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FDA Drug Safety Podcast for Healthcare Professionals: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)

Lesley Navin, a Consumer Safety Officer in the Division, will provide you with additional information about this Communication.

Guest Speaker: On January 13, 2012, the Food and Drug Administration issued a Drug Safety Communication notifying the public 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. Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label. At the time of Adcetris' approval in August 2011, one case of PML was described in the Warnings and Precautions section of the label.

In addition, a new Contraindication warning against use of Adcetris with the cancer drug bleomycin due to increased risk of pulmonary toxicity has been added to the drug label.

The signs and symptoms of PML may develop over the course of several weeks or months. They may include changes in mood or usual behavior, confusion, thinking problems, loss of memory, changes in vision, speech, or walking, and decreased strength or weakness on one side of the body. Patients who develop any signs and symptoms of PML should notify their healthcare professional immediately. Healthcare professionals should hold Adcetris dosing if PML is suspected and discontinue Adcetris if a diagnosis of PML is confirmed.

FDA recommends that healthcare professionals refer to the current Adcetris drug label for the latest prescribing recommendations. Patients should contact their healthcare professional if they have any questions or concerns about Adcetris.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. Concomitant use of Adcetris and bleomycin is contraindicated due to pulmonary toxicity.
  2. John Cunningham, or JC, virus infection resulting in PML and death has been reported in Adcetris-treated patients.
  3. The factors leading to reactivation of latent JC virus are not fully understood. In addition to Adcetris therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression.
  4. Patients should be instructed to report changes in mood or usual behavior, confusion, problems thinking, loss of memory, changes in walking or talking, decreased strength or weakness on one side of the body, or changes in vision.
  5. A possible diagnosis of PML should be considered in any patient currently receiving- or who has received Adcetris in the past, and who presents with new signs or symptoms of central nervous system abnormalities.
  6. Evaluation of PML may include consultation with a neurologist and performance of a brain MRI and/or lumbar puncture with analysis of cerebrospinal fluid by polymerase chain reaction for JC virus and/or brain biopsy.
  7. Adcetris dosing should be held for any suspected case of PML. Discontinue Adcetris dosing if a diagnosis of PML is confirmed.
  8. Adverse events involving Adcetris should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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