ASH News Daily 2016 - Issue 3 - A-4
Indication
GAZYVA® (obinutuzumab), in combination with bendamustine followed by GAZYVA monotherapy,
is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are
refractory to, a rituximab-containing regimen.
Boxed WARNINGS: 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
Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients
receiving GAZYVA
IMPORTANT SAFETY INFORMATION
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 including GAZYVA.
HBV reactivation has been reported in patients who are hepatitis
B surface antigen (HBsAg) positive and 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 (ie, 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, ie, 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
Infusion Reactions
* GAZYVA can cause severe and life-threatening infusion
reactions. Thirty-eight percent of patients experienced
a reaction on Day 1 during treatment with GAZYVA in
combination with bendamustine. Infusion reactions can also
occur with subsequent infusions. Symptoms may include
hypotension, tachycardia, dyspnea, and respiratory symptoms
(eg, bronchospasm, larynx and throat irritation, wheezing,
and laryngeal edema). Most frequently reported symptoms
include nausea, fatigue, dizziness, vomiting, diarrhea,
hypertension, flushing, headache, pyrexia, and chills
* Premedicate patients with acetaminophen, an antihistamine,
and a glucocorticoid. Institute medical management for
infusion reactions as needed. Closely monitor patients during
the entire infusion. Infusion reactions within 24 hours of
receiving GAZYVA have occurred
* For patients with any Grade 4 infusion reactions, including but
not limited to anaphylaxis, acute life-threatening respiratory
anti-HBc before initiating treatment with GAZYVA. For
symptoms, or other life-threatening infusion reaction: Stop the
patients who show evidence of hepatitis B infection (HBsAg
GAZYVA infusion. Permanently discontinue GAZYVA therapy
positive [regardless of antibody status] or HBsAg negative but
anti-HBc positive), consult physicians with expertise in managing * For patients with Grade 1, 2, or 3 infusion reactions: Interrupt
GAZYVA for Grade 3 reactions until resolution of symptoms.
hepatitis B regarding monitoring and consideration for HBV
Interrupt or reduce the rate of the infusion for Grade 1 or 2
antiviral therapy
reactions and manage symptoms
* Monitor patients with evidence of current or prior HBV
* For patients with preexisting cardiac or pulmonary conditions,
infection for clinical and laboratory signs of hepatitis or HBV
monitor more frequently throughout the infusion and the
reactivation during and for several months following treatment
post-infusion period since they may be at greater risk of
with GAZYVA
experiencing more severe reactions. Hypotension may
occur as part of the GAZYVA infusion reaction. Consider
* In patients who develop reactivation of HBV while
receiving GAZYVA, immediately discontinue GAZYVA and
withholding antihypertensive treatments for 12 hours prior
any concomitant chemotherapy and institute appropriate
to and during each GAZYVA infusion, and for the first
treatment. Resumption of GAZYVA in patients whose HBV
hour after administration until blood pressure is stable. For
reactivation resolves should be discussed with physicians
patients at increased risk of hypertensive crisis, consider the
with expertise in managing hepatitis B. Insufficient data exist
benefits versus the risks of withholding their antihypertensive
regarding the safety of resuming GAZYVA in patients who
medication
develop HBV reactivation
Progressive Multifocal Leukoencephalopathy
(PML)
* JC virus infection resulting in 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
Tumor Lysis Syndrome (TLS)
* Tumor lysis syndrome, including fatal cases, has been reported
in patients receiving GAZYVA. Patients with high tumor
burden, high circulating lymphocyte count (>25 x 109/L) or
renal impairment are at greater risk for TLS and should receive
appropriate tumor lysis prophylaxis with antihyperuricemics (eg,
allopurinol or rasburicase) and hydration prior to the infusion of
GAZYVA. During the initial days of GAZYVA treatment, monitor
the laboratory parameters of patients considered at risk for TLS.
For treatment of TLS, correct electrolyte abnormalities, monitor
renal function and fluid balance, and administer supportive care,
including dialysis as indicated
Please see the following pages for additional Important Safety Information and the brief summary of the full Prescribing
Information, including Boxed WARNINGS.
