Label Changes for:
Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER)
- Thrombocytopenia has been reported in patients receiving NEUPOGEN. Platelet counts should be monitored closely
- information on Amgen’s Lactation Surveillance Program
- added ... splenomegaly (enlarged spleen)
- 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
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.