Sorafenib

Mechanism-of-action classes: Kinase Inhibitors; Protein Kinase Inhibitors.

• Sorafenib tablets are a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma(1.1) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment (1.3) 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

• Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. (4) Sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.contraindicated

•The recommended dosage is 400 mg orally twice daily without food. (2.1) 2.1 Recommended Dosage The recommended dosage of sorafenib tablets is 400 mg orallytwice daily without food (at least 1 hourbefore or 2 hours after a meal) until the patient is no longer clinically benfiting from therapy or untilunacceptable toxicity. 2.2 Dose Modifications for Adverse Reactions Recommended Dosage Modifications The recommended dosage modifications for adverse reactions are provided in Tables 1, 2, and 3. Table 1: Recommended Dose Reductions forAdverse Reactions Dose Reduction Hepatocellular Carcinoma Differentiated Thyroid Carcinoma First Dose Reduction 400 mg orally once daily 400 mg orally in the morning and 200 mg orally in the evening about 12 hours apart OR 200 mg orally in the morning and 400 mg orally in the evening about 12 hours apart Second Dose Reduction 200 mg orally once daily OR 400 every other day 200 mg orally twice daily Third Dose Reduction None 200 mg orally once daily Table 2: Recommended Dosage Modifications of Sorafenib Tablets for Adverse Reactions Adverse Reaction Severity 1 Sorafenib T ablets Dosage M odification Cardiovascular Events [see Warnings and Precautions (5.1)] Cardiac Ischemia and/or Infarction Grade 2 and above Permanently discontinue. Congestive Heart Failure Grade 3 Interrupt2 until Grade 1 or less, resume at reduced dose by 1 dose level.3 Grade 4 Permanently discontinue. Hemorrhage [see Warnings and Precautions (5.2)] Grade 2 and above requiring medical intervention Permanently discontinue.

Cardiovascular Events: Consider temporary or permanent discontinuation of sorafenib tablets.(2.2, 5.1) Hemorrhage: Discontinue sorafenib tablets if needed. (5.2) 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.(5.3) Dermatologic Toxicities: Interrupt and/or decrease dose. Discontinue for severe or persistent reactions, or if Stevens-Johnson syndrome and toxic epidermal necrolysis is suspected.(5.4) Gastrointestinal Perforation: Discontinue sorafenib tablets. (5.5) Risk of Impaired Wound Healing: Withhold sorafenib tablets 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 sorafenib tablets after resolution of wound healing complications has not been established. (5.7) QT Prolongation: Monitor electrocardiograms and electrolytes in patients at increased risk for ventricular arrhythmias. Correct electrolytes. Interrupt if QTc greater than 500 msec or increases greater than 60 msec from baseline.( 2.2, 5.9, 12.2) Drug-Induced Liver Injury: Monitor liver function tests regularly; discontinue for unexplained transaminase elevations. (5.10) Embryo-Fetal Toxicity: Sorafenib tablets may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

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. (6) To report SUSPECTED ADVERSE REACTIONS, contact Yabao Pharmaceutical Co., Ltd. Beijing at 914-656-3049 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Cardiovascular events [see Warnings and Precautions ( 5.1 )] Hemorrhage [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Dermatologic toxicities [see Warnings and Precautions ( 5.4 )] Gastrointestinal perforation [see Warnings and Precautions ( 5.5 )] QT interval prolongation [see Warnings and Precautions ( 5.9 ) and Clinical Pharmacology( 12.2 )] Drug-induced liver injury [see Warnings and Precautions ( 5.10 )] Impairment of TSH suppression in DTC [see Warnings and Precautions ( 5.12 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described reflect exposure to sorafenib tablets in 504 patients who participated in placebo-controlled studies in hepatocellular carcinoma N=297), or differentiated thyroid carcinoma (N = 207).

Lactation: Advise women not to breastfeed. (8.2) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], sorafenib tablets may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. In animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily (see Data). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In animal reproduction studies, sorafenib was teratogenic and induced embryo-fetal toxicity (including increased post-implantation loss, resorptions, skeletal retardations, and retarded fetal weight) when administered orally to pregnant rats and rabbits during the period of organogenesis.

The adverse reactions observed at a dose of 800 mg twice daily (2 times the recommended dose) were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, withhold sorafenib tablets and institute supportive care.

• Dec 1, 2005NDANDA021923Bayer Hlthcare
• Sep 10, 2020ANDAANDA207012Mylan
• Nov 12, 2020ANDAANDA209567Teva Pharms Usa Inc
• Jun 7, 2022ANDAANDA216073Dr Reddys
• Nov 9, 2022ANDAANDA209050Yabao Pharm
• Apr 12, 2023ANDAANDA217095Torrent

1. 1Diarrhoea2,95114%
2. 2Palmar-plantar Erythrodysaesthesia Syndrome2,16611%
3. 3Hepatocellular Carcinoma1,8979.2%
4. 4Fatigue1,7948.7%
5. 5Off Label Use1,6948.2%
6. 6Rash1,4587.1%
7. 7Death1,4527.1%
8. 8Decreased Appetite1,4477.0%
9. 9Nausea1,3656.6%
10. 10Asthenia1,1865.8%
11. 11Hypertension1,1475.6%
12. 12Pyrexia1,0605.2%
13. 13Vomiting9814.8%
14. 14Pain In Extremity9654.7%
15. 15Weight Decreased9174.5%

