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Invokana, 300 mg, film-coated tablets, 30 pcs.

Data on adverse reactions observed during clinical trials1 of canagliflozin with a frequency of >2% are systematized for each organ system, depending on the frequency of occurrence, using the following classification: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000).

From the gastrointestinal tract:

often - constipation, thirst2, dry mouth.

From the kidneys and urinary tract:

often - polyuria and pollakiuria3, imperative urge to urinate, urinary tract infection4, urosepsis.

From the genital organs and breast:

often - balanitis and balanoposthitis5, vulvovaginal candidiasis6, vaginal infections.

1 Includes monotherapy and add-on therapy with metformin, metformin and sulfonylureas, as well as metformin and pioglitazone.

2 The category “thirst” includes the term “thirst”, and the term “polydipsia” also falls into this category.

3 The category “polyuria” or pollakiuria includes the terms “polyuria”, this category also includes the terms “increased volume of urine excreted, nocturia”.

4 The category “urinary tract infections” includes the term urinary tract infections as well as “cystitis and kidney infections”.

5 The category “balanitis” or “balanoposthitis” includes the terms “balanitis” and “balanoposthitis”, as well as “candida balanitis” and “genital fungal infections”.

6 The category “vulvovaginal candidiasis” includes the terms “vulvovaginal candidiasis”, “vulvovaginal fungal infections”, “vulvovaginitis”, as well as “vulvitis” and “genital fungal infections”.

Other adverse reactions that occurred in placebo-controlled studies of canagliflozin with an incidence of <2% were adverse reactions associated with intravascular volume depletion (postural dizziness, orthostatic hypotension, hypotension, dehydration and syncope), skin rash and urticaria.

Adverse reactions associated with a decrease in intravascular volume

The incidence of all intravascular volume depletion-related adverse reactions (postural dizziness, orthostatic hypotension, hypotension, dehydration, and syncope) was <2% with canagliflozin doses of 100 and 300 mg. In a pooled analysis, patients receiving loop diuretics, those with moderate renal impairment (GFR 30 to <60 mL/min/1.73 m2), and those aged >75 years had a higher incidence of these adverse reactions. In a cardiovascular risk study, the incidence of serious intravascular volume depletion-related adverse reactions was not increased with canagliflozin, and treatment discontinuations due to this type of adverse reaction were infrequent.

Hypoglycemia when used as an adjunct to therapy with insulin or insulin secretagogues

Hypoglycemia was reported more frequently when canagliflozin was used as an adjunct to insulin or sulfonylurea therapy. This is consistent with the expected increase in the incidence of hypoglycemia in cases where a drug that is not associated with the development of this condition is added to insulin or drugs that enhance its secretion (for example, sulfonylureas).

Changes in laboratory parameters

Increased serum potassium concentration

. Elevated serum potassium concentrations (>5.4 mEq/L and 15% above baseline) were reported in 4.4% of patients receiving canagliflozin 100 mg, 7% of patients receiving canagliflozin 300 mg, and in 4.8% of patients receiving placebo. Rarely, greater increases in serum potassium concentrations have been observed in patients with moderate renal impairment who have previously experienced increased potassium concentrations and/or who were receiving multiple drugs that reduce potassium excretion (potassium-sparing diuretics and ACE inhibitors). In general, the increase in potassium concentration was transient and did not require special treatment.

Increased serum creatinine and urea concentrations

. During the first 6 weeks after the start of treatment, there was a slight average increase in creatinine concentration (<5%) with a commensurate decrease in GFR, after which there was a general tendency for the values to return to baseline values. Within 6 weeks after the start of canagliflozin therapy, a moderate increase in urea concentration was observed (15–20%), subsequently this indicator remained stable. In patients with moderate renal impairment, increases in creatinine and urea concentrations were observed in 10–11 and approximately 12% of cases, respectively.

