|
MEDICATION GUIDE
XIGDUO® XR [ZIG-DO-OH X-R]
(dapagliflozin and metformin hydrochloride extended-release)
tablets, for oral use
|
|
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 condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the 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:
-
-
- o
- you feel cold in your hands or feet
- o
- you feel dizzy or lightheaded
- o
- you have a slow or irregular heartbeat
- o
- you feel very weak or tired
- o
- you have unusual (not normal) muscle pain
- o
- you have trouble breathing
- o
- you feel unusual sleepiness or sleep longer than usual
- o
- you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. Tell your healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with XIGDUO XR if you:
-
-
- o
- have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye.
- o
- have liver problems.
- o
- drink alcohol very often or drink a lot of alcohol in the short-term ("binge" drinking).
- o
- get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
- o
- have surgery.
- o
- have new or worsening symptoms of congestive heart failure such as shortness of breath or increased fluid or swelling of the legs.
- o
- have a heart attack, severe infection, or stroke.
- o
- are 65 years of age or older.
The best way to keep from having a problem with lactic acidosis from metformin is to tell your healthcare provider if you have any of the problems in the list above. Your healthcare provider may decide to stop your XIGDUO XR for a while if you have any of these things.
- •
-
Diabetic Ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. XIGDUO XR can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition which needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood.
-
-
Stop taking XIGDUO XR and call your healthcare provider or get medical help right away if you get any of the following. If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.
|
- o
- nausea
- o
- vomiting
- o
- stomach area (abdominal) pain
|
- o
- tiredness
- o
- trouble breathing
- o
- ketones in your urine or blood
|
|
XIGDUO XR can have other serious side effects. See “What are the possible side effects of XIGDUO XR?”
|
|
What is XIGDUO XR?
- •
- XIGDUO XR contains 2 prescription medicines called dapagliflozin (FARXIGA) and metformin HCl (GLUCOPHAGE). XIGDUO XR is used in adults with type 2 diabetes mellitus:
- o
- to improve blood sugar (glucose) control along with diet and exercise.
- o
- who have known cardiovascular disease or multiple cardiovascular risk factors and dapagliflozin is needed to reduce the risk of hospitalization for heart failure.
- o
- who have heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) and dapagliflozin is needed to reduce the risk of cardiovascular death and hospitalization for heart failure.
- o
- to reduce the risk of further worsening of your kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease.
- •
- XIGDUO XR is not for use to improve blood sugar (glucose) control in people with type 1 diabetes.
- •
- XIGDUO XR is only for use in adults with type 2 diabetes mellitus, because it contains the prescription medicine metformin HCl.
- •
- XIGDUO XR is not for use for treatment of chronic kidney disease in people with certain genetic forms of polycystic kidney disease, or who are taking or have recently received immunosuppressive therapy to treat kidney disease. If you have these conditions, XIGDUO XR is not expected to work for treatment of chronic kidney disease.
- •
- It is not known if XIGDUO XR is safe and effective in children younger than 18 years of age.
|
|
Who should not take XIGDUO XR?
Do not take XIGDUO XR if you:
- •
- have severe kidney problems or are on dialysis.
- •
- are allergic to dapagliflozin, metformin HCl, or any of the ingredients in XIGDUO XR. See the end of this Medication Guide for a complete list of ingredients in XIGDUO XR. Symptoms of a serious allergic reaction to XIGDUO XR may include:
- o
- rash
- o
- raised red patches on your skin (hives)
- o
- 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.
- •
- have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).
|
|
What should I tell my healthcare provider before taking XIGDUO XR?
Before you take XIGDUO XR, tell your healthcare provider if you:
- •
- have type 1 diabetes or have had diabetic ketoacidosis.
- •
- have a decrease in your insulin dose.
- •
- have a serious infection.
- •
- have a history of infection of the vagina or penis.
- •
- have kidney problems.
- •
- have liver problems.
- •
- have a history of urinary tract infections or problems with urination.
- •
- are on a low sodium (salt) diet. Your healthcare provider may ask you to change your diet.
- •
- have heart problems, including congestive heart failure.
- •
- are 65 years of age or older.
- •
- are going to have surgery. Your healthcare provider may stop XIGDUO XR before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking XIGDUO XR and when to start it again.
- •
- are eating less, or there is a change in your diet.
- •
- are dehydrated.
- •
- have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.
- •
- drink alcohol very often or drink a lot of alcohol in the short-term (“binge” drinking).
- •
- are going to get an injection of dye or contrast agents for an x-ray procedure. XIGDUO XR may need to be stopped for a short time. Talk to your healthcare provider about when you should stop XIGDUO XR and when you should start XIGDUO XR again. See “What is the most important information I should know about XIGDUO XR?”
- •
- have low levels of vitamin B12 in your blood.
- •
- are pregnant or plan to become pregnant. XIGDUO XR may harm your unborn baby. If you are pregnant or plan to become pregnant, talk to your healthcare provider about the best way to control your blood sugar.
- •
- are breastfeeding or plan to breastfeed. It is not known if XIGDUO XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking XIGDUO XR. You should not breastfeed if you take XIGDUO XR.
- •
- are a person who has not gone through menopause (premenopausal) who does not have periods regularly or at all. XIGDUO XR can cause the release of an egg from an ovary in a person (ovulation). This can increase your chance of getting pregnant. Tell your healthcare provider right away if you become pregnant while taking XIGDUO XR.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
XIGDUO XR may affect the way other medicines work and other medicines may affect the way XIGDUO XR works.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
|
|
How should I take XIGDUO XR?
