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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
Special Warnings and PrecautionsSkin and tissues1
  • Skin discolouration due to the active substance colour (yellow) was a very common adverse event occurring in approximately 30 % of patients. Patients should be advised that depigmentation of the hair or skin may also occur during treatment with SUTENT® (sunitinib). Other possible dermatologic effects may include dryness, thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet.
  • Mouth pain/irritation was reported in approximately 14 % of patients. Dysgeusia (taste disturbance) was reported in approximately 28 % of patients.
  • The above events were not cumulative, were typically reversible and generally did not result in treatment discontinuation.
  • Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM) and cases suggestive of Stevens-Johnson syndrome (SJS), some of which were fatal. If signs or symptoms of SJS or EM (e. g., progressive skin rash often with blisters or mucosal lesions) are present, SUTENT® (sunitinib) should be discontinued. If the diagnosis of SJS is confirmed, treatment must not be re-started. In some cases of suspected EM, patients tolerated the reintroduction of SUTENT® (sunitinib) at a lower dose after resolution of the reaction; some of these patients also received concomitant treatment with corticosteroids or antihistamines.
  • Haemorrhagic events reported through post-marketing experience, some of which were fatal, have included gastrointestinal (GI), respiratory, tumour, urinary tract and brain haemorrhage.
  • These events may occur suddenly, and in the case of pulmonary tumours, may present as severe or life-threatening haemoptysis or pulmonary haemorrhage.
  • Tumour haemorrhage has not been observed in patients with mRCC or other solid tumours. Cases of pulmonary haemorrhage some with a fatal outcome, have been observed in clinical trials and have been reported in post-marketing experience in patients treated with SUTENT® (sunitinib) for mRCC, GIST, and metastatic non-small cell lung cancer (NSCLC). SUTENT® (sunitinib) is not approved for use in patients with NSCLC.
  • In patients receiving SUTENT® (sunitinib) for treatment-naive mRCC, 39 % had bleeding events. Of patients receiving SUTENT® (sunitinib) for cytokine-refractory mRCC, 26 % experienced bleeding. Bleeding events, excluding epistaxis, occurred in 21,7 % of patients receivingSUTENT® (sunitinib) in a Phase 3 pNET study compared to 9,85 % of subjects receiving placebo. Routine assessment of these events should include complete blood counts and physical examination.
  • Treatment-related epistaxis was reported in % of patients with solid tumours. Epistaxis was the most common treatment-related haemorrhagic adverse event, having been reported for approximately half of the patients with solid tumours who experienced haemorrhagic events.
Gastrointestinal events1
  • Serious, sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred in patients with intraabdominal malignancies treated with SUTENT® (sunitinib).
  • Nausea, diarrhoea, stomatitis, dyspepsia and vomiting were the most commonly reported treatment-related gastrointestinal events. Supportive care for gastrointestinal adverse events requiring treatment may include medication with an anti-emetic or anti-diarrhoeal medication.
  • Pancreatitis has been reported in clinical trials of SUTENT® (sunitinib). Increases in serum lipase and amylase were observed in patients with various solid tumours who received SUTENT® (sunitinib). Increases in lipase levels were transient and were generally not accompanied by signs or symptoms of pancreatitis in subjects with various solid tumours. If symptoms of pancreatitis are present, patients should have proper medical follow-up.
  • Hepatotoxicity has been observed in patients treated with SUTENT® (sunitinib). Cases of hepatic failure, same | with a fatal outcome, were observed in < 1 % of solid tumour patients treated with SUTENT® (sunitinib). Liver function tests (alanine transaminase [ALT], aspartate transaminase [AST), bilirubin levels) should be monitored before initiation of treatment, during each cycle of treatment, and additionally as clinically indicated, SUTENT® (sunitinib) treatment should be interrupted for Grade 3 or 4 hepatic-related adverse events and discontinued if there is no resolution of the adverse events.
  • Decreased absolute neutrophil counts occurred commonly and decreased platelet counts were reported less commonly in clinical trials. Such events were not cumulative, were typically reversible and generally did not result in treatment discontinuation. In addition, some cases of fatal haemorrhage associated with thrombocytopenia were reported through post-marketing experience.
  • Complete blood counts should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT® (sunitinib).
  • Cardiovascular events, including heart failure, cardiomyopathy, myocardial ischaemia, angina pectoris and myocardial infarction, some of which were fatal, have been reported in clinical trials and through post-marketing experience. Decreases in left ventricular ejection fraction (LVEF) of ≥ 20 % and below the lower limit of normal occurred in approximately 2 % of SUTENT® (sunitinib)-treated GIST patients, 4 % of MRCC patients and 2 % of placebo-treated patients.
