Qtern

Qtern is a prescription medication used in combination with diet and exercise to treat type 2 diabetes mellitus. 

This medication is a single prescription product containing 2 medications: dapagliflozin and saxagliptin. Dapaglifozin belongs to a group of drugs called SGLT-2 inhibitors. These drugs work by causing the kidneys to get rid of more sugar in the urine. Saxagliptin belongs to a group of drugs called DPP-4 inhibitors. These drugs work by increasing insulin production to be able to control sugar after meals. 

Qtern comes as a tablet and is taken 1 time a day, in the morning, with or without food. 

Do not chew, divide, or break Qtern tablets. Swallow Qtern tablets whole.

Common side effects of Qtern include lung infection, urinary tract infection, and high cholesterol.

Qtern is a prescription medication used in combination with diet and exercise to treat adults type 2 diabetes mellitus. 

Type 2 diabetes mellitus is a disorder where the body does not make or use insulin appropriately. 

Qtern is not approved for those with type 1 diabetes mellitus. This medication is also not approved to treat those with diabetic ketoacidosis which is increased ketones in the blood and urine. 

It is not known if this medication is safe and effective in children younger than 18 years of age. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Qtern for the treatment of type 2 diabetes mellitus is 10 mg/5 mg (dapagliflozin/saxagliptin). 

Serious side effects have been reported with Qtern including the following:

Inflammation of the pancreas. Talk to your doctor if you experience any of the following symptoms: back pain, feeling bloated, nausea, loss of appetite, or racing heart.

Heart Failure. Talk to your doctor if you experience any of the following symptoms: sudden weight gain, shortness of breath, trouble breathing, or swelling of feet or legs. 

Vaginal yeast infection. Women may experience a yeast infection. Symptoms may include vaginal odor or itching as well as white or yellowish vaginal discharge.

Yeast infection in the penis. Men may experience a yeast infection of the skin around the penis. Symptoms may include redness, itching or swelling of the penis, odor, and pain.  

Bladder Cancer. Symptoms include pain during urination, dark urine, or blood in urine.

High levels of ketones in the blood or urine (ketoacidosis). This can occur even if your blood sugar level is less than 250 mg/dL. Call your healthcare provider immediately if you experience symptoms of ketoacidosis which may include tiredness, vomiting, trouble breathing, and stomach pain. 

Kidney problems. Injury to the kidneys can happen. If you reduce the amount of food or liquids you intake (when you are sick), talk to your healthcare provider right away. Also, if you lose a large of amount of liquids through vomiting, tell your healthcare provider right away. 

Infection of the urinary tract. If you have any symptoms of a urinary tract infection like burning feeling when urinating, the urge to urinate often, or pain in the lower stomach area, talk to your healthcare provider right away. 

Low Blood Sugar. When Qtern is taken with medications that can lower blood sugar such as insulin, there is a chance for low blood sugar. Tell your healthcare provider right away if you experience symptoms of low blood sugar such as hunger, shakiness, sweating, confusion, feeling weak, irritability, or fast heartbeat.

Increased LDL.  Qtern can increase bad cholesterol. Regular monitoring of cholesterol levels is recommended while taking Qtern. 

Severe joint pain. Talk to your healthcare provider if you experience pain in the joints of your hands, feet, knees, or wrists. 

Large, fluid-filled blisters. Talk to your healthcare provider if you experience blisters or peeling of the skin. 

Low blood pressure. Your healthcare provider will monitor your blood pressure before and during treatment. 

Severe allergic reaction. Tell your healthcare provider if you experience swelling of the face, eyes, lips, tongue, difficulty breathing or swallowing, or rash. 

Do not take Qtern if you:

• are allergic to Qtern or to any of its ingredients
• have moderate to severe kidney impairment
• end-stage renal disease
• are on dialysis

Serious side effects have been reported with Qtern. See the "Qtern Precautions" section. 

Common side effects of Qtern include the following:

• lung infection
• urinary tract infection
• high cholesterol
• headache
• diarrhea
• back pain

This is not a complete list of Qtern side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone. 

This is not a complete list of Qtern drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. There are limited studies with Qtern in pregnant women and as a result, is not enough to determine the risks for major birth defects or miscarriage. 

Qtern is not recommended to be given during second and third trimesters.

Talk to your healthcare provider about the best way to control your blood sugar during pregnancy. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Qtern crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication.

Qtern is not recommended while breastfeeding. Talk to your healthcare provider about the best way to feed your baby if you are taking Qtern.