Important Info for MSers on Novantrone/Mitoxantrone

[Guest guest]

I know there will be few MSers on this list on the drug, but thought

it was worth passing on:

http://www.msrc.co.uk/index.cfm?fuseaction=show & pageid=698

FDA recommendations for cardiac monitoring of patients with multiple

sclerosis (MS) who are treated with Novantrone

The FDA has issued an alert informing healthcare professionals about

additional recommendations for cardiac monitoring of patients with

multiple sclerosis (MS) who are treated with mitoxantrone (marketed as

Novantrone and as generics).

In 2005, the labeling for mitoxantrone was changed to recommend that

left ventricular ejection fraction (LVEF) be evaluated before

initiating treatment and before administering each dose of

mitoxantrone to patients with MS. These changes were established in

response to postmarketing and case reports in the medical literature

that described decreases in LVEF or frank congestive heart failure in

patients with MS who had received cumulative doses of mitoxantrone

that were lower than 100 mg/m2.

Since that time, the FDA has received information from a postmarketing

safety study that demonstrated poor adherence to these recommendations

in clinical practice. This study used insurance-claims data and

medical-record reviews to examine cardiac monitoring patterns in

clinical practice. In this study, it was noted that four patients

developed congestive heart failure 4 to 17 months after completing

therapy with mitoxantrone.

Given the potential severity of cardiotoxicity and evidence suggesting

poor adherence to the recommendations for monitoring cardiac function,

the FDA is currently working with the manufacturers of mitoxantrone to

remind healthcare professionals of the importance of adhering to the

recommendations for patients with MS who are treated with mitoxantrone.

In addition, the FDA and the manufacturers are now advising that all

patients with MS who have finished treatment with mitoxantrone receive

yearly quantitative LVEF evaluations to detect late-occurring cardiac

toxicity.

The FDA has issued the following recommendations for patients treated

with mitoxantrone.

For All Patients

Assess signs and symptoms of cardiac disease with a history, physical

examination, and ECG before initiating therapy with mitoxantrone.

Perform a baseline quantitative evaluation of LVEF.

For Patients With MS

Patients with a baseline LVEF below the lower limit of normal should

not be treated with mitoxantrone.

Patients should be assessed for cardiac signs and symptoms with a

history, physical examination, and ECG before each dose.

Patients should undergo a quantitative reevaluation of LVEF before

each dose, using the same methodology for each assessment. Additional

doses of mitoxantrone should not be administered to patients who have

experienced either a drop in LVEF to below the lower limit of normal

or a clinically significant reduction in LVEF during mitoxantrone

therapy.

Patients should not receive a cumulative mitoxantrone dose greater

than 140 mg/m2.

Patients should undergo yearly quantitative LVEF evaluations after

stopping mitoxantrone to monitor for late-occurring cardiotoxicity,

using the same methodology that was used for assessments that were

done during treatment.

Source: FDA (04/08/08)

More info at link above