The Time To Consider
GAZYVA Is Now
Indication
GAZYVA, in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial
remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular
lymphoma (FL).
Important Safety Information
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
Contraindications Hepatitis B Virus (HBV) Reactivation (cont’d)
• GAZYVA is contraindicated in patients with known
hypersensitivity reactions (e.g. anaphylaxis) to
obinutuzumab or to any of the excipients, or serum
sickness with prior obinutuzumab use
Warnings and Precautions
Hepatitis B Virus (HBV) 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 defi ned 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 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 • 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. Insuffi cient data exist regarding the safety
of resuming GAZYVA in patients who 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
Infusion Reactions
• GAZYVA can cause severe and life-threatening infusion
reactions. Sixty percent of patients with previously
untreated NHL experienced a reaction on Day 1 of
GAZYVA infusion. Infusion reactions can also occur
with subsequent infusions. Symptoms may include
hypotension, tachycardia, dyspnea, and respiratory
symptoms (e.g., bronchospasm, larynx and throat
irritation, wheezing, and laryngeal edema). Most
frequently reported symptoms include nausea, fatigue,
chest discomfort, dyspnea, dizziness, vomiting, diarrhea,
rash, hypertension, hypotension, fl ushing, 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
Please see additional Important Safety Information throughout as well as the brief summary
of the full Prescribing Information, including BOXED WARNINGS.