INSUNITINIB CAPSULE 12.5MG [SIN16269P]

Product Info

INSUNITINIB CAPSULE 12.5MG

[SIN16269P]

4.1 Therapeutic indications
Gastrointestinal Stromal Tumor
Sunitinib is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumor (GIST) 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
Sunitinib is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC) (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

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.

4.3 Contraindications
Use of sunitinib is contraindicated in patients with hypersensitivity to sunitinib or to any of the excipients.