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Segluromet is a brand name for Ertugliflozin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Segluromet 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…
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. The dose should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability using the recommended daily dose of 5 mg or 15 mg of ertugliflozin, while not exceeding the maximum recommended daily dose of metformin.
4). 5 mg twice daily (5 mg daily dose) and the dose of metformin similar to the dose already being taken. In patients tolerating a total daily dose of ertugliflozin 5 mg, the dose can be increased to a total daily dose of ertugliflozin 15 mg if additional glycaemic control is needed.
For patients switching from separate tablets of ertugliflozin and metformin Patients switching from separate tablets of ertugliflozin (5 mg or 15 mg total daily dose) and metformin to Segluromet should receive the same daily dose of ertugliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
8). Missed dose If a dose is missed, it should be taken as soon as the patient remembers. Patients should not take two doses of Segluromet at the same time. 4 Special populations Renal impairment A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter.
4). 4). 4). 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 Segluromet is available, individual monocomponents should be used instead of the fixed-dose combination.
GFR mL/min Metformin Ertugliflozin 60-89 Maximum daily dose is 3 000 mg. Dose reduction may be considered in relation to declining renal function. Maximum daily dose is 15 mg. Initiate with 5 mg. Up-titrate to 15 mg, as needed for glycaemic control.
45-59 Maximum daily dose is 2 000 mg. The starting dose is at most half of the maximum dose. Maximum daily dose is 15 mg. Initiate with 5 mg. Up-titrate to 15 mg, as needed for glycaemic control. 30-44 Maximum daily dose is 1 000 mg. The starting dose is at most half of the maximum dose.
Initiation is not recommended. < 30 Metformin is contraindicated. Not recommended. 4). Elderly Elderly patients are more likely to have decreased renal function. Because renal function abnormalities can occur after initiating ertugliflozin, and metformin is known to be substantially excreted by the kidneys, Segluromet should be used with caution in the elderly.
1). The incidence and type of adverse reactions in these two trials were similar to the adverse reactions seen with the individual monotherapies ertugliflozin and metformin as described below in Table 1. Ertugliflozin The safety and tolerability of ertugliflozin were assessed in 7 placebo- or active comparator-controlled studies with a total of 3 409 patients with type 2 diabetes mellitus treated with ertugliflozin 5 mg or 15 mg.
9 years. Pool of placebo-controlled trials The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials. 1). These data reflect exposure of 1 029 patients to ertugliflozin with a mean exposure 12 duration of approximately 25 weeks.
Patients received ertugliflozin 5 mg (N=519), ertugliflozin 15 mg (N=510), or placebo (N=515) once daily. The most commonly reported adverse reactions across the clinical program were urinary tract infections, vulvovaginal mycotic infection, and other female genital mycotic infections.
4). Tabulated list of adverse reactions Adverse reactions listed below are classified according to frequency and system organ class (SOC), within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness 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), not known (cannot be estimated from the available data).
Table 1:
Adverse reactions from placebo- and active comparator-controlled clinical trials and post-marketing experience System organ class Frequency Adverse reaction Infections and infestations Very common Common Not known Urinary tract infections†,1 Vulvovaginal mycotic infection and other female genital mycotic infections*,†,1 Balanitis candida and other male genital mycotic infections*,†,1 Necrotising fasciitis of the perineum (Fournier’s gangrene)*,b Metabolism and nutrition disorders Common Rare Very rare Hypoglycaemia*,†,1, Vitamin B12 decrease/deficiency*,2 DKA*,†,1 Lactic acidosis*,2 Nervous system disorders Common Taste disturbance2 Vascular disorders Common Volume depletion*,†,1 Gastrointestinal disorders Very common Gastrointestinal symptoms§,2 Hepatobiliary disorders Very rare Hepatitis2, Liver function test abnormal2 Skin and subcutaneous tissue disorders Very rare Not known Erythema2, Pruritus2, Urticaria2 Rashb,1 Renal and urinary disorders Common Uncommon Increased urination¶,1 Dysuria1, Blood creatinine increased/Glomerular filtration rate decreased†,1 Reproductive system and breast disorders 13 System organ class Frequency Adverse reaction Common Vulvovaginal pruritus1 General disorders and administration site conditions Common Thirst#,1 Investigations Common Serum lipids changedÞ,1, Haemoglobin increasedß,1, BUN increaseda,1 1 Adverse reaction with ertugliflozin.
General Segluromet should not be used in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis (DKA) in these patients. 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 vomiting, diarrhoea, fever or reduced fluid intake), metformin 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 care-givers should be informed of 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 metformin and seek immediate medical attention.
35), increased plasma lactate levels (> 5 mmol/L) and an increased anion gap and lactate/pyruvate ratio. 6 Patients with known or suspected mitochondrial diseases: In patients with known mitochondrial diseases such as Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternal Inherited Diabetes and 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. Administration of iodinated contrast agents Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
4); - acute condition with the potential to alter renal function, such as: - dehydration, - severe infection, - shock; - acute or chronic disease that may cause tissue hypoxia, such as: - cardiac or respiratory failure, - recent myocardial infarction, - shock; - hepatic impairment; - acute alcohol intoxication, alcoholism.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). 8). Paediatric population The safety and efficacy of Segluromet in children under 18 years of age have not been established. No data are available. 5 Method of administration Segluromet should be taken orally twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.
2 Adverse reaction with metformin. 4. † See subsections below for additional information. § Gastrointestinal 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.
¶ Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia. # Includes: thirst and polydipsia. 9%. 5%. 6%). 1%). b Adverse reactions were identified through post-marketing surveillance. Description of selected adverse reactions Ertugliflozin Volume depletion Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion.
In the pool of placebo-controlled studies, the incidence of adverse events related to volume depletion (dehydration, dizziness postural, presyncope, syncope, hypotension, and orthostatic hypotension) was low (< 2%) and not notably different across the ertugliflozin and placebo groups.
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5). 2). Segluromet should not be initiated in patients with a GFR below 45 mL/min. Segluromet should be discontinued when GFR is persistently below 45 mL/min. 2). More frequent renal function monitoring is recommended in patients with a GFR below 60 mL/min.
3). Surgery Segluromet must be discontinued at the time of surgery under general, spinal, or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Hypotension/Volume depletion Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction. 73 m2 or a creatinine clearance (CrCl) less than 60 mL/min), elderly patients (≥ 65 years), patients on diuretics, or patients on anti-hypertensive therapy with a history of hypotension.
Before initiating Segluromet, volume status should be assessed and corrected if indicated. Monitor for signs and symptoms after initiating therapy. Due to its mechanism of action, ertugliflozin induces an osmotic diuresis and increases serum creatinine and decreases eGFR.
8). , physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving ertugliflozin. Temporary interruption of treatment should be considered until the fluid loss is corrected.
7 Diabetic ketoacidosis Rare cases of DKA, including life-threatening and fatal cases, have been reported in clinical trials and post-marketing in patients treated with sodium glucose co-transporter-2 (SGLT2) inhibitors, including ertugliflozin.
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 ertugliflozin.
The risk of DKA 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 Segluromet should be discontinued immediately. Treatment should be interrupted in patients who […]