This is the text of a letter from Biogen. Contact the company for a copy of any referenced enclosures.
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.
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.
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.
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.
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 at www.fda.gov/medwatch or mailed to
5600 Fishers Lane,
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. Biogenís
knowledge of AVONEX includes 451,000 patient years of experience. For additional
information, please contact Biogen at 1-800-456-2255.
John Ferguson, MD
Drug Safety and Medical Information
Alfred Sandrock, MD, Ph.D.
AVONEX (Interferon beta-1a) Full Prescribing Information