Recent PubMed references pinned to Sorafenib as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• AFP Stimulates Glucose Metabolic Reprogramming Contributing to Hepatocellular Carcinoma Resist Sorafenib Through Activating PI3K/AKT Signalling Pathway.
  Journal of cellular and molecular medicine · 2026 · Zhou Y, Feng S, Chen Y, et al.
  PMID 42244055DOI 10.1111/jcmm.71226
• Exploring Synergistic Potential of Sorafenib and Atorvastatin to Launch Apoptosis and Ferroptosis-driven Mixed Cell Death Mechanism in Colorectal Cancer.
  AAPS PharmSciTech · 2026 · Yadav V, Dighe S, Dhake P, et al.
  PMID 42204072DOI 10.1208/s12249-026-03461-z
• Identification of Changes in the Transcriptome Profile of Human Hepatoma HepG2 Cells Exposed to Combined Sorafenib and Cannabis Treatment.
  International journal of molecular sciences · 2026 · Udomkritayachai K, Thiamsuk T, Jarujamrat T, et al.
  PMID 42196320DOI 10.3390/ijms27104342
• Astragaloside IV Reduces Sorafenib-Induced Cardiotoxicity by Inhibiting Apoptosis Through the STAT3/HIF-1α/Bcl-2 Signaling Pathway.
  International journal of molecular sciences · 2026 · Wang L, Liu B, You Q, et al.
  PMID 42196224DOI 10.3390/ijms27104243
• Deciphering Lipid Metabolic Landscape of Sorafenib-Treated Hepatocellular Carcinoma by Mass Spectrometry Imaging and Transcriptomics.
  Biomolecules · 2026 · Li D, Tuo Y, Sai L, et al.
  PMID 42194025DOI 10.3390/biom16050675
• Low concentrations of sorafenib increase dihydrosphingomyelin during antifibrotic processes in human hepatic stellate cells.
  Biochemical and biophysical research communications · 2026 · Kim Y, Ham B, Kim Y, et al.
  PMID 42092220DOI 10.1016/j.bbrc.2026.153785
• π-π-Anchored sorafenib on carbon black as a stable molecular redox electrocatalyst for thiol oxidation and point-of-care sensing in cancer cells.
  Journal of colloid and interface science · 2026 · Vignesh K, Napoleon AA, Sarkar S, et al.
  PMID 42070458DOI 10.1016/j.jcis.2026.140580
• KLF16 transcriptionally activates HSPB1 to participate in the sorafenib resistance of hepatocellular carcinoma by driving ferroptosis resistance.
  Pathology, research and practice · 2026 · Kong S, Zhao C, Lu F, et al.
  PMID 42066421DOI 10.1016/j.prp.2026.156496

The 10 most recently updated of 881 ClinicalTrials.gov registrations naming Sorafenib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Real-world Study of Immunotherapy Combination Regimens for Treating Liver Cancer in Cold Regions
  Active not recruiting · Observational · 1,000 enrolled · Harbin Medical University
  NCT07645209updated 2026-06-12
• Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
  Active not recruiting · Phase 2 · Interventional · 48 enrolled · M.D. Anderson Cancer Center
  NCT00494182updated 2026-06-12
• The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study
  Completed · Observational · 715 enrolled · Tongji Hospital
  NCT07639294updated 2026-06-10
• Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 74 enrolled · M.D. Anderson Cancer Center
  NCT03247088updated 2026-06-10
• Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
  Completed · Phase 3 · Interventional · 459 enrolled · SillaJen, Inc.
  NCT02562755updated 2026-06-08
• AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
  Recruiting · Phase 2 · Interventional · 12 enrolled · University of Florida
  NCT05669339updated 2026-06-04
• Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
  Completed · Phase 3 · Interventional · 1,645 enrolled · National Cancer Institute (NCI)
  NCT01371981updated 2026-06-02
• Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients
  Recruiting · Phase 1 · Phase 2 · Interventional · 64 enrolled · St. Jude Children's Research Hospital
  NCT05468359updated 2026-05-19
• A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
  Active not recruiting · Phase 3 · Interventional · 557 enrolled · Hoffmann-La Roche
  NCT04770896updated 2026-05-14
• Paediatric Hepatic International Tumour Trial
  Active not recruiting · Phase 3 · Interventional · 450 enrolled · University of Birmingham
  NCT03017326updated 2026-05-13

Frequently asked questions

How does Sorafenib work?

Mechanism-of-action classes: Kinase Inhibitors; Protein Kinase Inhibitors.

What is Sorafenib used for?

According to FDA labeling, Sorafenib carries indications including: Sorafenib tablets are a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma(1.1) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment (1.3) 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sorafenib?

Sorafenib is classified as Other protein kinase inhibitors, Kinase Inhibitor, Kinase Inhibitors, Protein Kinase Inhibitors, Cellular Proliferation Alteration.

What are the brand names for Sorafenib?

Sorafenib is marketed under brand names including Nexavar.

What are the contraindications for Sorafenib?

Sorafenib labeling lists contraindications including: Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. (4) Sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.. Always consult the full prescribing information and a clinician.