“The body is a complex dance between stimuli and response.”

Proventus.org.uk

Improving Life - Increasing Hope

Our booklets of information are provided free to our members

Booklets

All contents

UK Reg charity

No 1108986

terms and conditions

Helpline

Tel 01233 334 879

E-mail enquiries

Website Maker

Serif

WEBPLUSX2

You are encouraged to report negative side effects of prescription drugs.

Novantrone-Mitoxantrone-heart monitoring problems in Multiple Sclerosis treatment!

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 (Electro Cardigram) 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)

LVEF-left ventricular ejection fraction

The heart circulates blood through 2 separate systems. The two chambers on top of the heart (atriums) receive blood. And the two lower chambers (ventricles) pump the blood out.
The left chamber (ventricle) pumps oxygen-rich blood into the arteries, which carry it throughout the body.

This blood returns to the right chamber (atrium), which passes it down to the right chamber (ventricle).

The right chamber (ventricle) pumps this blood to the lungs, where it picks up oxygen. The oxygen-rich blood then returns to the left chamber (atrium), which passes it into the left chamber (ventricle), and round and round it goes in a continuous cycle.

Valves between the chambers prevent "backwash." That’s the easy part.

When the left chamber (ventricle) contracts, pushing blood out into the arteries, it's called "ejection" as it is "ejecting" the blood out into those arteries. The big chamber on the lower left is the one that pushes blood throughout your body, and that is where they usually measure heart function – the ventricle-the "ejection" part.

The "fraction" part is because that pumping chamber (the left ventricle) never quite manages to pump out all of the blood inside it - there's always some that remains behind waiting for the next contraction.

The amount the left chamber (ventricle) pumps out per beat is called the "ejection fraction". It's X% (the amount pumped out) of the total amount of blood in the left chamber (ventricle) per heart beat.