For Previously Untreated Stage II Bulky, III, and IV Follicular Lymphoma
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
•
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
Hepatitis B Virus (HBV) Reactivation (cont’d)
•
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.