Dear Healthcare Professional,
Welcome to the Prolia® Postmarketing Active Safety Surveillance Program. This program will help Amgen further understand the long-term safety profile of Prolia®. It is important for companies such as Amgen to obtain ongoing information on the safety of its products.
This program complements routine adverse event reporting systems, such as FDA’s MedWatch program, and will collect information on certain Adverse Events of Special Interest among patients who have received Prolia® (denosumab) therapy. As part of this program, US based prescribers are requested to ask their patients who are receiving Prolia® about the occurrence of Adverse Events of Special Interest during the course of routine medical practice. Prescribers can also authorize up to five (5) healthcare professional delegates to perform program-related tasks including reporting Adverse Events of Special Interest. Delegates will register separately for the program, must have an active state healthcare professional license (e.g. registered nurse) and will receive all program communications and training materials.
While participation in the program is not necessary to prescribe Prolia®, Amgen encourages all Prolia® prescribers and their delegates to register to support our efforts to continue to monitor the long-term safety of the product. You may report adverse events by phone anytime at 1-800-772-6436.
All that is required to become part of this voluntary program is some of your time to complete registration and training activities.
You may register for this program in one of three ways:
- Online by clicking on the register link on the left of this page
- Via US mail or fax by completing the enclosed paper registration form
- Via telephone by contacting Amgen at 1-800-772-6436
You may register before you prescribe Prolia® in your clinical practice. By registering, you will receive program-related correspondence and support adverse event data collection. Your information will be kept completely confidential on Amgen’s secure system and will be used solely for program purposes.
Your participation is voluntary and greatly appreciated.
Please click on the “Register” link on the left hand side of the page to get started. If you are already a registered participant please login now.
Thank you for your participation!
The Prolia® Postmarketing Active Safety Surveillance Program Team