Xigduo

Xigduo is a prescription-only combination medication that combines the two active ingredients dapagliflozin (SGLT2 inhibitor) and metformin (biguanide) in one tablet. It is used to treat type 2 diabetes mellitus in adults.

The fixed-dose combination is intended for patients who are already taking dapagliflozin and metformin as separate medications or for whom metformin alone is not sufficiently effective.

Xigduo is manufactured by AstraZeneca.

Xigduo combines two complementary mechanisms of action:

Dapagliflozin (SGLT2 inhibitor):

• Inhibits the reabsorption of sugar in the kidney
• Glucose is excreted in the urine
• Additionally lowers blood pressure and body weight

Metformin (biguanide):

• Inhibits the production of new sugar in the liver
• Improves the insulin sensitivity of cells
• Slows sugar absorption in the intestine

Advantages of the combination:

• Greater HbA1c reduction than either active ingredient alone
• No increased risk of hypoglycemia
• Weight-neutral to weight-lowering

Xigduo is suitable for:

• Adults with type 2 diabetes for whom metformin alone is not sufficient
• Patients who are already taking dapagliflozin and metformin separately (simplification)
• As part of a combination therapy with other antidiabetic medications

Not suitable:

• Type 1 diabetes
• Severe renal insufficiency (eGFR < 30 ml/min)
• Acute conditions with a risk of lactic acidosis
• Pregnancy and breastfeeding

Available strengths:

• 5 mg / 850 mg (dapagliflozin / metformin)
• 5 mg / 1000 mg

Dosage:

• Individually adjusted, based on previous therapy
• Usual: 1 tablet 2 times daily, each time with a meal

How to take:

• Take with meals (because of the metformin component)
• Swallow tablets whole without chewing

Dosing schedule:

• 1 tablet 2 times daily, each time with a meal

Important notes:

• Stop taking before or at the time of an examination with an iodinated contrast agent and restart no earlier than 48 hours afterwards, once kidney function has been checked and is stable (because of metformin)
• Drink enough fluids
• Regular monitoring of kidney function

Xigduo must not be taken in cases of:

• Hypersensitivity to dapagliflozin or metformin
• Severe renal insufficiency (eGFR < 30 ml/min)
• Any type of acute metabolic acidosis (e.g. lactic acidosis, diabetic ketoacidosis)
• Diabetic precoma
• Hepatic insufficiency
• Acute alcohol intoxication, alcoholism
• Acute conditions that can affect kidney function, such as dehydration, severe infection or shock
• Acute or chronic conditions that can lead to a lack of oxygen in the tissues, such as heart or lung failure, a recent heart attack or shock

Type 1 diabetes: Xigduo should not be used in type 1 diabetes. Safety and efficacy have not been established in this setting. Diabetic ketoacidosis was reported frequently in studies in type 1 diabetes.

Pregnancy/breastfeeding: If a pregnancy is planned and during pregnancy, diabetes should not be treated with Xigduo but with insulin. Xigduo should not be used during breastfeeding.

Combination of the side effects of both active ingredients:

From dapagliflozin:

• Genital fungal infections, urinary tract infections
• Increased urination

From metformin:

• Nausea, diarrhea, abdominal pain (especially at the beginning)
• Taste disturbances

Rare but serious side effects:

• Lactic acidosis (due to metformin)
• Diabetic ketoacidosis (due to dapagliflozin)

Contrast agents (iodinated): Stop taking before or at the time of the examination. Restart no earlier than 48 hours afterwards, once kidney function has been checked and is stable.

Alcohol: Increased risk of lactic acidosis. Avoid.

Diuretics: Increased dehydration possible.

Insulin / sulfonylureas: Increased risk of hypoglycemia – dose adjustment necessary.