Important Safety Information for QTERN® (dapagliflozin and saxagliptin) and FARXIGA® (dapagliflozin)
Who should not take QTERN or FARXIGA?
Do not take QTERN or FARXIGA if you:
- are allergic to dapagliflozin (FARXIGA), saxagliptin or any of the ingredients in QTERN. Symptoms of a serious allergic reaction 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 or FARXIGA and call your health care provider or go to the hospital emergency room right away
- have moderate to severe kidney problems or are on dialysis. Your health care provider should do blood tests to check how well your kidneys are working before and during your treatment with QTERN or FARXIGA
What are the possible side effects of QTERN or FARXIGA?
QTERN or FARXIGA may cause serious side effects including:
- Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking QTERN, tell your health care provider if you ever had pancreatitis, gallstones, history of alcoholism or high triglyceride levels. Stop taking QTERN and contact your health care 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. Before taking QTERN, tell your health care provider if you have ever had heart failure or problems with your kidneys. Contact your health care provider right away if you have any of the following symptoms of heart failure: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention in the feet, ankles or legs; an unusually fast increase in weight; unusual tiredness
- Dehydration (the loss of body water and salt) which 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 or have kidney problems
- Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with dapagliflozin (FARXIGA), one of the medicines in QTERN. Ketoacidosis is a serious condition which may require hospitalization and may lead to death. Symptoms may include nausea, tiredness, vomiting, trouble breathing, and abdominal pain. If you get any of these symptoms, stop taking QTERN or FARXIGA and call your health care provider right away. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL
- Kidney problems. Sudden kidney injury occurred in people taking dapagliflozin (FARXIGA), one of the medicines in QTERN. Talk to your health care provider right away if you reduce the amount you eat or drink, or if you lose liquids, for example, from vomiting, diarrhea, or excessive heat exposure
- Serious urinary tract infections (UTI), some that led to hospitalization, occurred in people taking dapagliflozin (FARXIGA), one of the medicines in QTERN. Tell your health care provider if you have any signs or symptoms of UTI including 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 with or without fever, back pain, nausea, or vomiting
- Low blood sugar (hypoglycemia). If you take QTERN or FARXIGA with another medicine that can cause low blood sugar such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. Symptoms of low blood sugar include shaking, sweating, rapid heartbeat, change in vision, hunger, headache, drowsiness, weakness, change in mood, confusion, or irritability. Follow your health care provider’s instructions for treating low blood sugar
- Bacterial infections under the skin of the genitals and areas around them. Rare but serious infections that cause severe tissue damage under the skin of the genitals and areas around them have happened with dapagliflozin (FARXIGA), one of the medications in QTERN. This infection has happened in women and men and may lead to hospitalization, surgeries and death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable and you also develop any pain or tenderness, swelling, or redness of the skin in the genitals and areas around them
- Serious allergic reactions have been reported in patients taking QTERN. If you have any symptoms of a serious allergic reaction, stop taking QTERN and get medical help right away
- Vaginal yeast infections in women who take QTERN or FARXIGA. Talk to your health care provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese) or vaginal itching
- Yeast infection of skin around the penis (balanitis) in men who take QTERN or FARXIGA. Talk to your health care provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis
- Increase in bad cholesterol (LDL). Your health care provider should check your LDL during treatment with QTERN or FARXIGA
- Bladder cancer. In studies of dapagliflozin (FARXIGA), one of the medicines in QTERN, bladder cancer occurred in a few more people who were taking FARXIGA than in people who were taking other diabetes medications. There were too few cases of bladder cancer to know if bladder cancer was related to FARXIGA. You should not take QTERN or FARXIGA if you have bladder cancer. Tell your health care provider right away if you have blood or a red color in your urine or pain while you urinate
- 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 health care provider 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 health care provider right away if you develop blisters or the breakdown of the outer layer of your skin
The most common side effects of QTERN include upper respiratory tract infection, urinary tract infection, and abnormal amounts of fats in the blood (dyslipidemia).
The most common side effects of FARXIGA include yeast infections of the vagina or penis, and changes in urination, including urgent need to urinate more often, in larger amounts, or at night.
What should I tell my health care provider before taking QTERN or FARXIGA?
Before you take QTERN or FARXIGA, tell your health care provider:
- all of your medical conditions, including problems with your kidneys, liver, bladder, heart or pancreas
- if you have had, or have risk factors for, ketoacidosis (including type 1 diabetes, are eating less due to illness, surgery, or a change in your diet, are going to have surgery, or binge drink)
- if you are pregnant, or plan to become pregnant. QTERN or FARXIGA may harm your unborn baby
- if you are breastfeeding or plan to breastfeed. It is unknown if QTERN or FARXIGA passes into your breast milk. Breastfeeding is not recommended while taking QTERN
- about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
QTERN is a prescription medicine that contains dapagliflozin and saxagliptin. QTERN is used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
FARXIGA (dapagliflozin) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
QTERN and FARXIGA are not for people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in your blood or urine).
Please see US Full Prescribing Information and Medication Guide for QTERN and FARXIGA.
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