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Nexavar: Full Drug Profile

Medically reviewed by Min Clinic Staff | Updated: January 2026

Nexavar - General Information

Nexavar (rINN), marketed as Nexavar by Bayer, is a drug approved for the treatment of advanced renal cell carcinoma (primary kidney cancer). It has also received "Fast Track" designation by the FDA for the treatment of advanced hepatocellular carcinoma (primary liver cancer), and has since performed well in Phase III trials.
Nexavar is a small molecular inhibitor of Raf kinase, PDGF (platelet-derived growth factor), VEGF receptor 2 & 3 kinases and c Kit the receptor for Stem cell factor. A growing number of drugs target most of these pathways. The originality of Nexavar lays in its simultaneous targeting of the Raf/Mek/Erk pathway.

 

Pharmacology of Nexavar

Nexavar is a multikinase inhibitor targeting several serine/threonine and receptor tyrosine kinases. It is commonly available as a tosylate salt. Nexavar is a multikinase inhibitor that decreases tumor cell proliferation in vitro. Nexavar inhibits tumor growth of the murine renal cell carcinoma, RENCA, and several other human tumor xenografts in athymic mice. A reduction in tumor angiogenesis occurs in some tumor xenograft models.

 

Nexavar for patients

NEXAVAR® (NEX-A-VAR)
(sorafenib)
tablets 200 mg

Read the Patient Information that comes with NEXAVAR before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor or healthcare professional about your medical condition or your treatment.

What is the most important information I should know about NEXAVAR?

NEXAVAR may cause birth defects or death of an unborn baby.

  • Women should not get pregnant during treatment with NEXAVAR and for at least 2 weeks after stopping treatment.
  • Men and women should use effective birth control during treatment with NEXAVAR and for at least 2 weeks after stopping treatment.

Call your doctor right away if you become pregnant during treatment with NEXAVAR.

What is NEXAVAR?

NEXAVAR is an anticancer medicine to treat adults with kidney cancer called advanced renal cell carcinoma.

NEXAVAR has not been studied in children.

Who should not take NEXAVAR?

Do not take NEXAVAR if you are allergic to anything in it. See the end of this leaflet for a complete list of ingredients.

What should I tell my doctor before starting NEXAVAR?

Tell your doctor about all of your health conditions, including if you:
  • have kidney problems in addition to kidney cancer
  • have liver problems
  • have high blood pressure
  • have bleeding problems
  • have heart problems or chest pain
  • are pregnant. See “What is the most important information I should know about NEXAVAR?”
  • are breast-feeding. NEXAVAR may harm your baby.

Tell your doctor about all the medicines you take including prescription and non- prescription medicines, vitamins and herbal supplements. NEXAVAR and certain other medicines can interact with each other and cause serious side effects. Especially, tell your doctor if you take warfarin (Coumadin®)*.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take other medicines with NEXAVAR until you have talked with your doctor.

If you need to have a surgical or dental procedure, tell your doctor that you are taking NEXAVAR.

How do I take NEXAVAR?

  • Take NEXAVAR exactly as prescribed. You will stay on NEXAVAR as long as your doctor thinks it is helping you.
  • The usual dose of NEXAVAR is 2 tablets taken twice a day (for a total of 4 tablets per day). Your doctor may adjust your dose during treatment or stop treatment for some time if you have side effects.
  • Swallow NEXAVAR tablets whole with water.
  • Take NEXAVAR on an empty stomach (at least 1 hour before or 2 hours after a meal).
  • If you miss a dose of NEXAVAR, skip the missed dose, and take your next dose at your regular time. Do not double your dose of NEXAVAR. Call your doctor right away if you take too much NEXAVAR.

What are possible side effects of NEXAVAR?

