Qtern

Dapagliflozin and saxagliptin are oral diabetes medicines that help control blood sugar levels. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Saxagliptin works by regulating the levels of insulin your body produces after eating.

Dapagliflozin and saxagliptin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Dapagliflozin and saxagliptin is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.

This medicine is not for treating type 1 diabetes.

Dapagliflozin and saxagliptin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis.

Taking dapagliflozin and saxagliptin can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Stop taking this medicine and call your doctor at once if you have signs of a pancreatitis, such as severe pain in your upper stomach spreading to your back, with or without vomiting,

Dapagliflozin and saxagliptin can also cause infections in the bladder or genitals (penis or vagina). Call your doctor if you have genital pain or itching, genital odor or discharge, increased urination, pain or burning when you urinate, or blood in your urine.

Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.

You should not use dapagliflozin and saxagliptin if you are allergic to it, or if you have:

• severe kidney disease (or if you are on dialysis);
• a history of severe allergic or skin reaction after taking dapagliflozin or saxagliptin; or
• diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure dapagliflozin and saxagliptin is safe for you, tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• bladder cancer;
• a bladder infection;
• problems with your pancreas, including surgery;
• gallstones;
• high cholesterol or triglycerides (a type of fat in the blood);
• alcoholism;
• if you are on a low salt diet; or
• if you are 65 or older.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dapagliflozin and saxagliptin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have:

• severe or ongoing pain in your joints;
• serious skin reaction--itching, blisters, breakdown of the outer layer of skin;
• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);
• signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, pain in your pelvis or back; or
• signs of a genital infection (penis or vagina)--pain, burning, itching, rash, redness, odor, or discharge.

Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.

Common side effects may include:

• urination problems;
• abnormal blood levels of cholesterol or triglycerides (a type of fat in the blood); or
• runny nose, stuffy nose, sinus pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You should not use this medicine if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis.

Taking dapagliflozin and saxagliptin can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Stop taking this medicine and call your doctor at once if you have signs of a pancreatitis, such as severe pain in your upper stomach spreading to your back, with or without vomiting,

Dapagliflozin and saxagliptin can also cause infections in the bladder or genitals (penis or vagina). Call your doctor if you have genital pain or itching, genital odor or discharge, increased urination, pain or burning when you urinate, or blood in your urine.

Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have:

• severe or ongoing pain in your joints;

• serious skin reaction--itching, blisters, breakdown of the outer layer of skin;

• ketoacidosis (too much acid in the blood)--nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);

• signs of a bladder infection--pain or burning when you urinate, increased urination, blood in your urine, pain in your pelvis or back; or

• signs of a genital infection (penis or vagina)--pain, burning, itching, rash, redness, odor, or discharge.

Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.

Common side effects may include:

• urination problems;

• abnormal blood levels of cholesterol or triglycerides (a type of fat in the blood); or

• runny nose, stuffy nose, sinus pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of saxagliptin and dapagliflozin combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of saxagliptin and dapagliflozin combination in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Balofloxacin
• Besifloxacin
• Ceritinib
• Ciprofloxacin
• Eliglustat
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Lanreotide
• Levofloxacin
• Lomefloxacin
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Simeprevir
• Sparfloxacin
• Thioctic Acid
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Acetohexamide
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Chlorpropamide
• Esmolol
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol
• Tolazamide
• Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Pancreatic insulin deficiency, history of—May increase risk for more serious side effects.

• Bladder cancer, history of or
• Dehydration or
• Dyslipidemia (high fats or cholesterol in the blood) or
• Genital yeast (fungus) infections (eg, balanitis, balanoposthitis, vulvovaginitis), history of or
• Hypotension (low blood pressure) or
• Ketoacidosis (high ketones and acid in the blood) or
• Kidney disease or
• Pancreas problems (eg, pancreatitis) or
• Urinary tract infection (eg, pyelonephritis, urosepsis), history of—Use with caution. May make these conditions worse.

• Diabetic ketoacidosis (high ketones and acid in the blood) or
• Kidney disease, severe or
• Patients receiving dialysis or
• Type I diabetes—Should not be used in patients with these conditions.

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not change your dose unless directed by your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Tell your doctor if you are on a low-salt diet.

Swallow the tablet whole. Do not cut, break, or chew it. You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For type 2 diabetes:
    • Adults—At first, 1 tablet once a day, taken in the morning. Each tablet contains 5 milligrams (mg) of saxagliptin and 10 mg of dapagliflozin. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

If you are rapidly gaining weight, having chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.

Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, rapid weight gain, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.

This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions. These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may be associated with the development of bladder cancer and should not be used in patients with active bladder cancer. Check with your doctor right away if you have blood in your urine or pain while urinating.

This medicine may cause severe joint pain. Call your doctor right away if you have severe joint pain with this medicine.

This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

You should not use Qtern if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis.

Taking Qtern can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Stop taking Qtern and call your doctor at once if you have signs of a pancreatitis, such as severe pain in your upper stomach spreading to your back, with or without vomiting.

Qtern can also cause infections in the bladder or genitals (penis or vagina). Call your doctor if you have genital pain or itching, genital odor or discharge, increased urination, pain or burning when you urinate, or blood in your urine.

Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.

Qtern is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Dapagliflozin can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have ketones in the urine.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

This medicine can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Qtern.

Store Qtern at room temperature away from moisture and heat.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Qtern affects you.
• Low blood sugar can happen. The chance of low blood sugar may be raised when this medicine is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Qtern.
• Talk with your doctor before you drink alcohol.
• Follow the diet and workout plan that your doctor told you about.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• Check your blood sugar as you have been told by your doctor.
• Bladder cancer has happened in a few more people taking this medicine than in those taking other drugs for diabetes. It is not known if this drug led to these cases of bladder cancer. Talk with your doctor.
• Kidney problems have happened with Qtern (dapagliflozin and saxagliptin). Sometimes, kidney problems may need to be treated in the hospital. Dialysis may also be needed. Talk with your doctor.
• A very bad and sometimes deadly pancreas problem (pancreatitis) has happened with other drugs like this one. Talk with your doctor.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• If loose stools (diarrhea) happen or you are throwing up, call your doctor. You will need to drink more fluids to keep from losing too much fluid.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine is not for use in adults 75 years and older. It has not been shown to work in these people. Talk with the doctor.
• Do not give to a child. Talk with your doctor.