Sunitinib 12.5 Eurodrug Dosage/Direction for Use

Therapy with sunitinib should be initiated by a physician experienced in the administration of anticancer agents.
Posology: For GIST and MRCC, the recommended dose of sunitinib 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 sunitinib 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 tolerability.
CYP3A4 inhibitors/inducers: Co-administration of sunitinib with potent CYP3A4 inducers, such as rifampicin, should be avoided (see Precautions and Interactions). 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 Precautions and Interactions). 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.
Special populations: Paediatric population: The safety and efficacy of sunitinib in patients below 18 years of age have not been established.
Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Elderly: Approximately one-third of the patients in clinical studies who received sunitinib were 65 years of age or over. No significant differences in safety or efficacy were observed between younger and older patients.
Hepatic impairment: 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 and therefore its use in patients with severe hepatic impairment cannot be recommended (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No starting dose adjustment is required when administering sunitinib to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on haemodialysis. Subsequent dose adjustments should be based on individual safety and tolerability (see see Pharmacology: Pharmacokinetics under Actions).
Method of administration: Sunitinib is for oral administration. It may be taken with or without food.
If a dose is missed, the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.