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FaslodexMarch 30 2016

Doctors ordering tests which include estradiol should state if their patient is on fulvestrant (Faslodex), the Medicines and Healthcare Products Regulatory Agency is advising.

A medical device alert issued on March 24 states that there is a possible interference from the drug with certain types of estradiol immunoassays. It may mean that assessing the menopausal status of women on fulvestrant may require other means, such as liquid chromatography-mass spectrometry (LC-MS).

Estradiol immunoassays from Siemens Healthcare Diagnostics and Roche Diagnostics have been found to give falsely elevated estradiol results, said the MHRA. Other estradiol assays from other manufacturers may also be affected by fulvestrant and are currently under investigation.

“Fulvestrant has a similar chemical structure to estradiol and may cross-react with the antibodies used in immunoassays.”

Fulvestrant is indicated for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.

“If the listed estradiol assays are used for this group of post-menopausal women, falsely elevated estradiol results could lead to misinterpretation of the menopausal status of these women. This may result in treatment with fulvestrant being altered.”

Link:

MHRA alert

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