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Label Changes for:

Faslodex (fulvestrant)

July 2016

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 (CDER)

July 2016

WARNINGS AND PRECAUTIONS

Injection Site Reaction (addition)
  • Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with FASLODEX injection. Caution should be taken while administering FASLODEX at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve.

ADVERSE REACTIONS

  • The following adverse reactions are discussed in more detail in other sections of the labeling:
    • Injection Site Reaction

MEDICATION GUIDE

What are the possible side effects of FASLODEX?

  • FASLODEX may cause injection site related nerve damage. Call your healthcare provider if you develop any of the following symptoms in your legs following a FASLODEX injection:
    • Numbness
    • Tingling
    • Weakness

 

May 2016

WARNINGS AND PRECAUTIONS

Immunoassay Measurement of Serum Estradiol  
  • Due to structural similarity of fulvestrant and estradiol, FASLODEX can interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.

 

March 2016

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
  • Based on findings from animal studies and its mechanism of action, FASLODEX can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at daily doses that are significantly less than the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with FASLODEX and for one year after the last dose.

 

July 2012

ADVERSE REACTIONS

Post-Marketing Experience
  • elevation of bilirubin, elevation of gamma GT, hepatitis, and liver failure have been reported infrequently (<1%).

  

September 2010

WARNINGS and PRECAUTIONS

Hepatic Impairment
  • A 250 mg dose is recommended in patients with moderate hepatic impairment

USE IN SPECIFIC POPULATIONS

Hepatic Impairment
  • A dose of FASLODEX 250 mg is recommended in patients with moderate hepatic impairment (Child-Pugh class B). 

 

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