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In the post auto-HSCT consolidation treatment of patients with classical Hodgkin lymphoma ( HL ) at high risk of relapse or progression , ADCETRIS ® ( brentuximab vedotin ) significantly increased PFS compared to placebo 1
18.8
month median PFS benefit 1
ADCETRIS : 42.9 months ( 95 % CI : 30.4 , 42.9 † ) Placebo : 24.1 months ( 95 % CI : 11.5 , NE ) HR = 0.57 ( 95 % CI : 0.40 , 0.81 ) P = 0.001
NE = Not estimable . † Estimates are unreliable .
STUDY DESIGN : ADCETRIS was evaluated as post auto-HSCT consolidation treatment in a multicenter , randomized , double-blind , placebo-controlled trial of 329 patients aged ≥18 years with classical Hodgkin lymphoma ( histologically confirmed ) at high risk of relapse or disease progression within 30-45 days post auto-HSCT . Patients were randomized to receive ADCETRIS 1.8 mg / kg ( n = 165 ) or placebo ( n = 164 ) q3w for up to 16 cycles . High risk of relapse / progression was defined by ≥1 of the following risk factors : refractory disease , relapse < 12 months after frontline therapy , relapse ≥12 months with extranodal disease . Primary endpoint was PFS per independent review facility . 1 , 2
The most common adverse reactions ( ≥20 %) in the ADCETRIS-treatment arm ( 167 patients ), regardless of causality , were : neutropenia , peripheral sensory neuropathy , thrombocytopenia , anemia , upper respiratory tract infection , fatigue , peripheral motor neuropathy , nausea , cough , and diarrhea 1
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therapies and underlying disease that may cause immunosuppression . Consider the diagnosis of PML in any patient presenting with new-onset signs and symptoms of central nervous system abnormalities . Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed .
• Pulmonary toxicity : Events of noninfectious pulmonary toxicity including pneumonitis , interstitial lung disease , and acute respiratory distress syndrome , some with fatal outcomes , have been reported . Monitor patients for signs and symptoms of pulmonary toxicity , including cough and dyspnea . In the event of new or worsening pulmonary symptoms , hold ADCETRIS dosing during evaluation and until symptomatic improvement .
• Serious dermatologic reactions : Stevens-Johnson syndrome ( SJS ) and toxic epidermal necrolysis ( TEN ), including fatal outcomes , have been reported with ADCETRIS . If SJS or TEN occurs , discontinue ADCETRIS and administer appropriate medical therapy .
• Gastrointestinal ( GI ) complications : Fatal and serious GI complications , including perforation , hemorrhage , erosion , ulcer , intestinal obstruction , enterocolitis , neutropenic colitis , and ileus , have been reported in ADCETRIS-treated patients . Lymphoma with preexisting GI involvement may increase the risk of perforation . In the event of new or worsening GI symptoms , perform a prompt diagnostic evaluation and treat appropriately .
• Embryo-fetal toxicity : Based on the mechanism of action and findings in animals , ADCETRIS can cause fetal harm when administered to a pregnant woman . Females of reproductive potential should avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS .
Adverse Reactions :
The most common serious adverse reactions in the ADCETRIS-treated arm , regardless of causality , were pneumonia , pyrexia , vomiting , nausea , hepatotoxicity , and peripheral sensory neuropathy .
References : 1 . ADCETRIS [ Prescribing Information ]. Bothell , WA : Seattle Genetics , Inc .; March 2016 . 2 . Moskowitz CH , Nademanee A , Masszi T , et al ; for the AETHERA Study Group . Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin ’ s lymphoma at risk of relapse or progression ( AETHERA ): a randomised , double-blind , placebo-controlled , phase 3 trial . Lancet . 2015 ; 385:1853-1862 .
Drug Interactions :
Concomitant use of strong CYP3A4 inhibitors or inducers , or P-gp inhibitors , has the potential to affect the exposure to monomethyl auristatin E ( MMAE ).
Use in Specific Populations :
MMAE exposure and adverse reactions are increased in patients with moderate or severe hepatic impairment or severe renal impairment . Avoid use .
Advise females of reproductive potential to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS .
Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS .
Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS .
Please see brief summary of Prescribing Information on following page and full Prescribing Information at ADCETRIS . com .
ADCETRIS , Seattle Genetics , and their logos are US registered trademarks of Seattle Genetics , Inc . © 2016 Seattle Genetics , Inc ., Bothell , WA 98021 All rights reserved . Printed in USA USP-BVP-2015-0161 ( 2 )