  • In the treatment-naive mRCC study, 27 % of patients on SUTENT® (sunitinib) had an LVEF value below the lower limit of normal. Two patients (< 1 %) who received SUTENT® (sunitinib) were diagnosed with congestive heart failure.
  • Cardiac failure, congestive cardiac failure or left ventricular failure were reported in 0,8 % of patients with solid tumours and 1 % of patients treated with placebo. In the Phase 3 study, one (1,2 %) patient who received SUTENT® (sunitinib) had treatment-related fatal cardiac failure.
  • The relationship between receptor tyrosinase kinase (RTK) inhibition and cardiac function remains unclear but seems to be a class effect. Data from non-clinical (in vitro and in vivo) studies, at doses higher than the recommended human dose, indicate that SUTENT® (sunitinib) has the potential to inhibit the cardiac action potential repolarisation process (e.g., prolongation of QT interval). Increases in the QTc interval to over 500 msec occurred in 0,5 % and changes from baseline in excess of 60 msec occurred in 1,1 % of the 450 solid tumour patients; both these parameters are recognised as potentially significant changes.
QT interval prolongation1
  • At approximately twice the therapeutic concentrations, SUTENT® (sunitinib) has been shown to prolong the ATCE (Fredericias correction) interval. QT interval prolongation may lead to an increased risk for ventricular dysrhythmias including torsade de pointes. Torsade de pointes has been observed in < 0,1 % of SUTENT® (sunitinib)-exposed patients. SUTENT® (sunitinib) should be used with caution in patients with a known history of QT interval prolongation, patients who are taking antidysrhythmics or patients with relevant pre-existing cardiac disease, bradycardia, or electrolyte disturbances. Concomitant
    treatment with strong CYP3A4 inhibitors, which may increase SUTENT® (sunitinib) plasma concentrations, should be used with caution and the dose of SUTENT® (sunitinib) reduced.
  • Patients treated with SUTENT® (sunitinib) should have regular blood pressure assessments.
  • Hypertension was a very common adverse event reported in clinical trials in patients with solid tumours, including primarily GIST and cytokine-refractory RCC.
  • SUTENT® (sunitinib) dosing was reduced or temporarily delayed in approximately 2,7 % of this patient population. None of these patients were discontinued from treatment with SUTENT® (sunitinib). Hypertension was reported in approximately 33,9 % of patients receiving SUTENT® (sunitinib) for treatment-naive mRCC. Severe hypertension (> 200 mmHg systolic or 110 mmHg diastolic) occurred in 4,7 % of this patient population.
  • Severe hypertension occurred in 12 % of treatment-naive patients on SUTENT® (sunitinib).
  • Patients should be screened for hypertension and controlled as appropriate. Temporary suspension of SUTENT® (sunitinib) therapy is recommended in patients with severe hypertension that is not controlled with medical management. Treatment may be resumed once hypertension is appropriately controlled
Aneurysms and artery dissections1
  • The use of vascular endothelial growth factor (VEGF) pathway inhibitors in patients with or without hypertension may promote ]the formation of aneurysms and/or artery dissections. Before initiating SUTENT® (sunitinib), this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Thyroid dysfunction1
  • Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism or hyperthyroidism should be treated as per standard medical treatment prior to the start of SUTENT® (sunitinib) treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction whilst on SUTENT® (sunitinib) treatment. Patients with signs and/or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.
  • Hypothyroidism was reported as an adverse event in 16 % of patients on SUTENT® (sunitinib) in the treatment-naive mRCC study and in 4 % of subjects across 2 cytokine-refractory mRCC studies. Overall 7 % of the cytokine-refractory mRCC population had either clinical or laboratory evidence of treatment-emergent hypothyroidism.
  • Cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience.
  • In clinical studies of SUTENT® (sunitinib), seizures have been observed in subjects with radiological evidence of brain metastases.In addition, there have been rare (< 1 %) reports, some fatal, of subjects presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS). Patients with seizures and signs/symptoms consistent with RPLS, such as hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness, should be controlled with medical management including control of hypertension. Temporary suspension of SUTENT® (sunitinib) therapy is recommended in patients with seizures or RPLS. Following resolution, treatment may be resumed at the discretion of the treating medical practitioner.
Surgical procedures1
  • Cases of impaired wound healing have been reported during SUTENT® (sunitinib) therapy. Temporary interruption of SUTENT® (sunitinib) therapy is recommended for precautionary reasons in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of re-initiation of therapy following major surgical intervention. Therefore, the decision to resume SUTENT® (sunitinib) therapy following a major surgical intervention should be based upon clinical judgement of recovery from surgery.
