Glyxambi

Glyxambi Adverse Reactions

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: The most frequent adverse reaction was urinary tract infection (7.5 % with GLYXAMBI 10 mg empagliflozin / 5 mg linagliptin and 8.5 % with GLYXAMBI 25 mg empagliflozin / 5 mg linagliptin) (see Description of selected adverse reactions as follows). The most serious adverse reactions were ketoacidosis (< 0.1%), pancreatitis (0.2%), hypersensitivity (0.6%), and hypoglycaemia (2.4%) (see Precautions).
Overall, the safety profile of GLYXAMBI was in line with the safety profiles of the individual active substances (empagliflozin and linagliptin). No additional adverse reactions were identified with GLYXAMBI.
The adverse reactions shown in the table as follows (see Table 5) are listed by system organ class and are based on the safety profiles of empagliflozin and linagliptin monotherapy. The information about adverse reactions not reported in GLYXAMBI clinical trials is based on the experience from empagliflozin and linagliptin. Adverse reactions marked with an asterisk (*) are further discussed in "Description of selected adverse reactions" as follows.
Tabulated list of adverse reactions: Frequency categories 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), very rare (< 1/10,000) and not known (cannot be estimated from the available data).(See Table 5).

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Description of selected adverse reactions:
Hypoglycaemia: In pooled clinical trials of GLYXAMBI in patients with type 2 diabetes and inadequate glycaemic control on background metformin, the frequency of the reported hypoglycaemic events was 2.4 %. The incidence of confirmed hypoglycaemic events was low (< 1.5 %). There was no notable difference of the incidence in patients treated with different dose strengths of GLYXAMBI compared to the treatment with empagliflozin or linagliptin.
One patient administered GLYXAMBI experienced a confirmed (investigator-defined), major hypoglycaemic event (defined as an event requiring assistance) in the active- or placebo-controlled trials (overall frequency 0.1 %).
Based on the experience with empagliflozin and linagliptin, an increase of the risk of hypoglycaemia is expected with the concomitant treatment of insulin and/or sulphonylurea (see Precautions and information as follows).
Hypoglycaemia with empagliflozin: The frequency of hypoglycaemia depended on the background therapy in the respective studies and was similar for empagliflozin and placebo as monotherapy, as add-on to metformin, and as add-on to pioglitazone +/- metformin. The frequency of patients with hypoglycaemia was increased in patients treated with empagliflozin compared to placebo when given as add-on to metformin plus sulphonylurea (empagliflozin 10 mg: 16.1 %, empagliflozin 25 mg: 11.5 %, placebo: 8.4 %), add-on to basal insulin +/- metformin and +/-sulphonylurea (empagliflozin 10 mg: 19.5 %, empagliflozin 25 mg: 28.4 %, placebo: 20.6 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1 %, placebo 35.3 % over the 78 week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8 %, empagliflozin 25 mg: 41.3 %, placebo: 37.2 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1 %, empagliflozin 25 mg: 57.7 %, placebo: 58 % over the 52-week trial).
Major hypoglycaemia with empagliflozin (events requiring assistance): The frequency of patients with major hypoglycaemic events was low (< 1 %) and similar for empagliflozin and placebo as monotherapy, as add-on to metformin +/- sulphonylurea, and as add-on to pioglitazone +/- metformin.
The frequency of patients with major hypoglycaemic events was increased in patients treated with empagliflozin compared to placebo when given as add-on to basal insulin +/- metformin and +/- sulphonylurea (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo: 0 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo 0 % over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 1.6 %, empagliflozin 25 mg: 0.5 %, placebo: 1.6 % during initial 18 weeks treatment when insulin could not be adjusted and over the 52-week trial).
Hypoglycaemia with linagliptin: The most frequently reported adverse event in clinical trials with linagliptin was hypoglycaemia observed under the triple combination, linagliptin plus metformin plus sulphonylurea (22.9 % vs 14.8 % in placebo).
Hypoglycaemias in the placebo-controlled studies (10.9 %; N=471) were mild (80 %; N=384), moderate (16.6 %; N=78) or severe (1.9 %; N=9) in intensity.
