Indications and Important Safety Information

Описание: Indications and Important Safety Information for ADCETRIS.

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. See full Prescribing Information: https://www.pfi.sr/bvpi


Indication
ADCETRIS is a prescription medication indicated for the treatment of adult patients with previously untreated Stage III/IV classical Hodgkin lymphoma (cHL), 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 new-onset 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.

The most common adverse reactions (≥20%) in adult patients are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash. The most common laboratory abnormalities (≥20%) in adult patients are decreased neutrophils, increased creatinine, decreased hemoglobin, decreased lymphocytes, increased glucose, increased ALT, and increased AST.
The most common Grade ≥3 adverse reactions (≥5%) in combination with AVEPC in pediatric patients were neutropenia, anemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection

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

Breastfeeding is not recommended during ADCETRIS treatment.

To report adverse events related to Pfizer products call 1-800-438-1985 (US only) or contact the US Food and Drug Administration (FDA) at fda.gov/MedWatch or call 1-800-FDA-1088.
ADCETRIS and its logo are US registered trademarks of Seagen Inc.
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May 2025. PP-A1T-USA-0883.