Member Alert – Potential Shortage of Thyrogen

AACE has learned that Genzyme, manufacturers of Thyrogen, are facing a potential shortage during the next few months due to a change in its manufacturing facility. Physicians who are considering Thyrogen for their patients may want to consider altering the treatment timetable to begin in July 2011.

Here is a copy of the letter Genzyme is sending to physicians:

“Genzyme Corporation is reporting that global supply of Thyrogen will fluctuate through July, 2011 causing temporary shortages in certain countries. Genzyme anticipates a shortage in the United States beginning in mid-April and extending through mid-June and is notifying health care providers of the supply interruption so that they may schedule individual patient treatments appropriately during this time. Ex-US supply communications are being managed by Genzyme affiliates at the regional level.

Regional disparities in supply are expected to continue to occur due to the logistical complexities of managing global demand with limited inventory.

Genzyme continues to work toward obtaining regulatory approvals worldwide for the fill/finish transfer to a third party contract manufacturing facility. All Thyrogen released from both Genzyme’s Allston plant and from the third party contract manufacturing facility has met all applicable quality standards and is safe for use in patients for whom it is indicated.

Genzyme remains focused on restoring normal supply of Thyrogen globally as soon as possible.”

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