Urinary tract infection: In clinical trials with GLYXAMBI, there was no notable difference of the frequency of urinary tract infections in patients treated with GLYXAMBI (GLYXAMBI 25 mg/5 mg: 8.5 %; GLYXAMBI 10 mg/5 mg: 7.5 %) compared to the patients treated with empagliflozin and linagliptin. The frequencies have been comparable to those reported from the empagliflozin clinical trials (see also Precautions).
In empagliflozin trials, the overall frequency of urinary tract infection was similar in patients treated with empagliflozin 25 mg and placebo (7.0 % and 7.2 %), and higher in patients treated with empagliflozin 10 mg (8.8 %). Similar to placebo, urinary tract infection was reported more frequently for empagliflozin in patients with a history of chronic or recurrent urinary tract infections. The intensity of urinary tract infections was similar to placebo for mild, moderate and severe intensity reports. Urinary tract infection was reported more frequently in female patients treated with empagliflozin compared to placebo, but not in male patients.
Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection: In clinical trials with GLYXAMBI, genital infections in patients treated with GLYXAMBI (GLYXAMBI 25 mg/5 mg: 3.0 %; GLYXAMBI 10 mg/5 mg: 2.5 %) were reported more frequently than for linagliptin but less frequently than for empagliflozin. Overall, the frequencies for GLYXAMBI have been comparable to those reported from the empagliflozin clinical trials.
In empagliflozin trials, vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently for empagliflozin 10 mg (4.0 %) and empagliflozin 25 mg (3.9 %) compared to placebo (1.0 %). These infections were reported more frequently for empagliflozin compared to placebo in female patients, and the difference in frequency was less pronounced in male patients. The genital tract infections were mild and moderate in intensity, none was severe in intensity.
Increased urination: In clinical trials with GLYXAMBI, increased urination in patients treated with GLYXAMBI (GLYXAMBI 25 mg/5 mg: 2.6 %; GLYXAMBI 10 mg/5 mg: 1.4 %) was reported more frequently than for linagliptin and with similar frequency than for empagliflozin. Overall, the frequencies for GLYXAMBI have been comparable to those reported from the empagliflozin clinical trials.
In clinical trials with empagliflozin, increased urination (including the predefined terms pollakiuria, polyuria, nocturia) was observed at higher frequencies in patients treated with empagliflozin (empagliflozin 10 mg: 3.5 %, empagliflozin 25 mg: 3.3 %) compared to placebo (1.4 %). Increased urination was mostly mild or moderate in intensity. The frequency of reported nocturia was comparable between placebo and empagliflozin (< 1 %).
Volume depletion: In clinical trials with GLYXAMBI, there was no notable difference in the frequency of volume depletion in patients treated with GLYXAMBI (GLYXAMBI 25 mg/5 mg: 0.4 %; GLYXAMBI 10 mg/5 mg: 0.8 %) compared to the patients treated with empagliflozin and linagliptin. The frequencies have been comparable to those reported from the empagliflozin clinical trials.
In clinical trials with empagliflozin, the overall frequency of volume depletion [including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope] was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.6 %, empagliflozin 25 mg: 0.4 %) and placebo (0.3 %). The frequency of volume depletion events was increased in patients 75 years and older treated with empagliflozin 10 mg (2.3 %) or empagliflozin 25 mg (4.3 %) compared to placebo (2.1 %).
Blood creatinine increased/Glomerular filtration rate decreased: In clinical trials with GLYXAMBI, the frequency of patients with increased blood creatinine (GLYXAMBI 25 mg/5 mg: 0.4%; GLYXAMBI 10 mg/5 mg: 0%) and decreased glomerular filtration rate (GLYXAMBI 25 mg/5 mg: 0.4%; GLYXAMBI 10 mg/5 mg: 0.6%) has been comparable to those reported from the empagliflozin clinical trials.
The overall frequency of patients with increased blood creatinine and decreased glomerular filtration rate were similar between empagliflozin and placebo (blood creatinine increased: empagliflozin 10 mg 0.6%, empagliflozin 25 mg 0.1%, placebo 0.5%; glomerular filtration rate decreased: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, placebo 0.3%).
Elderly: In clinical trials, nineteen patients 75 years or older were treated with GLYXAMBI. No patient was older than 85 years. The safety profile of GLYXAMBI did not differ in the elderly. Based on empagliflozin experiences, elderly patients may be at increased risk of volume depletion (see Dosage & Administration, Precautions and Pharmacology: Pharmacokinetics under Actions).
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