Sicherheitsalarm
New Boxed Warning for Progressive Multifocal Leukoencephalopathy (PML) and Contraindication for Adcetris (Brentuximab vedotin)
The U.S. Food and Drug Adminstration has announced that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the prescribing information. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the prescribing information.
Also, a new Contraindication warning against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary (lung) toxicity has been added to the prescribing information.
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Was bedeutet das?
Adcetris is used to treat very serious conditions including Hodgkin’s lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma. The benefits of Adcetris for these conditions will continue to outweigh the risks for most patients. If you are receiving or have recently received Adcetris, please be aware of the following:
- Cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with Adcetris. The signs and symptoms of PML may develop over the course of several weeks or months.
- Signs and symptoms of PML may include: Changes in mood or usual behavior; Confusion, thinking problems, loss of memory; Changes in vision, speech, or walking; Decreased strength or weakness on one side of the body.
- If you develop any signs and symptoms suggestive of PML, you should notify your healthcare professional immediately.
- If you are receiving Adcetris in combination with bleomycin, you should also talk to your physician about this combination of medications.
If you have any questions or concerns about Adcetris, please talk to your healthcare professional.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.