Xigduo (Dapagliflozin and Metformin): What is it used for, How does it work, What are the side effects?

What is XIGDUO used for?

XIGDUO (Dapagliflozin and Metformin) is used along with diet and exercise in adults with type 2 diabetes to help control their blood sugar levels. XIGDUO can be used:

• in patients taking dapagliflozin (FORXIGA) and metformin as separate tablets, or
• in patients taking dapagliflozin (FORXIGA), metformin and a sulfonylurea as separate tablets, or
• in patients taking dapagliflozin (FORXIGA), metformin and sitagliptin as separate tablets, or
• in patients taking dapagliflozin (FORXIGA), metformin and insulin.

How does XIGDUO work?

XIGDUO contains dapagliflozin and metformin hydrochloride. Dapagliflozin removes excess sugar from the body through the urine. Metformin helps your body respond better to the insulin it makes naturally. It helps to lower the amount of sugar made by the liver and lower the amount of sugar moved from the gut into the blood.

Who should not take XIGDUO?

Do not take XIGDUO if you:

• have unstable and/or insulin-dependent (Type I) diabetes mellitus.
• have increased ketones in the blood or urine (metabolic acidosis) or have had ketoacidosis with or without coma.
• have diabetic ketoacidosis (DKA, a complication of diabetes) or a history of DKA.
• have a history of too much acid in the blood (lactic acidosis).
• have or ever had kidney or liver problems.
• consume large amounts of alcohol all the time or short-term ‘binge’.
• have heart failure or other severe heart problems.
• are stressed, have a serious infection, have recently had a trauma, are about to have surgery or are recovering from surgery.
• are dehydrated (have lost a lot of water from your body).
• are allergic (hypersensitive) to dapagliflozin, metformin hydrochloride or any of the ingredients listed below.
• are pregnant or planning to become pregnant; it is not known if XIGDUO will harm your unborn baby. Talk to your doctor about the best way to control your blood sugar while you are pregnant.
• are breast-feeding or plan to breast-feed; it is not known if XIGDUO will pass into your breast milk. Talk to your doctor if you would like to breast feed.
• will have certain x-ray tests with injectable dyes or contrast agents. Talk to your physician or pharmacist about when to stop XIGDUO and when to start again.

What are the ingredients in XIGDUO?

XIGDUO contains dapagliflozin (as dapagliflozin propanediol monohydrate) and metformin hydrochloride.

Nonmedicinal ingredients: cellulose microcrystalline, hydroxypropylcellulose, magnesium stearate (extragranular) and sodium starch glycolate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, macrogol/polyethylene glycol, talc, titanium dioxide, yellow iron oxide and/or red iron oxide.

What strenghts is XIGDUO available in?

XIGDUO is supplied as tablets containing dapagliflozin/metformin hydrochloride 5 mg/850 mg or 5 mg/1000 mg.

Warnings and Precautions for XIGDUO:

Serious Warnings and Precautions

• XIGDUO contains metformin and it can rarely cause a serious condition that can cause death called lactic acidosis. Alcohol may increase the risk of lactic acidosis. Do not drink a lot of alcohol while taking XIGDUO (see Lactic Acidosis:).
• Diabetic ketoacidosis (DKA) is a serious and life-threatening condition that requires urgent hospitalization. DKA has been reported in patients with type 2 diabetes mellitus (T2DM) with normal or high blood sugar levels, who are treated with dapagliflozin and other sodium-glucose co-transporter 2 (SGLT2) inhibitors. Some cases of DKA have led to death.
• Seek medical attention right away and stop taking XIGDUO immediately if you have any of the following symptoms (even if your blood sugar levels are normal): difficulty breathing, nausea, vomiting, stomach pain, loss of appetite, confusion, feeling very thirsty, feeling unusually tired, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
• Do not use XIGDUO if you have:
  • DKA or a history of DKA
  • type 1 diabetes

Lactic Acidosis:

Stop taking XIGDUO and tell your doctor if you get the following symptoms of lactic acidosis:

• You feel very weak and tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing or fast breathing.
• You have stomach pain with nausea and vomiting, or diarrhea.
• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded.
• You feel unusual fatigue and drowsiness.
• You have a slow or irregular heart beat.
• Your medical condition suddenly changes.
• You develop or experience a worsening of heart problems and particularly heart failure.

