Label Changes for:
Neupogen (filgrastim)
May 2012
Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER)
May 2012
ADVERSE REACTIONS
Postmarketing Experience
- decreased bone density and osteoporosis in pediatric SCN patients
PATIENT PACKAGE INSERT
What about pregnancy or breast-feeding?
- If you become pregnant during NEUPOGEN treatment, you are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. You should call 1-800-77-AMGEN (1-800-772-6436) to enroll
How to Prepare the dose of Neupogen in Vials or Prefilled Syringes ..... section updated
June 2010
PRECAUTIONS
Pregnancy Category C
- Women who become pregnant during Neupogen treatment are encouraged to enroll in Amgren's Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.
