Safety Alerts & Recalls

What does this mean?

Most healthcare providers involved in the management of patients taking Rapamune (sirolimus) work closely with their laboratories to provide appropriate therapeutic drug monitoring for their patients taking this medicine. However, if you are taking Rapamune (sirolimus) and are having difficulty finding the right dose, you may wish to discuss this updated prescribing information with your doctor. If you have questions about this alert or if you think you are experiencing side effects from Rapamune (sirolimus), please follow up with your healthcare provider.

Updated Information on Monitoring of Rapamune (Sirolimus) Drug Levels

Wyeth has updated the prescribing information related to monitoring levels of Rapamune (sirolimus) in the body, often called therapeutic drug monitoring (TDM). The labeling was revised to inform healthcare providers that test results may vary based on the type of test and laboratory that performs the test.

As a result, the following is recommended: 1) Healthcare providers involved in the management of patients taking Rapamune (sirolimus) should be familiar with the tests used in their laboratory and be notified of any changes to the tests, and

2) Patients should use the same laboratory each time their Rapamune (sirolimus) drug level is measured.

Rapamune contains the active ingredient sirolimus and is indicated for the prevention of organ rejection in patients aged 13 years or older receiving kidney transplants.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-01-15
Last Updated: 2010-03-01

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