SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(九)
-C can occur with empagliflozin. Monitor and treat as appropriate.
5.10 Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with SYNJARDY XR.
6 ADVERSE REACTIONS
The following important adverse reactions are described below and elsewhere in the labeling:
Lactic Acidosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS (5.1)]
Hypotension [see WARNINGS AND PRECAUTIONS (5.2)]
Ketoacidosis [see WARNINGS AND PRECAUTIONS (5.3)]
Acute Kidney Injury and Impairment in Renal Function [see WARNINGS AND PRECAUTIONS (5.4)]
Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS (5.5)]
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see WARNINGS AND PRECAUTIONS (5.6)]
Genital Mycotic Infections [see WARNINGS AND PRECAUTIONS (5.7)]
Vitamin B12 Deficiency [see WARNINGS AND PRECAUTIONS (5.8)]
Increased Low-Density Lipoprotein Cholesterol (LDL-C) [see WARNINGS AND PRECAUTIONS (5.9)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of concomitantly administered empagliflozin (daily dose 10 mg and 25 mg) and metformin hydrochloride (mean daily dose of approximately 1800 mg) has been eva luated in 3456 patients with type 2 diabetes mellitus treated for 16 to 24 weeks, of which 926 patients received placebo, 1271 patients received a daily dose of empagliflozin 10 mg, and 1259 patients received a daily dose of empagliflozin 25 mg. Discontinuation of therapy due to adverse events across treatment groups was 3.0%, 2.8%, and 2.9% for placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively.
Empagliflozin Add-On Combination Therapy with Metformin
In a 24-week placebo-controlled trial of empagliflozin 10 mg and 25 mg administered once daily added to metformin, there were no adverse reactions reported regardless of investigator assessment of causality in ≥5% of patients and more commonly than in patients given placebo.
Empagliflozin Add-On Combination Therapy with Metformin and Sulfonylurea
In a 24-week placebo-controlled trial of empagliflozin 10 mg and 25 mg administered once daily added to metformin and sulfonylurea, adverse reactions reported regardless of investigator assessment of causality in ≥5% of patients and more commonly than in patients given placebo are presented in Table 1 (see also Table 4).
Table 1 Adverse Reactions Reported in ≥5% of Patients Treated with Empagliflozin added on to Metformin plus Sulfonylurea and Greater than with Placebo in a 24-week Placebo Controlled Clinical Study
Number (%) of Patients
Placebo
n=225 Empagliflozin 10 mg
n=224 Empagliflozin 25 mg
n=217
Hypoglycemia 22 (9.8) 35 (15.6) 28 (12.9)
Urinary tract infection 15 (6.7) 21 (9.4) 15 (6.9)
Nasopharyngitis 11 (4.9) 18 (8.0) 13 (6.0)
Empagliflozin
The data in Table 2 are derived from a pool of four 24-week placebo-controlled trials and 18-week data from a placebo-controlled trial with basal insulin. E |
