Patient Information Sheet
Gefitinib (marketed as Iressa)
This is a summary of the most important information
about Iressa. For details, talk to your healthcare professional.
FDA ALERT [06/2005]: FDA has approved new
labeling for Iressa that states the medicine should be used only in
cancer patients who have already taken the medicine and whose doctor
believes it is helping them. New patients should not be given Iressa
because in a large study Iressa did not make people live longer.
There are other medicines for non-small cell lung cancer (NSCLC)
that have shown an ability to make people live longer.
This information reflects
FDA’s current analysis of all available data concerning this drug.
FDA intends to update this sheet when additional information or
analyses become available.
What Is Iressa?
Iressa is a medicine used to kill cancer cells
(chemotherapy). It is used alone for the continued treatment of
patients who are benefiting or have benefited from Iressa. Iressa is
approved for patients with non-small cell lung cancer (NSCLC) that:
-
has progressed after treatment with platinum based
and docetaxel chemotherapies, or
-
did not respond to treatment with platinum based or
docetaxel chemotherapies.
What Are The Risks?
The following are the major possible risks and side
effects of Iressa therapy. This list is not complete.
-
Liver damage.
-
Eye problems, such as pain, redness or change
in vision. Some patients have had an injury to the surface of the
eye (cornea). This may be caused by eyelashes growing inside the
eyelid.
-
Other side effects with Iressa may include:
diarrhea, rash acne, dry skin, nausea, vomiting, itching, loss of
appetite, weakness, weight loss
What Should I Tell My Healthcare
Professional?
Before being treated with Iressa tell your
healthcare professional if you:
-
have or had liver problems.
-
are trying to become pregnant, are already pregnant,
or are breast-feeding
While being treated with Iressa call your healthcare
professional right away if you develop:
-
severe or continual diarrhea, nausea, vomiting, or
loss of appetite. These conditions can lead to low body fluids
(dehydration).
-
an eye problem
-
any new symptoms
Are There Any Interactions With
Drugs or Foods?
Tell your healthcare professional about all the
medicines you take, including prescription and over-the-counter
drugs, and supplements. Especially tell your health care provider if
you take:
These medicines may affect how Iressa works, or
Iressa may affect how these medicines work.
Iressa FDA Approved 2003
Patient Information Sheet Revised 06/2005
Back
to Top
Back to Iressa
PDF requires the free Adobe
Acrobat Reader
Date created: June 17, 2005 |