ALSUNI CAPSULES 12.5MG [SIN16579P]

Product Info

ALSUNI CAPSULES 12.5MG

[SIN16579P]

4.1 Therapeutic indications

Gastrointestinal stromal tumour (GIST)
Sunitinib is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesylate treatment due to resistance or intolerance (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Metastatic renal cell carcinoma (MRCC)
Sunitinib is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC) in adults (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pancreatic neuroendocrine tumours (pNET)
Sunitinib is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.

4.2 Posology and method of administration

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 increments or decrements may be applied based on individual safety and tolerability. Daily dose should not exceed 75 mg or down to 25 mg.

For pNET, dose modifications 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 inhibitors/inducers
Co-administration of sunitinib with potent CYP3A4 inducers, such as rifampicin, 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 potent 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 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 pediatric patients have not been established.

Sunitinib should not be used in pediatric population until further data become available.

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 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 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.