dapagliflozin and saxagliptin

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Pronunciation: DAP a gli FLOE zin and SAX a GLIP tin

Brand: Qtern

What is the most important information I should know about dapagliflozin and saxagliptin?

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.

What is dapagliflozin and saxagliptin?

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.

What should I discuss with my healthcare provider before taking dapagliflozin and saxagliptin?

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.

How should I take dapagliflozin and saxagliptin?

This medicine is usually taken once per day in the morning. Follow all directions on your prescription label. Your doctor may occasionally change your dose. 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 dapagliflozin and saxagliptin.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An dapagliflozin and saxagliptin overdose can cause life threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I avoid while taking dapagliflozin and saxagliptin?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

What are the possible side effects of dapagliflozin and saxagliptin?

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.

What other drugs will affect dapagliflozin and saxagliptin?

Other drugs may increase or decrease the effects of dapagliflozin and saxagliptin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about dapagliflozin and saxagliptin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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