Safety

Invokana (canagliflozin) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

March 2016

Summary View

CONTRAINDICATIONS

  • History of a serious hypersensitivity reaction to Invokana, such as anaphylaxis or angioedema.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported with Invokana. These reactions generally occurred within hours to days after initiating Invokana. If hypersensitivity reactions occur, discontinue use of Invokana; treat and monitor until signs and symptoms resolve.

ADVERSE REACTIONS

Postmarketing Experience
  • Anaphylaxis, Angioedema

 

September 2015

Summary View

WARNINGS AND PRECAUTIONS

Bone Fracture
  • An increased risk of bone fracture, occurring as early as 12 weeks after treatment initiation, was observed in patients using canagliflozin. Consider factors that contribute to fracture risk prior to initiating Invokamet

ADVERSE REACTIONS

Clinical Studies Experience

Falls

  • In a pool of nine clinical trials with mean duration of exposure to canagliflozin of 85 weeks, the proportion of patients who experienced falls was 1.3%, 1.5%, and 2.1% with comparator, canagliflozin 100 mg, and canagliflozin 300 mg, respectively. The higher risk of falls for patients treated with canagliflozin was observed within the first few weeks of treatment.

Bone Fracture

  • The occurrence of bone fractures was evaluated in a pool of nine clinical trials with a mean duration of exposure to canagliflozin of 85 weeks. The incidence rates of adjudicated bone fractures were 1.1, 1.4, and 1.5 per 100 patient-years of exposure in the comparator, canagliflozin 100 mg, and canagliflozin 300 mg groups, respectively. Fractures were observed as early as 12 weeks after treatment initiation and were more likely to be low trauma (e.g., fall from no more than standing height), and affect the upper extremities

USE IN SPECIFIC POPULATIONS

Renal Impairment

*Section edited to read:

  • The efficacy and safety of canagliflozin were evaluated in a study that included patients with moderate renal impairment (eGFR 30 to less than 50 mL/min/1.73 m2). These patients had less overall glycemic efficacy and had a higher occurrence of adverse reactions related to reduced intravascular volume, renal-related adverse reactions, and decreases in eGFR compared to patients with mild renal impairment or normal renal function (eGFR greater than or equal to 60 mL/min/1.73 m2). Dose-related, transient mean increases in serum potassium were observed early after initiation of canagliflozin  (i.e., within 3 weeks) in this trial. Increases in serum potassium of greater than 5.4 mEq/L and 15% above baseline occurred in 16.1%, 12.4%, and 27.0% of patients treated with placebo, canagliflozin 100 mg, and canagliflozin 300 mg, respectively. Severe elevations (greater than or equal to 6.5 mEq/L) occurred in 1.1%, 2.2%, and 2.2% of patients treated with placebo, canagliflozin 100 mg, and canagliflozin 300 mg, respectively. The efficacy and safety of canagliflozin have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), with ESRD, or receiving dialysis. Canagliflozin is not expected to be effective in these patient populations.

 

March 2015

Summary View

ADVERSE REACTIONS

Clinical Studies Experience

Genital Mycotic Infections

  • Added...In females, discontinuation due to genital mycotic infections occurred in 0% and 0.7% of patients treated with placebo and canagliflozin, respectively.
  • Added...In males, discontinuations due to genital mycotic infections occurred in 0% and 0.5% of patients treated with placebo and canagliflozin, respectively.

 

May 2014

Summary View

7 DRUG INTERACTIONS

7.3 Positive Urine Glucose Test
  • Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
7.4 Interference with 1,5-anhydroglucitol (1,5-AG) Assay
  • Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

 

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