Alerts
Mitoxantrone (Novantrone) - Cardiac Monitoring
July 30, 2008
The FDA is reminding health care professionals to monitor left ventricular ejection fraction (LVEF) in patients with multiple sclerosis (MS) receiving mitoxantrone. A post-marketing safety study using insurance claims data and medical chart reviews evaluated compliance with these cardiac monitoring recommendations which were introduced in 2005. The study revealed poor compliance with the LVEF monitoring recommendations. As stated in the labeling of mitoxantrone, evaluate LVEF at baseline and before each dose of mitoxantrone. Discontinue mitoxantrone therapy in patients with MS experiencing a decrease in LVEF below the lower limit of normal or experiencing a clinically significant decrease. Patients with MS must not exceed a cumulative mitoxantrone dose of 140 mg/m2.
In addition to the recommendations above, the FDA and the manufacturers of mitoxantrone have released the following new recommendation for cardiac monitoring: patients with MS who have completed mitoxantrone therapy are to have yearly assessments of LVEF. The FDA is working with the manufacturers of mitoxantrone to encourage compliance with all cardiac monitoring recommendations for mitoxantrone use.
More information on the mitoxantrone warnings and the previous MedWatch alert on this topic can be found online at:
- MedWatch Warning
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm092708.htm - Information for Healthcare Professionals
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126445.htm - Mitoxantrone Label (I add this in)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf - MedWatch Warning (2005):
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151930.htm - Dear Healthcare Professional Letter (2005):
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164682.pdf - Patient Information (2005)
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164685.pdf
Updated
July 30, 2008; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
