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U.S. Department of Health and Human Services

Safety

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Sutent (sunitinib malate) capsules

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

August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Thyroid Dysfunction - Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical practice prior to the start of Sutent treatment.
 

ADVERSE REACTIONS

  • Hepatobiliary disorders: cholecystitis, particularly acalculous cholecystitis

 

November 2012

Summary View

ADVERSE REACTIONS

Post-Marketing Experience
  • necrotizing fasciitis, pyoderma gangrenosum 

 

 

April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Osteonecrosis of the Jaw (ONJ)
  • ONJ has been observed in clinical trials and has been reported in post-marketing experience in patients treated with sunitinib. Concomitant exposure to other risk factors, such as bisphosphonates or dental disease, may increase the risk of osteonecrosis of the jaw.
Tumor Lysis Syndrome (TLS)
  • Cases of TLS, some fatal, have been observed in clinical trials and have been reported in post-marketing experience, primarily in patients with RCC or GIST treated with SUTENT. Patients generally at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and treated as clinically indicated
 

ADVERSE REACTIONS

Post-marketing Experience
  • Cases of ONJ have been reported in patients treated with Sutent
  • Cases of TLS, some fatal, have been reported in patients treated with Sutent
  • Cases of pulmonary hemorrhage, some fatal, have been reported in patients treated with Sutent)]
 

MEDICATION GUIDE

Tell your healthcare provider about all the medicines you take:
  • You may have an increased risk of severe jaw bone problems (osteonecrosis) if you take Sutent and a bisphosphonate medicine. Especially tell your healthcare provider if you are taking or have taken Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelid or Zometa
 
What are possible side effects of Sutent?
  • Jaw-bone problems (Osteonecrosis) Severe jaw bone problems may happen when you take Sutent. Your healthcare provider should examine your mouth before you start SUTENT. Your healthcare provider may tell you to see your dentist before you start Sutent.
  • ---Tumor lysis syndrome (TLS) TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS may cause you to have nausea, shortness of breath, irregular heartbeat, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute kidney failure. Your healthcare provider may do blood tests to check you for TLS.

 

May 2011

Summary View

WARNINGS AND PRECAUTIONS

Wound Healing
  • Cases of impaired wound healing have been reported during Sutent therapy. Temporary interruption of Sutent therapy is recommended for precautionary reasons in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of reinitiation of therapy following major surgical intervention. Therefore, the decision to resume Sutent therapy following a major surgical intervention should be based upon clinical judgment of recovery from surgery

ADVERSE REACTIONS

Postmarketing Experience
  • Cases of arterial thromboembolic events, sometimes fatal, have been reported in patients treated with Sutent. The most frequent events included cerebrovascular accident, transient ischemic attack and cerebral infarction.

 

July 2010

Summary View 

BOXED WARNING

WARNING: HEPATOTOXICITY
  • Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe and deaths have been reported.

 

WARNINGS AND PRECAUTIONS

Hepatotoxicity
  • Sutent has been associated with hepatotoxicity which may resulting in liver failure or death. and liver failure. Liver failure has been observed in clinical trials (7/2281 [0.3%]) and post-marketing experience. Liver failure signs include jaundice, elevated transaminases and/or hyperbilirubinemia in conjunction with encephalopathy, coagulopathy, and/or renal failure. Monitor liver function tests (ALT, AST, bilirubin) before initiation of treatment, during each cycle of treatment, and as clinically indicated. Sutent should be interrupted for Grade 3 or 4 drug-related hepatic related adverse events and discontinued if there is no resolution. Do not restart Sutent if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure. Safety in patients with ALT or AST >2.5 x ULN or, if due to liver metastases, >5.0 x ULN has not been established.

ADVERSE REACTIONS

Pancreatic and Hepatic Function
  • Hepatotoxicity was observed in patients receiving Sutent.
Post-marketing Experience
  • cases of renal impairment and/or failure, in some cases with fatal outcome, hypersensitivity reactions; including angioedema, and cases of fistula formation
  • cases of fatal hemorrhage associated with thrombocytopenia, and pulmonary embolism, in some cases with a fatal outcome