Qtern

Qtern (dapagliflozin/saxagliptan) is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Qtern contains a combination of dapagliflozin and saxagliptin, two oral diabetes medicines that help control blood sugar levels. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that works by helping the kidneys remove glucose from your bloodstream through your urine. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by increasing the levels of hormones that help your body release insulin after eating.

Qtern is not recommended for people with type 1 diabetes.

Qtern (dapagliflozin/saxagliptan) received FDA approval on February 27, 2017. There is no generic.

Qtern is usually taken once a day in the morning, with or without food. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Swallow the tablet whole and do not crush, cut, or chew it.

Your kidney function will need to be checked before and during treatment with this medicine.

Call your doctor if you are sick with vomiting or diarrhea, if you eat or drink less than usual, or if you are sweating more than usual. Losing too much fluid while taking Qtern can cause dehydration, low blood pressure, or kidney problems.

Your blood sugar will need to be checked often, and you may also be asked to test the level of ketones in your blood or urine. Qtern can cause life-threatening ketoacidosis, even if your blood sugar is normal. Contact your doctor if a test shows that you have ketones, even if you feel well.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky, especially if you also take insulin or a sulfonylurea. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or 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.

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.

If you need surgery or a procedure that involves fasting, your doctor may tell you to stop taking Qtern at least 3 days beforehand to lower your risk of ketoacidosis. You can usually restart it once you are stable and eating and drinking normally again.

This medicine can affect the results of certain medical tests, and your urine will test positive for glucose while you are taking it. Tell any doctor who treats you that you are using Qtern.

Store at room temperature away from moisture and heat.

You should not use Qtern if you have moderate to severe kidney disease (an eGFR below 45 mL/min/1.73 m2), end-stage renal disease, or if you are on dialysis.

Qtern can cause life-threatening ketoacidosis (too much acid in the blood), even if your blood sugar is normal. Stop taking Qtern and get medical help right away if you have nausea, vomiting, stomach pain, tiredness, or trouble breathing.

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

Saxagliptin, one of the medicines in Qtern, may increase the risk of being hospitalized for heart failure, especially in people who already have heart or kidney problems. Call your doctor right away if you have increasing shortness of breath, swelling in your feet or ankles, rapid weight gain, or unusual tiredness.

Qtern can cause serious infections in the genital area, including a rare but life-threatening infection called Fournier's gangrene. Get medical help right away if you have pain, tenderness, redness, or swelling of the genitals or the area between the genitals and rectum, along with a fever or feeling unwell.

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

You should not use Qtern if you have:

• moderate to severe kidney disease, end-stage renal disease, or if you are on dialysis; or
• had a serious allergic reaction to dapagliflozin or saxagliptin, including anaphylaxis, angioedema (swelling of the face, lips, tongue, or throat), or a severe skin reaction.

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

• kidney or liver disease
• heart problems, including heart failure
• diabetic ketoacidosis
• problems with your pancreas, including pancreatitis or pancreas surgery
• gallstones
• high triglycerides (a type of fat in the blood)
• bladder infections, genital infections, or other urination problems
• swelling of the face, lips, tongue, or throat (angioedema) after taking another DPP-4 inhibitor medicine
• low blood pressure, or if you take a diuretic (water pill)
• type 1 diabetes
• a planned surgery
• if you follow a ketogenic (very low carbohydrate) diet
• if you drink alcohol often or binge drink
• if you are on a low salt diet; or
• if you are 65 or older
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed.

Pregnancy and breastfeeding

Follow your doctor's instructions about using this medicine if you are pregnant or planning to become pregnant. You should not use Qtern during the second or third trimester of pregnancy because it may harm the baby's developing kidneys. Blood sugar control is very important during pregnancy, and your treatment needs may be different during each trimester.

You should not breastfeed while using this medicine.

Qtern is not approved for use by anyone younger than 18 years old.

The most common Qtern side effects are upper respiratory tract infection (affecting about 14% of people), urinary tract infection (about 6%), and abnormal blood levels of cholesterol or triglycerides (about 5%).

Other common Qtern side effects may include:

• cold or flu-like symptoms such as a stuffy or runny nose, sinus pain, or sore throat
• urinary tract infection (UTI)
• abnormal blood levels of cholesterol or triglycerides
• headache
• diarrhea
• back pain
• genital yeast infection
• joint pain
• urinating more than usual or discomfort when urinating.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Qtern: hives; itching; flaking or peeling skin; trouble swallowing; difficult breathing; swelling of your face, lips, tongue, or throat. Serious allergic reactions, including anaphylaxis and angioedema, have occurred with saxagliptin, one of the medicines in Qtern, sometimes after the first dose.

