Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
SUTENT® 12.5 mg hard capsules
SUTENT® 25 mg hard capsules
SUTENT® 37.5 mg hard capsules
SUTENT® 50 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SUTENT® 12.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
SUTENT® 25 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 25.0 mg of sunitinib
SUTENT® 37.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib
SUTENT® 50 mg hard capsules
Each capsule contains sunitinib malate equivalent to 50 mg of sunitinib
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
SUTENT® 12.5 mg
Hard capsule
Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules.
SUTENT® 25 mg
Hard Capsule
Gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” on the cap and “STN 25 mg ”on the body and containing yellow to orange granules.
SUTENT® 37.5 mg
Hard Capsule
Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap and “STN 37.5 mg” on the body and containing yellow to orange granules.
SUTENT® 50 mg
Hard capsule
Gelatin capsules with caramel cap and caramel body, printed with white ink “Pfizer” on the cap and “STN 50 mg” on the body and containing yellow to orange granules.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Gastrointestinal stromal tumour (GIST)
SUTENT is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
SUTENT is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
SUTENT is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.
Experience with SUTENT as first-line treatment is limited (see section 5.1).
4.2 Posology and method of administration
Therapy with sunitinib should be initiated by a physician experienced in the administration of anti-cancer agents.
For GIST and MRCC, the recommended dose of SUTENT is 50 mg taken orally once daily, for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) to comprise a complete cycle of 6 weeks.
For pNET, the recommended dose of SUTENT is 37.5 mg taken orally once daily without a scheduled rest period
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 tolerabili
