| This is the text of a letter
from Biogen.
Contact the company for a copy of any referenced enclosures.
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March 7, 2003
Dear Healthcare Professional:
Biogen wishes to inform you of several changes to the prescribing
information for AVONEX (Interferon beta-1a). Since AVONEX
was introduced to the market in 1996, Biogen has continued
to gather information on the safety and efficacy of AVONEX.
In November 2002, the Immunogenicity section of the prescribing
information was updated to describe recent experience with
antibody formation. On January 31, 2003 Biogen received
approval from the U.S. Food and Drug Administration to include
in the Indications and Usage Section, MS patients with a first
clinical episode and MRI features consistent with MS.
The clinical study data on which this change was based is
now included in the Clinical Studies Section. The labeling
has been revised to include important new safety information
and patient Medication Guide. A copy of the revised
full prescribing information and Medication Guide are enclosed;
a summary of the important changes is presented below.
Clinical Studies:
The clinical studies section of the labeling has been updated
to include the results of a study showing efficacy in MS patients
who had recently experienced an isolated demyelinating event
and who had MRI lesions typical of MS.
Indications and Usage:
Additionally, to address the findings in this group of patients,
the Indications and Usage section of the labeling has been
revised accordingly.
Safety Information:
Warnings:
This section has been revised to include a cautionary note
regarding use in patients with depression and other severe
psychiatric symptoms, and post-marketing reports of depression,
suicidal ideation and/or development of new or worsening of
pre-existing other psychiatric disorders, including psychosis.
New warnings added to the labeling include rare reports of
anaphylaxis and other allergic reactions, and post-marketing
reports of decreased peripheral blood counts, including pancytopenia
and thrombocytopenia.
Precautions:
To address post-marketing reports of autoimmune disorders,
including autoimmune hepatitis, and hepatic injury manifesting
itself as elevated serum enzyme levels and hepatitis, two
new subsections have been added to the section.
Adverse Reactions:
This section of the labeling has been thoroughly revised
and updated to reflect the combined safety data from the two
placebo-controlled studies, to clarify the adverse reactions
most commonly reported and associated with the use of AVONEX
and to include a new subsection to address safety information
obtained from post-marketing reports.
Other changes include a complete revision of the Patient
Information section. The new patient section is now a Medication
Guide, which provides important new patient safety information
and more comprehensive instructions for patient self-administration
of AVONEX
Healthcare professionals should report any serious adverse
events possibly associated with the use of AVONEX (Interferon
beta-1a) to Biogen at 1-800-456-2255. Alternatively, this
information may be reported to FDA's MedWatch reporting system
by phone (1-800-FDA-1088), facsimile (1-800-FDA-1078), or
the MedWatch
website or mailed to MedWatch, HF-2, 5600 Fishers Lane,
Rockville, MD 20852-9787.
Biogen is pleased to have served patients with Multiple Sclerosis
and the healthcare providers who provide their medical care.
We are proud of our over six-year record of outstanding patient
service and support. Biogen's knowledge of AVONEX includes
451,000 patient years of experience. For additional information,
please contact Biogen at 1-800-456-2255.
Sincerely,
John Ferguson, MD
Vice President
Drug Safety and Medical Information
Alfred Sandrock, MD, Ph.D.
Senior Director,
Medical Research
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