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Sutent

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Pancreatic neuroendocrine tumours (pNET)Pancreatic neuroendocrine tumours (pNET)ContraindicationsDosage and AdministrationEfficacyInteractionsMechanism of actionPost-marketing ExperiencePrescribing InformationSafetySpecial PopulationsSpecial Warnings and PrecautionsMetastatic renal cell carcinoma (mRCC)Metastatic renal cell carcinoma (mRCC)ContraindicationsDosage and AdministrationEfficacyInteractionsMechanism of actionPost-marketing ExperiencePrescribing InformationSafetySpecial PopulationsSpecial Warnings and PrecautionsGastrointestinal stromal tumour (GIST)Gastrointestinal stromal tumour (GIST)
ContraindicationsDosage and AdministrationEfficacyInteractionsMechanism of actionPost-marketing ExperiencePrescribing InformationSafetySpecial PopulationsSpecial Warnings and Precautions
Post-marketing ExperienceThe following adverse events have been identified during post-approval use of SUTENT® (sunitinib):Infection and infestations1
  • Cases of serious infection (with or without neutropenia) in some cases with fatal outcome. The infections most commonly observed with SUTENT® (sunitinib treatment were respiratory infections (e.g., pneumonia, bronchitis), urinary tract infections, skin infections (e.g., cellulitis) sepsis/septic shock and abscess (e.g., oral, genital, anorectal, skin, limb, visceral). Infections may be bacterial or fungal.
Blood and lymphatic system disorders1
  • Cases of thrombotic microangiopathy and haemolytic uraemic syndrome have been reported. Temporary suspension of SUTENT® (sunitinib) is recommended. Following resolution, treatment may be resumed at the discretion of the treating medical practitioner.
Immune system disorders1
  • Hypersensitivity reactions, including angioedema.
Endocrine disorders1
  • Cases of hyperthyroidism some followed by hypothyroidism, and thyroiditis.
Metabolism and nutrition disorders1
  • Cases of Tumour Lysis Syndrome, some fatal. Decreases in blood glucose, in some cases clinically symptomatic.
Nervous system disorders11
  • Taste disturbance, including ageusia.
Cardiac disorders1
  • Cardiac failure, congestive cardiac failure, prolonged QT interval and torsade de pointes. Cardiomyopathy, myocardial ischaemia, left ventricular failure and myocardial infarction, in some cases with fatal outcome.
Vascular disorders1
  • Cases of arterial thromboembolic events, sometimes fatal. The most frequent events included cerebrovascular accident, transient ischaemic attack, ischaemic stroke and cerebral infarction. Risk factors associated with arterial thromboembolic events, in addition to the underlying malignant disease and age 2 65 years, included hypertension, diabetes mellitus and prior thromboembolic disease.
Respiratory, thoracic and mediastinal disorders1
  • Pulmonary embolism, in some cases with fatal outcome.
Gastrointestinal disorders1
  • Pancreatitis, gastrointestinal perforation, oesophagitis.
Hepato-biliary disorders1
  • Hepatic failure (including fatal events), hepatitis B reactivation (including fatal events) and cholecystitis, particularly acalculous cholecystitis.
Skin and subcutaneous tissue disorders1
  • Cases of pyoderma gangrenosum, erythema multiforme and Stevens-Johnson syndrome.
Musculoskeletal and connective tissue disorders1
  • Cases of myopathy and/or rhabdomyolysis, with or without acute renal failure, in some cases with fatal outcome. Most of these patients had pre-existing risk factors and/or were receiving concomitant medications known to be associated with these adverse reactions. Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice.
  • Cases of fistula formation, sometimes associated with tumour necrosis and/or regression, in some cases with fatal outcome.
  • Cases of osteonecrosis of the jaw (ONJ), most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to IV bisphosphonates and/or a history of dental disease requiring invasive dental procedures.
Renal and urinary disorders1
  • Cases of renal impairment and/or failure, in some cases with fatal outcome. Cases of proteinuria and cases of nephrotic syndrome.
Investigations1
  • Increased TSH and increased blood uric acid.
Haemorrhagic events1
  • Cases of pulmonary, gastrointestinal, tumour, urinary tract, and brain haemorrhage, some fatal.
References:Pfizer Laboratories (Pty) Ltd. SUTENT® (sunitinib) 12,5 mg, 25 mg, 50 mg capsules. Final Approved Package Insert - 12 July 2021
PP-SUT-ZAF-0084

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