Label Changes for:

Neupogen (filgrastim)

September 2013

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)

 

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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