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
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.
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.
• Hematologic toxicities: Prolonged (≥1 week)
severe neutropenia and Grade 3 or 4
thrombocytopenia or anemia can occur with
ADCETRIS. Febrile neutropenia has been reported • Hepatotoxicity: Serious cases of hepatotoxicity,
with ADCETRIS. Monitor complete blood counts
including fatal outcomes, have occurred
prior to each dose of ADCETRIS and consider
with ADCETRIS. Cases were consistent with
Contraindication:
more frequent monitoring for patients with Grade
hepatocellular injury, including elevations of
ADCETRIS is contraindicated with concomitant
3 or 4 neutropenia. Monitor patients for fever. If
transaminases and/or bilirubin, and occurred
bleomycin due to pulmonary toxicity (e.g., interstitial
Grade 3 or 4 neutropenia develops, consider dose
after the first dose of ADCETRIS or rechallenge.
infiltration and/or inflammation).
delays, reductions, discontinuation, or G-CSF
Preexisting liver disease, elevated baseline liver
prophylaxis with subsequent doses.
Warnings and Precautions:
enzymes, and concomitant medications may also
• Peripheral neuropathy (PN): ADCETRIS treatment • Serious infections and opportunistic infections:
increase the risk. Monitor liver enzymes and
causes a PN that is predominantly sensory. Cases
Infections such as pneumonia, bacteremia, and
bilirubin. Patients experiencing new, worsening,
of motor PN have also been reported. ADCETRISsepsis or septic shock (including fatal outcomes)
or recurrent hepatotoxicity may require a delay,
induced PN is cumulative. Monitor patients for
have been reported in patients treated with
change in dose, or discontinuation of ADCETRIS.
symptoms of neuropathy, such as hypoesthesia,
ADCETRIS. Closely monitor patients during
• Progressive multifocal leukoencephalopathy
hyperesthesia, paresthesia, discomfort, a burning
treatment for the emergence of possible bacterial,
(PML): JC virus infection resulting in PML and
sensation, neuropathic pain or weakness and
fungal or viral infections.
death has been reported in ADCETRIS-treated
institute dose modifications accordingly.
• Tumor lysis syndrome: Closely monitor patients with patients. First onset of symptoms occurred at
Progressive multifocal leukoencephalopathy
(PML): JC virus infection resulting in PML and
death can occur in patients receiving ADCETRIS®
(brentuximab vedotin).
• Anaphylaxis and infusion reactions: Infusion-related rapidly proliferating tumor and high tumor burden.
reactions, including anaphylaxis, have occurred
• Increased toxicity in the presence of severe renal
with ADCETRIS. Monitor patients during infusion.
impairment: The frequency of ≥Grade 3 adverse
If an infusion-related reaction occurs, interrupt
reactions and deaths was greater in patients with
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