Active Ingredient and Strength	SORAFENIB TOSYLATE EQV SORAFENIB - 200 MG
Dosage Form	TABLET, FILM COATED
Manufacturer and Country	REMEDICA LTD - CYPRUS PHAROS MT LTD - MALTA
Registration Number	SIN16485P
Licence Holder	INTEGA PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	L01XE05

4.1 Indication(s)

INFENIB is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

INFENIB is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior systemic therapy or are considered unsuitable for such therapy.

INFENIB is indicated for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

4.2 Dosage and method of administration

Recommended dose

The recommended daily dose of sorafenib is 400 mg (2 x 200 mg tablets) taken twice a day, either without food or together with a moderate fat meal.

Method of administration
For oral use. To be swallowed with a glass of water.

Duration of treatment

Treatment should be continued until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Dose titration, dose adjustment, special monitoring advice

Dose Reduction for Hepatocellular Carcinoma and advanced Renal cell Carcinoma
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of sorafenib therapy. When dose reduction is necessary during the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the sorafenib dose should be reduced to two tablets of 200 mg once daily (see “Special Warnings and Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dose Reduction for Differentiated Thyroid Carcinoma
Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of sorafenib therapy.
When dose reduction is necessary during the treatment of differentiated thyroid carcinoma, the sorafenib dose should be reduced to 600mg daily in divided doses (two tablets of 200mg and one tablet of 200mg twelve hours apart).
If additional dose reduction is necessary, sorafenib may be reduced to one tablet of 200mg twice daily, followed by one tablet of 200mg once daily. After improvement of non-hematological adverse reactions, the dose of sorafenib may be increased.

Special Populations

Pediatric Patients

The safety and effectiveness of sorafenib in paediatric patients has not been established.

Elderly (above 65 years), Gender and Body Weight

No dose adjustment is required on the basis of patient age (above 65 years), gender, or body weight.

Hepatic impairment

No dose adjustment is required in patients with Child-Pugh A or B hepatic impairment. Sorafenib has not been studied in patients with Child-Pugh C hepatic impairment (see “Pharmacokinetics Properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dose adjustment is required in patients with mild, moderate, or severe renal impairment not requiring dialysis. Sorafenib has not been studied in patients undergoing dialysis (see “Pharmacokinetics Properties” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.

4.3 Contraindications

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients in the tablet.