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Label Changes for:

Farxiga (dapagliflozin)

June 2016

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

June 2016

CONTRAINDICATIONS

  • Update phrase end-stage renal disease (ESRD) to (eGFR less than 30 mL/min/1.73 m2) end-stage renal disease (ESRD)

WARNINGS AND PRECAUTIONS

Acute Kidney Injury and Impairment in Renal Function replaces subheading Impairment in Renal Function

(additions)

  • FARXIGA causes intravascular volume contraction, and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving FARXIGA; some reports involved patients younger than 65 years of age.
  • Before initiating FARXIGA, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure, and concomitant medications (diuretics, ACE inhibitors, ARBs, NSAIDs). Consider temporarily discontinuing FARXIGA in any setting of reduced oral intake (such as acute illness or fasting) or fluid losses (gastrointestinal illness or excessive heat exposure); monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue FARXIGA promptly and institute treatment.
  • (addition to 3rd bullet) Use of FARXIGA is not recommended in patients with an eGFR persistently between 30 and less than 60 mL/min/1.73 m2 and is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2.

ADVERSE REACTIONS

Acute Kidney Injury and Impairment in Renal Function replaces Impairment in Renal Function in bulleted list
Postmarketing Experience
Acute Kidney Injury and Impairment in Renal Function (addition)

PATIENT COUNSELING INFORMATION

Acute Kidney Injury (addition)
  • Inform patients that acute kidney injury has been reported during use of FARXIGA. Advise patients to seek medical advice immediately if they have reduced oral intake (due to acute illness or fasting) or increased fluid losses (due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue FARXIGA use in those settings.

MEDICATION GUIDE

What are the possible side effects of FARXIGA?

FARXIGA may cause serious side effects, including:

See “What is the most important information I should know about FARXIGA?”

  • Kidney problems. Sudden kidney injury has happened to people taking FARXIGA. Talk to your doctor right away if you:
    • reduce the amount of food or liquid you drink for example, if you are sick and cannot eat or
    • you start to lose liquids from your body for example, from vomiting, diarrhea or being in the sun too long.

 

August 2014

DRUG INTERACTIONS

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.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
  • Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
     

 

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