- •
- Take XIGDUO XR exactly as your healthcare provider tells you to take it.
- •
- Your healthcare provider will tell you how much XIGDUO XR to take and when to take it. Your healthcare provider may change your dose if needed.
- •
- Take XIGDUO XR by mouth 1 time each day with meals to lower your chance of an upset stomach. Talk to your healthcare provider about the best time of day for you.
- •
- Swallow XIGDUO XR whole. Do not crush, cut, or chew XIGDUO XR.
- •
- You may sometimes pass a soft mass in your stools (bowel movement) that looks like XIGDUO XR tablets.
- •
- If you miss a dose of XIGDUO XR, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take 2 doses of XIGDUO XR at the same time. Talk with your healthcare provider if you have questions about a missed dose.
- •
- If you take too much XIGDUO XR, call your healthcare provider or go to the nearest hospital emergency room right away.
- •
- When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine you need may change. Tell your healthcare provider right away if you have any of these conditions and follow your healthcare provider’s instructions.
- •
- Your healthcare provider may tell you to take XIGDUO XR along with other diabetes medicines. Low blood sugar can happen more often when XIGDUO XR is taken with certain other diabetes medicines. See “What are the possible side effects of XIGUDO XR?”.
- •
- XIGDUO XR will cause your urine to test positive for glucose.
- •
- Your healthcare provider may do certain blood tests before you start XIGDUO XR and during treatment as needed. Your healthcare provider may change your dose of XIGDUO XR based on the results of your blood tests.
|
|
What should I avoid while taking XIGDUO XR?
- •
- Avoid drinking alcohol very often or drinking a lot of alcohol in a short period of time (“binge” drinking). It can increase your chances of getting serious side effects.
|
|
What are the possible side effects of XIGDUO XR?
XIGDUO XR may cause serious side effects including:
See “What is the most important information I should know about XIGDUO XR?”.
- •
-
Dehydration. XIGDUO XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with type 2 diabetes mellitus who are taking dapagliflozin, a medicine in XIGDUO XR.
-
- You may be at a higher risk of dehydration if you:
- o
- take medicines to lower your blood pressure, including water pills (diuretics)
- o
- are on a low salt diet
- o
- have kidney problems
- o
- are 65 years of age or older
-
- Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink on a daily basis. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example if you cannot eat or you start to lose liquids from your body, for example from vomiting, diarrhea, or being in the sun too long.
- •
-
Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin, one of the medicines in XIGDUO XR. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection, such as 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. Sometimes people also may have a fever, back pain, nausea or vomiting.
- •
-
Low blood sugar (hypoglycemia). If you take XIGDUO XR with another medicine that can cause low blood sugar, such as sulfonylureas or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take XIGDUO XR. Signs and symptoms of low blood sugar may include:
|
- ∘
- headache
- ∘
- confusion
- ∘
- hunger
- ∘
- shaking or feeling jittery
|
- ∘
- drowsiness
- ∘
- dizziness
- ∘
- fast heartbeat
|
- ∘
- weakness
- ∘
- sweating
- ∘
- irritability
|
- •
-
A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take dapagliflozin, one of the medicines in XIGDUO XR. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries and may lead to death. Seek medical attention immediately if you have a fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:
|
- ∘
- pain or tenderness
|
- ∘
- swelling
|
- ∘
- redness of skin (erythema)
|
- •
-
Serious allergic reaction. If you have any symptoms of a serious allergic reaction, stop taking XIGDUO XR and call your healthcare provider right away or go to the nearest hospital emergency room. See “Who should not take XIGDUO XR?”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes.
- •
-
Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.
- •
-
Vaginal yeast infection. Women who take XIGDUO XR may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
- ∘
- vaginal odor
- ∘
- white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
- ∘
- vaginal itching
- •
-
Yeast infection of the penis (balanitis). Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of a yeast infection of the penis include:
- ∘
- redness, itching, or swelling of the penis
- ∘
- foul smelling discharge from the penis
- ∘
- rash of the penis
- ∘
- pain in the skin around the penis
-
- Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
The most common side effects of XIGDUO XR include:
|
-
-
- ∘
- vaginal yeast infections
- ∘
- diarrhea
- ∘
- headache
|
- ∘
- stuffy or runny nose and sore throat
- ∘
- urinary tract infection
|
|
Tell your healthcare provider or pharmacist if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of XIGDUO XR. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
|
|
How should I store XIGDUO XR?
Store XIGDUO XR at room temperature between 68°F and 77°F (20°C and 25°C).
Keep XIGDUO XR and all medicines out of the reach of children.
|
|
General information about the safe and effective use of XIGDUO XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XIGDUO XR for a condition for which it is not prescribed. Do not give XIGDUO XR to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about XIGDUO XR. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about XIGDUO XR that is written for health professionals.
For more information, go to www.xigduoxr.com or call 1-800-236-9933
|
|
What are the ingredients in XIGDUO XR?
Active ingredients: dapagliflozin and metformin hydrochloride
Inactive ingredients: microcrystalline cellulose, lactose anhydrous, crospovidone, silicon dioxide, magnesium stearate, carboxymethylcellulose sodium, and hypromellose.
The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the XIGDUO XR 5 mg/500 mg tablets contains FD&C Yellow No. 6/Sunset Yellow FCF aluminum lake and the film coating for the XIGDUO XR 2.5 mg/1000 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg tablets contains iron oxides.
|
|
Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
|