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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
SafetySummary of the safety profile1

The most important serious adverse events associated with SUTENT® (sunitinib) treatment of solid tumour patients were pulmonary embolism, thrombocytopenia, tumour haemorrhage, febrile neutropenia, and hypertension.

The most very common adverse events of any grade included: fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia and vomiting; skin discolouration; rash; hand-foot syndrome (palmar-plantar erythrodysaesthesia; dry skin; hair colour changes; mucosal inflammation; asthenia, dysgeusia, anorexia and hypertension. Fatigue, hypertension and neutropenia were the most common adverse events of Grade 3 maximum severity; and increased lipase was the most frequently occurring adverse event of Grade 4 maximum severity in patients with solid tumours.

Tabulated list of adverse reactions1

The treatment-emergent, all causality frequency of adverse events reported in patients who received SUTENT® (sunitinib) in single-medicine studies in advanced RCC, GIST and pNET and from post-marketing experience are listed below, by system organ class, frequency category and grade of severity.

Frequencies are defined as: very common (1/10), common (1/100 to < 1/10), uncommon (1/1 000 to < 1/100), rare (1/10 000 to < 1/1000), very rare (< 1/10 000).

Adverse events reported in SUTENT® (sunitinib) single-medicine studies in advanced RCC, GIST and pNET experience:1
  1. Thrombotic microangiopathy: The following terms have been combined: thrombotic microangiopathy, thrombotic thrombocytopenic purpura, haemolytic uraemic syndrome
  2. Myocardial ischaemia: The following terms have been combined: acute coronary syndrome, angina pectoris, unstable angina, coronary artery occlusion, myocardial ischaemia
  3. Decreased ejection fraction: The following terms have been combined: decreased ejection fraction and abnormal ejection fraction
  4. Myocardial infarction: The following terms have been combined: acute myocardial infarction, myocardial infarction, silent myocardial infarction
  5. Aneurysms and artery dissections: The following terms have been combined: aneurysm ruptured, aortic aneurysm, aortic aneurysm rupture and aortic dissection.
  6. Oropharyngeal pain: The following terms have been combined: pharyngolaryngeal pain and oropharyngeal pain
  7. Haemoptysis: The following terms have been combined: hemoptysis and pulmonary haemorrhage
  8. Abdominal pain: The following terms have been combined: abdominal pain, lower abdominal pain, upper abdominal pain
  9. Stomatitis: The following terms have been combined: stomatitis and aphthous stomatitis
  10. Cholecystitis: The following terms have been combined: cholecystitis and acalculous cholecystitis
  11. Skin discolouration: The following terms have been combined: skin discolouration, yellow skin, pigmentation disorder
  12. Rash: The following terms have been combined: dermatitis psoriasiform, exfoliative rash, rash, erythematous rash, follicular rash,generalized rash, macular rash, maculopapular rash, papular rash, pruritic rash
  13.  Fatigue: The following terms have been combined: fatigue and asthenia
  14. Oedema: The following terms have been combined: face oedema, oedema, peripheral oedema
  15. Increased amylase: The following terms have been combined: amylase, increased amylase
 Infections and infestations are described in the post-marketing experience section Event may be 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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