Healthcare Provider Introductory Letter Redline - Amgen

IMPORTANT PRESCRIBING INFORMATION
Subject: Denosumab supplied as Prolia ® and XGEVA ®
July 22, 2011
Dear Healthcare Provider:
Amgen would like to notify you that, Prolia (denosumab) contains the same active ingredient
found in Xgeva (denosumab). Specifically, this letter informs you of the differences in
indication, product strength, dose, and frequency of administration to help prevent medication
errors.
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for
fracture defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or
patients who have failed or are intolerant to other available osteoporosis therapy. Prolia is
supplied as a 60 mg (60 mg/mL) single use prefilled syringe and should be administered as a
60 mg subcutaneous injection every 6 months.
Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases
from solid tumors. Xgeva is not indicated for the prevention of skeletal-related events in patients
with multiple myeloma. Xgeva is supplied as a 120 mg (70 mg/mL) single-use vial and should
be administered as a 120 mg subcutaneous injection every 4 weeks.
Over- or underdosing can occur if the incorrect dosage form of denosumab is administered to
your patient. To prevent these medication errors, you should always double check the product
name, product strength, and dose prior to administration. Prolia Prescribing Information has
been updated with the information that Prolia contains the same active ingredient (denosumab)
found in Xgeva and that patients receiving Prolia should not receive Xgeva. Similar information
has also been added to the Prolia Medication Guide.
Reporting Patient Adverse Events and Medication Errors:
Contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch if any of the following occur:
1) medication errors associated with the incorrect use of Xgeva or Prolia; or
2) any suspected adverse reactions associated with use of Xgeva or Prolia
Please contact our Medical Information department at 1-800-772-6436 or visit
http://www.amgenmedinfo.com/ if you have any questions about either the information
contained in this letter or the safe and effective use of Xgeva or Prolia.
The full prescribing information for Prolia and Xgeva contain important and distinct risk
information.

Prolia is contraindicated in patients with hypocalcemia and hypocalcemia must be corrected
before initiating Prolia. Serious infections including skin infections leading to hospitalization
may occur. Dermatitis, rashes, eczema, and osteonecrosis of the jaw (ONJ) have been reported.
Xgeva can cause severe hypocalcemia. ONJ can occur in patients receiving Xgeva.
Please refer to the accompanying FDA-approved labeling for a complete discussion of the risks
associated with Prolia and Xgeva, as the presentation of risk information in this letter is not
comprehensive. The updated Prolia Prescribing Information and Medication Guide are enclosed,
along with the Xgeva Prescribing Information.
Sincerely,
Sean E. Harper, MD
Senior Vice President, Global Development and Chief Medical Officer
Amgen Inc.