NEXAVAR TABLET 200 MG [SIN13339P]
Active ingredients: SORAFENIB TOSYLATE 274 MG EQV SORAFENIB
Last updated on 9 October 2026
Product Info
NEXAVAR TABLET 200 MG
[SIN13339P]
Product information
Active Ingredient and Strength | SORAFENIB TOSYLATE 274 MG EQV SORAFENIB - 200 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | BAYER AG - GERMANY |
Registration Number | SIN13339P |
Licence Holder | BAYER (SOUTH EAST ASIA) PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L01EX02 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Indication(s)
NEXAVAR is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
NEXAVAR 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.
NEXAVAR is indicated for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.
Dosing
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.
Contraindications
4.3 Contraindications
Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients in the tablet.