Share on Facebook Share on Twitter Email
Answers.com

Sorafenib

 
Drug Info: Sorafenib
Home > Library > Health > Drug Info

Brand names: Nexavar®



Sorafenib oral tablets

What are Sorafenib oral tablets?

SORAFENIB (Nexavar®) is a medicine used to help treat cancer. It is used for renal (kidney) cancer, and might be used to treat other cancers as well. Generic sorafenib tablets are not available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• bleeding problems
• dental disease
• infection (especially cold sores or shingles)
• heart disease (like heart failure)
• jaundice
• kidney disease
• liver disease
• an unusual or allergic reaction to sorafenib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Take this medicine by mouth. You should take it on an empty stomach, either one hour before eating or two hours after eating. Follow the directions on the prescription label. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with Sorafenib?

• carbamazepine
• dexamethasone
• docetaxel
• doxorubicin
• fluorouracil
• irinotecan
• phenobarbital
• phenytoin
• rifabutin
• rifampicin
• rifampin
• St. John's wort or any herbal products containing St. John's wort
• warfarin

Tell your prescriber or health care professional about all other medicines that you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Sorafenib?

Visit your prescriber or health care professional for checks on your progress. You will need to have regular blood checks. The side effects of this medicine may continue after you finish your treatment; report side effects promptly.

This medicine will decrease your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. This medicine may increase your risk to bruise or bleed. Call your prescriber or health care professional if you notice any unusual bleeding. Be careful not to cut, bruise or injure yourself because you may get an infection and bleed more than usual.

Be careful brushing and flossing your teeth or using a toothpick while taking this medicine because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are taking sorafenib.

Do not have any vaccinations without your prescriber's approval and avoid anyone who has recently had the oral polio vaccine.

There is a risk of birth defects if sorafenib is given during pregnancy. Women should not become pregnant while being treated with this medicine. Women should use effective birth control while taking sorafenib and for at least 2 weeks after stopping treatment.

If you are going to have surgery or any other procedures, tell your doctor you are taking sorafenib.

Sorafenib can cause high blood pressure especially during the first 6 weeks of therapy. Your prescriber or health care professional will monitor your blood pressure. Call your prescriber of health care professional if you have dizziness or episodes of lightheadedness.

Rarely, heart attack has been reported during sorafenib therapy. Notify your prescriber or health care professional immediately if you have chest pain, tightness, or excessive sweating. Call 911 if urgent care is required.

What side effects may I notice from receiving Sorafenib?

Side effects that you should report to your doctor or health care professional as soon as possible:
 • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• dizziness
• fever or chills, sore throat
• pain, tingling, numbness in the hands or feet
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• shortness of breath, chest pain, swelling in a leg
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
• decreased appetite
• diarrhea
• dry skin
• hair loss
• mouth sores
• nausea
• stomach pain

Where can I keep my medicine?

Store the tablets at room temperature between 15—30 degrees C (59—86 degrees F). Throw away any unused medicine after the expiration date on the label.

Keep out of the reach of children in a container that small children cannot open.

Last updated: 12/21/2005 5:18:00 PM

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

Search unanswered questions...

Enter a question here...
Search: All sources Community Q&A Reference topics

Wikipedia: Sorafenib
Top
Home > Library > Miscellaneous > Wikipedia
Sorafenib
Systematic (IUPAC) name
4-[4-[[4-chloro-3-(trifluoromethyl)phenyl]carbamoylamino]
phenoxy]-N-methyl-pyridine-2-carboxamide
Identifiers
CAS number 284461-73-0
ATC code L01XE05
PubChem 216239
DrugBank APRD01304
Chemical data
Formula C21H16ClF3N4O3 
Mol. mass 464.825 g/mol
SMILES eMolecules & PubChem
Synonyms Nexavar
Sorafenib tosylate
Pharmacokinetic data
Bioavailability 29-49%
Protein binding 99.5%
Metabolism Hepatic oxidation and glucuronidation (CYP3A4-mediated)
Half life 25–48 hours
Excretion Fecal (77%) and renal (19%)
Therapeutic considerations
Licence data

EU EMEA:link, US FDA:link
Pregnancy cat.

D(AU) D(US)
Legal status

℞-only(US)
Routes Oral

Sorafenib (marketed as Nexavar by Bayer), is a drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma) and advanced primary liver cancer (hepatocellular carcinoma).

Contents

Pharmacology

Sorafenib is a small molecular inhibitor of several Tyrosine protein kinases.[1]

(Protein kinases are overactive in many of the molecular pathways that cause cells to become cancerous. These pathways include Raf kinase, PDGF (platelet-derived growth factor), VEGF receptor 2 and 3 kinases and c Kit the receptor for Stem cell factor. A growing number of drugs target most of these pathways.)

Sorafenib is unique in targeting the Raf/Mek/Erk pathway (MAP Kinase pathway).[2]

Approval

Renal cancer

Sorafenib was approved by the U.S. Food and Drug Administration (FDA) in December 2005,[3] and received European Commission marketing authorization in July 2006[4], both for use in the treatment of advanced renal cancer.

