INSUNITINIB CAPSULE 50MG

INTEGA PTE LTD

INTEGA PTE LTD

Therapeutic

Prescription Only

CAPSULE, GELATIN COATED

**4.2 Posology and method of administration** Therapy should be initiated by a physician experienced in the administration of anti-cancer agents. 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 off 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. Sunitinib 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. Dose Modifications _Safety and Tolerability_ For GIST and MRCC, dose modifications in 12.5 mg increments or decrements may be applied based on individual safety and tolerability up to 75 mg or down to 25 mg. For pNET, dose modification in 12.5 mg increments or decrements 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 Inhibition/Induction_ Co-administration of sunitinib with strong CYP3A4 inducers such as rifampin, should be avoided (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If this is not possible, the dose of sunitinib may need to be increased in 12.5 mg increments to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily, based on careful monitoring of tolerability. Co-administration of sunitinib with strong CYP3A4 inhibitors, such as ketoconazole, should be avoided (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). If this is not possible, the dose of sunitinib may need to be reduced in 12.5 mg decrements to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily, based on careful monitoring of the tolerability. Selection of an alternate concomitant medication with no or minimal potential to induce or inhibit CYP3A4 should be considered. Pediatric Use The safety and efficacy of sunitinib in pediatric patients have not been established. Sunitinib should not be used in pediatric population until further data become available. Elderly Patients Use Approximately 34% of the subjects in clinical studies of sunitinib were 65 years of age or over. No significant differences in safety or efficacy were observed between younger and older patients. Hepatic Insufficiency No dose adjustment is recommended when administering sunitinib to patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Sunitinib has not been studied in subjects with severe (Child-Pugh Class C) hepatic impairment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Renal Insufficiency No starting dose adjustment is required when administering sunitinib 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.