Brand Name
US Brand Name
Xigduo XR

Description:
Dapagliflozin and metformin combination is used together with proper diet and exercise to treat type 2 diabetes. It is also used to lower the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease or multiple cardiovascular risk factors. This medicine is also used to lower the risk of cardiovascular death and hospitalization in patients with heart failure with reduced ejection fraction (the heart is weak and cannot pump enough blood to the rest of the body.

Dapagliflozin and metformin combination is also used to lower the risk of worsening of kidney disease, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease.

Dapagliflozin works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. It does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet, Extended Release

Before Using:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of dapagliflozin and metformin combination in children younger than 10 years of age to treat type 2 diabetes and in children to treat other conditions. Safety and efficacy have not been established.

Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dapagliflozin and metformin combination in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving dapagliflozin and metformin combination.

Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Abiraterone Acetate, Micronized
• Acarbose
• Acetazolamide
• Alogliptin
• Aspirin
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Dasabuvir
• Delafloxacin
• Diatrizoate
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Enoxacin
• Ethiodized Oil
• Fedratinib
• Fexinidazole
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iodipamide
• Iodixanol
• Iohexol
• Iopamidol
• Iopanoic Acid
• Iopromide
• Iothalamate
• Iotrolan
• Ioversol
• Ioxaglate
• Ipodate
• Isavuconazole
• Lanreotide Acetate
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lithium
• Lomefloxacin
• Mavorixafor
• Methazolamide
• Metolazone
• Metrizamide
• Moxifloxacin
• Nateglinide
• Norfloxacin
• Octreotide Acetate
• Ofloxacin
• Ombitasvir
• Paritaprevir
• Pasireotide Diaspartate
• Pioglitazone
• Polythiazide
• Pramlintide
• Ranolazine
• Repaglinide
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Tafenoquine
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Topiramate
• Triamterene
• Trimethoprim
• Trovafloxacin
• Vandetanib
• Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Colesevelam
• Esmolol
• Fenugreek
• Glecaprevir
• Glucomannan
• Goldenseal
• Guar Gum
• Hydrastis
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Patiromer
• Penbutolol
• Phenelzine
• Pibrentasvir
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tranylcypromine
• Verapamil

Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problem, underactive or
• Alcohol abuse, history of or
• Cardiovascular collapse (shock) or
• Congestive heart failure or
• Dehydration, severe or
• Heart attack, acute or
• Heart failure, history of or
• Hypovolemia (low blood volume) or
• Liver disease, history of or
• Pancreatic insulin deficiency (eg, pancreatitis, pancreatic surgery), history of or
• Pituitary gland problem, underactive or
• Poorly nourished condition or
• Sepsis (severe infection) or
• Weakened physical condition—Use with caution. May cause side effects to become worse.
• Anemia (low red blood cells) or
• Dehydration or
• Genital yeast (fungus) infection (eg, balanitis, balanoposthitis, vulvovaginitis), history of or
• Hypotension (low blood pressure) or
• Kidney disease or
• Urinary tract infections (eg, pyelonephritis, urosepsis), history of or
• Vitamin B12 deficiency—Use with caution. May make these conditions worse.
• Diabetic ketoacidosis (high ketones and acid in the blood) or
• Kidney disease, severe (eg, polycystic kidney disease) or
• Metabolic acidosis (acid in the blood) or
• Patients receiving dialysis or
• Type I diabetes—Should not be used in patients with these conditions.
• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may cause problems with blood sugar control.
• Hypoxia (low oxygen in the blood) or
• Kidney damage or
• Liver damage or
• Radiologic procedures (eg, X-rays, CT scans, MRIs) that require dyes to be injected into your vein—May increase your risk for lactic acidosis (too much acid in the blood).

Proper Use:
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not change your dose unless directed by your doctor.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine in the morning with food. Swallow the extended-release tablet whole. Do not crush, break, or chew it.

While taking the extended-release tablet, part of it may pass into your stools. This is normal and is nothing to worry about.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.

Tell your doctor if you are on a low-salt or sodium diet.

Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release tablets):
For type 2 diabetes:

• Adults and children 10 years of age and older—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than dapagliflozin 10 mg and metformin 2000 mg per day.
• Children younger than 10 years of age—Use and dose must be determined by your doctor.

To lower risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease:

• Adults—10 milligrams (mg) once a day.
• Children—Use and dose must be determined by your doctor.

To lower risk of cardiovascular death and hospitalization in patients with heart failure:

• Adults—10 milligrams (mg) once a day.
• Children—Use and dose must be determined by your doctor.

To lower risk of worsening of kidney disease, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease:

• Adults—10 milligrams (mg) once a day.
• Children—Use and dose must be determined by your doctor.

Missed Dose:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage:
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions:
It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Serious allergic reactions may occur with this medicine. Check with your doctor right away if you have a skin rash, hives or welts, itching, redness of the skin, trouble breathing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

Using this medicine during the second and third part of your pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.

It is very important to follow carefully any instructions from your doctor about:

• Alcohol—Drinking alcohol may cause severe low blood sugar and increase risk for lactic acidosis. Discuss this with your doctor.
• Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. Check with your doctor right away if you have decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, stomach discomfort, and unusual sleepiness, tiredness, or weakness.

Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.

Diabetic ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.

Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, urine glucose tests may not be accurate). Also, you may need to stop taking this medicine at least 3 days before you have a surgery or other procedures that require fasting.

This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.

This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.

This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with other diabetes medicines (eg, insulin, glipizide, glyburide). The symptoms of low blood sugar must be treated before they cause you to pass out. People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual. Some symptoms of high blood sugar include: blurred vision, drowsiness, dry mouth, flushed and dry skin, fruit-like breath odor, increased frequency and amount of urination, ketones in the urine, loss of appetite, nausea or vomiting, rapid and deep breathing, tiredness, or unusual thirst. If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

• Bladder pain
• bloody or cloudy urine
• change in the color, amount, or odor of vaginal discharge
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

Rare:

• Decreased appetite
• diarrhea
• fast, shallow breathing
• general feeling of discomfort
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• muscle pain or cramping
• nausea
• sleepiness
• stomach discomfort
• unusual tiredness or weakness

Incidence not known:

• Anxiety
• blurred vision
• chest tightness
• chills
• clay-colored stools
• cold sweats
• confusion
• cool, pale skin
• dark urine
• depression
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• fever
• headache
• hives, itching, or rash
• hoarseness
• increased hunger
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• loss of consciousness
• nightmares
• pain, tenderness, redness, or swelling of the area between the anus and genitals
• redness of the skin
• seizures
• shakiness
• slurred speech
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• trouble swallowing
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

• Muscle aches
• sore throat
• stuffy or runny nose

Less common:

• Back pain
• body aches or pain
• difficulty having a bowel movement
• tender, swollen glands in the neck
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects.