Qtern: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is QTERN used for?

QTERN is used with metformin, along with diet and exercise, to improve blood sugar levels in adults with type 2 diabetes who:

• are not controlled on metformin and saxagliptin (ONGLYZA^®), or
• are currently treated with metformin, saxagliptin and dapagliflozin (FORXIGA^®) as separate tablets.

QTERN replaces both dapagliflozin and saxagliptin. If you are already taking saxagliptin and / or dapagliflozin as separate tablets, you must stop taking these drugs when you start QTERN.

How does QTERN work?

QTERN contains saxagliptin and dapagliflozin. Saxagliptin belongs to a class of medicines called DPP4 inhibitors (dipeptidyl peptidase 4 inhibitors). Dapagliflozin belongs to a class of medicines called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors).

Saxagliptin lowers blood sugar levels after a meal. It also lowers blood sugar levels between meals and decreases the amount of sugar made by your body.

Dapagliflozin removes excess sugar from the body and passes it through your urine.

What are the ingredients in QTERN?

Medicinal ingredients: saxagliptin (as saxagliptin hydrochloride) and dapagliflozin (as dapagliflozin propanediol monohydrate)

Non-medicinal ingredients: anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide, black iron oxide (5 mg/5 mg only), red iron oxide, yellow iron oxide (5 mg/10 mg only)

QTERN comes in the following dosage forms:

As tablets containing:

• 5 mg saxagliptin and 5 mg dapagliflozin or;
• 5 mg saxagliptin and 10 mg dapagliflozin.

Do not use QTERN if you:

• have type 1 diabetes;
• have or have had diabetic ketoacidosis (DKA), diabetic pre-coma or diabetic coma;
• have moderate to severe kidney problems or you have end-stage renal disease (ESRD) that requires dialysis;
• have severe liver disease;
• have bladder cancer;
• take pioglitazone, a medicine used to lower your blood sugar level;

• are pregnant, or are planning to become pregnant;

• are breast-feeding, or are planning to breast feed;
• are under 18 years of age;
• are allergic to medicines in the DPP4 inhibitor class;
• are allergic to medicines in the SGLT2 inhibitor class;
• are allergic to any of the ingredients in QTERN.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take QTERN. Talk about any health conditions or problems you may have, including if you:

• have an increased chance of developing diabetic ketoacidosis (DKA), including if you:

  • are dehydrated or suffer from excessive vomiting, diarrhea, or sweating
  • are on a very low carbohydrate diet
  • drink a lot of alcohol
  • have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas
  • are hospitalized for major surgery, serious infection or serious medical illness
  • have a history of diabetic ketoacidosis (DKA);
• are 65 years of age or older. The use of QTERN is not recommended in patients who are older than 75 year of age;
• have or have had any kidney problems;
• have heart disease;
• have low blood pressure;
• have or have had heart failure;
• have or have had problems with your pancreas, including inflammation of the pancreas, known as pancreatitis;
• are or get dehydrated. Or, if you have excessive vomiting, diarrhea or sweating. Or, if you are not able to eat or drink;
• are taking a medicine to lower your blood pressure;
• are taking a diuretic, known as a water pill. Diuretics are used to remove excess water from the body;
• are taking other medicines to lower your blood sugar. Tell your doctor about all of the medicines you are taking to control your diabetes;
• have a history of bladder cancer;
• have or have had liver problems;
• have been told by a doctor that you have a reduced immune system. For example if you have had organ transplantation. Or if you have human immunodeficiency virus infection / acquired immune deficiency syndrome (HIV/AIDS);
• have a history of yeast infections of the vagina or penis. QTERN increases your chance of getting a yeast infection of the penis or vagina and this is more likely if you have had a yeast infection in the past;
• get urinary tract infections often.

Other warnings you should know about:

Saxagliptin, one of the medicines in QTERN may increase risk for Heart Failure. Heart Failure is when your heart is unable to pump enough blood to meet the needs of the body. You are at greater risk of Heart Failure if you have or have had:

• heart or blood vessel disease including heart failure and heart attack
• kidney disease
• several risk factors of getting heart disease

Symptoms of heart failure include one or more of the following: tiredness, swollen ankles, a fast increase in weight and increased shortness of breath especially when lying down. This is serious. Stop taking QTERN and get immediate medical help if this happens to you.

