ty.
CYP3A4 inhibitors/inducers
Co-administration of SUTENT with potent CYP3A4 inducers such as rifampicin, should be avoided (see sections 4.4 and 4.5). If this is not possible, the dose of SUTENT may need to be increased in 12.5 mg steps (up to 87.5 mg per day for GIST and MRCC or 62.5 mg per day for pNET) based on careful monitoring of tolerability.
Co-administration of SUTENT with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5). If this is not possible, the doses of SUTENT may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of the tolerability.
Selection of an alternative concomitant medicinal product with no, or minimal potential to induce or inhibit CYP3A4 should be considered.
Special populations
Paediatric population
The safety and efficacy of sunitinib in patients below 18 years of age have not been established.
No data are available.
There is no relevant use of Sutent in children from birth to less than 6 years in the indication of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance. There is no relevant use of Sutent in the paediatric population in the indications treatment of advanced/metastatic renal cell carcinoma and treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression.
Use of SUTENT in the paediatric population is not recommended.
Elderly patients ( 65 years old)
Approximately one third of the patients in clinical studies who received sunitinib were 65 or over. No significant differences in safety or effectiveness were observed between younger and older patients.
Hepatic Insufficiency
No starting dose adjustment is recommended when administering sunitinib to patients with mild or moderate (Child-Pugh Class A and B) hepatic impairment. Sunitinib has not been studied in subjects with severe (Child-Pugh Class C) hepatic impairment (see section 5.2).
Renal Insufficiency
No starting dose adjustment is required when administering SUTENT to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on hemodialysis. Subsequent dose adjustments should be based on individual safety and tolerability (see section 5.2).
Method of administration
SUTENT is for oral administration. It may be taken with or without food.
If a dse is missed the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
Co-administration with potent CYP3A4 inducers should be avoided because it may decrease sunitinib plasma concentration (see sections 4.2 and 4.5).
Co-administration with potent CYP3A4 inhibitors should be avoided because it may increase the plasma concentration of sunitinib (see sections 4.2 and 4.5).
Skin and tissues disorders
Skin discolouration, possibly due to the active substance colour (yellow) is a common adverse reaction occurring in approximately 30% of patients. Patients should be advised that depigmentation of the hair or skin may also occur during treatment with sunitinib. Other possible dermatologic effects may include dryness, thickness or cracking of the s |
