to take and when to take it. Your healthcare provider may change your dose if needed.
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- Swallow QTERN whole. Do not crush, cut or chew QTERN tablets.
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- If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of QTERN at the same time unless your healthcare provider tells you to do so. Talk to your healthcare provider if you have questions about a missed dose.
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- If you take too much QTERN, call your healthcare provider, or go to the nearest hospital emergency room right away.
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- During periods of stress on the body, such as fever, trauma, infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions.
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- Your healthcare provider may tell you to take QTERN along with other diabetes medicines. Low blood sugar can happen more often when QTERN is taken with certain other diabetes medicines. See “What are the possible side effects of QTERN?”.
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- QTERN will cause your urine to test positive for glucose.
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- Your healthcare provider may do certain blood tests before you start QTERN and during treatment as needed. Your healthcare provider may change your dose of QTERN based on the results of your blood tests.
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What are the possible side effects of QTERN?
QTERN may cause serious side effects, including:
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- See “What is the most important information I should know about QTERN?”.
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Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
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Low blood sugar (hypoglycemia). If you take QTERN with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, this can increase your risk of getting low blood sugar. Tell your healthcare provider if you take other diabetes medicines. Signs and symptoms of low blood sugar may include:
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- headache
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- confusion
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- hunger
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- shaking or feeling jittery
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- drowsiness
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- dizziness
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- fast heartbeat
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- weakness
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- sweating
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- irritability
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A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take dapagliflozin, one of the medicines in QTERN. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:
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- pain or tenderness
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- swelling
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- redness of skin (erythema)
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Serious allergic reaction. If you have any symptoms of a serious allergic reactions, stop taking QTERN and call your healthcare provider right away or go to the nearest hospital emergency room. See “Who should not take QTERN?”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
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Vaginal yeast infection. Women who take QTERN may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
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- vaginal odor
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- white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
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- vaginal itching
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Yeast infection of the penis (balanitis). Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
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- redness, itching, or swelling of the penis
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- foul smelling discharge from the penis
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- rash of the penis
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- pain in the skin around the penis
Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
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Joint pain. Some people who take DPP-4 inhibitors like saxagliptin, one of the medicines in QTERN, may develop joint pain that can be severe. Call your healthcare provider right away if you have severe joint pain.
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Skin reaction. Some people who take DPP-4 inhibitors like saxagliptin, one of the medicines in QTERN, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking QTERN.
The most common side effects of QTERN include:
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- upper respiratory tract infection
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- urinary tract infection
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- abnormal amounts of fats in the blood (dyslipidemia)
These are not all of the possible side effects of QTERN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store QTERN?
Store QTERN at room temperature between 68○F and 77○F (20○C and 25○C).
Keep QTERN and all medicines out of the reach of children.
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General information about the safe and effective use of QTERN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QTERN for a condition for which it was not prescribed. Do not give QTERN to other people, even if they have the same symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about QTERN that is written for health professionals.
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What are the ingredients in QTERN?
Active ingredients: dapagliflozin and saxagliptin
Inactive ingredients: anhydrous lactose, croscarmellose sodium, iron oxides, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, silicon dioxide, talc, titanium dioxide; hydrochloric acid and sodium hydroxide as needed.
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QTERN is a registered trademark of the AstraZeneca group of companies.
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
For more information about QTERN, go to www.QTERN.com or call 1-800-236-9933.
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