d use machines
No studies on the effects on the ability to drive and use machines have been performed. Patients should be advised that they may experience dizziness during treatment with sunitinib.
4.8 Undesirable effects
The most important serious adverse reactions associated with SUTENT in patients with solid tumours were pulmonary embolism (1%), thrombocytopoenia (1%), tumour haemorrhage (0.9%), febrile neutropoenia (0.4%), and hypertension (0.4%). The most common adverse reactions (experienced by at least 20% of the patients) of any grade included: fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia and vomiting; skin discolouration; dysgeusia and anorexia. Fatigue, hypertension and neutropoenia were the most common Grade 3 adverse reactions and increased lipase was the most frequent Grade 4 adverse reaction in patients with solid tumours. Hepatitis and hepatic failure occurred in <1% of patients and prolonged QT interval in < 0.1% (see section 4.4).
Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibly related to sunitinib included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, rhabdomyolysis, cerebrovascular accident, dehydration, adrenal insufficiency, renal failure, respiratory failure, pleural effusion, pneumothorax, shock, and sudden death.
Adverse reactions that were reported in >2% of GIST and MRCC patients and in >5% of pNET patients in the phase 3 study are listed below, by system organ class, frequency and grade of severity (NCI-CTCAE). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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 <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Table 1 – Adverse reactions reported in GIST studies with SUTENT
System Organ Class
Frequency
Adverse reactions
All Grades
n (%)
Grade 3
n (%)
Grade 4
n (%)
Blood and the lymphatic system disorders
Very common
Anaemia
86 (19.5%)
24 (5.5%)
3 (0.7%)
Very common
Neutropoenia
81 (18.4%)
39 (8.9%)
5 (1.1%)
Very common
Thrombocytopoenia
67 (15.2%)
19 (4.3%)
6 (1.4%)
Common
Leukopoenia
26 (5.9%)
9 (2.0%)
1 (0.2%)
Common
Lymphopoenia
10 (2.3%)
3 (0.7%)
1 (0.2%)
Endocrine disorders
Very common
Hypothyroidism
59 (13.4%)
5 (1.1%)
1 (0.2%)
Metabolism and nutrition disorders
Very common
Decreased appetite a
117 (26.6%)
8 (1.8%)
0 (0.0%)
Psychiatric disorders
Common
Insomnia
14 (3.2%)
0 (0.0%)
0 (0.0%)
Nervous system disorders
Very common
Taste disturbance b
105 (23.9%)
1 (0.2%)
0 (0.0%)
Very common
Headache
76 (17.3%)
5 (1.1%)
0 (0.0%)
Common
Paraesthesia
27 (6.1%)
1 (0.2%)
0 (0.0%)
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