For the first-line treatment of CLL in combination with chlorambucil1
START WITH GAZYVA
Learn more about
GAZYVA at the 2014
ASH Annual Meeting
AT BOOTH 1909
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) include obinutuzumab (GAZYVA®) +
chlorambucil as a preferred first-line regimen for CLL patients with comorbidities, without del(17p)2,a,b
NCCN treatment suggestions for patients with del(17p) are not segmented by age or comorbidities. Obinutuzumab (GAZYVA) + chlorambucil is included as a suggested
treatment for this patient population. Suggested treatment regimens are listed in alphabetical order.
b
Obinutuzumab (GAZYVA) + chlorambucil is listed first as a suggested treatment regimen for this patient population. Treatment regimens are listed in order of preference.
Note: All recommendations are category 2A unless otherwise indicated.
a
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 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 labora F