CLINICAL NEWS
Written in Blood
Continued from page 38
A New Topical Treatment
for Cutaneous T-Cell
Lymphoma
The investigational topical drug resiquimod was
safe and effective in clearing treated and untreated skin lesions in patients with early-stage
cutaneous T-cell lymphoma (CTCL), according
to results from a phase I trial published in Blood.
Currently, the only curative therapy for
CTCLs, a group of non-Hodgkin lymphomas de-
GAZYVA® (obinutuzumab)
Injection, for intravenous infusion
Initial U.S. Approval: 2013
This is a brief summary of information about
GAZYVA. Before prescribing, please see full
Prescribing Information.
WARNING: HEPATITIS B VIRUS REACTIVATION and
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
• Hepatitis B Virus (HBV) reactivation, in some cases
resulting in fulminant hepatitis, hepatic failure, and
death, can occur in patients receiving CD20-directed
cytolytic antibodies, including GAZYVA. Screen
all patients for HBV infection before treatment
initiation. Monitor HBV-positive patients during and
after treatment with GAZYVA. Discontinue GAZYVA
and concomitant medications in the event of HBV
reactivation [see Warnings and Precautions (5.1)].
• Progressive Multifocal Leukoencephalopathy (PML)
including fatal PML, can occur in patients receiving
GAZYVA [see Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
GAZYVA, in combination with chlorambucil, is indicated for
the treatment of patients with previously untreated chronic
lymphocytic leukemia (CLL) [see Clinical Studies (14.1)].
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Hepatitis B Virus Reactivation
Hepatitis B virus (HBV) reactivation, in some cases resulting
in fulminant hepatitis, hepatic failure, and death, can occur
in patients treated with anti-CD20 antibodies such as
GAZYVA. HBV reactivation has been reported in patients
who are hepatitis B surface antigen (HBsAg) positive and
also in patients who are HBsAg negative but are hepatitis
B core antibody (anti-HBc) positive. Reactivation has also
occurred in patients who appear to have resolved hepatitis
B infection (i.e., HBsAg negative, anti-HBc positive, and
hepatitis B surface antibody [anti-HBs] positive).
HBV reactivation is defined as an abrupt increase in
HBV replication manifesting as a rapid increase in serum
HBV DNA level or detection of HBsAg in a person who
was previously HBsAg negative and anti-HBc positive.
Reactivation of HBV replication is often followed by
hepatitis, i.e., increase in transaminase levels and, in severe
cases, increase in bilirubin levels, liver failure, and death.
Screen all patients for HBV infection by measuring HBsAg
and anti-HBc before initiating treatment with GAZYVA.
For patients who show evidence of hepatitis B infection
(HBsAg positive [regardless of antibody status] or HBsAg
negative but anti-HBc positive), consult physicians with
expertise in managing hepatitis B regarding monitoring and
consideration for HBV antiviral therapy.
Monitor patients with evidence of current or prior HBV
infection for clinical and laboratory signs of hepatitis or
HBV reactivation during and for several months following
treatment with GAZYVA. HBV reactivation has been
reported for other CD20-directed cytolytic antibodies
following completion of therapy.
In patients who develop reactivation of HBV while receiving
GAZYVA, immediately discontinue GAZYVA and any
concomitant chemotherapy, and institute appropriate
treatment. Resumption of GAZYVA in patients whose HBV
reactivation resolves should be discussed with physicians
with expertise in managing hepatitis B. Insufficient data
exist regarding the safety of resuming GAZYVA in patients
who develop HBV reactivation.
5.2 Progressive Multifocal Leukoencephalopathy
JC virus infection resulting in progressive multifocal
leukoencephalopathy (PML), which can be fatal, was
observed in patients treated with GAZYVA. Consider the
diagnosis of PML in any patient presenting with new onset
or changes to preexisting neurologic manifestations.
Evaluation of PML includes, but is not limited to, consultation
with a neurologist, brain MRI, and lumbar puncture.
Discontinue GAZYVA therapy and consider discontinuation
or reduction of any concomitant chemotherapy or
immunosuppressive therapy in patients who develop PML.
5.3 Infusion Reactions
GAZYVA can cause s ]