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Label Changes for:

Sutent (sunitinib malate) capsules

December 2014

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

December 2014


*The following was added

  • SUTENT has been associated with symptomatic hypoglycemia, which may result in loss of consciousness, or require hospitalization. Hypoglycemia has occurred in clinical trials in 2% of the patients treated with SUTENT for RCC and GIST and in approximately 10% of the patients treated with SUTENT for pNET. For patients being treated with SUTENT for pNET, pre-existing abnormalities in glucose homeostasis were not present in all patients who experienced hypoglycemia. Reductions in blood glucose levels may be worse in diabetic patients. Check blood glucose levels regularly during and after discontinuation of treatment with SUTENT. Assess if anti-diabetic drug dosage needs to be adjusted to minimize the risk of hypoglycemia.


*The following was added:

  • Hypoglycemia Patients should be advised of the signs, symptoms, and risks associated with hypoglycemia that may occur during treatment with SUTENT. Hypoglycemia may be more severe in patients with diabetes taking anti-diabetic medications. Severe hypoglycemia including loss of consciousness or requiring hospitalization has been reported. Patients should be advised to immediately inform their healthcare provider if severe signs or symptoms of hypoglycemia occur.


June 2014


  • Proteinuria and nephrotic syndrome have been reported. Some of these cases have resulted in renal failure and fatal outcomes. Monitor patients for the development or worsening of proteinuria. Perform baseline and periodic urinalyses during treatment, with follow up measurement of 24-hour urine protein as clinically indicated. Interrupt Sutent and dose reduce for 24-hour urine protein ≥ 3 grams. Discontinue Sutent for patients with nephrotic syndrome or repeat episodes of urine protein ≥ 3 grams despite dose reductions. The safety of continued Sutent treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Dermatologic Toxicities
  • Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which were fatal. If signs or symptoms of SJS, TEN, or EM (e.g., progressive skin rash often with blisters or mucosal lesions) are present, Sutent treatment should be discontinued. If a diagnosis of SJS or TEN is suspected, Sutent treatment must not be re-started.
  • Necrotizing fasciitis, including fatal cases, has been reported in patients treated with Sutent, including of the perineum and secondary to fistula formation. Discontinue Sutent in patients who develop necrotizing fasciitis.


August 2013


  • 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.