Xigduo XR (Dapagliflozin/Metformin Hcl)

Do’s

• Before starting Xigduo XR, read the Medication Guide provided by your pharmacist. If you have any questions, ask your healthcare provider for clarification.
• Take Xigduo XR by mouth as directed by your healthcare provider, usually once daily in the morning with food. Swallow the tablets whole.
• The dosage of Xigduo XR is based on your medical condition, response to treatment, and other medications you may be taking. Inform your healthcare provider about all the products you use, including prescription drugs, nonprescription drugs, and herbal products.
• To reduce the risk of side effects, such as diarrhea, nausea, and vomiting, your healthcare provider may direct you to start this medication at a low dose and gradually increase your dose. Follow their instructions carefully in this regard.
• Take Xigduo XR regularly to get the most benefit from it. To help you remember, take it at the same time each day.
• If your condition does not improve or worsens (e.g., if your blood sugar is too high or too low), inform your healthcare provider.

Don’ts

• Do not crush or chew the tablets, as doing so can release all of the drug at once, increasing the risk of side effects.

Common Side Effects: 

• Changes in urination frequency or amount
• Bloody urine
• Difficult or painful urination
• Lower back or side pain
• Chills
• Fast or troubled breathing
• Stomach pain
• Nausea
• Vomiting
• Severe weakness
• Increased hunger
• Headache
• Confusion
• Shaking
• Trembling
• Sweating 

Severe Side Effects: 

• Metformin-associated lactic acidosis is a severe side effect characterized by elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio, and metformin plasma levels generally greater than 5 mcg/mL.

This is not an exhaustive list of side effects. If you experience any unusual symptoms or side effects while taking Xigduo XR, consult your healthcare provider. 

Before starting Xigduo XR and while taking it, various lab and medical tests such as kidney function, liver function, blood sugar, hemoglobin A1c, ketones, complete blood counts, cholesterol, and vitamin B12 should be conducted. Keep all medical and lab appointments and consult your healthcare provider for more details.

Dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range due to the greater frequency of decreased hepatic, renal, or cardiac function, and the higher risk of lactic acidosis. Renal function should be assessed more frequently in elderly patients.

Xigduo XR is contraindicated in patients with an eGFR below 30 mL/min/1.73 m2, end-stage renal disease, or on dialysis due to the metformin component. Renal function should be assessed before initiating Xigduo XR therapy and periodically thereafter. In patients with volume depletion, correcting this condition prior to initiation of Xigduo XR is recommended.

Xigduo XR should be discontinued at the time of, or prior to, an iodinated contrast imaging procedure in patients with a history of liver disease, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Re-evaluation of eGFR 48 hours after the imaging procedure is recommended, and Xigduo XR should be restarted if renal function is stable.

Xigduo XR has no established safety and efficacy in pediatrics. Consult a healthcare provider before taking Xigduo XR during pregnancy or nursing. Rare reports of cholestatic and hepatocellular injury have been noted.

Consult your healthcare provider for detailed information on the warnings and precautions associated with Xigduo XR.