The proportion of patients with a greater decrease in GFR (>30%) compared with baseline observed at any stage of treatment was 2% when using canagliflozin at a dose of 100 mg; 4.1% - when using the drug at a dose of 300 mg and 2.1% - when using placebo. These declines in GFR were often transient, with fewer patients experiencing similar declines in GFR by the end of the study. In a pooled analysis of patients with moderate renal impairment, the proportion of patients with a greater reduction in GFR (>30%) from baseline at any time during treatment was 9.3% with canagliflozin 100 mg, 12 .2% when used at a dose of 300 mg, and 4.9% when using placebo. After discontinuation of canagliflozin, these changes in laboratory parameters underwent positive dynamics or returned to baseline levels.

Increased LDL concentrations

. A dose-dependent increase in LDL cholesterol concentrations was observed with canagliflozin. The mean percentage changes in LDL cholesterol from baseline compared to placebo were 0.11 mmol/L (4.5%) and 0.21 mmol/L (8%) with canagliflozin 100 and 300 mg, respectively. The mean baseline LDL concentrations were 2.76; 2.7 and 2.83 mmol/l when using canagliflozin in doses of 100 and 300 mg and placebo, respectively.

Increased hemoglobin concentration

. With canagliflozin 100 and 300 mg, there was a small increase in the mean percentage change in hemoglobin concentration from baseline (3.5% and 3.8%, respectively) compared with a slight decrease in the placebo group (−1.1%). There was a comparable small increase in mean percentage change in red blood cell count and hematocrit from baseline. The majority of patients experienced an increase in hemoglobin concentration (>20 g/L), occurring in 6% of patients receiving canagliflozin at a dose of 100 mg, in 5.5% of patients receiving canagliflozin at a dose of 300 mg, and in 1% of patients receiving canagliflozin at a dose of 300 mg. those receiving placebo.

Most values remained within normal limits.

Decreased serum uric acid concentration

. With canagliflozin 100 and 300 mg, there was a modest decrease in mean uric acid concentration from baseline (−10.1% and −10.6%, respectively) compared with placebo, which showed a slight increase in mean uric acid concentration from baseline (1. 9%). The decrease in serum uric acid concentrations in the canagliflozin groups was maximum or near maximum at week 6 and persisted throughout therapy. There was a transient increase in the concentration of uric acid in the urine. A pooled analysis of canagliflozin 100 and 300 mg showed that the incidence of nephrolithiasis was not increased.

Security regarding SSS

. There was no increase in cardiovascular risk with canagliflozin compared with the placebo group.

Invokana®

Data on adverse reactions observed during clinical trials1 of canagliflozin with a frequency of ≥2% are systematized for each organ system depending on the frequency of occurrence using the following classification: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000).

Gastrointestinal disorders:

Common: constipation, thirst2, dry mouth.

Renal and urinary tract disorders:

Frequent: polyuria and pollakiuria3, urinary urgency, urinary tract infection4, urosepsis.

Disorders of the genital organs and breast:

Frequent: balanitis and balanoposthitis5, vulvovaginal candidiasis6, vaginal infections.

1 Includes monotherapy and add-on therapy with metformin, metformin and sulfonylureas, as well as metformin and pioglitazone.

2 The category “thirst” includes the term “thirst”, and the term “polydipsia” also falls into this category.

3 The category “polyuria or pollakiuria” includes the terms “polyuria”; this category also includes the terms “increased volume of urine excreted”, “nocturia”.

4 The category “urinary tract infections” includes the term “urinary tract infections” and also includes the terms “cystitis” and “kidney infections”.

5 The category “balanitis or balanoposthitis” includes the terms “balanitis” and “balanoposthitis”, as well as the terms “candida balanitis” and “genital fungal infections”.

6 The category “vulvovaginal candidiasis” includes the terms “vulvovaginal candidiasis”, “vulvovaginal fungal infections”, “vulvovaginitis”, as well as the terms “vulvitis” and “genital fungal infections”.

Adverse reactions associated with a decrease in intravascular volume

But in a pooled analysis, patients receiving loop diuretics, patients with moderate renal impairment (GFR 30 to <60 mL/min/1.73 m2), and patients aged ≥ 75 years had a higher incidence of these adverse events. reactions. In a cardiovascular risk study, the incidence of serious intravascular volume depletion-related adverse reactions was not increased with canagliflozin, and treatment discontinuations due to this type of adverse reaction were infrequent.

