CLINICAL NEWS
Literature Scan
Continued from page 22
New Agent PER977 Shows Promise
in Reversing Anticoagulation
Although newer target-specific oral anticoagulants represent great advances in the
prevention and treatment of blood clots,
their use is limited by a lack of effective
reversal agents. Severe or life-threatening
bleeding thus remains a dangerous
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 و