Your blood sugar may get too high (hyperglycemia) if you have fever, infection, surgery, or trauma (stress conditions). In such cases contact your doctor as your medication may need to be adjusted.

QTERN may cause dizziness or light-headedness. Do not drive or use machines until you know how the medicine affects you.

QTERN may cause changes in the amount of cholesterol or fats in your blood.

QTERN may cause abnormal kidney function. Your doctor will do blood tests to monitor how well your kidneys are working while you are taking QTERN.

QTERN contains lactose. Do not take QTERN if a doctor has told you that you have one of the following hereditary diseases: galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with QTERN:

• some medicines you take for diabetes to lower your blood sugar levels;
• medicines used to treat seizures such as carbamazepine, phenytoin or phenobarbital may require that your doctor monitor control of your blood sugar levels more closely;
• rifampin (used to treat bacterial infections), or dexamethazone (a steroid) may require that your doctor monitor control of your blood sugar levels more closely;
• medicines used to lower your blood pressure;
• diuretics, known as water pills, such as furosemide. They are used to remove excess water from the body;
• ketoconazole if taken by mouth, used to treat fungal infections;
• an herbal medicine called St. John’s wort.

How to take QTERN:

Follow the directions given to you by your doctor.

Take QTERN:

• once a day
• at any time of the day, at around the same time each day
• by mouth
• with or without food

Swallow whole. Do not cut or divide tablets.

Diet and exercise can help your body control its blood sugar better. It is important to stay on the diet and exercise program recommended by your doctor while taking QTERN.

Usual dose:

The recommended starting dose of QTERN is one 5 mg/5 mg tablet taken once a day. In some patients the dose may be increased to one 5 mg/10 mg tablet taken once a day. Your doctor will tell you which dose of QTERN to take.

Overdose:

Missed Dose:

• If you forget to take a dose of QTERN, take it as soon as you remember. If you do not remember until it is almost time for your next dose, skip the missed dose.
• Never take two doses of QTERN at the same time.

What are possible side effects from using QTERN?

These are not all the possible side effects you may feel when taking QTERN. If you experience any side effects not listed here, contact your healthcare professional. Please also see the Serious Warnings and Precautions box.

Side effects may include:

• common cold (sore throat, stuffy and / or runny nose)
• cough (with or without phlegm)
• flu (fever, tiredness, body aches)
• diarrhea
• nausea and vomiting
• abdominal pain
• constipation
• dry mouth
• passing more urine than usual or needing to pass urine more often
• back pain
• joint paint (pain in the arms, legs, hands or feet)
• headache and / or dizziness
• weight loss
• rash

If any of these affects you severely, tell your doctor or pharmacist.

Diabetic ketoacidosis (DKA) is a serious medical condition normally seen at high blood sugar levels; however, it has also been seen at near normal blood sugar levels. Get medical help right away if you have any of the symptoms in the table below under Diabetic ketoacidosis (DKA) even if your blood sugar levels are normal.

Your doctor will tell you what to do if you get any of the symptoms of low blood sugar. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, change in vision, hunger, headache and a change in mood. If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice and then talk to your healthcare professional.

QTERN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results. They may check kidney function, blood fat levels (Low Density Lipoprotein cholesterol or LDL-C) and amount of red blood cells in your blood (hematocrit).

QTERN will cause your urine to test positive for sugar (glucose). This is expected when you take QTERN.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store between 2-30°C.

Keep out of reach and sight of children.

If you want more information about QTERN:

• Talk to your healthcare professional

• Find the full current product monograph that is prepared for healthcare professionals and includes the current Patient Medication Information by visiting the Health Canada website; the sponsor’s website www.astrazeneca.ca, or by contacting the sponsor, AstraZeneca Canada Inc. at:

  Questions or concerns: 1-800-668-6000

NOTE: The PATIENT MEDICATION INFORMATION leaflet provides you with the most current information at the time of printing.

QTERN^® and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

©AstraZeneca 2021

Last Revised: June 29, 2021