Hypoglycemia when used as an adjunct to therapy with insulin or insulin secretagogues

Changes in laboratory parameters

Increased serum potassium concentration

Cases of increased serum potassium concentration (> 5.4 mEq/L and 15% above the baseline concentration) were observed in 4.4% of patients receiving canagliflozin at a dose of 100 mg, in 7.0% of patients receiving canagliflozin at a dose of 300 mg , and in 4.8% of patients receiving placebo. Rarely, greater increases in serum potassium concentrations have been observed in patients with moderate renal impairment who have previously experienced increased potassium concentrations and/or who were receiving multiple drugs that reduce potassium excretion (potassium-sparing diuretics and angiotensin-converting enzyme (ACE) inhibitors). In general, the increase in potassium concentration was transient and did not require special treatment.

Increased serum creatinine and urea concentrations

During the first six weeks after the start of treatment, there was a slight average increase in creatinine concentration (<5%) with a commensurate decrease in GFR, after which there was a general tendency for the values to return to baseline values. Within six weeks of starting canagliflozin therapy, a moderate increase in urea concentrations was observed (15-20%), subsequently this indicator remained stable. In patients with moderate renal impairment, increases in creatinine and urea concentrations were observed in 10-11% and approximately 12% of cases, respectively.

The proportion of patients with a greater decrease in GFR (> 30%) compared to baseline, observed at any stage of treatment, was 2.0% when using canagliflozin at a dose of 100 mg, 4.1% when using the drug at a dose of 300 mg and 2.1% when using placebo. These declines in GFR were often transient, with fewer patients experiencing similar declines in GFR by the end of the study. In a pooled analysis of patients with moderate renal impairment, the proportion of patients with a greater reduction in GFR (>30%) from baseline at any time during treatment was 9.3% with canagliflozin 100 mg, 12 .2% when used at a dose of 300 mg, and 4.9% when using placebo. After discontinuation of canagliflozin, these changes in laboratory parameters underwent positive dynamics or returned to baseline levels.

Increased low-density lipoprotein (LDL) concentrations

A dose-dependent increase in LDL cholesterol concentrations was observed with canagliflozin. Mean percentage changes in LDL cholesterol from baseline compared to placebo were 0.11 mmol/L (4.5%) and 0.21 mmol/L (8.0%) with canagliflozin 100 mg and 300 mg, respectively. . Mean baseline LDL concentrations were 2.76 mmol/L, 2.70 mmol/L, and 2.83 mmol/L with canagliflozin 100 and 300 mg and placebo, respectively.

Increased hemoglobin concentration

With canagliflozin 100 mg and 300 mg, there was a small increase in mean percentage change in hemoglobin concentration from baseline (3.5% and 3.8%, respectively) compared with a slight decrease in the placebo group (-1.1%). There was a comparable small increase in mean percentage change in red blood cell count and hematocrit from baseline. The majority of patients experienced an increase in hemoglobin concentration (>20 g/L), occurring in 6.0% of patients receiving canagliflozin at a dose of 100 mg, in 5.5% of patients receiving canagliflozin at a dose of 300 mg, and in 1. 0% of patients receiving placebo. Most values remained within normal limits.

Decreased serum uric acid concentration

Canagliflozin 100 mg and 300 mg doses showed a modest decrease in mean uric acid concentration from baseline (-10.1% and -10.6%, respectively) compared with placebo, which showed a slight increase in mean uric acid concentration from baseline. (1.9%). The reduction in serum uric acid concentrations in the canagliflozin groups was maximum or near maximum at week 6 and was maintained throughout therapy. There was a transient increase in the concentration of uric acid in the urine. A pooled analysis of canagliflozin 100 mg and 300 mg showed that the incidence of nephrolithiasis was not increased.

Cardiovascular safety

There was no increase in cardiovascular risk with canagliflozin compared with the placebo group.