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Komboglyze is a brand name for Saxagliptin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Komboglyze is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: • in patients inadequately controlled on their maximally tolerated dose of metformin alone • in combination with other medicinal products for the treatment of diabetes, including insulin, in…
Verbatim from this product's EMA label. Tap a section to expand.
5 mg twice daily, plus the dose of metformin already being taken. 3 For patients switching from separate tablets of saxagliptin and metformin Patients switching from separate tablets of saxagliptin and metformin should receive the doses of saxagliptin and metformin already being taken.
5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. 4). 5 mg twice daily (5 mg total daily dose), and a dose of metformin similar to the dose already being taken. 4). 5 mg twice daily (5 mg total daily dose), and a dose of metformin similar to the dose already being taken.
Special populations Renal impairment No dose adjustment is recommended for patients with mild renal impairment (GFR 60-89 mL/min). A GFR should be assessed before initiation of treatment with metformin containing 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 Komboglyze 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 Saxagliptin 60-89 Maximum daily dose is 3000 mg. Dose reduction may be considered in relation to declining renal function. Maximum total daily dose is 5 mg. 45-59 Maximum daily dose is 2000 mg.
The starting dose is at most half of the maximum dose. Maximum total daily dose is 5 mg. 30-44 Maximum daily dose is 1000 mg. The starting dose is at most half of the maximum dose. 5 mg. < 30 Metformin is contraindicated. 5 mg. 5). Elderly (≥ 65 years) As metformin and saxagliptin are excreted by the kidney, this medicinal product should be used with caution in the elderly.
2). Paediatric population The safety and efficacy of this medicinal product in children and adolescents from birth to < 18 years of age have not been established. No data are available. Method of administration Komboglyze should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
2). Saxagliptin Summary of the safety profile There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with saxagliptin. In a pooled analysis of 1,681 patients with type 2 diabetes, including 882 patients treated with saxagliptin 5 mg, randomised in five double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control, the overall incidence of AEs in patients treated with saxagliptin 5 mg was similar to placebo.
8%). Tabulated list of adverse reactions Adverse reactions reported in ≥ 5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in ≥ 2% of patients treated with saxagliptin 5 mg and ≥ 1% more frequently compared to placebo are shown in Table 2.
The adverse reactions are listed by system organ class and absolute frequency. Frequencies are defined as 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), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Table 2 Frequency of adverse reactions by system organ class System organ class Adverse reaction Frequency of adverse reactions by treatment regimen Saxagliptin with metformin1 Infections and infestations Upper respiratory infection Common Urinary tract infection Common Gastroenteritis Common 10 Sinusitis Common Nasopharyngitis Common2 Nervous system disorders Headache Common Gastrointestinal disorders Vomiting Common 1Includes saxagliptin in add-on to metformin and initial combination with metformin.
General Komboglyze should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Acute pancreatitis Use of DPP4 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, this medicinal product should not be restarted.
Caution should be exercised in patients with a history of pancreatitis. In postmarketing experience of saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis. 5 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, heat, reduced fluid intake), Komboglyze should be temporarily discontinued and contact with a health care professional is recommended.
Medicinal products that can acutely impair renal function (such as antihypertensives, 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 Komboglyze 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 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.
6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2Only in the initial combination therapy. Postmarketing experience from clinical trials and spontaneous reports Table 3 shows additional adverse reactions which have been reported in postmarketing experience with saxagliptin. The frequencies are based on the experience from clinical trials.
4) Rare Dermatitis Uncommon Pruritus Uncommon Rash2 Common Urticaria Uncommon Bullous pemphigoid Not known 1 Frequency estimates are based on the pooled analysis of the saxagliptin monotherapy, add-on to metformin and initial combination with metformin, add-on to sulphonylurea and add-on to thiazolidinedione clinical trials.
2 These reactions were also identified in the pre-approval clinical trials, but do not meet the criteria for Table 2. 5 mg once daily and 8173 patients on placebo. 2%, respectively). 3% in both saxagliptin-treated patients and placebo-treated patients in the intent-to-treat population.
1% in both saxagliptin-treated patients and placebo- treated patients. 8% among patients treated with placebo. 6%, respectively). The increased risk of overall hypoglycaemia and major hypoglycaemia observed in the saxagliptin-treated group occurred primarily in subjects treated with SU at baseline and not in subjects on insulin or metformin monotherapy at baseline.
The increased risk of overall and major hypoglycaemia was primarily observed in subjects with A1C < 7% at baseline. 4% of placebo-treated patients. 007]. 1. Description of selected adverse reactions AEs, considered by the investigator to be at least possibly drug-related and reported in at least two more patients treated with saxagliptin 5 mg compared to control, are described below by treatment regimen.
As monotherapy: dizziness (common) and fatigue (common). As add-on to metformin: dyspepsia (common) and myalgia (common). As initial combination with metformin: gastritis (common), arthralgia* (uncommon), myalgia (uncommon), and erectile dysfunction (uncommon).
As add-on to metformin and a sulphonylurea: dizziness (common), fatigue (common) and flatulence (common). 4). Hypoglycaemia Adverse reactions of hypoglycaemia were […]
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). - For renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year.
5 mg/850 mg once daily. It is not recommended to initiate treatment in these patients. Treatment may be continued in the well-informed patients with close monitoring. 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 antihypertensive or diuretic therapy or when starting treatment with a NSAID. Surgery Komboglyze must be discontinued at the time of surgery with general, spinal or epidural anaesthesia.
Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition provided that renal function has been re-evaluated and found to be stable. Administration of iodinated contrast agents Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis.
5). 3). Skin lesions were not observed at an increased incidence in clinical trials. Postmarketing reports of rash have been described in the DPP4 inhibitor class. 8). Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Bullous pemphigoid Postmarketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP4 inhibitor use, including saxagliptin. In reported cases, patients typically responded to topical or systemic immunosuppressive treatment and discontinuation of the DPP4 inhibitor.
8). Hypersensitivity reactions As this medicinal product contains saxagliptin, it should not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase 4 (DPP4) inhibitor. During postmarketing […]