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Qtern

Generic Name: dapagliflozin and saxagliptin
Dosage Form: Tablets
Date of Approval: February 27, 2017
Company: AstraZeneca

Treatment for: Type-2 Diabetes

FDA Approves Qtern

The U.S. Food and Drug Administration (FDA) has approved Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the once-daily treatment of adult patients with type 2 diabetes.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information

Serious side effects can happen to people taking Qtern, including:

  • Inflammation of the pancreas (pancreatitis). Saxagliptin, one of the active ingredients, 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
    • inflammation of your pancreas (pancreatitis)
    • stones in your gallbladder (gallstones)
    • a history of alcoholism
    • high blood triglyceride levels
    It is not known if having these medical problems will make you more likely to get pancreatitis with Qtern.
    Stop treatment 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.
  • 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:
      • increasing shortness of breath or trouble breathing, especially when you lie down
      • swelling or fluid retention, especially in the feet, ankles or legs
      • an unusually fast increase in weight
      • unusual tiredness
      These may be symptoms of heart failure.
  • 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). You may be at a higher risk of dehydration if you:
    • have low blood pressure
    • take medicines to lower your blood pressure, including water pills (diuretics)
    • are 65 years of age or older
    • are on a low salt diet
    • have kidney problems
  • Vaginal yeast infection.
  • Women who take Qtern may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
    • vaginal odor
    • white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
    • vaginal itching
  • Yeast infection of the penis (balanitis). Men who take Qtern may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:
    • redness, itching, or swelling of the penis
    • rash of the penis
    • foul smelling discharge from the penis
    • 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 medication and your symptoms do not go away.
  • Bladder cancer. In studies of dapagliflozin in people with diabetes, bladder cancer occurred in a few more people who were taking dapagliflozin than in people who were taking other diabetes medications. There were too few cases to know if bladder cancer was related to dapagliflozin. You should not take Qtern if you have bladder cancer. Tell your healthcare provider right away if you have any of the following symptoms:
    • blood or a red color in your urine
    • pain while you urinate

What is Qtern?

Qtern is a prescription medicine that contains dapagliflozin and saxagliptin. It is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
Qtern is not for:

  • people with type 1 diabetes.
  • people with diabetic ketoacidosis (increased ketones in your blood or urine).
It is not known if Qtern is safe and effective in children younger than 18 years of age.

Who should not take Qtern?

Do not take Qtern if you:

  • are allergic to dapagliflozin, saxagliptin, or any of the other ingredients. See the end of this Medication Guide for a list of active and inactive ingredients.
    Symptoms of a serious allergic reaction to Qtern may include:
    • swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
    • difficulty with swallowing or breathing
    • skin rash, itching, flaking or peeling
    • raised red patches on your skin (hives)
    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.
  • have severe kidney problems, or are on dialysis.

Before taking Qtern

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • have type 1 diabetes or have had diabetic ketoacidosis (increased ketones in your blood or urine).
  • have kidney problems.
  • have liver problems.
  • have a history of urinary tract infections or problems urinating.
  • have or have had bladder cancer.
  • are going to have surgery.
  • are eating less due to illness, surgery or a change in your diet.
  • have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
  • drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking).
  • 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.
  • 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 during treatment.

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.

Qtern may affect the way other medicines work, and vice versa. Contact your healthcare provider if you will be starting or stopping certain other types of medications, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of Qtern might need to be changed.

How should I take Qtern?

  • Take Qtern exactly as your healthcare provider tells you to take it.
  • Take the tablets by mouth one time each day, in the morning with or without food.
  • Swallow the tablets whole. Do not split or cut the tablets.
  • During periods of stress on the body, such as fever, trauma, infection, or surgery, contact your healthcare provider right away as your medication needs may change.
  • Stay on your prescribed diet and exercise program during treatment.
  • Your healthcare provider may do certain blood tests before and during your treatment.
  • Your healthcare provider should test your blood to measure how well your kidneys are working before and during your treatment.
  • Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
  • 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.
  • 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 two doses 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.
  • If you take too much or overdose, call your healthcare provider, or go to the nearest hospital emergency room right away.

Qtern side effects

Qtern may cause serious side effects, including:

  • See Important information.
  • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 or type 2 diabetes, during treatment with dapagliflozin, one of the active ingredients in Qtern. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking treatment and call your healthcare provider right away if you get any of the following symptoms:
    • nausea
    • tiredness
    • vomiting
    • trouble breathing
    • stomach area (abdominal) pain
    If you get any of these symptoms during treatment, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
  • Kidney problems. Sudden kidney injury has happened to people taking dapagliflozin. Talk to your healthcare provider right away if you:
    • reduce the amount of food or liquid you drink for example, if you are sick and cannot eat or
    • you start to lose liquids from your body when vomiting, diarrhea or being in the sun too long.
  • 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.
  • Low blood sugar (hypoglycemia). When either of the medicines in Qtern, saxagliptin or dapagliflozin, are taken 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:
    • shaking or feeling jittery
    • hunger
    • change in mood
    • sweating
    • headache
    • confusion
    • rapid heartbeat
    • drowsiness
    • irritability
    • change in vision
    • weakness
  • Increased fats in your blood (bad cholesterol or LDL).
  • Joint pain. Some people who take medicines called DPP-4 inhibitors like saxagliptin, may develop joint pain that can be severe. Call your healthcare provider right away if you have severe joint pain.
  • Skin reaction. Some people who take medicines called DPP-4 inhibitors, one of the active ingredients, 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 treatment.

The most common side effects of Qtern include:

  • upper respiratory tract infection
  • urinary tract infection
  • dyslipidemia – abnormal amounts of fats in the blood

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 the FDA at 1-800-FDA-1088.

How should I store Qtern?

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

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Qtern

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides.

Do not use this medicine for a condition for which it was not prescribed. Do not give it 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 that is written for health professionals.

What are the ingredients in Qtern?

Active ingredients: saxagliptin and dapagliflozin

Inactive ingredients: anhydrous lactose, croscarmellose sodium, iron oxides, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, silicon dioxide, talc, and titanium dioxide.

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