Sunitix (Sunitinib)
Sunitix is used for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.
Sunitix is used for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
It is limited to use Sunitinib as the first line treatment.
Description
DOSAGE AND ADMINISTRATION
Sunitix should be taken only under the guidance of experienced Oncologists.
The recommended dose of Sunitix for GIST and MRCC is 50 mg orally once daily, for 4 consecutive weeks. It should be followed by a 2-week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks.
The recommended dose of Sunitinib for pNET is 37.5 mg orally once daily with or without food, continuously without a scheduled offtreatment period.
Available in: 12.5mg , 25mg , 50mg
Dose adjustments
Safety and tolerability
For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability. Daily dose should not exceed 75 mg nor be decreased below 25 mg.
For pNET, dose modification in 12.5 mg steps may be applied based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
Dose interruptions may be required based on individual safety and tolerability.
CYP3A4 inhibitors/inducers
Co-administration of sunitinib 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 sunitinib 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 sunitinib with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5). If this is not possible, the dose of sunitinib 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 tolerability.
Selection of an alternative concomitant medicinal product with no or minimal potential to induce or inhibit CYP3A4 should be considered.
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