Sorafenib is a kinase inhibitor indicated for the treatment of unresectable hepatocellular carcinoma, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Sorafenib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma. • Advanced renal cell carcinoma. • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment
Source: US FDA prescribing information
Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (c-CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT- 3, RET, RET/PTC, VEGFR-1, VEGFR- 2, VEGFR- 3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis and apoptosis. Sorafenib inhibited tumor growth of HCC, RCC, and DTC human tumor xenografts in immunocompromised mice. Reductions in tumor angiogenesis were seen in models of HCC and RCC upon sorafenib treatment, and increases in tumor apoptosis were observed in models of HCC, RCC, and DTC.
Source: US FDA prescribing information
The recommended dosage is 400 mg orally twice daily without food. Recommended Dosage The recommended dosage of NEXAVAR is 400 mg orally twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity.
Source: US FDA prescribing information
• NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR. • NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. • NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR. • NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.
Source: US FDA prescribing information
• Cardiovascular Events: Consider temporary or permanent discontinuation of NEXAVAR. • Hemorrhage: Discontinue NEXAVAR if needed. • Hypertension: Monitor blood pressure weekly during the first 6 weeks and periodically thereafter. Consider temporary or permanent discontinuation for severe or persistent hypertension despite antihypertensive therapy. • Dermatologic Toxicities: Interrupt and/or decrease dose. Discontinue for severe or persistent reactions, or if Stevens-Johnson syndrome and toxic epidermal necrolysis is suspected. • Gastrointestinal Perforation: Discontinue NEXAVAR. • Risk of Impaired Wound Healing: Withhold NEXAVAR for at least 10 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of NEXAVAR after resolution of wound healing complications has not been established.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed elsewhere in the labeling: • Cardiovascular events • Hemorrhage • Hypertension • Dermatologic toxicities • Gastrointestinal perforation • QT interval prolongation • Drug-induced liver injury • Impairment of TSH suppression in DTC The most common adverse reactions (≥20%) are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.
Source: US FDA prescribing information
• Strong CYP3A Inducers: Avoid strong CYP3A4 inducers. Effect of Other Drugs on NEXAVAR Strong CYP3A4 Inducers The concomitant use of NEXAVAR with rifampin, a strong CYP3A4 inducer decreased the mean AUC of sorafenib, which may decrease the antitumor activity. Avoid concomitant use of NEXAVAR with strong CYP3A4 inducers, when possible, because these drugs can decrease the systemic exposure to sorafenib. Neomycin The concomitant use of NEXAVAR with neomycin decreased the mean AUC of sorafenib, which may decrease the antitumor activity. Avoid concomitant use of NEXAVAR with neomycin. The effects of other antibiotics on the pharmacokinetics of sorafenib have not been studied.
Source: US FDA prescribing information
Store at 20°C to 25° C (68°F to 77° F), excursions permitted to 15°C to 30° C (59°F to 86° F). Store in a dry place.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Sorafenib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Sorafenib 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Nexavar 200 mg tabletOral | Bayer HealthCare Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Sorafenib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Sorafenib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Sorafenib, including Nexavar.
Yes. The US FDA first approved Sorafenib on 1 December 2005, according to Drugs@FDA.
Yes. Sorafenib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Sorafenib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Sorafenib is classified under ATC code L01EX02 (Sorafenib).
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