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U.S. Department of Health and Human Services

Safety

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Inlyta (axitinib) tablets

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

 

August 2014

Summary View

WARNINGS AND PRECAUTIONS

Cardiac Failure
  • In a controlled clinical study with Inlyta for the treatment of patients with RCC, cardiac failure was reported in 6/359 patients (2%) receiving Inlyta and 3/355 patients (1%) receiving sorafenib. Grade 3/4 cardiac failure was observed in 2/359 patients (1%) receiving INLYTA and 1/355 patients (<1%) receiving sorafenib. Fatal cardiac failure was reported in 2/359 patients (1%) receiving Inlyta and 1/355 patients (<1%) receiving sorafenib. Monitor for signs or symptoms of cardiac failure throughout treatment with Inlyta. Management of cardiac failure may require permanent discontinuation of Inlyta

PATIENT COUNSELING INFORMATION

Cardiac Failure
  • Advise patients that cardiac failure may develop during Inlyta treatment and that signs or symptoms of cardiac failure should be regularly monitored for during treatment

 

September 2013

Summary View

6 ADVERSE REACTIONS  

  • added.....glossodynia
  • addition of adverse drug reactions (Table 1) 
  • addition of hypercalcemia  (Table 2)