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Iressa®

Brand Name: Iressa®
Active Ingredient:   geftinib
Strength(s): 250 mg
Dosage Form(s):   Tablets
Company Name:    AstraZeneca Pharmaceuticals LP
Availability:         Prescription only
*Date Approved by FDA:   May 5, 2003
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Iressa used for?  

  • Iressa is a chemotherapy medicine (medicines used to kill cancer cells) that is used alone for the treatment of non-small cell lung cancer (NSCLC) that: 
    • has progressed after treatment with platinum based or docetaxel chemotherapies, or  
    • did not respond to treatment with platinum based or docetaxel chemotherapies.  
  • At this time, it is not known whether Iressa will improve symptoms of NSCLC or help patients live longer.  
  • Iressa should not be the first chemotherapy medicine that is used to treat NSCLC. Iressa did not show any benefit when used with doublet, platinum-based chemotherapy to treat NSCLC.

Who should not take Iressa?  

Do not take Iressa if you are allergic to Iressa or to any of the ingredients in Iressa.

Special Warnings with Iressa:

  • Iressa may cause interstitial lung disease (ILD). ILD is a serious and life-threatening lung disease. The symptoms of ILD are trouble breathing, with or without a cough or fever. ILD may become severe in a very short period of time. 
  • Iressa may cause liver damage called hepatotoxicity. 
  • Iressa may cause eye damage called corneal erosions. 

Call your health care provider right away if you develop: 

  • severe or continual diarrhea, nausea, vomiting, or loss of appetite. These conditions can lead to dehydration (lack of body fluids). 
  • worsening lung symptoms (shortness of breath, cough, fever). 
  • an eye irritation. 
  • any new symptoms.

What should I tell my doctor or health care provider before using Iressa?

Tell your health care provider if you: 

  • have or had liver problems. 
  • are trying to become pregnant, are already pregnant, or are breast-feeding. 

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take: 

  • rifampicin, phenytoin 
  • warfarin 
  • ketoconazole, itraconazole 
  • ranitidine, cimetidine 

These medicines may affect how Iressa works, or Iressa may affect how these medicines work.

What are some possible side effects of Iressa? (This is NOT a complete list of side effects reported with Iressa. Your health care provider or pharmacist can discuss with you a more complete list of side effects.)

Some common side effects with Iressa include: 

  • Diarrhea 
  • Rash 
  • acne 
  • Dry skin 
  • Nausea 
  • Vomiting 
  • Itching 
  • Loss of appetite 
  • Weakness  
  • Weight loss

For more detailed information about Iressa, ask your health care provider or pharmacist.

http://www.fda.gov/cder/foi/label/2003/21399_iressa_lbl.pdf    Iressa's Approved Label 

Posted 6/13/03

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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