
Sunicent50 mg
Incepta Pharmaceuticals Ltd.
FDA-Approved Indications Advanced Renal Cell Carcinoma (RCC): Sunitinib is indicated for the treatment of advanced renal cell carcinoma.
Sunitinib is used as monotherapy in each of these settings. Use of Sunitinib outside these approved settings (off-label) should only occur under specialist oncology supervision.
| Indication | Recommended Dose | Schedule |
|---|---|---|
| Renal cell carcinoma (advanced or adjuvant) | 50 mg Sunitinib orally once daily | 4 weeks on treatment followed by 2 weeks off (repeated cycles); adjuvant therapy is typically continued for approximately 9 cycles |
| Gastrointestinal stromal tumor (GIST) | 50 mg Sunitinib orally once daily | 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) |
| Pancreatic neuroendocrine tumor (pNET) | 37.5 mg Sunitinib orally once daily | Continuous dosing, without a scheduled off-treatment period |
Dose adjustments to Sunitinib are made in 12.5 mg increments or decrements based on individual safety and tolerability, generally within a range of 25 mg to 75 mg per day for RCC/GIST. Dose interruption and/or reduction is recommended for significant toxicity; see Precautions and Warnings.
No dose adjustment is required for Sunitinib in patients with mild to moderate hepatic impairment (Child-Pugh Class A or B). Sunitinib has not been studied in patients with severe (Child-Pugh Class C) hepatic impairment and is not recommended in this group.
No initial dose adjustment of Sunitinib is required for mild to moderate renal impairment. Patients with end-stage renal disease on hemodialysis may be started at the standard dose with close monitoring, as data are limited.
Sunitinib capsules should be swallowed whole, with or without food, at approximately the same time each day. If a dose is missed, it should not be doubled; the next dose should be taken at the usual scheduled time. Grapefruit and grapefruit juice should be avoided.
See Precautions and Warnings for detailed discussion of hepatotoxicity, cardiotoxicity, QT prolongation, severe hypertension, hemorrhage, thrombotic microangiopathy, adrenal insufficiency, gastrointestinal perforation/fistula, osteonecrosis of the jaw, and impaired wound healing associated with Sunitinib.
Sunitinib is contraindicated in patients with known hypersensitivity to Sunitinib or to any component of the formulation.
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