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Qtrilmet is a brand name for Saxagliptin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus: - to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control. - when already being treated with metformin and saxagliptin and…
Verbatim from this product's EMA label. Tap a section to expand.
Posology Each tablet contains a fixed dose of metformin, saxagliptin and dapagliflozin (see section 2). Medicinal product no longer authorised 3 The maximum recommended daily dose of Qtrilmet is metformin 2,000 mg/saxagliptin 5 mg/dapagliflozin 10 mg.
For patients inadequately controlled on dual combination with either saxagliptin or dapagliflozin and metformin Patients should receive a total daily dose of Qtrilmet equivalent to saxagliptin 5 mg, dapagliflozin 10 mg, plus the total daily dose of metformin, or the nearest therapeutically appropriate dose, already being taken.
The dose should be taken as two tablets orally, once daily at the same time of the day, with food. Switching from separate tablets of metformin, saxagliptin and dapagliflozin Patients switching from separate tablets of metformin, saxagliptin 5 mg and dapagliflozin 10 mg to Qtrilmet should receive the same daily dose of metformin, saxagliptin and dapagliflozin already being taken or the nearest therapeutically appropriate dose of metformin.
The dose should be taken as two tablets orally, once daily at the same time of the day, with food. 2). Missed doses If a daily dose is missed and it is ≥ 12 hours until the next dose, the dose should be taken. If a daily 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 Elderly Because elderly patients (≥ 65 years) are more likely to have decreased renal function, this medicinal product should be used with caution as age increases. 4). 2). Due to the limited therapeutic experience with this medicinal product in patients 75 years and older, initiation of therapy is not recommended in this population.
Renal impairment No dose adjustment is recommended for Qtrilmet in patients with mild renal impairment, GFR 60-89 mL/min. A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter.
g. every 3-6 months. 2). 2). 3). 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 administrationMedicinal product no longer authorised 4 Qtrilmet dose is taken orally once daily at the same time of the day with food to reduce the gastrointestinal adverse reactions associated with metformin.
Summary of the safety profile The most frequently reported adverse reactions associated with Qtrilmet are upper respiratory tract infections (very common), hypoglycaemia when used with SU (very common), gastrointestinal symptoms (very common) and urinary tract infections (common).
Medicinal product no longer authorised 13 The safety profile of the combined use of metformin, saxagliptin and dapagliflozin is comparable to the adverse reactions identified for the respective mono-components. 1). Additional safety data include clinical trials, post-authorisation safety studies and post-marketing experience with the mono-components.
The adverse reactions associated with Qtrilmet are presented in Table 1. 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 ( 1/100,000 to < 1/10,000) and not known (cannot be estimated from the available data).
Table 1. Compilation of adverse reactions for Qtrilmet System organ class Very common CommonA UncommonB Rare Very rare Not known Infections and infestations Upper respiratory tract infection¶1 Urinary tract infection#¶ 2, vulvo- vaginitis, balanitis and related genital infection# 3, gastro- enteritis¶D Fungal infection# Necrotising fasciitis of the perineum (Fournier's gangrene) #,C,7 Immune system disorders Hypersen- sitivity reactions¶ C Anaphyl- actic reactions including anaphylactic shock¶ C Metabolism and nutrition disorders Hypo- glycaemiaD#¶ (when used with SU) Dyslipid- aemia# 4 Volume depletion#, thirst# Diabetic ketoacidosis #,H,7 Lactic acidosis§, Vitamin B12 deficiency§G Nervous system disorders Headache¶, dizziness¶ Gastro- intestinal disorders Gastro- intestinal symptoms§ F DyspepsiaD ¤ gastritisD ¤ taste disturbance§ Constipation# , dry mouth#, pancreatitis¶ C Hepatobiliary disorders Liver function disorders§ , hepatitis§ Renal and urinary disorders Dysuria#, polyuria# D, 5 Nocturia#, renal impairment# Skin and subcutaneous tissue Rash# ¶ 6 Dermatitis¶C, pruritus¶ C, urticaria¶ C Angio- edema¶ C Erythema§ Bullous pemphi- goidC,7Medicinal product no longer authorised 14 System organ class Very common CommonA UncommonB Rare Very rare Not known disorders Musculo- skeletal and connective tissue disorders Arthralgia¤, back pain#, myalgiaD ¤ Reproductive system and breast disorders Erectile dysfunction¤, pruritus genital#, vulvovaginal pruritus# General disorders and administratio n site conditions Fatigue¶ D, oedema peripheral¶ D Investigations Creatinine renal clearance decreased# , haematocrit increased# E Blood creatinine increased#, blood urea increased#, weight decreased# # Adverse reaction reported for dapagliflozin.
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), Qtrilmet should be temporarily discontinued and contact with a health care professional is recommended. Medicinal products that can acutely impair renal function (such as anti-hypertensives, diuretics, and NSAIDs) should be initiated with caution in metformin-treated patients.
5). Patients and/or care-givers 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 Qtrilmet and seek immediate medical attention.
Medicinal product no longer authorised 5 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.
In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres. 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 Qtrilmet should be discontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Each tablet is to be swallowed whole. Occasionally, the inactive ingredients of this medicine will be eliminated in the faeces as a soft, hydrated mass that may resemble the original tablet.
¶ Adverse reaction reported for saxagliptin. § Adverse reaction reported for metformin. ¤ Adverse reaction reported for the combined use of saxagliptin and metformin. A Adverse reactions, except for taste disturbance, reported in ≥ 2% of subjects treated with the combined use of saxagliptin + dapagliflozin + metformin in the pooled safety analysis, or if reported in < 2% in the pooled safety analysis, they were based on the individual mono-components data.
B Frequencies of all uncommon adverse reactions were based on the individual mono-components data. C Adverse reaction originates from saxagliptin or dapagliflozin post-marketing surveillance data. D Adverse reactions were reported in ≥ 2% of subjects with any of the mono-components, and ≥ 1% more than placebo, but not in the pooled safety analysis.
4% of placebo subjects. F Gastrointestinal symptoms (subsumed terms included nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite) occur most frequently during initiation of therapy and resolve spontaneously in most cases.
G Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency. Consideration of such etiology is recommended if a patient presents with megaloblastic anaemia.
H Reported in the dapagliflozin cardiovascular outcomes study in patients with type 2 diabetes. 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 Polyuria includes the following preferred terms: polyuria, and pollakiuria. 6 Rash was reported during the postmarketing use of saxagliptin and dapagliflozin.
Medicinal product no longer authorised 15 7 See […]
Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with Qtrilmet may be restarted when the ketone values are normal and the patient’s condition has stabilised. Before initiating Qtrilmet, 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 with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
The safety and efficacy in patients with type 1 diabetes have not been established and Qtrilmet should not be used in patients with type 1 diabetes. In type 1 diabetes mellitus studies with dapagliflozin, DKA was reported with common frequency.
2). In subjects with moderate to severe renal impairment (patients with GFR < 60 mL/min), a higher proportion of subjects treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH), and hypotension, compared with placebo.
Therefore, Qtrilmet should not be used in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min). This medicinal product has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
4). 5);Medicinal product no longer authorised 6 - for renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year. If renal function falls below GFR < 60 mL/min, treatment should be discontinued.
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), which may be more pronounced in patients with very high […]