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Sorafenib (trade names include Nexavar, Sorafenat, Soranib, Soranix) is an anti-cancer drug from protein kinase inhibitors pharmacological group. This medication is used for the treatment of advanced primary liver cancer (hepatocellular carcinoma), primary kidney cancer (advanced renal cell carcinoma, advanced renal cancer), FLT3-ITD positive AML and radioactive iodine resistant advanced thyroid carcinoma. It is in researcj studies for the treatment of lung, brain (recurrent glioblastoma), ovarian cancer, desmoid tumor (aggressive fibromatosis). It works by inhibiting protein kinases enzymes in cancer cells.
Pharmacological and medical categories:
Anti cancer drugs
Anti tumor medicines
Medications for the treatment of liver tumors
Tyrosine kinase inhibitors
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XE - Protein kinase inhibitors
L01XE05 - Sorafenib
Malignant neoplasm of liver and intrahepatic bile ducts - C22
Liver cell carcinoma - C22.0
Malignant neoplasm of bronchus and lung - C34
Malignant neoplasm of ovary - C56
Malignant neoplasm of kidney, except renal pelvis - C64
Malignant neoplasm of brain - C71
Malignant neoplasm of thyroid gland - C73
Neoplasm of uncertain behavior of other and unspecified sites - D48
Fibroblastic disorders - M72
Indications and usage:
Nexavar (Sorafenib Tosylate) is a kinase inhibitor indicated for the treatment of:
Unresectable hepatocellular carcinoma
Advanced renal cell carcinoma
Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment
Dosage and administration:
400 mg (2 tablets) orally twice daily without food.
Treatment interruption and/or dose reduction may be needed to manage adverse reactions.
There is no specific treatment for sorafenib overdose. The highest dose of Nexavar studied clinically is 800 mg twice daily. The adverse reactions observed at this 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, sorafenib should be withheld and supportive care instituted.
Dosage forms and strengths:
Nexavar (Sorafenib Tosylate) 200 mg oral tablets.
Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Nexavar.
This drug in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.
Warnings and precautions:
Cardiovascular Events: Consider temporary or permanent discontinuation of Nexavar.
Bleeding: Discontinue Nexavar if needed.
Hypertension: Monitor blood pressure weekly during the first 6 weeks and periodically thereafter.
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.
QT Prolongation: Monitor electrocardiograms and electrolytes inpatients at increased risk for ventricular arrhythmias.
Drug-Induced Liver Injury: Monitor liver function tests regularly; discontinue for unexplained transaminase elevations.
Embryo-Fetal Toxicity: Sorafenib may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Impairment of TSH suppression in DTC: Monitor TSH monthly and adjust thyroid replacement therapy in patients with thyroid cancer.
Adverse reactions, side effects:
The most common adverse reactions ( >= 20%) for Nexavar tablets are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.
Avoid strong CYP3A4 inducers.
Use in specific populations:
Lactation: Advise women not to breastfeed.
Females and Males of Reproductive Potential: Verify pregnancy status prior to initiation of Nexavar (Sorafenib Tosylate) 200 mg tablets,
D - Australia
D - United States (Positive evidence of risk)
Salts and other forms:
Synonyms, international and chemical names:
Brands, generics, trade names:
Nexavar - Bayer, Onyx Pharmaceuticals
Sorafenat - Natco Pharma
Soranib - Cipla
Soranix - Beacon Pharmaceuticals
Sorafenib main article on Wikipedia: https://en.wikipedia.org/wiki/Sorafenib
Sorafenib compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Sorafenib
Sorafenib Tosylate compound on PubChem: https://pubchem.ncbi.nlm.nih.gov/compound/Sorafenib-tosylate
Sorafenib on DrugBank: https://www.drugbank.ca/drugs/DB00398
Sorafenib Tosylate on DrugBank: https://www.drugbank.ca/salts/DBSALT000165
Sorafenib FAQ on MedlinePlus (revised 02/15/2019): https://medlineplus.gov/druginfo/meds/a607051.html
Nexavar (Sorafenib Tosylate) film-coated tablets drug label info on DailyMed (revised July 9, 2020): https://dailymed.nlm.nih.gov/dailymed/lookup...
Sorafenib for sale on Pharma Doctor: https://pharma-doctor.com/sorafenib.html
Sorafenib international drug names on Drugs.com: https://www.drugs.com/international/sorafenib.html
Nexavar (Sorafenib Tosylate) tablets for oral use official prescribing information from the U.S. FDA (revised 12/2018): https://www.accessdata.fda.gov/drugsatfda_docs/label...
Nexavar (Sorafenib Tosylate) information from Bayer pharmaceutical company: https://www.bayer.com/en/google-search.aspx?query=nexavar
Nexavar (Sorafenib Tosylate) tablets official website (for U.S. visitors only): https://www.nexavar-us.com/
Nexavar (Sorafenib Tosylate) tablets official website for healthcare professionals (for U.S. visitors only): https://www.hcp.nexavar-us.com/
Nexavar (Sorafenib Tosylate) 200 mg film-coated tablets package information leaflet Medicines.org.uk (revised 09/2019): https://www.medicines.org.uk/emc/files/pil.226.pdf
Sorafenat (Sorafenib, Nexavar generic) 200 mg tablets from Natco Pharma Ltd prescribing information on Practo: https://www.practo.com/medicine-info/sorafenat-tablet-49138
Soranib (Sorafenib Tosylate) 200 mg film-coated tablets prescribing information from Cipla pharmaceutical company (revised December 2017): https://www.ciplamed.com/content/soranib-tablets
Revised: April 2021
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