Please make a selection
Patient/Caregiver Information
Dear Patient,
AstraZeneca announced on June 17, 2005 that after discussions with
the U.S. Food and Drug Administration (FDA), the company is making
a change to the IRESSA® (gefitinib tablets) label.
Based on the FDA’s assessment of currently available data,
the revised label indicates that IRESSA is only to be used in
patients who are benefiting or have benefited from IRESSA. No new
patients will be allowed access to IRESSA unless they are being
enrolled into a qualifying clinical trial approved by an
Institutional Review Board (IRB) prior to June 17, 2005.
AstraZeneca also announced that the IRESSA Access Program
will be initiated to ensure that only patients who have benefited
from IRESSA prior to September 15, 2005 or who are enrolled in a
qualifying clinical trial will be able to fill renewal
prescriptions for IRESSA. Before September 15, 2005, you can
continue to obtain IRESSA by prescription from local pharmacies.
After September 15, 2005, you will fill your renewal prescriptions
through Priority Healthcare, the specialty mail order pharmacy
administering the IRESSA Access Program.
After September 15, 2005, the following steps are needed before
your prescription can be filled:
-
You must read, complete and sign a Patient Consent Form for the
IRESSA Access Program after discussing your treatment
with your doctor. (Forms are available from your
physician, by calling AstraZeneca at 1-800-601-8933 or from
this website.
-
Your physician must complete a Physician Certification Form
stating you were taking IRESSA prior to September 15, 2005 or
are participating in a clinical trial that was approved by an
IRB prior to June 17, 2005.
-
Your physician must send the signed Patient Consent and
Physician Certification forms and a prescription to the
IRESSA Access Program (address and fax number are on the
forms)
-
To fill a prescription after September 15, 2005, you must
call Priority Healthcare, a specialty pharmacy, at
1-800-601-8933. In preparation for this call to Priority
Healthcare, please have your insurance card available and a
method of payment for any co-pay you are responsible for under
your coverage.
-
When all the above steps have been completed, your IRESSA
prescription will be shipped by Priority Healthcare to your
home address, or any other address you designate.
Prior to September 15, 2005, you can continue to obtain
IRESSA by prescription from your local pharmacy. Starting September
15, 2005, all prescriptions must be filled by Priority Healthcare;
do not go to your local pharmacy for IRESSA prescription
renewals. If you are currently in a clinical trial for
IRESSA and receive IRESSA directly from your physician, this
program does not apply to you.
AstraZeneca remains committed to continuing IRESSA research and
providing new data to the FDA as it becomes available. This will
include clinical trials that will examine the use of IRESSA in
patients refractory to currently available chemotherapies.
Current IRESSA patients should be assured that their uninterrupted
access to IRESSA is AstraZeneca’s primary concern.
Information on the IRESSA Access Program, including
enrollment forms are available by calling AstraZeneca at
1-800-601-8933 or from this website.
Patient Q&A
Q: I am currently on Iressa - will I still be able to get
it?
A: AstraZeneca’s highest priority is to ensure continued
access to IRESSA in the US for patients that are currently
benefiting from the drug. If you are currently taking IRESSA and in
consultation with your doctor you both feel that you are benefiting
from IRESSA and that other available therapies are not best for you
at this time, your doctor can continue to renew your IRESSA
prescription and you will be able to fill your prescription through
the IRESSA Access Program after September 15, 2005. Prior to
that time, please continue to fill your IRESSA prescription as you
normally would. Patients will also be able to renew prescriptions
for IRESSA after September 15, 2005 if they were previously on
IRESSA and benefited but are not currently taking IRESSA due to
other medical reasons.
Q: What should patients who are currently on IRESSA in the U.S.
do to maintain their access to IRESSA?
A: Before September 15, 2005, patients in the U.S. may continue to
obtain IRESSA by prescription from their local pharmacies. After
September 15, 2005, only existing patients will be able to refill
prescriptions unless they are part of an ongoing approved clinical
trial. Renewal prescriptions will be handled through the IRESSA
Access Program via a mail order pharmacy. Patients will need to
read and sign a patient consent form after discussing their
treatment with their doctor. In order to write a renewal
prescription, Physicians must complete a Physician
Certification Form stating that a patient was taking IRESSA prior
to September 15, 2005 or that the patients is participating in a
qualifying clinical trial. Forms are available by calling
AstraZeneca at 1-800-601-8933 or from this website.
Q: What will IRESSA cost through the IRESSA Access Program?
A: Prescriptions filled through the IRESSA Access Program
will be priced in line with what pharmacies are charging for IRESSA
today. Priority Healthcare, a large national mail order pharmacy,
will administer the IRESSA Access Program. They take all
forms of insurance and can help you with your insurance coverage
questions.
Q: Will I be able to continue to get my IRESSA prescription
filled at my local pharmacy?
A: Prior to September 15, 2005 patients can continue to fill IRESSA
prescriptions as they always have. After September 15, 2005 current
patients should fill renewal prescriptions through the IRESSA
Access Program run by Priority Healthcare, a mail order
pharmacy.
Q: Can my pharmacist enroll me in the IRESSA Access
Program?
A: Prior to September 15, 2005 your local pharmacist can fill your
IRESSA prescription, but they cannot enroll you in the IRESSA
Access Program that will enable you to have prescriptions
renewed after September 15, 2005. Only your treating physician can
enroll you in the IRESSA Access Program.
Q: How can I get more information on the Iressa Access
Program?
A: Your physician or his/her staff will have information on the
program. Information is also available by calling AstraZeneca at
1-800-601-8933 between the hours of 8am and 6pm EST Monday through
Friday or from this website.
IRESSA Access Program Patient Consent Form
Additional information about IRESSA®
(gefitinib tablets) has recently become available.
As a result of that information, the IRESSA Access Program is
being implemented effective September 15, 2005. The IRESSA
Access Program places limitations on the types of patients who
can take IRESSA and the way qualifying patients can receive
their supply of IRESSA.
You may be eligible to obtain IRESSA through the IRESSA Access
Program. For you to be able to decide whether you want to
sign up for the IRESSA Access Program, you should understand
enough about the risks and benefits of IRESSA therapy to make
an informed decision. This process is known as informed
consent. Once you have been informed and have had any
questions you may have about IRESSA answered, you will be asked
to sign this consent form if you wish to receive IRESSA through
the IRESSA Access Program. You do not have to sign this consent
form. If you do not sign this consent form, you will not be
able to receive IRESSA after September 15, 2005.
Click here to download the patient consent form for the IRESSA Access Program
Please click here for Full Prescribing Information
Additional Resources
|