GAZ-082916-0093c_R01_HEMA_GAD_JA_ASH_Daily_News_Ad.indd 1-2
Table of Contents for the Digital Edition of ASH News Daily 2016 - Issue 3
ASH News Daily 2016 - Issue 3 - A-1
ASH News Daily 2016 - Issue 3 - A-2
ASH News Daily 2016 - Issue 3 - A-3
ASH News Daily 2016 - Issue 3 - A-4
ASH News Daily 2016 - Issue 3 - A-5
ASH News Daily 2016 - Issue 3 - A-6
ASH News Daily 2016 - Issue 3 - A-7
ASH News Daily 2016 - Issue 3 - A-8
ASH News Daily 2016 - Issue 3 - A-9
ASH News Daily 2016 - Issue 3 - A-10
ASH News Daily 2016 - Issue 3 - A-11
ASH News Daily 2016 - Issue 3 - A-12
ASH News Daily 2016 - Issue 3 - A-13
ASH News Daily 2016 - Issue 3 - A-14
ASH News Daily 2016 - Issue 3 - A-15
ASH News Daily 2016 - Issue 3 - A-16
ASH News Daily 2016 - Issue 3 - A-17
ASH News Daily 2016 - Issue 3 - A-18
ASH News Daily 2016 - Issue 3 - A-19
ASH News Daily 2016 - Issue 3 - A-20
ASH News Daily 2016 - Issue 3 - A-21
ASH News Daily 2016 - Issue 3 - A-22
ASH News Daily 2016 - Issue 3 - A-23
ASH News Daily 2016 - Issue 3 - A-24
ASH News Daily 2016 - Issue 3 - A-25
ASH News Daily 2016 - Issue 3 - A-26
ASH News Daily 2016 - Issue 3 - B-1
ASH News Daily 2016 - Issue 3 - B-2
ASH News Daily 2016 - Issue 3 - B-3
ASH News Daily 2016 - Issue 3 - B-4
ASH News Daily 2016 - Issue 3 - B-5
ASH News Daily 2016 - Issue 3 - B-6
ASH News Daily 2016 - Issue 3 - B-7
ASH News Daily 2016 - Issue 3 - B-8
ASH News Daily 2016 - Issue 3 - B-9
ASH News Daily 2016 - Issue 3 - B-10
ASH News Daily 2016 - Issue 3 - B-11
ASH News Daily 2016 - Issue 3 - B-12
ASH News Daily 2016 - Issue 3 - B-13
ASH News Daily 2016 - Issue 3 - B-14
ASH News Daily 2016 - Issue 3 - B-15
ASH News Daily 2016 - Issue 3 - B-16
ASH News Daily 2016 - Issue 3 - B-17
ASH News Daily 2016 - Issue 3 - B-18
ASH News Daily 2016 - Issue 3 - B-19
ASH News Daily 2016 - Issue 3 - B-20
ASH News Daily 2016 - Issue 3 - B-21
ASH News Daily 2016 - Issue 3 - B-22
ASH News Daily 2016 - Issue 3 - B-23
ASH News Daily 2016 - Issue 3 - B-24
ASH News Daily 2016 - Issue 3 - B-25
ASH News Daily 2016 - Issue 3 - B-26
ASH News Daily 2016 - Issue 3 - B-27
ASH News Daily 2016 - Issue 3 - B-28
ASH News Daily 2016 - Issue 3 - B-29
ASH News Daily 2016 - Issue 3 - B-30
ASH News Daily 2016 - Issue 3 - B-31
ASH News Daily 2016 - Issue 3 - B-32
ASH News Daily 2016 - Issue 3 - B-33
ASH News Daily 2016 - Issue 3 - B-34
ASH News Daily 2016 - Issue 3 - B-35
ASH News Daily 2016 - Issue 3 - B-36
ASH News Daily 2016 - Issue 3 - B-37
ASH News Daily 2016 - Issue 3 - B-38
ASH News Daily 2016 - Issue 3 - B-39
ASH News Daily 2016 - Issue 3 - B-40
ASH News Daily 2016 - Issue 3 - B-41
ASH News Daily 2016 - Issue 3 - B-42
ASH News Daily 2016 - Issue 3 - B-43
ASH News Daily 2016 - Issue 3 - B-44
ASH News Daily 2016 - Issue 3 - B-45
ASH News Daily 2016 - Issue 3 - B-46
ASH News Daily 2016 - Issue 3 - B-47
ASH News Daily 2016 - Issue 3 - B-48
ASH News Daily 2016 - Issue 3 - C-1
ASH News Daily 2016 - Issue 3 - C-2
ASH News Daily 2016 - Issue 3 - C-3
ASH News Daily 2016 - Issue 3 - C-4
ASH News Daily 2016 - Issue 3 - C-5
ASH News Daily 2016 - Issue 3 - C-6
ASH News Daily 2016 - Issue 3 - C-7
ASH News Daily 2016 - Issue 3 - C-8
ASH News Daily 2016 - Issue 3 - C-9
ASH News Daily 2016 - Issue 3 - C-10
ASH News Daily 2016 - Issue 3 - C-11
ASH News Daily 2016 - Issue 3 - C-12
ASH News Daily 2016 - Issue 3 - C-13
ASH News Daily 2016 - Issue 3 - C-14
ASH News Daily 2016 - Issue 3 - C-15
ASH News Daily 2016 - Issue 3 - C-16
ASH News Daily 2016 - Issue 3 - C-17
ASH News Daily 2016 - Issue 3 - C-18
ASH News Daily 2016 - Issue 3 - C-19
ASH News Daily 2016 - Issue 3 - C-20
ASH News Daily 2016 - Issue 3 - C-21
ASH News Daily 2016 - Issue 3 - C-22
ASH News Daily 2016 - Issue 3 - C-23
ASH News Daily 2016 - Issue 3 - C-24
ASH News Daily 2016 - Issue 3 - C-25
ASH News Daily 2016 - Issue 3 - C-26
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