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Label Changes for:

Neupogen (filgrastim)

July 2015

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER)

July 2015

WARNINGS AND PRECAUTIONS

Glomerulonephritis
  • 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

ADVERSE REACTION

Postmarketing Experience
  • …glomerulonephritis…

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…
     

 

September 2013

PRECAUTIONS

Thrombocytopenia
  • Thrombocytopenia has been reported in patients receiving NEUPOGEN. Platelet counts should be monitored closely
Nursing Mothers
  • information on Amgen’s Lactation Surveillance Program

ADVERSE REACTIONS

Postmarketing Experience
  • added ... splenomegaly (enlarged spleen)

 

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. 

 

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