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PATIENT CONSENT
TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE
DISCUSSION OF THE RISKS AND WRITTEN INFORMED CONSENT HAS BEEN OBTAINED.
IMPORTANT INFORMATION AND WARNING
Reports of potentially life-threatening cases of severe hepatocellular
injury, including fulminant liver failure resulting in death, have
been reported in association with use of TASMAR.
PATIENT CONSENT
treatment with TASMAR
has been personally described to me by Dr.____________________________________________
The following points of information, among others,
have been specifically discussed and made clear and I have had the
opportunity to ask any questions concerning this information:
(patient’s name)
understand that TASMAR is used to treat certain types of patients
with Parkinson’s disease and my physician has told me that I am
this type of patient.
Initials:___________________________________
2. I understand that there is a serious risk that I could develop
severe liver failure, which may be potentially fatal, by using TASMAR.
Initials:___________________________________
3. I understand that there are no laboratory tests that will predict
if I am at an increased risk for fatal liver failure.
Initials:___________________________________
4. I understand that I should have the recommended blood work
before my treatment with TASMAR is begun or continued and every
2 weeks for the first year, then every 4 weeks for the next 6 months,
and then every 8 weeks thereafter while taking TASMAR. I understand
that although this blood work may help detect if I develop liver
failure it may do so only after significant, irreversible and potentially
fatal damage has already occurred.
Initials:__________________________________
5. I understand that I must immediately report any unusual symptoms
to Dr.__________ and be especially aware of persistent nausea, fatigue,
lethargy, decreased appetite, jaundice (yellowing of skin or the
whites of the eyes), dark urine, itchiness or right-sided abdominal
pain.
Initials:__________________________________
I now authorize Dr. ________________________________________________________to
begin my treatment with TASMAR; OR, if my treatment has already
begun with TASMAR, to continue such treatment.
Patient/Caretaker__________________________________________________________
Address__________________________________________________________________
_________________________________________________________________________
Telephone ________________________________________________________________
PHYSICIAN STATEMENT:
I have fully explained to the patient,_______________________________________,
the nature and purpose of the treatment with TASMAR (tolcapone)
and the potential risks associated with that treatment. I have asked
the patient if he/she has any questions regarding this treatment
or the risks and have answered those questions to the best of my
ability. I also acknowledge that I have read and understand the
prescribing information listed above.
Physician
Date
NOTE TO PHYSICIAN: It is strongly recommended that you retain
a signed copy of the informed consent with the patient’s medical
records.
SUPPLY OF PATIENT CONSENT FORMS:
A supply of “Patient Consent” forms as printed above, is
available, free of charge, from your local Roche representative,
or may be obtained by calling 1-800-526-6367. Permission to
use the above Patient Consent by photocopy reproduction is also
hereby granted by Roche Laboratories Inc.
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