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Ibritumomab tiuxetan associated with severe cutaneous or mucocutaneous reactions


Biogen Idec has informed Healthcare Professional of new safety information which is being added to the prescribing information for Zevalin ( Ibritumomab tiuxetan ).

Severe cutaneous or mucocutaneous reactions, some with fatal outcome, have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience.

Similar events have been associated with Rituxan ( Rituximab ), a component of the Zevalin therapeutic regimen.

The potential risk of these reactions should be considered when using the Zevalin therapeutic regimen.

Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.

In September 2005, the Boxed Warnings, Warnings, and Adeverse Reactions sections of the Prescribing Information were updated to include this important new safety information.

A summary of the changes is presented below ;

Boxed Warnings

This section has been revised to include the following information: “ Severe cutaneous and mucocutaneous reactions,some with fatal outcome,have been reported in association with the Zevalin therapeutic regimen. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further component of the Zevalin therapeutic regimen and should seek prompt medical evaluation. “

Warnings

This section has been revised to include the following information: “ There have been postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis in patients who received the Zevalin therapeutic regimen. Some of these events were fatal. The onset of the reactions was variable; in some cases, acute, ( days ) and in others, delayed ( 3-4 months ). Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.”

Adverse Reactions

This section has been revised to include the following information: “ The most serious adverse reactions caused by the Zevalin therapeutic regimen include prolonged and severe cytopenias, infections ( predominantly bacterial in origin ), hemorrhage while thrombocytopenic ( resulting in deaths ), and allergic reactions ( bronchospasm and angioedema ). In addition, patients who have received the Zevalin therapeutic regimen have developed myeloid malignancies and dysplasias. Fatal infusion reactions have occurred following the infusion of Rituximab. In postmarketing reports, cutaneous and mucocutaneous reactions have been associated with the Zevalin therapeutic regimen. “


The Zevalin regimen combines the anti-CD20 monoclonal antibodies Zevalin ( Ibritumomab tiuxetan ) and Rituxan with indium-111- and yttrium-90 labeled radioisotopes.
The regimen is indicated for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma ( NHL ), including patients with follicular B-cell NHL that are refractory to Rituxan.

Source: FDA, 2005


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