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Important Safety Information about ReFacto® (moroctocog alfa), Antihemophilic Factor (Recombinant) [BDDrFVIII]) -Wyeth Canada

Date: 2003-09-26

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IMPORTANT SAFETY INFORMATION
about ReFacto^® (moroctocog alfa), Antihemophilic Factor (Recombinant) [BDDrFVIII])

September 15, 2003

Dear Health Care Professional,

ReFacto, Antihemophilic Factor (Recombinant) [BDDrFVIII] has been licensed in Canada since 2002, and is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). ReFacto does not contain von Willebrand factor and hence is not indicated in von Willebrand's disease.

As a follow-up to our previous discussions, we are advising you of certain amendments to the Product Monograph (see attached*) that Wyeth Canada has made to address information provided to us via voluntary reports of adverse events from the post-marketing setting.

It is Wyeth's customary practice to work closely with hemophilia clinicians and to strongly encourage voluntary adverse event reporting regarding the use of ReFacto. Such reporting enables the medical profession and Wyeth to continue to increase the collective knowledge of Refacto. It also provides further direction in our scientific exploration in this therapeutic area.

In response to voluntary reports of less than expected therapeutic effect, changes to the Precautions and Adverse Reactions sections of the Product Monograph have been made. The Company has included the following information in both sections of the Product Monograph:

Reports of lack of effect, mainly in prophylaxis patients, have been received during the clinical trials and in the post-marketing setting. The lack of effect and/or low factor VIII recovery has been reported in patients with inhibitors but also in patients who had no evidence of inhibitors. The lack of effect has been described as bleeding into target joints, bleeding into new joints, other bleeding or a subjective feeling by the patient of new onset bleeding. In order to ensure an adequate therapeutic response, it is important TO INDIVIDUALLY TITRATE AND MONITOR each patient's dose of ReFacto, particularlywhen initiating treatment with ReFacto.

It is estimated that from the International Birth Date (13 April 1999) through 12 April 2003, approximately 5,800 (± 1000) patients used ReFacto in the post-marketing setting. Cumulatively through 12 April 2003, 85 post-marketing reports of less than desired therapeutic effect and/or low recovery with ReFacto, for which concurrent inhibitor data is negative or not provided have been received. These 85 reports represent 81 patients. Available data regarding these reports is somewhat limited due to their voluntary nature. Reports of less than expected therapeutic effect have not exhibited consistent characteristics. Reports have described bleeding into target joints, bleeding into new joints, other bleeding or subjective feelings by patients of new onset bleeding. In some instances, patients either had a history of inhibitors or had an inhibitor at the time of the report. Some patients reported low FVIII recovery or bleeding despite the absence of inhibitors. In some instances bleeding was not documented but the report was submitted because the patient experienced increased bruising, the sensation of bleeding into target joints, or required higher than anticipated doses for bleed resolution. Some reports describe patients who experienced increased bleeding after switching therapy to ReFacto. For patients who experience a less than desired effect it is important to titrate the dose of ReFacto to achieve the desired effect.

Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with drug treatments.

The identification, characterization, and management of drug-related adverse events is dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Health care professionals are asked to report any suspected adverse reactions in patients receiving ReFacto^® (moroctocog alfa, Antihemophilic Factor (Recombinant) [BDDrFVIII]) directly to Wyeth or the Marketed Health Products Directorate.

Wyeth Canada
Medical Information & Pharmacovigilance Department
50 Minthorn Boulevard
MARKHAM, Ontario, L3T 7Y2
Tel: 1-800-461-8844
Fax: (905)-470-4385
Email: canadaadverseeventreporting@wyeth.com

Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.

If you have any questions about this information, please contact Wyeth Medical Information at 1-800-461-8844.

Sincerely,

original signed by

Neil Maresky, M.B., B. Ch.
Vice President
Scientific Affairs

*The Product Monograph can be obtained from the manufacturer Wyeth Canada (50 Minthorn Boulevard, MARKHAM, Ontario, L3T 7Y2)