JARDIANCE DUO®
Side effects and safety
Common adverse reactions (excluding hypoglycemia) associated with the use of empagliflozin. The adverse reactions were not present at baseline, occurred more commonly on empagliflozin than on placebo and occurred in greater than or equal to 2% of patients treated with empagliflozin 10 mg or empagliflozin 25 mg.
Table 1. Adverse reactions reported in ≥2% of patients treated with empagliflozin and greater than placebo in pooled placebo-controlled clinical studies of empagliflozin monotherapy or combination therapy
| Number (%) of patients | |||
|---|---|---|---|
| Placebo N=995 | Empagliflozin 10 mg N=999 | Empagliflozin 25 mg N=977 | |
| Urinary tract infection* | 7.6% | 9.3% | 7.6% |
| Female genital mycotic infections | 1.5% | 5.4% | 6.4% |
| Upper respiratory tract infection† | 3.8% | 3.1% | 4.0% |
| Increased urination‡ | 1.0% | 3.4% | 3.2% |
| Dyslipidemia | 3.4% | 3.9% | 2.9% |
| Arthralgia | 2.2% | 2.4% | 2.3% |
| Male genital mycotic infections§ | 0.4% | 3.1% | 1.6% |
| Nausea | 1.4% | 2.3% | 1.1% |
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 evaluated.
Table 2. 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) |
The incidence of hypoglycemia increased when empagliflozin was administered with insulin or sulfonylurea.
Table 3. Incidence of overall¶ and severe|| hypoglycemic events in placebo-controlled clinical studies**
| Number (%) of Patients | |||
|---|---|---|---|
| Monotherapy (24 weeks) | Placebo (n=229) | Empagliflozin 10 mg (n=224) | Empagliflozin 25 mg (n=223) |
| Overall (%) | 0.4% | 0.4% | 0.4% |
| Severe (%) | 0% | 0% | 0% |
| In Combination with Metformin (24 weeks) | Placebo + Metformin (n=206) | Empagliflozin 10 mg + Metformin (n=217) | Empagliflozin 25 mg + Metformin (n=214) |
| Overall (%) | 0.5% | 1.8% | 1.4% |
| Severe (%) | 0% | 0% | 0% |
| In Combination with Metformin + Sulfonylurea (24 weeks) | Placebo (n=225) | Empagliflozin 10 mg + Metformin + Sulfonylurea (n=224) | Empagliflozin 25 mg + Metformin + Sulfonylurea (n=217) |
| Overall (%) | 8.4% | 16.1% | 11.5% |
| Severe (%) | 0% | 0% | 0% |
| In Combination with Pioglitazone +/- Metformin (24 weeks) | Placebo (n=165) | Empagliflozin 10 mg + Pioglitazone +/- Metformin (n=165) | Empagliflozin 25 mg + Pioglitazone +/- Metformin (n=168) |
| Overall (%) | 1.8% | 1.2% | 2.4% |
| Severe (%) | 0% | 0% | 0% |
| In Combination with Basal Insulin +/-Metformin (18 weeks)†† | Placebo (n=170) | Empagliflozin 10 mg (n=169) | Empagliflozin 25 mg (n=155) |
| Overall (%) | 20.6% | 19.5% | 28.4% |
| Severe (%) | 0% | 0% | 1.3% |
| In Combination with MDI Insulin +/- Metformin (18 weeks) | Placebo (n=188) | Empagliflozin 10 mg (n=186) | Empagliflozin 25 mg (n=189) |
| Overall (%) | 37.2% | 39.8% | 41.3% |
| Severe (%) | 0.5% | 0.5% | 0.5% |
Safety of JARDIANCE DUO® in pediatric patients under 18 years of age have not been established.
JARDIANCE DUO® is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Footnotes:
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*Predefined adverse event grouping, including, but not limited to, urinary tract infection, asymptomatic bacteriuria, cystitis.
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†Female genital mycotic infections include the following adverse reactions: vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, genital infection fungal, genitourinary tract infection, vulvovaginitis, cervicitis, urogenital infection fungal, vaginitis bacterial. Percentages calculated with the number of female subjects in each group as denominator: placebo (N=481), empagliflozin 10 mg (N=443), empagliflozin 25 mg (N=420).
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‡Predefined adverse event grouping, including, but not limited to, polyuria, pollakiuria, and nocturia.
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§Male genital mycotic infections include the following adverse reactions: balanoposthitis, balanitis, genital infections fungal, genitourinary tract infection, balanitis candida, scrotal abscess, penile infection. Percentages calculated with the number of male subjects in each group as denominator: placebo (N=514), empagliflozin 10 mg (N=556), empagliflozin 25 mg (N=557).
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¶Overall hypoglycemic events: plasma or capillary glucose of less than or equal to 70 mg/dL.
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||Severe hypoglycemic events: requiring assistance regardless of blood glucose.
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**Treated set (patients who had received at least one dose of study drug).
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††Insulin dose could not be adjusted during the initial 18 Week treatment period.
Reference:
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JARDIANCE DUO® approved package insert. Updated in December 2020 and approved in June 2021.