A new day with ECHELON-1

Adam Forman, MD, gives an expert overview of the groundbreaking data from the latest ECHELON-1 update.

Official video for ADCETRIS® (brentuximab vedotin) for injection. This video is intended for US healthcare professionals only. See Select Safety Information below, including BOXED WARNING. Select Safety Information does not include all information needed to use ADCETRIS safely and effectively. See full Prescribing Information: https://webfiles.pfizer.com/Adcetris_...

Indication

ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III/IV classical Hodgkin lymphoma, in combination with doxorubicin, vinblastine, and dacarbazine.

Select Safety Information

BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.

CONTRAINDICATION: ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (eg, interstitial infiltration and/or inflammation).

Warnings and Precautions

Peripheral neuropathy (PN): predominantly sensory; motor PN has also been reported. Institute dose modifications accordingly and permanently discontinue ADCETRIS for Grade 4.

Anaphylaxis and infusion reactions: If infusion reaction occurs, interrupt infusion. If anaphylaxis occurs, immediately and permanently discontinue infusion. Premedicate patients with prior infusion-related reaction.

Hematologic toxicities including fatal and serious cases of febrile neutropenia: Monitor complete blood counts prior to each dose. Consider G-CSF prophylaxis, if applicable. If Grade 3 or 4 neutropenia develops, consider dose modification, discontinuation, or G-CSF prophylaxis.

Serious infections and opportunistic infections, including fatal outcomes: Closely monitor patients for emergence of infections.

Tumor lysis syndrome: Monitor closely and take appropriate measures.

Increased toxicity in the presence of severe renal impairment or moderate or severe hepatic impairment: Avoid use.

Hepatotoxicity including fatal and serious cases: Monitor liver enzymes and bilirubin. New, worsening, or recurrent hepatotoxicity may require a dose modification or discontinuation of ADCETRIS.

PML including fatal cases: Hold ADCETRIS dosing if PML is suspected and discontinue ADCETRIS if PML is confirmed.

Pulmonary toxicity including fatal and serious noninfectious events (pneumonitis, interstitial lung disease, acute respiratory distress syndrome): If new or worsening pulmonary symptoms occur, hold ADCETRIS dosing until symptomatic improvement.

Serious dermatologic reactions including fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): Discontinue ADCETRIS if SJS or TEN occurs.

Gastrointestinal (GI) complications including fatal cases of acute pancreatitis and GI complications (perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, ileus).

Hyperglycemia including serious cases such as hyperglycemia, exacerbation of preexisting diabetes mellitus, and ketoacidosis (including fatal outcomes): Monitor serum glucose. Administer antihyperglycemic medications as clinically indicated.

Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception during ADCETRIS treatment and for 2 months after the last dose of ADCETRIS. Advise male patients with female partners of reproductive potential to use effective contraception during ADCETRIS treatment and for 4 months after the last dose of ADCETRIS.

Serious adverse reactions were reported in 43% of ADCETRIS+AVD-treated patients and 27% of ABVD-treated patients. The most common serious adverse reactions in ADCETRIS+AVD-treated patients were febrile neutropenia (17%), pyrexia (7%), neutropenia and pneumonia (3% each).

The most common adverse reactions (≥20% in any study) were peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, mucositis, thrombocytopenia, and febrile neutropenia.

Concomitant use of strong CYP3A4 inhibitors has the potential to affect exposure to monomethyl auristatin E (MMAE). Close monitor adverse reactions.

Breastfeeding is not recommended during ADCETRIS treatment.

More information on safe and effective use of ADCETRIS, including dose management for specific adverse reactions: See full Prescribing Information: https://webfiles.pfizer.com/Adcetris_...