Liver cancer

The European Commission granted marketing authorization to the drug for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, in October 2007[5], and FDA approval for this indication followed in November 2007.[6]

In November 2009, the UK's National Institute of Clinical Excellence declined to approve the drug for use within the NHS in England, Wales and Northern Ireland, stating that its effectiveness (increasing survival in primary liver cancer by 6 months) did not justify its high price, at up to £3000 per patient per month.[7] In Scotland the drug had already been refused authorization by the Scottish Medicines Consortium for use within NHS Scotland, for the same reason.[7]

Studies

Kidney

An article in The New England Journal of Medicine, published January 2007, showed compared with placebo, treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed; the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group (hazard ratio for disease progression in the sorafenib group, 0.44; 95% confidence interval [CI], 0.35 to 0.55; P<0.01). The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death, as compared with placebo (hazard ratio, 0.72; 95% CI, 0.54 to 0.94; P=0.02), although this benefit was not statistically significant according to the O'Brien–Fleming threshold. Partial responses were reported as the best response in 10% of patients receiving sorafenib and in 2% of those receiving placebo (P<0.001). A few reports described patients with stage IV renal cell carcinomas that were successfully treated with a multimodal approach including neurosurgical, radiation, and Sorafenib.[8]

Liver

At ASCO 2007, results from the SHARP trial were presented, which showed efficacy of sorafenib in hepatocellular carcinoma. The primary endpoint was overall survival, which showed a 44% improvement in patients who received sorafenib compared to placebo (hazard ratio 0.69; 95% CI, 0.55 to 0.87; p=0.0001). Both median survival and time to progression showed 3-month improvements. There was no difference in quality of life measures, possibly attributable to toxicity of sorafenib or symptoms related to underlying progression of liver disease. Of note, this trial only included patients with Child-Pugh Class A (ie mildest) cirrhosis. The results of the study appear in the July 24, 2008, edition of The New England Journal of Medicine. Because of this trial Sorafenib obtained FDA approval for the treatment of advanced hepatocelluar carcinoma in November 2007.

Lung

In some kinds of lung cancer (with squamous-cell histology) sorafenib administered in addition to paclitaxel and carboplatin may be detrimental to patients.[citation needed]

Thyroid cancer

A phase 3 clinical trial has started recruiting (Nov 2009) to use sorafenib for non-responsive thyroid cancer.[9]

Adverse effects

Adverse effects of sorafenib include skin rash, hand-foot skin reactions, diarrhea, and hypertension. A case of diffuse yellow discoloration of the skin has been reported.[10] Sorafenib has also been implicated in the development of reversible posterior leukoencephalopathy syndrome and reversible erythrocytosis.[11]

References

  1. ^ Wilhelm SM, Adnane L, Newell P, Villanueva A, Llovet JM, Lynch M (October 2008). "Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling". Molecular Cancer Therapeutics 7 (10): 3129–40. doi:10.1158/1535-7163.MCT-08-0013. PMID 18852116. 
  2. ^ "SorafenibSunitinibdifferences". http://www.healthvalue.net/SorafenibSunitinibdifferences.html. Retrieved August 15, 2007. 
  3. ^ FDA Approval letter for use of sorafenib in advanced renal cancer
  4. ^ European Commission - Enterprise and industry. Nexavar. Retrieved April 24, 2007.
  5. ^ DGnews [1]. Retrieved November 2, 2007.
  6. ^ FDA Approval letter for use of sorafenib in inoperable hepatocellular carcinoma
  7. ^ a b BBC News: Liver drug 'too expensive'
  8. ^ Walid MS, Johnston KW (2009). "Successful treatment of a brain-metastasized renal cell carcinoma". Ger Med Sci 7. doi:10.3205/000087. PMID 19911072. 
  9. ^ http://www.lifescience-online.com/,18181?portalPage=Lifescience+Today.News "Phase 3 Trial of Nexavar in Patients With Non-Responsive Thyroid Cancer"
  10. ^ Dasanu CA, et al. (March 2007). "Yellow skin discoloration associated with sorafenib use for treatment of metastatic renal cell carcinoma". Southern Medical Journal 100 (3): 328–30. PMID 17396743. 
  11. ^ Alexandrescu DT, McClure R, Farzanmehr H, Dasanu CA (August 2008). "Secondary erythrocytosis produced by the tyrosine kinase inhibitors sunitinib and sorafenib". J. Clin. Oncol. 26 (24): 4047–8. doi:10.1200/JCO.2008.18.3525. PMID 18711201. http://www.jco.org/cgi/pmidlookup?view=long&pmid=18711201. 

External links

v • d • e
Targeted therapy / extracellular chemotherapeutic agents/antineoplastic agents (L01)
CI monoclonal antibodies ("-mab")
Others for solid tumors
Tyrosine kinase inhibitors ("-nib")
Other

This entry is from Wikipedia, the leading user-contributed encyclopedia. It may not have been reviewed by professional editors (see full disclaimer)

 
 
Learn More
Sorafenib oral tablets
Sorafenib tosylate Oral tablet
Sorafenib Tosilato, Tableta oral

Help us answer these
How mush price of sorafenib?

Post a question - any question - to the WikiAnswers community:

 

Copyrights:

Drug Info. Gold Standard. Copyright © 2008 by Gold Standard. All rights reserved.  Read more
Wikipedia. This article is licensed under the Creative Commons Attribution/Share-Alike License. It uses material from the Wikipedia article "Sorafenib".  Read more