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INVOKANA® safety, tolerability, and common adverse events

  • In 4 pooled 26-week placebo-controlled trials, the most commonly reported adverse events (≥5%) were female genital mycotic infection, urinary tract infection (UTI), and increased urination1

Adverse Events Reported in ≥2% of Patients Treated With INVOKANA® in
4 Pooled 26-Week Placebo-Controlled Trials1

  Placebo
(n=646)
INVOKANA® 100 mg
(n=833)
INVOKANA® 300 mg
(n=834)
UTI* 3.8% 5.9% 4.4%
Male genital mycotic infection 0.7% 4.2% 3.8%
Female genital mycotic infection 2.8% 10.6% 11.6%
Vulvovaginal pruritus§ 0% 1.6% 3.2%
Increased urination|| 0.7% 5.1% 4.6%
Thirst 0.1% 2.8% 2.4%
Constipation 0.9% 1.8% 2.4%
Nausea 1.6% 2.1% 2.3%

The 4 placebo-controlled trials included 1 monotherapy trial and 3 add-on combination trials with metformin, metformin + a sulfonylurea, or metformin + pioglitazone.
*Urinary tract infection includes urinary tract infection, cystitis, kidney infection, and urosepsis.
Male genital mycotic infection includes balanitis or balanoposthitis, balanitis Candida, and genital infection fungal; placebo (n=334), INVOKANA® 100 mg (n=408), and INVOKANA® 300 mg (n=404).
Female genital mycotic infection includes vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal; placebo (n=312), INVOKANA® 100 mg (n=425), and INVOKANA® 300 mg (n=430).
§Placebo (n=312), INVOKANA® 100 mg (n=425), INVOKANA® 300 mg (n=430).
||Increased urination includes polyuria, pollakiuria, urine output increased, micturition urgency, and nocturia.
Thirst includes thirst, dry mouth, and polydipsia.

Additional safety information

LDL-C increases

Dose-Related Increases in LDL-C With INVOKANA® in 4 Pooled 26-Week Placebo-Controlled Trials1

  INVOKANA® 100 mg
(n=833)
INVOKANA® 300 mg
(n=834)
Baseline 104-110 mg/dL 104-110 mg/dL
Change from baseline# 4.4 mg/dL 8.2 mg/dL
Percent change from baseline# 4.5% 8.0%

The 4 placebo-controlled trials included 1 monotherapy trial and 3 add-on combination trials with metformin, metformin + a sulfonylurea, or metformin + pioglitazone.

#Data are placebo adjusted.

Volume depletion–related adverse events

Proportion of Patients With ≥1 Volume Depletion–Related Adverse Event
(Pooled Results From 8 Clinical Trials; N=9439)1

Baseline characteristics Control group** INVOKANA® 100 mg INVOKANA® 300 mg
Overall population 1.5% 2.3% 3.4%
≥75 years of age†† 2.6% 4.9% 8.7%
eGFR <60 mL/min/1.73 m2†† 2.5% 4.7% 8.1%
Use of loop diuretic†† 4.7% 3.2% 8.8%

**Includes placebo and active-comparator groups.
††Patients could have more than 1 characteristic.

Patients’ volume status should be assessed and corrected, as necessary, before and during treatment with INVOKANA®.1

Hypoglycemia

Insulin and insulin secretagogues (eg, sulfonylureas) are known to cause hypoglycemia. The use of INVOKANA® in combination with insulin therapy or an insulin secretagogue1:

  • Was associated with a higher incidence of hypoglycemia
  • May require a lower dose of insulin or insulin secretagogue to reduce the risk of hypoglycemia

Incidence of Hypoglycemia With INVOKANA® in Combination With Insulin or a Sulfonylurea
(With or Without Metformin)1

  Placebo INVOKANA® 100 mg INVOKANA® 300 mg
+ a sulfonylurea (18 weeks) n=69 n=74 n=72
Overall 5.8% 4.1% 12.5%
Severe 0% 0% 0%
+ metformin and a sulfonylurea (26 weeks) n=156 n=157 n=156
Overall 15.4% 27.4% 30.1%
Severe 0.6% 0.6% 0%
+ insulin (18 weeks) n=565 n=566 n=587
Overall 36.8% 49.3% 48.6%
Severe 2.5% 1.8% 2.7%


In a head-to-head trial of INVOKANA® 300 mg vs Januvia® 100 mg in combination with metformin and a sulfonylurea, incidence of hypoglycemia was:

  • 43.2% vs 40.7%, respectively1
  • Severe hypoglycemia: 4.0% and 3.4%, respectively1

Incidence of Hypoglycemia With INVOKANA® as Monotherapy, in Combination With Metformin, 
or With Metformin + Pioglitazone1

  Placebo INVOKANA® 100 mg INVOKANA® 300 mg
Monotherapy (26 weeks)
n=192 n=195 n=197
Overall 2.6% 3.6% 3.0%
Severe 0% 0% 0%
+ metformin (26 weeks)
n=183 n=368 n=367
Overall 1.6% 4.3% 4.6%
Severe 0% 0.3% 0.3%
+ metformin and pioglitazone (26 weeks)
n=115 n=113 n=114
Overall 2.6% 2.7% 5.3%
Severe 0% 0% 0%


In a head-to-head trial vs glimepiride in combination with metformin, INVOKANA® provided a lower incidence of hypoglycemia1:

  • Glimepiride: 34.2%
  • INVOKANA® 100 mg: 5.6%
  • INVOKANA® 300 mg: 4.9%

 

SELECT IMPORTANT SAFETY INFORMATION

Bone Fracture: Increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, was observed in patients using INVOKANA®. Consider factors that contribute to fracture risk prior to initiating INVOKANA®.

 

See DOSING AND PRESCRIBING

See the results of INVOKANA® AS MONOTHERAPY, VS JANUVIA®, VS GLIMEPIRIDE , in PATIENTS WITH RENAL IMPAIRMENT, and in OLDER PATIENTS.

Reference: 1. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.