Seek medical attention right away if you have pain, tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, together with a fever above 100.4 degrees F (38 degrees C) or feeling generally unwell. These symptoms may get worse quickly and can be signs of a rare but life-threatening bacterial infection called necrotizing fasciitis of the perineum (Fournier's gangrene), which requires urgent treatment.

Serious urinary tract infections, including kidney infection (pyelonephritis) and a life-threatening blood infection that starts in the urinary tract (urosepsis), have also occurred in people taking SGLT2 inhibitors, including Qtern, and some people have needed hospital treatment. You may be more likely to develop these infections if you have had them before.

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

• ketoacidosis (too much acid in the blood): nausea, vomiting, stomach pain, tiredness, confusion, unusual drowsiness, or trouble breathing
• pancreatitis: severe pain in your upper stomach that will not go away and may spread to your back, with or without vomiting
• severe or ongoing pain in your joints
• a serious skin reaction: blisters or breakdown of the outer layer of skin (these can be signs of a condition called bullous pemphigoid, which may need hospital treatment).

Call your doctor at once if you have:

• symptoms of heart failure: increasing shortness of breath (especially when you lie down), swelling in your feet, ankles, or legs, rapid weight gain, or unusual tiredness
• little or no urination
• dehydration or low blood pressure: dizziness, weakness, feeling light-headed (like you might pass out)
• low blood sugar (hypoglycemia): headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
• signs of a bladder or kidney infection: pain or burning when you urinate, increased urination, blood in your urine, fever, or pain in your pelvis or back.

In a large clinical trial, more people taking saxagliptin were hospitalized for heart failure than those taking a placebo. The risk was higher in people who already had heart failure or kidney problems. Tell your doctor if you have ever had heart failure, and report any symptoms straight away.

Some side effects, such as those related to dehydration and low blood pressure, may be more likely in older adults, people with kidney problems, and people taking diuretics (water pills).

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 the FDA at 1-800-FDA-1088.

Usual adult dose for type 2 diabetes:

• For patients not already taking dapagliflozin: dapagliflozin 5 mg/saxagliptin 5 mg orally once a day, taken in the morning
• The dose may be increased to dapagliflozin 10 mg/saxagliptin 5 mg orally once a day in patients tolerating the lower dose who require additional glycemic control.

Comments:

• Assess renal function before starting therapy and periodically thereafter.
• Volume depletion should be corrected before starting therapy.
• Contraindicated in patients with an eGFR below 45 mL/min/1.73 m2, end-stage renal disease, or on dialysis.
• Swallow tablets whole; do not crush, cut, or chew.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Take the missed dose as soon as you remember. Do not double your next dose to make up for a missed one.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Qtern can lower your blood pressure, especially when you first start taking it.

Avoid becoming dehydrated. Drink plenty of fluids, especially during exercise, hot weather, or illness.

Some medicines should not be taken with Qtern. Certain antibiotics, antifungal medicines, and HIV/AIDS medicines that strongly block an enzyme called CYP3A4/5 (such as ketoconazole, itraconazole, clarithromycin, and ritonavir) can significantly increase the level of saxagliptin in your body and should not be used with Qtern. Tell your doctor if you start or stop taking any of these types of medicines.

Taking Qtern with insulin or medicines that increase insulin release (such as a sulfonylurea like glimepiride or glipizide) can raise your risk of low blood sugar. Your doctor may lower the dose of your other diabetes medicines when you start Qtern.

Tell your doctor if you take lithium. SGLT2 inhibitors like Qtern may lower the level of lithium in your blood, and your doctor may need to check your lithium levels more often when you start Qtern or change your dose.

Qtern will make urine glucose tests read positive, and it can make some blood tests used to monitor blood sugar (1,5-AG assays) unreliable. Your doctor will use other methods, such as HbA1c, to monitor your blood sugar control.

Other drugs may interact with dapagliflozin and saxagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Store Qtern at room temperature between 68 degrees F and 77 degrees F (20 degrees C and 25 degrees C).

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

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.

Qtern (dapagliflozin and saxagliptin) is a registered trademark of the AstraZeneca group of companies and is distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.