NEXAVAR may cause serious side effects, including:
  • birth defects or death of an unborn baby. See “What is the most important information I should know about NEXAVAR?”
  • a skin problem called hand-foot skin reaction. This causes redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you get this side effect, your doctor may adjust your dose or stop treatment for some time.
  • high blood pressure. Your blood pressure should be checked weekly during the first 6 weeks of starting NEXAVAR. High blood pressure should be monitored and treated during treatment with NEXAVAR.
  • heart problems. Talk to your doctor about these potential problems.
  • bleeding problems. NEXAVAR may increase your chance of bleeding.
Other side effects with NEXAVAR may include:
  • rash, redness or itching of your skin
  • hair thinning or patchy hair loss
  • diarrhea (frequent and/or loose bowel movements)
  • nausea and/or vomiting
  • mouth sores
  • weakness
  • loss of appetite
  • numbness, tingling or pain in your hands and feet

Talk with your doctor about ways to manage any side effects.

These are not all the side effects with NEXAVAR. Ask your doctor or pharmacist for more information.

How should I store NEXAVAR?

  • Store NEXAVAR tablets at room temperature between 59° - 86° F (15° to 30° C), in a dry place.
  • Keep NEXAVAR and all medicines out of the reach of children.

General information about NEXAVAR

Medicines are sometimes prescribed for purposes other than those listed in the patient information leaflet. Do not use NEXAVAR for a condition for which it is not prescribed. Do not share your medicine with other people even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about NEXAVAR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about NEXAVAR that is written for healthcare professionals.

Website and toll free number:

www.nexavar.com
1-866-NEXAVAR (1-866-639-2827)

What are the ingredients in NEXAVAR?

Active Ingredient: sorafenib tosylate

Inactive Ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium lauryl sulphate, magnesium stearate, polyethylene glycol, titanium dioxide and ferric oxide red.

 

Nexavar Interactions

Caution is recommended when administering NEXAVAR with compounds that are metabolized/eliminated predominantly by the UGT1A1 pathway (e.g. irinotecan). Concomitant treatment with NEXAVAR resulted in a 21% increase in the AUC of doxorubicin. Caution is recommended when administering doxorubicin with NEXAVAR. Sorafenib inhibits CYP2B6 and CYP2C8 in vitro with Ki values of 6 and 1-2 μM, respectively. Systemic exposure to substrates of CYP2B6 and CYP2C8 is expected to increase when co-administered with NEXAVAR. Caution is recommended when administering substrates of CYP2B6 and CYP2C8 with NEXAVAR.

 

Nexavar Contraindications

NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR.

 

Additional information about Nexavar

Nexavar Indication: For the treatment of patients with advanced renal cell carcinoma. Mechanism Of Action: Nexavar interacts with multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in angiogenesis, thus sorafenib reduces blood flow to the tumor. Drug Interactions: Not Available Food Interactions: Not Available Generic Name: Sorafenib Synonyms: Sorafenib tosylate Drug Category: Anticancer Agents Drug Type: Small Molecule; Approved; Investigational Other Brand Names containing Sorafenib: Nexavar; Absorption: The mean relative bioavailability is 38-49% for the tablet form, when compared to an oral solution. With a high-fat meal, bioavailability is reduced by 29% compared to administration in the fasted state. Toxicity (Overdose): The highest dose of sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic events. 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. Protein Binding: 99.5% Biotransformation: Sorafenib is metabolized primarily in the liver, undergoing oxidative metabolism, mediated by CYP3A4, as well as glucuronidation mediated by UGT1A9. Sorafenib accounts for approximately 70-85% of the circulating analytes in plasma at steady- state. Eight metabolites of sorafenib have been identified, of which five have been detected in plasma. The main circulating metabolite of sorafenib in plasma, the pyridine N-oxide, shows in vitro potency similar to that of sorafenib. This metabolite comprises approximately 9-16% of circulating analytes at steady-state. Half Life: 25-48 hours Dosage Forms of Nexavar: Tablet Oral Chemical IUPAC Name: 4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]phenoxy]-N-methylpyridine-2-carboxamide Chemical Formula: C21H16ClF3N4O3 Sorafenib on Wikipedia: https://en.wikipedia.org/wiki/Sorafenib Organisms Affected: Humans and other mammals