Osteonecrosis of the Jaw (ONJ)1
  • ONJ has been uncommonly observed in clinical trials and has been reported in post-marketing experience in patients treated with SUTENT® (sunitinib). The majority of cases occurred in patients who had received prior or concomitant treatment with intravenous (IV) bisphosphonates, for which ONJ is an identified risk. Caution should therefore be exercised when SUTENT® (sunitinib) and IV bisphosphonates are used either simultaneously or sequentially.
  • Invasive dental procedures are also an identified risk factor for ONJ. Prior to treatment with SUTENT® (sunitinib), a dental examination and appropriate preventative dentistry should be considered. In patients being treated with SUTENT® (sunitinib), who have previously received or are receiving IV bisphosphonates, invasive dental procedures should be avoided, if possible.
Venous thromboembolic events1
  • Thirteen patients (3 %) receiving SUTENT® (sunitinib) for treatment-naive mRCC had venous thrombotic events reported such as pulmonary embolism.
Pulmonary embolism1
  • Pulmonary embolism was reported in approximately 2,2 % of patients with solid tumours who received SUTENT® (sunitinib). None of these events resulted in a patient discontinuing treatment with SUTENT® (sunitinib): however a dose reduction or temporary delay in treatment occurred in a few cases. There were no further occurrences of pulmonary embolism in these patients after treatment was resumed.
Tumour Lysis Syndrome (TLS)1
  • Cases of TLS, some fatal, have been observed in clinical trials and have been reported in post- marketing experience in patients treated with SUTENT® (sunitinib). Patients generally at risk of TLS are those with high tumour burden prior to treatment. These patients should be monitored closely and treated as clinically indicated.
Necrotising fasciitis1
  • Cases of necrotising fasciitis, including of the perineum, sometimes fatal, have been reported. SUTENT® (sunitinib) therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Thrombotic microangiopathy1
  • Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and haemolytic uraemic syndrome (HUS), frequently leading to renal failure or a fatal outcome, has been reported in clinical trials and in post-marketing experience of SUTENT® (sunitinib) as monotherapy and in combination with bevacizumab. Discontinue SUTENT® (sunitinib) in patients developing TMA.
  • Cases of proteinuria and nephrotic syndrome have been reported. Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria. The safety of continued SUTENT® (sunitinib) treatment in patients with moderate to severe proteinuria has not been systematically evaluated. Discontinue SUTENT® (sunitinib) in patients with nephrotic syndrome..
  • Decreases in blood glucose, in some cases clinically symptomatic, have been reported during SUTENT® (sunitinib) treatment. Blood glucose levels in diabetic patients should be checked regularly in order to assess if anti-diabetic medicine dosage needs to be adjusted to minimise the risk of hypoglycaemia.
Viral reactivation1
  • Hepatitis B reactivation, including fatal outcomes have occurred in patients treated with SUTENT® (sunitinib). Hepatitis B virus (HBV) status should be established before initiating treatment with SUTENT® (sunitinib). Patients should be monitored for signs and symptoms (fever, chills, weakness, confusion, vomiting and jaundice) and appropriate therapy should be instituted as indicated. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Class effects of Tyrosine Kinase Inhibitors (TKIs) such as contained in SUTENT® (sunitinib)1
  • Although TKIs may have different kinase inhibition profiles and/or off-target binding profiles, there is some evidence that the TKIs share to a variable degree, class related cerebrovascular adverse events (e.g. cerebrovascular accident, transient ischaemic attack, ischaemic stroke, and cerebral infarction).
  • These cerebrovascular adverse events may occur in patients on treatment with TKIs with or without risk factors for these events and may occur at any time during treatment with TKIs.
  • Patients on treatment with SUTENT® (sunitinib) should be carefully monitored, and relevant risk factors managed to reduce the risk for these class-related cerebrovascular adverse events.
  • Treatment with SUTENT® (sunitinib) should be discontinued, and alternative treatment options be considered in patients who developed these class related cerebrovascular adverse events.
  • There is no specific antidote for overdosage with SUTENT® (sunitinib). Treatment of overdose is symptomatic and supportive.
Effects on ability to drive and use machines1
  • No studies on the effects on the ability to drive or operate machinery have been performed. Patients should be advised that they may experience dizziness during treatment with SUTENT® (sunitinib).
References:Pfizer Laboratories (Pty) Ltd. SUTENT® (sunitinib) 12,5 mg, 25 mg, 50 mg capsules. Final Approved Package Insert - 12 July 2021

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