What is the most important information I should know about QTERNMET XR?

Serious side effects can happen to people taking QTERNMET XR, including:

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Lactic Acidosis. Metformin, one of the medicines in QTERNMET XR, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

 

Call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis:

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you feel cold in your hands or feet

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you feel dizzy or lightheaded

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you have a slow or irregular heartbeat

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you feel very weak or tired

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you have unusual (not normal) muscle pain

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you have trouble breathing

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you feel unusual sleepiness or sleep longer than usual

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you have stomach pains, nausea, or vomiting

 

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. Tell your healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with QTERNMET XR if you:

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have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye

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have liver problems

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drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking

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get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids

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have surgery

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have a heart attack, severe infection, or stroke.

 

The best way to keep from having a problem with lactic acidosis from metformin is to tell your healthcare provider if you have any of the problems in the list above. Your healthcare provider may decide to stop your QTERNMET XR for a while if you have any of these problems.

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Inflammation of the pancreas (pancreatitis). Saxagliptin, one of the medicines in QTERNMET XR, 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 QTERNMET XR, 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

 

It is not known if having these medical problems will make you more likely to get pancreatitis with QTERNMET XR.

 

Stop taking QTERNMET XR 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 QTERNMET XR, 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

These may be symptoms of heart failure.

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Dehydration. QTERNMET XR 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). You may be at a higher risk of dehydration if you:

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have low blood pressure

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take medicines to lower your blood pressure, including water pills (diuretics)

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are 65 years of age or older

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are on a low salt diet

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have kidney problems

QTERNMET XR can have other serious side effects. See “What are the possible side effects of QTERNMET XR?”

What is QTERNMET XR?

QTERNMET XR is a prescription medicine that contains dapagliflozin, saxagliptin, and metformin hydrochloride. QTERNMET XR is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

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QTERNMET XR is not for people with type 1 diabetes.

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QTERNMET XR is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

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QTERNMET XR is only for people currently taking metformin.

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It is not known if QTERNMET XR is safe and effective in children younger than 18 years of age.

Who should not take QTERNMET XR?

Do not take QTERNMET XR if you:

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are allergic to dapagliflozin, saxagliptin, metformin, or any of the ingredients in QTERNMET XR. See the end of this Medication Guide for a list of ingredients in QTERNMET XR.
Symptoms of a serious allergic reaction to QTERNMET XR 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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skin rash, itching, flaking or peeling

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raised red areas on your skin (hives)

 

If you have any of these symptoms, stop taking QTERNMET XR 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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have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).

Before taking QTERNMET XR, 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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are going to have surgery. Your doctor may stop QTERNMET XR before you have surgery. If QTERNMET XR was stopped, talk to your healthcare provider about when to restart QTERNMET XR.

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are eating less, or there is a change in your diet.

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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 kidney problems.

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have liver problems.

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have a history of urinary tract infections or problems urinating.

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have heart problems, including heart failure.

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have had swelling of the face, lips, tongue and throat (angioedema) when you used a medicine called a dipeptidyl peptidase-4 (DPP-4) inhibitor like saxagliptin, one of the medicines in QTERNMET XR. If you are not sure if you have taken this medicine, ask your healthcare provider.

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have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.

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are going to get injection of dye or contrast agents for an x-ray procedure. QTERNMET XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop QTERNMET XR and when you should start QTERNMET XR again. See “What is the most important information I should know about QTERNMET XR?”

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are pregnant or plan to become pregnant. QTERNMET XR may harm your unborn baby. If you are pregnant or plan to become pregnant, call your healthcare provider right away to talk about the best way to control your blood sugar.

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are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. QTERNMET XR can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant.

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are breastfeeding or plan to breastfeed. It is not known if QTERNMET XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking QTERNMET XR. Breastfeeding is not recommended while taking QTERNMET XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

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.

QTERNMET XR may affect the way other medicines work, and other medicines may affect how QTERNMET XR 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 QTERNMET XR might need to be changed.

How should I take QTERNMET XR?

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Take QTERNMET XR exactly as your healthcare provider tells you to take it.

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Do not change your dose of QTERNMET XR without talking to your healthcare provider.

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Take QTERNMET by mouth 1 time each day in the morning with food.

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Swallow QTERNMET XR whole. Do not cut, crush or chew QTERNMET XR tablets.

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You may sometimes pass a soft mass in your stools (bowel movement) that looks like QTERNMET XR tablets.

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During periods of stress on the body, such as fever, trauma, infection or surgery, contact your healthcare provider right away as your medicine needs may change.

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Stay on your prescribed diet and exercise program while taking QTERNMET XR.

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Your healthcare provider may do certain blood tests before you start QTERNMET XR and during your treatment.

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Your healthcare provider should test your blood to measure how well your kidneys are working before and during your treatment with QTERNMET XR.

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Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.

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Follow your healthcare provider’s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you.

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QTERNMET XR will cause your urine to test positive for glucose.

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If you miss a daily dose of QTERNMET XR and it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.

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If you miss a daily dose of QTERNMET XR and it is less than 12 hours until your next dose, skip the missed dose. Take the next dose at your regular time.

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If you take too much QTERNMET XR, call your healthcare provider, or go to the nearest hospital emergency room right away.

What should I avoid while taking QTERNMET XR?

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Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.

These are not all of the possible side effects of QTERNMET XR.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store QTERNMET XR?

Store QTERNMET XR at room temperature between 68°F to 77°F (20°C to 25°C).

Keep QTERNMET XR and all medicines out of the reach of children.

General information about the safe and effective use of QTERNMET XR.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QTERNMET XR for a condition for which it was not prescribed. Do not give QTERNMET XR 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 QTERNMET XR that is written for health professionals.

What are the ingredients in QTERNMET XR?

Active ingredients: dapagliflozin, saxagliptin, and metformin hydrochloride

Inactive ingredients: carboxymethyl cellulose sodium, crospovidone, hypromellose 2208, iron oxides, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, macrogol/polyethylene glycol, silicon dioxide, talc, and titanium dioxide.