Calendar
December 5 – 8, 2015
57th ASH Annual Meeting and Exposition
Orlando, Florida
The American Society of Hematology (ASH) invites you
to attend the 57th ASH Annual Meeting in Orlando,
Florida. As the premier event in malignant and non-malignant hematology, this meeting will provide attendees
with an invaluable educational experience.
The Orange County Convention Center in Orlando is the site of
this year's ASH Annual Meeting and Exposition.
Highlights of ASH®
Get a synopsis of the top hematology research
presented at the latest ASH Annual Meeting and learn
how it can help improve your patient management
and care strategies at the 2016 Highlights of ASH. This
is your chance to evaluate your diagnostic techniques
and therapeutic approaches and discuss with leading
hematology experts and colleagues how new research
and clinical updates can be translated into new patient
care strategies.
January 22 – 23, 2016
Dallas, TX
Atlanta, GA
January 29 – 30, 2016
New York, NY
San Diego, CA
March 5 – 6, 2016
Brisbane, Australia
April 29 – 30, 2016
Natal, Brazil
January 15 – 16, 2016
Seattle, WA
Toronto, ON
Live: 15”
ADCETRIS® (brentuximab vedotin) for injection, for intravenous use
Brief Summary: see package insert for complete prescribing information
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.
INDICATIONS AND USAGE
Classical Hodgkin Lymphoma (HL) Post-auto-HSCT Consolidation
ADCETRIS® (brentuximab vedotin) for injection is a CD30-directed antibody-drug conjugate indicated for
the treatment of classical HL at high risk of relapse or progression as post-autologous hematopoietic stem
cell transplantation (auto-HSCT) consolidation.
DOSAGE AND ADMINISTRATION
Dosage Recommendations
Administer ADCETRIS as an intravenous infusion over 30 minutes every 3 weeks until a maximum of
16 cycles, disease progression or unacceptable toxicity. Initiate ADCETRIS treatment within 4-6 weeks
post-auto-HSCT or upon recovery from auto-HSCT.
Embryo-Fetal Toxicity
There are no adequate and well-controlled studies of ADCETRIS in pregnant women. However, based on its
mechanism of action and findings in animals, ADCETRIS can cause fetal harm when administered to a
pregnant woman. Brentuximab vedotin caused embryo-fetal toxicities, including significantly decreased
embryo viability and fetal malformations, in animals at maternal exposures that were similar to human
exposures at the recommended doses for patients with classical HL and sALCL. If this drug is used during
pregnancy, or if the patient becomes pregnant while receiving the drug, the patient should be apprised of
the potential hazard to the fetus.
ADVERSE REACTIONS
Summary of Clinical Trial Experience in Classical HL Post-auto-HSCT Consolidation (Study 3)
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in
clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not
reflect the rates observed in practice.
The recommended dose is 1.8 mg/kg up to 180 mg. Reduce the dose in patients with mild hepatic impairment
(Child-Pugh A) to 1.2 mg/kg up to 120 mg. Avoid use in patients with moderate (Child-Pugh B) or severe
(Child-Pugh C) hepatic impairment or severe renal impairment (CLcr <30 mL/min).
ADCETRIS was studied in 329 patients with classical HL at high risk of relapse or progression post-auto-HSCT
in a randomized, double-blind, placebo-controlled clinical trial in which the recommended starting dose
and schedule was 1.8 mg/kg of ADCETRIS administered intravenously over 30 minutes every 3 weeks or
placebo for up to 16 cycles. Of the 329 enrolled patients, 327 (167 brentuximab vedotin, 160 placebo)
received at least one dose of study treatment. The median number of treatment cycles in each study arm
was 15 (range, 1–16) and 80 patients (48%) in the ADCETRIS-treatment arm received 16 cycles.
Dose Modification
Peripheral Neuropathy: For new or worsening Grade 2 or 3 neuropathy, dosing should be held until
neuropathy improves to Grade 1 or baseline and then restarted at 1.2 mg/kg. For Grade 4 peripheral
neuropathy, ADCETRIS should be discontinued.
Standard international guidelines were followed for infection prophylaxis for herpes simplex virus (HSV),
varicella-zoster virus (VZV), and Pneumocystis jiroveci pneumonia (PCP) post-aut