Important Safety Information on Thyrogen
Therapeutic Goods Administration Endorsed Letter
Genzyme Australasia Pty Ltd
P.O. Box 282
NORTH RYDE B/C 2113
Tel: 612 9978 3900
Fax: 612 9889 3900
November 17, 2009
Re: Important Information Regarding Reports of Foreign Particles in Thyrogen® (thyrotropin alfa)
Genzyme has detected foreign particles in some products filled at the Allston Landing facility in the course of routine quality control processes. Genzyme has also received customer reports of foreign particles in some vials of these products. The particles observed include non-latex rubber originating from the stopper, or stainless steel particles or fiber-like materials originating from the manufacturing process. To help ensure that patients are not exposed to foreign particles during product administration, we are writing to alert health care practitioners of the potential presence of such foreign particles and reinforce recommendations consistent with the Australian approved Product Information for product preparation and administration.
Foreign particles identified by visual inspection prior to administration ranged in size from 140-295 microns. Intramuscular injection of foreign particles of this size may cause local reactions at the site of injection. These include injection site reactions such as pain, local swelling and foreign body granuloma as well as local allergic reactions including rash and urticaria.
To better understand these potential risks to patients, Genzyme has received the Thyrogen global safety database which contains all adverse events reported to Genzyme from January 2004 through 5 November 2009 and did not identify any safety concerns that could be potentially related to the intramuscular injection of foreign particles.
We are providing the following recommendations for Thyrogen:
- Perform a visual examination of the lyophilised product prior to reconstitution. Do not use if there are foreign particles.
- Follow the preparation instructions provided in the Dosage and Administration section of the approved product labelling.
- As stated in the approved product labelling, visually inspect the reconstituted product for any foreign particles within each vial and when withdrawn into the syringe. Do not use if there are any foreign particles.
- If foreign particles are observed, report to Genzyme Medical Information at 1800-359-131. Genzyme will provide replacement product and will work with you regarding options for re-scheduling or proceeding with the Thyrogen treatment/testing protocol.
- Please return vials containing foreign particles per instructions to be provided by Genzyme Medical Information.
Should you require further information or have any questions, please do not hesitate to contact us at 1800-359-131. We can also be reached by email at Medinfo_ANZ@genzyme.com.
original signed by
Katy Williams Day
Director, Regulatory & Scientific Affairs
ABN 24 083 420 526