BEFORE you use XIGDUO talk to your doctor or pharmacist if you:

• have type 1 diabetes (your body does not produce any insulin). XIGDUO should not be used in patients with Type 1 diabetes.
• have an increased chance of developing DKA, including if you:
  • are dehydrated or suffer from excessive vomiting, diarrhea, or sweating;
  • are on a very low carbohydrate diet;
  • drink a lot of alcohol;
  • have/have had problems with your pancreas, including pancreatitis or surgery on your pancreas;
  • are hospitalized for major surgery, serious infection or serious medical illnesses;
  • have a history of diabetic ketoacidosis (DKA).
• are older than 65 years of age.
• have heart problems or low blood pressure.
• are taking medicines for high blood pressure or taking a water pill (used to remove excess water from the body).
• are taking medicines to lower blood sugar such as glyburide, gliclazide or glimepiride (sulfonylureas) or insulin. Taking XIGDUO with any of these medications can increase the risk of having low blood sugar (hypoglycemia).
• have a problem with your adrenal glands (found on top of your kidneys) or pituitary gland (found in your brain).
• will be having surgery.
• have had a heart attack, severe infection, or stroke.
• feel very weak and tired.
• are 80 years of age or older and have not had your kidney function tested.
• have low B₁₂ levels.
• have had an allergic reaction to SGLT2 inhibitors (used to treat Type 2 diabetes).
• often get urinary tract infections.

XIGDUO is not recommended for use in patients under 18 years of age. XIGDUO will cause your urine to test positive for sugar (glucose). XIGDUO may cause changes in the amount of cholesterol or fats in your blood.

XIGDUO increases the chance of getting a yeast infection of the penis or vagina. This is more likely in people who have had yeast infections in the past.

XIGDUO may cause abnormal kidney function. Your doctor will do blood tests to monitor how well your kidneys are working while you are taking XIGDUO.

XIGDUO may cause necrotizing fasciitis of the perineum (area between and around the anus and genitals). This is a rare but serious and potentially life-threatening infection that can affect both men and women. It is also known as Fournier’s gangrene and requires urgent treatment. If you experience tenderness, redness or swelling of the genitals or the area from the genitals to the rectum, especially if you also have a fever or are feeling very weak, tired, or uncomfortable, seek medical attention immediately. These may be signs of Fournier’s gangrene.

Driving and using machines:

XIGDUO may cause dizziness or lightheadedness. Do not drive or use machines until you know how the medicine affects you.

What are some interactions with XIGDUO?

Talk to your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Some drugs may interact with XIGDUO. Tell your doctor if you are taking:

• Medicines for diabetes; low blood sugar (hypoglycemia) may occur if you already take another medication to treat diabetes.
• Nifedipine (used to treat high blood pressure and chest pain).
• Cationic drugs (e.g. amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin).
• Certain “blood thinners” (phenprocoumon or other Vitamin K anticoagulants).
• Diuretics (water pills), especially loop diuretics, that may increase the risk of lactic acidosis (e.g. furosemide).
• Other drugs that tend to produce high blood sugar (hyperglycemia) and may lead to a loss of blood sugar control. Some examples of drugs that can increase the blood sugar include:
  • Thiazide and other diuretics (water pills)
  • Corticosteroids (used to treat joint pain and swelling)
  • Phenothiazines (used to treat schizophrenia)
  • Thyroid products
  • Estrogens or estrogens plus progestogen
  • Oral contraceptives (birth control pills)
  • Phenytoin (used to treat epilepsy)
  • Nicotinic Acid
  • Sympathomimetics (used for heart problems)
  • Calcium channel blocking drugs (used for high blood pressure)
  • Isoniazid (used to treat tuberculosis)
  • Beta-2-agonists (used to treat breathing problems)
• ACE inhibitor drugs (may lower blood glucose).

What is the usual dose of XIGDUO?

Usual adult dose: The recommended adult dose is one tablet (5 mg/850 mg or 5 mg/1000 mg), twice daily, taken with a meal.

What to do if you overdose on XIGDUO?

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

What to do if you miss a dose of XIGDUO?

If you miss a dose of XIGDUO, wait for the next dose at the usual time. Do not take a double dose

What are the side effects of XIGDUO? What to do about them?

These are not all the possible side effects you may feel when taking XIGDUO. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Side effects may include:

• sore throat
• the flu
• constipation
• diarrhea
• nausea
• back pain
• pain in the arms, legs, hands or feet
• headache
• rash

If any of these affects you severely, tell your doctor or pharmacist.

XIGDUO can cause abnormal blood test results. Your doctor will decide when to perform blood tests. They may check how well your kidneys are working, blood fat levels (cholesterol) and the amount of red blood cells in your blood (hematocrit).

Diabetic Ketoacidosis (DKA) is a serious medical condition normally seen at high blood sugar levels; however it has also been seen at near normal blood sugar levels. Get medical help right away if you have any of the symptoms under DKA in the table below, even if your blood sugar levels are normal.

This is not a complete list of side effects. For any unexpected effects while taking XIGDUO, contact your doctor or pharmacist.

How to store XIGDUO?

Store at room temperature (15 to 30°C). Keep XIGDUO out of the reach and sight of children.

Reference: FDA Monograph

Disclaimer: We have made every effort to ensure that all information is factually correct and up to date, however this article is not comprehensive and does not contain all relevant information about the topic. IT should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should consult your doctor or pharmacist before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.