Loading…
Qtern is a brand name for Saxagliptin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: - to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control, - when already being…
Verbatim from this product's EMA label. Tap a section to expand.
8). Missed dose If a dose is missed and it is ≥ 12 hours until the next dose, the dose should be taken. If a dose is missed and it is < 12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time.
Special populations Renal impairment No dose adjustment is recommended based on renal function. 2). 3 Hepatic impairment This medicinal product can be used in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be evaluated prior to initiation and during treatment.
4). Elderly (≥ 65 years) No dose adjustment is recommended based on age. Paediatric population The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established. No data are available.
Method of administration Qtern is taken orally once daily. It may be taken at any time of day with or without food. Tablet is to be swallowed whole.
1). The pooled safety analysis comprised 3 treatment groups: saxagliptin plus dapagliflozin plus metformin (492 subjects), saxagliptin plus metformin (336 subjects), and dapagliflozin plus metformin (341 subjects). The safety profile of the combined use of saxagliptin plus dapagliflozin plus metformin was comparable to the adverse reactions identified for the respective monocomponents.
10 The most frequently reported adverse reactions associated with Qtern are upper respiratory tract infections (very common), hypoglycaemia when used with SU (very common), and urinary tract infections (common). 4). Tabulated list of adverse reactions The adverse reactions are presented in table 1.
The safety profile is based on the summarised data from the saxagliptin/dapagliflozin combination clinical trials pooled safety data, and also clinical trials, post-authorisation safety studies and post-marketing experience with the monocomponents.
The adverse reactions are listed by system organ class (SOC) and frequency. Frequency categories were defined according to 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. Compilation of reported adverse reactions System organ class Very common CommonA UncommonB Rare Very rare Not known Infections and infestations Upper respiratory tract infection1 Urinary tract infection2, vulvovaginitis , balanitis and related genital infection3, gastroenteritis D Fungal infection Necrotising fasciitis of the perineum (Fournier’s gangrene)C,F,7 Immune system disorders Hypersensitiv ity reactionsC Anaphylactic reactions including anaphylactic shockC Metabolism and nutrition disorders Hypoglycaem iaD (when used with SU) Dyslipidaemi a4 Volume depletionF, thirst Diabetic ketoacidosisF, G,7 Nervous system disorders Headache, dizziness Gastrointesti nal disorders Abdominal painC, diarrhoea, dyspepsiaD, gastritisD, nauseaC, vomitingD Constipation, dry mouth, pancreatitisC Skin and subcutaneou s tissue disorders Rash5 DermatitisC, pruritusC, urticariaC AngioedemaC Bullous pemphigoidC,7 Musculoskel etal and connective tissue disorders Arthralgia, back pain, myalgiaD 11 System organ class Very common CommonA UncommonB Rare Very rare Not known Renal and urinary disorders Dysuria, polyuriaD,6 Nocturia Tubulo- interstitial nephritis Reproductiv e system and breast disorders Erectile dysfunction, pruritus genital, vulvovaginal pruritus General disorders and administrati on site conditions FatigueD, oedema peripheralD Investigation s Creatinine renal clearance decreased during initial treatmentF, haematocrit increasedE Blood creatinine increased during initial treatmentF, blood urea increased, weight decreased A Adverse reactions reported in ≥ 2% of subjects treated with the combined use of saxagliptin + dapagliflozin in the pooled safety analysis, or if reported in < 2% in the pooled safety analysis, they were based on the individual monocomponents data.
Acute pancreatitis Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, severe abdominal pain. If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
Caution should be exercised in patients with a history of pancreatitis. 8). 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.
This medicinal product should not be used in patients with a GFR persistently < 45 mL/min. The saxagliptin/dapagliflozin fixed dose combination has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
2). If renal function persistently falls below GFR < 45 mL/min, treatment with this medicinal product should be discontinued. 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). Use in patients with hepatic impairment There is limited experience in clinical trials in patients with hepatic impairment.
2). The saxagliptin/dapagliflozin fixed dose combination can be used in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be evaluated prior to initiation and during treatment. 2). Diabetic ketoacidosis Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin.
1).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Saxagliptin in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
B Frequencies of all uncommon adverse reactions were based on the individual monocomponents data. C Adverse reaction originates from saxagliptin or dapagliflozin post-marketing surveillance data. D Adverse reactions were reported in ≥ 2% of subjects with either monocomponent and ≥ 1% more than placebo, but not in the pooled analysis.
4% of placebo subjects. F Frequency is based on events in the dapagliflozin clinical programme. G Reported in the dapagliflozin cardiovascular outcomes study in patients with type 2 diabetes (DECLARE). Frequency is based on annual rate.
1 Upper respiratory tract infection includes the following preferred terms: nasopharyngitis, influenza, upper respiratory tract infection, pharyngitis, rhinitis, sinusitis, pharyngitis bacterial, tonsillitis, acute tonsillitis, laryngitis, viral pharyngitis, and viral upper respiratory tract infection.
2 Urinary tract infection includes the following preferred terms: urinary tract infection, Escherichia urinary tract infection, pyelonephritis, and prostatitis. 3 Vulvovaginitis, balanitis and related genital infection include the following preferred terms: vulvovaginal mycotic infection, balanoposthitis, genital infection fungal, vaginal infection, and vulvovaginitis.
4 Dyslipidaemia includes the following preferred terms: dyslipidaemia, hyperlipidaemia, hypercholesterolaemia, and hypertriglyceridaemia. 5 Rash was reported during the post-marketing use of saxagliptin and dapagliflozin. Preferred terms reported in dapagliflozin clinical trials included in order of frequency: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous.
6 Polyuria includes the following preferred terms: polyuria, and pollakiuria. 4 SU=sulphonylurea Description of selected adverse reactions Vulvovaginitis, balanitis and related genital infections Saxagliptin/dapagliflozin combination: The reported adverse events of vulvovaginitis, balanitis and related genital infections from pooled safety analysis were reflective of the safety profile of 12 dapagliflozin.
9% of subjects in the dapagliflozin plus metformin group. The majority of the genital infection adverse events […]
In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres (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 this medicinal product 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.
Before initiating treatment with this medicinal product, 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 that lead to restricted food intake or 5 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 with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
The safety and efficacy of the saxagliptin/dapagliflozin fixed dose combination in patients with type 1 diabetes have not been established and it should not be used for treatment of patients with type 1 diabetes. In type 1 diabetes mellitus studies with […]