Qtern

What is the most important information I should know about Qtern?

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

• 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:
  • 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 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.

• 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.

• 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 medicines in Qtern. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with dapagliflozin. 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 Qtern 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 with Qtern, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.

• 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:
  • 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

  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.

Who should not take Qtern?

Do not take Qtern if you:

• are allergic to dapagliflozin, saxagliptin, or any of the ingredients in Qtern. See below for a list of ingredients in Qtern.
  Symptoms of a serious allergic reaction to Qtern may include:
  • swelling of the face, lips, throat and other areas of your skin
  • difficulty with swallowing or breathing
  • skin rash, itching, flaking, or peeling
  • raised red areas 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 moderate to severe kidney problems or are on dialysis.

What should I tell my healthcare provider before taking Qtern?

Before taking Qtern, 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).
• are going to have surgery. Your doctor may stop your Qtern before you have surgery. Talk to your doctor if you are having surgery about when to stop taking Qtern and when to start it again.
• are eating less, or there is a change in your diet.
• drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).
• have kidney problems.
• have liver problems.
• have a history of urinary tract infections or problems urinating.
• have heart problems, including heart failure.
• 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 if you have taken this medicine before, ask your healthcare provider.
• have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
• 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 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.

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 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.

How should I take Qtern?

• Take Qtern exactly as your healthcare provider tells you to take it.
• Do not change your dose of Qtern without talking to your healthcare provider.
• Take Qtern by mouth 1 time each day in the morning with or without food.
• Swallow Qtern whole. Do not crush, cut or chew Qtern tablets.
• During periods of stress on the body, such as fever, trauma, infection, or surgery, contact your healthcare provider right away as your medicine may need to be changed.
• Stay on your prescribed diet and exercise program while taking Qtern.
• Your healthcare provider may do certain blood tests before you start Qtern and during your treatment.
• Your healthcare provider should test your blood to measure how well your kidneys are working before and during your treatment with Qtern.
• Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
• Qtern will cause your urine to test positive for glucose.
• 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 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.
• If you take too much Qtern, call your healthcare provider, or go to the nearest hospital emergency room right away.

What are the possible side effects of Qtern?

Qtern may cause serious side effects, including:

• See “What is the most important information I should know about Qtern?”
• 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). 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:
  • shaking or feeling jittery
  • hunger
  • change in mood
  • sweating
  • headache
  • confusion
  • rapid heartbeat
  • drowsiness
  • irritability
  • change in vision
  • weakness
• 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:
  • pain or tenderness
  • swelling
  • redness of skin (erythema)
• Serious allergic reaction. Qtern may cause serious allergic reactions. Stop taking Qtern and get medical help right away if you develop any of the following symptoms of a serious allergic reaction including:
  • swelling of the face, lips, tongue, and throat and other areas of your skin
  • difficulty with swallowing or breathing
  • skin rash, itching, flaking, or peeling
  • raised red patches on your skin (hives)
• 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 (for example, balanitis or balanoposthitis). 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 medicine and your symptoms do not go away.

• 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.
• 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:

• upper respiratory tract infection
• urinary tract infection
• 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.

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.

How should I store Qtern?

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

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

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.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 5 MG/5 MG

 

• 30 tablets                     NDC 0310-6770-30
• Qtern®
• (dapagliflozin and saxagliptin)
• tablets
• 5 mg/5 mg
• Dispense with Enclosed
• Medication Guide
• Rx only
• Mfd. for: AstraZeneca Pharmaceuticals LP
• Wilmington, DE 19850
• AstraZeneca

SRC: NLM .