TM Owner AstraZeneca
Xigduo XR 10mg/1000mg Film-coated extended-release tablet
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Indications & Clinical Uses
- Xigduo XR 10 mg/1000 mg (dapagliflozin and metformin hydrochloride extended-release) tablets combine dapagliflozin, an SGLT2 inhibitor, with metformin, a biguanide, in one once-daily tablet.
- It is used alongside diet and exercise to improve blood sugar control in adults and children aged 10 years and over with type 2 diabetes.
- In adults only, dapagliflozin also reduces the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death and heart failure hospitalisation in chronic kidney disease at risk of progression, reduces cardiovascular death and heart failure events in heart failure, and reduces heart failure hospitalisation in type 2 diabetes with established cardiovascular disease.
- It is not for type 1 diabetes.
- Xigduo XR is an extended-release, once-daily tablet and is not interchangeable with the twice-daily immediate-release Xigduo sold in the EU and UK.
- Take it once daily in the morning with food.
Side Effects
- BOXED WARNING: lactic acidosis.
- Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension and resistant bradyarrhythmias; risk factors include kidney impairment, age over 65, iodinated contrast imaging, surgery, low-oxygen states, excessive alcohol, liver impairment and mitochondrial disease.
- If suspected, stop Xigduo XR and seek hospital care.
- Most frequent side effects (5% or more) are female genital fungal infections, nasopharyngitis (cold symptoms), urinary tract infection, diarrhoea and headache; nausea and vomiting are also common with extended-release metformin.
- Serious effects include diabetic ketoacidosis (which can occur with normal blood sugar), volume depletion, genital and urinary infections including urosepsis, pyelonephritis and necrotising fasciitis of the perineum (Fournier's gangrene), low blood sugar with insulin or sulfonylureas, acute kidney injury and vitamin B12 deficiency.
Precautions & Warnings
- Contraindications are severe kidney impairment (eGFR below 30 mL/min/1.73 m2) or end-stage kidney disease, serious hypersensitivity to dapagliflozin or metformin, and metabolic acidosis including ketoacidosis.
- Starting treatment is not recommended when eGFR is 30 to 45.
- Stop Xigduo XR at or before iodinated contrast imaging in patients with eGFR below 60 or certain risk factors, and restart after kidney function is confirmed stable at 48 hours.
- Swallow tablets whole; never crush, cut or chew.
- Assess volume status and kidney function before starting, consider ketone monitoring, and measure vitamin B12 annually.
- Avoid excessive alcohol.
- Use is not recommended in the second and third trimesters of pregnancy; discuss breastfeeding with your provider.
- Follow the storage temperature printed on the pack, as it could not be confirmed from the label extract reviewed.
Avoid Interactions
- Medicines that can increase risk: carbonic anhydrase inhibitors (topiramate, zonisamide) raise the risk of lactic acidosis; drugs that reduce metformin clearance (ranolazine, vandetanib, dolutegravir, cimetidine) can increase metformin levels; alcohol potentiates metformin's effect on lactate; insulin and insulin secretagogues (sulfonylureas) increase hypoglycaemia risk and may need a lower dose.
- Lithium levels should be monitored more often.
- Urine glucose tests and the 1,5-anhydroglucitol assay are unreliable while taking dapagliflozin; use other blood sugar monitoring.
- No medicines are listed as reducing its effect.
- Tell your healthcare provider about all prescription and non-prescription medicines and supplements you take.
References
Frequently Asked Questions
Xigduo XR (dapagliflozin and metformin extended-release) improves blood sugar control in adults and children aged 10 and over with type 2 diabetes. In adults, dapagliflozin also lowers the risk of kidney disease progression and of heart failure hospitalisation. It is not for type 1 diabetes.
Take Xigduo XR (dapagliflozin and metformin extended-release) by mouth once daily in the morning with food. Swallow the tablet whole and never crush, cut or chew it. Do not change the dose or switch it for immediate-release twice-daily tablets without your provider's advice.
Xigduo XR (dapagliflozin and metformin) commonly causes genital yeast infections, cold symptoms, urinary tract infections, diarrhoea and headache. Nausea and vomiting can also occur. Stop and get emergency help for signs of lactic acidosis, ketoacidosis, or genital or perineal pain with fever (Fournier's gangrene).
Xigduo XR (dapagliflozin and metformin) carries a boxed warning for lactic acidosis, which can cause death. Risk is higher with kidney or liver problems, heavy alcohol use, contrast dye imaging and low-oxygen states. If you suspect it, stop the tablets and go to hospital.
Avoid excessive alcohol with Xigduo XR (dapagliflozin and metformin). Tell your provider about topiramate, zonisamide, dolutegravir, ranolazine, cimetidine, lithium, insulin and sulfonylureas. Stop the tablets at or before iodinated contrast imaging if you have kidney problems, as your provider directs.
Yes. Your provider checks kidney function (eGFR) before and during Xigduo XR (dapagliflozin and metformin) treatment. Vitamin B12 levels are measured yearly, and ketones may be checked if you feel unwell. Treatment is not started when eGFR is 30 to 45.
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