Important Safety Information
for XIGDUO® XR (dapagliflozin and metformin HCl
What is the most important information I should know about XIGDUO XR?
XIGDUO XR can cause serious side effects, including lactic acidosis. Metformin, one of the medicines in XIGDUO XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking XIGDUO XR and call your healthcare provider right away if you have any of the following symptoms which could be signs of lactic acidosis: feel cold in your hands or feet, feel very weak or tired, unusual (not normal) muscle pain, trouble breathing, unusual sleepiness or sleep longer than usual, stomach pains, nausea or vomiting, feel dizzy or lightheaded, or have a slow or irregular heartbeat.
You have a higher chance of getting lactic acidosis with XIGDUO XR if you have severe kidney problems, your kidneys are affected by certain x-ray tests that use injectable dye, have liver problems, drink alcohol (very often or a lot of alcohol in short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have surgery, have a heart attack, severe infection, or stroke.
Who should not take XIGDUO XR?
Do not take XIGDUO XR if you:
- have moderate to severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with XIGDUO XR
- are allergic to dapagliflozin, metformin, or any of the ingredients in XIGDUO XR. Symptoms of a serious allergic reaction may include: skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking XIGDUO XR and contact your healthcare provider or go to the nearest hospital emergency room right away
What are the possible side effects of XIGDUO XR?
Serious side effects can happen in people who take XIGDUO XR, including:
- 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. Talk to your doctor about what you can do to prevent dehydration
- Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with dapagliflozin, one of the medicines in XIGDUO XR. 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 XIGDUO XR and call your healthcare 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 XIGDUO XR. Talk to your doctor 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 lead to hospitalization, occurred in people taking dapagliflozin, one of the medicines in XIGDUO XR. Tell your doctor 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) can occur if you take with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include shaking, sweating, fast heartbeat, dizziness, hunger, headache and irritability. Follow your healthcare 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, one of the medications in XIGDUO XR. 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
- Vaginal yeast infections in women who take XIGDUO XR. Talk to your healthcare 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 XIGDUO XR. Talk to your healthcare 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-C). Your healthcare provider should check your LDL-C during treatment with XIGDUO XR
- Bladder cancer. In studies of dapagliflozin in people with diabetes, bladder cancer occurred in a few more people who were taking dapagliflozin 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 dapagliflozin. Tell your healthcare provider right away if you have blood or a red color in your urine or pain while you urinate
What should I tell my doctor before taking XIGDUO XR?
Tell your healthcare 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 change in your diet, are going to have surgery, or binge drink)
- if you are going to get an injection of dye or contrast agents for an x-ray procedure
- if you are pregnant, or plan to become pregnant. XIGDUO XR may harm your unborn baby
- if you are breastfeeding, or plan to breastfeed. It is unknown if XIGDUO XR passes into your breast milk
- about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements
The most common side effects of XIGDUO XR include yeast infections of the vagina or penis, stuffy or runny nose and sore throat, diarrhea, headache, nausea, and vomiting.
What is XIGDUO XR?
XIGDUO XR contains 2 prescription medicines called dapagliflozin and metformin. XIGDUO XR is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes when treatment with either dapagliflozin or metformin has not controlled your blood sugar.
XIGDUO XR is not for people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).
Please see Medication Guide and US Full Prescribing Information for XIGDUO XR, including Boxed WARNING about lactic acidosis.
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