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Xigduo is a brand name for Dapagliflozin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: • in patients insufficiently controlled on their maximally tolerated dose of metformin alone • in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min) The recommended dose is one tablet twice daily. Each tablet contains a fixed dose of dapagliflozin and metformin (see section 2). 3 For patients insufficiently controlled on metformin monotherapy or metformin in combination with other medicinal products for the treatment of diabetes Patients insufficiently controlled on metformin alone or in combination with other medicinal products for the treatment of diabetes should receive a total daily dose of Xigduo equivalent to dapagliflozin 10 mg, plus the total daily dose of metformin, or the nearest therapeutically appropriate dose, already being taken.
8). For patients switching from separate tablets of dapagliflozin and metformin Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Xigduo should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Special populations Renal impairment A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter. g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min. If no adequate strength of Xigduo is available, individual monocomponents should be used instead of the fixed dose combination. Table 1.
Dosage in patients with renal impairment GFR mL/min Metformin Dapagliflozin 60-89 Maximum daily dose is 3000 mg. Dose reduction may be considered in relation to declining renal function. Maximum daily dose is 10 mg. 45-59 Maximum daily dose is 2000 mg.
The starting dose is at most half of the maximum dose. Maximum daily dose is 10 mg. 30-44 Maximum daily dose is 1000 mg. The starting dose is at most half of the maximum dose. Maximum daily dose is 10 mg. The glucose lowering efficacy of dapagliflozin is reduced.
< 30 Metformin is contraindicated. Maximum daily dose is 10 mg. Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. The glucose lowering efficacy of dapagliflozin is likely absent.
2). There have been no therapeutic clinical trials conducted with Xigduo tablets. Dapagliflozin plus metformin Summary of the safety profile In an analysis of 5 placebo-controlled dapagliflozin add-on to metformin studies, the safety results were similar to that of the pre-specified pooled analysis of 13 placebo-controlled dapagliflozin studies (see Dapagliflozin, Summary of the safety profile below).
No additional adverse reactions were identified for the dapagliflozin plus metformin group compared with those reported for the individual components. In the separate dapagliflozin add-on to metformin pooled analysis, 623 subjects were treated with dapagliflozin 10 mg as add-on to metformin and 523 were treated with placebo plus metformin.
Dapagliflozin Summary of the safety profile In the clinical studies in type 2 diabetes, more than 15,000 patients have been treated with dapagliflozin. The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
1), 8,574 patients received dapagliflozin 10 mg and 8,569 received placebo for a median exposure time of 48 months. In total, there were 30,623 patient-years of exposure to dapagliflozin. The most frequently reported adverse reactions across the clinical studies were genital infections.
Tabulated list of adverse reactions The following adverse reactions have been identified in the placebo-controlled dapagliflozin plus metformin clinical studies, dapagliflozin clinical studies and metformin clinical studies and post-marketing experience.
None were found to be dose-related. Adverse reactions listed below are classified according to frequency and system organ class. Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Lactic acidosis Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis.
In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), Xigduo should be temporarily discontinued and contact with a healthcare professional is recommended. Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and non-steroidal anti-inflammatory drugs [NSAIDs]) should be initiated with caution in metformin-treated patients.
5). Patients and/or caregivers should be informed on the risk of lactic acidosis. Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. In case of suspected symptoms, the patient should stop taking Xigduo and seek immediate medical attention.
35), increased plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio. Patients with known or suspected mitochondrial diseases In patients with known mitochondrial diseases such as Mitochondrial Encephalomyopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternally Inherited Diabetes and 5 Deafness (MIDD), metformin is not recommended due to the risk of lactic acidosis exacerbation and neurologic complications which may lead to worsening of the disease.
In case of signs and symptoms suggestive of MELAS syndrome or MIDD after the intake of metformin, treatment with metformin should be withdrawn immediately and prompt diagnostic evaluation should be performed. 2). 4). 2). 3). Decreased renal function in elderly patients is frequent and asymptomatic.
Special caution should be exercised in situations where renal function may become impaired, for example when initiating anti-hypertensive or diuretic therapy or when starting treatment with a NSAID. 1). It may be more pronounced in patients with high blood glucose concentrations.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2). Elderly (≥ 65 years) Because metformin is eliminated in part by the kidney, and because elderly patients are more likely to have decreased renal function, this medicinal product should be used with caution as age increases. 4). Paediatric population The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established.
No data are available. Method of administration Xigduo should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
11 Table 2. Adverse reactions in dapagliflozin and metformin immediate-release clinical trial and post-marketing dataa System organ class Very common Common Uncommon Rare Very rare Infections and infestations Vulvovaginitis, balanitis and related genital infections*,b,c Urinary tract infection*,b,d Fungal infection** Necrotising fasciitis of the perineum (Fournier’s gangrene)b,j Metabolism and nutrition disorders Hypoglycaemia (when used with SU or insulin)b Vitamin B12 decrease/ deficiencyj,§ Volume depletionb,e Thirst** Diabetic ketoacidosisb,j,k Lactic acidosis Nervous system disorders Taste disturbance§ Dizziness Gastrointestinal disorders Gastro- intestinal symptomsh,§ Constipation** Dry mouth** Hepatobiliary disorders Liver function disorders§ Hepatitis§ Skin and subcutaneous tissue disorders Rashl Urticaria§ Erythema§ Pruritus§ Musculo- skeletal and connective tissue disorders Back pain* Renal and urinary disorders Dysuria Polyuria*,f Nocturia** Tubulo- interstitial nephritis Reproductive system and breast disorders Vulvovaginal pruritus** Pruritus genital** Investigations Haematocrit increasedg Creatinine renal clearance decreased during initial treatmentb Dyslipidaemiai Blood creatinine increased during initial treatment**,b Blood urea increased** Weight decreased** aThe table shows adverse reactions identified from up to 24-week (short-term) data regardless of glycaemic rescue, except those marked with § (see below).
bSee corresponding subsection below for additional information. g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
dUrinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
g. the predefined preferred terms: dehydration, hypovolaemia, hypotension. fPolyuria includes the preferred terms: pollakiuria, polyuria, urine output increased. 33% for placebo. 4% of placebo subjects. hGastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
7%. 4. kReported in the cardiovascular outcomes study in patients with type 2 diabetes (DECLARE). Frequency is based on annual rate. lAdverse reaction was identified through post-marketing surveillance with the use of dapagliflozin. Rash includes the following preferred terms, listed in order of frequency in clinical trials: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous.
4%), respectively. *Reported in ≥ 2% of subjects […]
Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients on anti-hypertensive therapy with a history of hypotension or elderly patients. g. g. physical examination, blood pressure measurements, laboratory tests including haematocrit and electrolytes) is recommended.
8). Diabetic ketoacidosis Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with sodium-glucose co-transporter 2 (SGLT2) inhibitors, including dapagliflozin.
In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL). It is not known if DKA is more likely to occur with higher doses of dapagliflozin.
The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
In patients where DKA is suspected or diagnosed, treatment with dapagliflozin should be discontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised.
6 Before initiating dapagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered. Prolonged ketoacidosis and prolonged glucosuria have been observed with dapagliflozin. 2). Dapagliflozin-independent factors, such as insulin deficiency, might be involved in prolonged periods of ketoacidosis.
g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions […]