Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER)
WARNINGS AND PRECAUTIONS
- Glomerulonephritis has occurred in patients receiving NEUPOGEN. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of NEUPOGEN. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NEUPOGEN
PATIENT COUNSELING INFORMATION
- …Glomerulonephritis may occur. Symptoms include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production. Advise patients to report signs or symptoms of glomerulonephritis to their physician immediately…
- 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.