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