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: ADCETRIS treatment
causes a peripheral neuropathy that is
predominantly sensory. Cases of peripheral
motor neuropathy have also been reported.
ADCETRIS-induced peripheral neuropathy 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: Infusionrelated 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.
• 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,