Indication
ADCETRIS is indicated for the treatment of patients with classical HL at high risk of relapse or progression as post autologous hematopoietic stem cell transplantation ( auto-HSCT ) consolidation .
Important Safety Information
BOXED WARNING
Progressive multifocal leukoencephalopathy ( PML ): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS ® ( brentuximab vedotin ).
Contraindication :
ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity ( e . g ., interstitial infiltration and / or inflammation ).
Warnings and Precautions :
• Peripheral neuropathy ( PN ): ADCETRIS treatment causes a PN that is predominantly sensory . Cases of motor PN have also been reported . ADCETRISinduced PN is cumulative . Monitor patients for symptoms of neuropathy , such as hypoesthesia , hyperesthesia , paresthesia , discomfort , a burning sensation , neuropathic pain or weakness and institute dose modifications accordingly .
• Anaphylaxis and infusion reactions : Infusion-related reactions , including anaphylaxis , have occurred with ADCETRIS . Monitor patients during infusion . If an infusion-related reaction occurs , interrupt the infusion and institute appropriate medical management . If anaphylaxis occurs , immediately and permanently discontinue the infusion and administer appropriate medical therapy . Patients who experienced a prior infusion-related reaction should be premedicated for subsequent infusions . Premedication may include acetaminophen , an antihistamine , and a corticosteroid .
• Hematologic toxicities : Prolonged ( ≥1 week ) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS . Febrile neutropenia has been reported with ADCETRIS . Monitor complete blood counts prior to each dose of ADCETRIS and consider more frequent monitoring for patients with Grade 3 or 4 neutropenia . Monitor patients for fever . If Grade 3 or 4 neutropenia develops , consider dose delays , reductions , discontinuation , or G-CSF prophylaxis with subsequent doses .
• Serious infections and opportunistic infections : Infections such as pneumonia , bacteremia , and sepsis or septic shock ( including fatal outcomes ) have been reported in patients treated with ADCETRIS . Closely monitor patients during treatment for the emergence of possible bacterial , fungal or viral infections .
• Tumor lysis syndrome : Closely monitor patients with rapidly proliferating tumor and high tumor burden .
• Increased toxicity in the presence of severe renal impairment : The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment compared to patients with normal renal function . Avoid the use of ADCETRIS in patients with severe renal impairment .
• Increased toxicity in the presence of moderate or severe hepatic impairment : The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment compared to patients with normal hepatic function . Avoid the use of ADCETRIS in patients with moderate or severe hepatic impairment .
• Hepatotoxicity : Serious cases of hepatotoxicity , including fatal outcomes , have occurred with ADCETRIS . Cases were consistent with hepatocellular injury , including elevations of transaminases and / or bilirubin , and occurred after the first dose of ADCETRIS or rechallenge . Preexisting liver disease , elevated baseline liver enzymes , and concomitant medications may also increase the risk . Monitor liver enzymes and bilirubin . Patients experiencing new , worsening , or recurrent hepatotoxicity may require a delay , change in dose , or discontinuation of ADCETRIS .
• Progressive multifocal leukoencephalopathy ( PML ): JC virus infection resulting in PML and death has been reported in ADCETRIS-treated patients . First onset of symptoms occurred at various times from initiation of ADCETRIS therapy , with some cases occurring within 3 months of initial exposure . In addition to ADCETRIS therapy , other possible contributory factors include prior