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The Food and Drug Administration on Jan. 13 announced that a boxed warning will be added to the label of brentuximab vedotin because of reports of two cases of progressive multifocal leukoencephalopathy associated with the drug’s use in lymphoma patients.
Brentuximab vedotin (Adcetris) was approved in August 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. At the time of its approval, the warnings and precautions label described one case of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal brain infection. These two additional cases prompted the new boxed warning because of the serious nature of the infection, the FDA release stated.
Additionally, a contraindication warning against the use of brentuximab vedotin in combination with the antitumor antibiotic bleomycin (Blenoxane) has been added to the label because of an association with an increased risk of pulmonary toxicity.
Signs and symptoms of PML include mood or behavior changes; confusion; altered cognitive abilities; memory loss; vision, speech, and motor function changes; and unilateral weakness or decreased strength that can develop over several weeks or months, according to the statement.
The new label advises patients who develop signs or symptoms of the condition to notify their health care provider immediately. If PML is suspected, health care professionals are advised to hold dosing pending the diagnosis of PML, and discontinue the drug if the diagnosis is confirmed.
To listen to a podcast concerning the brentuximab warning, click on the "Listen" button below. Podcast courstesy of the FDA.
The Food and Drug Administration on Jan. 13 announced that a boxed warning will be added to the label of brentuximab vedotin because of reports of two cases of progressive multifocal leukoencephalopathy associated with the drug’s use in lymphoma patients.
Brentuximab vedotin (Adcetris) was approved in August 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. At the time of its approval, the warnings and precautions label described one case of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal brain infection. These two additional cases prompted the new boxed warning because of the serious nature of the infection, the FDA release stated.
Additionally, a contraindication warning against the use of brentuximab vedotin in combination with the antitumor antibiotic bleomycin (Blenoxane) has been added to the label because of an association with an increased risk of pulmonary toxicity.
Signs and symptoms of PML include mood or behavior changes; confusion; altered cognitive abilities; memory loss; vision, speech, and motor function changes; and unilateral weakness or decreased strength that can develop over several weeks or months, according to the statement.
The new label advises patients who develop signs or symptoms of the condition to notify their health care provider immediately. If PML is suspected, health care professionals are advised to hold dosing pending the diagnosis of PML, and discontinue the drug if the diagnosis is confirmed.
To listen to a podcast concerning the brentuximab warning, click on the "Listen" button below. Podcast courstesy of the FDA.
The Food and Drug Administration on Jan. 13 announced that a boxed warning will be added to the label of brentuximab vedotin because of reports of two cases of progressive multifocal leukoencephalopathy associated with the drug’s use in lymphoma patients.
Brentuximab vedotin (Adcetris) was approved in August 2011 for the treatment of Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma. At the time of its approval, the warnings and precautions label described one case of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal brain infection. These two additional cases prompted the new boxed warning because of the serious nature of the infection, the FDA release stated.
Additionally, a contraindication warning against the use of brentuximab vedotin in combination with the antitumor antibiotic bleomycin (Blenoxane) has been added to the label because of an association with an increased risk of pulmonary toxicity.
Signs and symptoms of PML include mood or behavior changes; confusion; altered cognitive abilities; memory loss; vision, speech, and motor function changes; and unilateral weakness or decreased strength that can develop over several weeks or months, according to the statement.
The new label advises patients who develop signs or symptoms of the condition to notify their health care provider immediately. If PML is suspected, health care professionals are advised to hold dosing pending the diagnosis of PML, and discontinue the drug if the diagnosis is confirmed.
To listen to a podcast concerning the brentuximab warning, click on the "Listen" button below. Podcast courstesy of the FDA.