A Pharmacist’s/Nurse’s Guide to
ISTODAX® (romidepsin) for
Injection for the Treatment of
Peripheral T-Cell Lymphoma
OVERVIEW OF PTCL
Peripheral T-cell lymphomas (PTCLs)
are a heterogeneous group of neoplasms that include any non-Hodgkin
lymphoma (NHL) originating from mature, post-thymic T-cells or natural killer
(NK) T-cells.1 PTCL accounts for about
10% of all NHL cases and is typically
associated with a poor prognosis.1,2
Although PTCL comprises only a small
percentage of all NHL diagnoses, it
has a growing incidence and primarily aggressive nature.2-4
There are several subtypes of
PTCL, the most common of which are
PTCL-NOS (not otherwise specified),
angioimmunoblastic T-cell lymphoma
(AITL), anaplastic lymphoma kinase
(ALK) positive anaplastic large cell
lymphoma (ALCL), and ALK negative
ALCL.4 Moreover, the majority of patients with PTCL have advanced disease at the time of diagnosis.4,5
TREATMENT OF PTCL WITH ISTODAX
ISTODAX is indicated for treatment of
PTCL in patients who have received
at least one prior therapy. This in-
dication is based on response rate.
Clinical benefit such as improve-
ment in overall survival has not been
demonstrated.
Important Safety Information
WARNINGS AND PRECAUTIONS:
• Myelosuppression: ISTODAX can
cause thrombocytopenia, leukope-
nia (neutropenia and lymphope-
nia), and anemia; monitor blood
counts regularly during treatment
with ISTODAX; interrupt and/or
modify the dose as necessary
• Infections: Fatal and serious in-
fections, including pneumonia,
sepsis, and viral reactivation,
including Epstein Barr and hepa-
titis B viruses, have been reported
during and within 30 days after
treatment with ISTODAX in clini-
cal trials. The risk of life threat-
ening infections may be greater
in patients with a history of prior
treatment with monoclonal anti-
bodies directed against lympho-
cyte antigens and in patients with
disease involvement of the bone
marrow. Reactivation of Epstein
Barr viral infection led to liver
failure. Consider monitoring for
reactivation and antiviral prophy-
laxis in patients with evidence of
prior hepatitis B infection. Gan-
ciclovir prophylaxis failed to
prevent Epstein Barr viral reacti-
vation in one case
Mechanism of Action
ISTODAX is a histone deacetylase
(HDAC) inhibitor (Figure 1). HDACs
*Dr. Edwards provided expert insight for this promotional supplement. Dr. Edwards is on the speakers’ bureaus for Celgene Corporation; Merck &
Co., Inc.; Millennium Pharmaceuticals, Inc.; Onyx
Pharmaceuticals, Inc.; and Seattle Genetics, Inc.
Dr. Edwards received compensation for his participation in this program.
A SUPPLEMENT TO VOL. 32 SUPPL. 9
This supplement is sponsored by Celgene Corporation.
ISTODAX (romidepsin) for injection is indicated for treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one
prior therapy. This indication is based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.
Michael S. Edwards,
PharmD, MBA, BCOP,
FASHP*
Director, Oncology
Pharmacy Residency (retired)
Walter Reed National
Military Medical Center
Bethesda, Maryland
Figure 1. ISTODAX is an HDAC Inhibitor6-8
In vitro, ISTODAX causes the accumulation of acetylated histones, and induces cell cycle arrest and
apoptosis of some cancer cell lines with IC50 values in the nanomolar range6
Romidepsin-HDAC
Interaction
Romidepsin
HDAC–Non-Histone
Protein Interaction
HDAC–Histone
Interaction
Acetylated Histones
Acetylated Non-Histone Protein
Cell Nucleus
HDACs
catalyze the
deacetylation of histone
and non-histone
proteins6
ISTODAX is an
HDAC inhibitor6
