Changes in the TASMAR Labeling FAQ
On February 17, 2006,
the Food & Drug Administration (FDA) approved reduced liver monitoring for TASMAR® (tolcapone).
Why did the FDA allow this change?
In May 2005, Valeant Pharmaceuticals submitted a supplemental new drug application for TASMAR that included updated safety data and proposed language for reduced liver monitoring requirements.
The updated safety data includes:
• Reports as of May 2005 of 3 cases of
fatal fulminant hepatic failure from more than 40,000 patient years
of worldwide use.
• An analysis of laboratory monitoring
data in over 3,400 TASMAR-treated patients participating in clinical
trials that indicated increases in SGPT/ALT
or SGOT/AST, when present, generally occurred within the first 6 months
of
treatment with TASMAR.
As a result, the FDA accepted changes to
the TASMAR prescribing information that allow a reduced liver monitoring
schedule for
the first 6 months of treatment and recommend periodic monitoring
at intervals deemed clinically relevant thereafter.
What does this mean for patients currently on TASMAR?
With reduced liver monitoring language in the prescribing information
for TASMAR, patients currently on TASMAR will find that liver
monitoring might be reduced. Periodic liver monitoring (every
2-4 weeks) is recommended for
the first 6 months of treatment. After 6 months, liver monitoring
is recommended at intervals deemed clinically relevant.
If the dose is increased to 200 mg tid (see DOSAGE AND ADMINISTRATION
section), liver enzyme monitoring should take place before increasing
the dose and then be conducted every 2 to 4 weeks for the following
6 months of therapy. After six months, periodic monitoring is
recommended at intervals deemed clinically relevant.
What about patients who have started TASMAR within the past 6 months?
Liver enzyme tests can be reduced to a less frequent schedule
for these patients. For the initial 6 months, patients need periodic
monitoring (i.e., every 2 to 4 weeks) rather than tests every
2 weeks.
After 6 months, liver monitoring is recommended at intervals
deemed clinically relevant.
How is starting a patient on TASMAR different?
The same procedures still apply for patients starting TASMAR:
• A baseline liver enzyme test is needed
to exclude the presence of liver disease
• A patient consent form needs to be signed
However, when a patient begins TASMAR therapy,
liver enzyme tests only need to occur periodically (i.e. every 2
to 4 weeks) rather
than every
2 weeks. After the first 6 months, liver enzyme tests are recommended
at intervals deemed clinically relevant.
Is the patient consent form still valid?
Yes. Before starting treatment, patients still need to be informed
of the risks of using TASMAR and a written consent form must be
signed. Part of
this consent form includes acknowledgement of the liver monitoring
recommendations.
What about the Valeant Liver Monitoring Program?
Due to the reduced liver monitoring recommendations for TASMAR,
the Valeant Liver Monitoring Program will be discontinued. For
the first
6 months
of treatment, patients can schedule their periodic liver test through
their
healthcare provider. After 6 months, liver tests are recommended
at intervals deemed clinically relevant.
Who can I contact with questions?
For more information regarding TASMAR, please contact your Valeant
sales representative or access the complete prescribing
information for TASMAR. |
