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Dapagliflozin Viatris is a brand name for Dapagliflozin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Type 2 diabetes mellitus The recommended dose is 10 mg dapagliflozin once daily. 8). Heart failure The recommended dose is 10 mg dapagliflozin once daily. Chronic kidney disease The recommended dose is 10 mg dapagliflozin once daily.
Special populations Renal impairment No dose adjustment is required based on renal function. Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. In patients with type 2 diabetes mellitus, the glucose lowering efficacy of dapagliflozin is reduced when the glomerular filtration rate (GFR) is < 45 mL/min and is likely absent in patients with severe renal impairment.
2). Hepatic impairment No dose adjustment is necessary for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. 2). Elderly (≥ 65 years) No dose adjustment is recommended based on age.
2). No data are available for children below 10 years of age. The safety and efficacy of dapagliflozin for the treatment of heart failure or for the treatment of chronic kidney disease in children < 18 years have not yet been established.
No data are available. Method of administration Dapagliflozin Viatris can be taken orally once daily at any time of day with or without food. Tablets are to be swallowed whole. The tablet cannot be divided into equal doses. 4
Summary of the safety profile Type 2 diabetes mellitus 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.
Heart failure In the dapagliflozin cardiovascular outcome study in patients with heart failure with reduced ejection fraction (DAPA-HF study), 2 368 patients were treated with dapagliflozin 10 mg and 2 368 patients with placebo for a median exposure time of 18 months.
73 m2. In the dapagliflozin cardiovascular outcome study in patients with heart failure with left ventricular ejection fraction > 40% (DELIVER), 3 126 patients were treated with dapagliflozin 10 mg and 3 127 patients with placebo for a median exposure time of 27 months.
73 m2. The overall safety profile of dapagliflozin in patients with heart failure was consistent with the known safety profile of dapagliflozin. Chronic kidney disease In the dapagliflozin renal outcome study in patients with chronic kidney disease (DAPA-CKD), 2 149 patients were treated with dapagliflozin 10 mg and 2 149 patients with placebo for a median 9 exposure time of 27 months.
73 m2, and albuminuria (urine albumin creatinine ratio [UACR] ≥ 200 and ≤ 5000 mg/g). 73 m2. The overall safety profile of dapagliflozin in patients with chronic kidney disease was consistent with the known safety profile of dapagliflozin.
4). Renal impairment Due to limited experience, it is not recommended to initiate treatment with dapagliflozin in patients with GFR < 25 mL/min. 2). In one study in patients with type 2 diabetes mellitus with moderate renal impairment (GFR < 60 mL/min), a higher proportion of patients treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH) and hypotension, compared with placebo.
Hepatic impairment There is limited experience in clinical studies in patients with hepatic impairment. 2). 1). It may be more pronounced in patients with very high blood glucose concentrations. 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). 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. 5 In patients where DKA is suspected or diagnosed, dapagliflozin treatment should be stopped immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Tabulated list of adverse reactions The following adverse reactions have been identified in the placebo-controlled clinical studies and post-marketing surveillance. None were found to be dose-related. Adverse reactions listed below are classified according to frequency and system organ class (SOC).
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).
Table 1. Adverse reactions in placebo-controlled clinical studiesa and post-marketing experience 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,i Metabolism and nutrition disorders Hypoglycaemia (when used with SU or insulin)b Volume depletionb,e Thirst** Diabetic ketoacidosis (when used in type 2 diabetes mellitus)b,i,k Nervous system disorders Dizziness Gastrointestinal disorders Constipation** Dry mouth** Skin and subcutaneous tissue disorders Rashj Angioedema Musculoskeletal and connective tissue disorders Back pain* Renal and urinary disorders Dysuria Polyuria*,f Nocturia** Tubulointerstitial nephritis Reproductive system and breast disorders Vulvovaginal pruritus** Pruritus genital** Investigations Haematocrit increasedg Creatinine renal clearance decreased during initial treatmentb Dyslipidaemiah Blood creatinine increased during initial treatment**,b Blood urea increased** Weight decreased** 10 a The table shows up to 24-week (short-term) data regardless of glycaemic rescue.
b See 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.
d Urinary 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. f Polyuria includes the preferred terms: pollakiuria, polyuria, urine output increased. 33% for placebo. 4% of placebo subjects. 7%. 4 j Adverse reaction was identified through post-marketing surveillance.
Rash includes the following preferred terms, listed in order of frequency in clinical studies: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous. In active- and placebo-controlled clinical studies (dapagliflozin, N=5936, All […]
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.
Before initiating dapagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered. 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 that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
SGLT2 inhibitors should be used with caution in these patients. Restarting SGLT2 inhibitor treatment in patients experiencing a DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
In type 1 diabetes mellitus studies with dapagliflozin, DKA was reported with common frequency. Dapagliflozin should not be used for treatment of patients with type 1 diabetes. 8). This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Patients should be advised to seek medical attention if they experience a combination of symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise. Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis.
If Fournier’s gangrene is suspected, Dapagliflozin Viatris should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted. Urinary tract infections Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis.
Elderly (≥ 65 years) Elderly patients may be at a greater risk for volume depletion and are more likely to be treated with diuretics. Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB).
1). 6 Cardiac failure Experience with dapagliflozin in NYHA class IV is limited. Infiltrative cardiomyopathy Patients with infiltrative cardiomyopathy have not been studied. Chronic kidney disease […]