ASH News Daily 2016 - Issue 3 - A-20

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 (PN): ADCETRIS treatment
causes a PN that is predominantly sensory. Cases
of motor PN have also been reported. ADCETRISinduced PN 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.

the infusion and institute appropriate medical
reactions and deaths was greater in patients with
management. If anaphylaxis occurs, immediately
severe renal impairment compared to patients with
and permanently discontinue the infusion and
normal renal function. Avoid the use of ADCETRIS
administer appropriate medical therapy. Patients
in patients with severe renal impairment.
who experienced a prior infusion-related reaction
* Increased toxicity in the presence of moderate
should be premedicated for subsequent infusions.
or severe hepatic impairment: The frequency
Premedication may include acetaminophen, an
of ≥Grade 3 adverse reactions and deaths was
antihistamine, and a corticosteroid.
greater in patients with moderate or severe
* Hematologic toxicities: Prolonged (≥1 week)
hepatic impairment compared to patients
severe neutropenia and Grade 3 or 4
with normal hepatic function. Avoid the use of
thrombocytopenia or anemia can occur with
ADCETRIS in patients with moderate or severe
ADCETRIS. Febrile neutropenia has been reported hepatic impairment.
with ADCETRIS. Monitor complete blood counts
* Hepatotoxicity: Serious cases of hepatotoxicity,
prior to each dose of ADCETRIS and consider
including fatal outcomes, have occurred
more frequent monitoring for patients with Grade
with ADCETRIS. Cases were consistent with
3 or 4 neutropenia. Monitor patients for fever. If
hepatocellular injury, including elevations of
Grade 3 or 4 neutropenia develops, consider dose
transaminases and/or bilirubin, and occurred
delays, reductions, discontinuation, or G-CSF
after the first dose of ADCETRIS or rechallenge.
prophylaxis with subsequent doses.
Preexisting liver disease, elevated baseline liver
* Serious infections and opportunistic infections:
enzymes, and concomitant medications may also
Infections such as pneumonia, bacteremia, and
increase the risk. Monitor liver enzymes and
sepsis or septic shock (including fatal outcomes)
bilirubin. Patients experiencing new, worsening,
have been reported in patients treated with
or recurrent hepatotoxicity may require a delay,
ADCETRIS. Closely monitor patients during
change in dose, or discontinuation of ADCETRIS.
treatment for the emergence of possible bacterial, * Progressive multifocal leukoencephalopathy
fungal or viral infections.
(PML): JC virus infection resulting in PML and

* Tumor lysis syndrome: Closely monitor patients
* Anaphylaxis and infusion reactions: Infusion-related with rapidly proliferating tumor and high tumor
burden.
reactions, including anaphylaxis, have occurred
with ADCETRIS. Monitor patients during infusion.
* Increased toxicity in the presence of severe renal
If an infusion-related reaction occurs, interrupt
impairment: The frequency of ≥Grade 3 adverse

death has been reported in ADCETRIS-treated
patients. First onset of symptoms occurred at
various times from initiation of ADCETRIS therapy,
with some cases occurring within 3 months of
initial exposure. In addition to ADCETRIS therapy,

Table of Contents for the Digital Edition of ASH News Daily 2016 - Issue 3