A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rituxan Warnings, Precautions, Pregnancy, Nursing, Abuse - Rituximab
Rituxan Warnings, Precautions, Pregnancy, Nursing, Abuse - Rituximab
WARNINGS
General
RITUXAN™(Rituximab) is associated with hypersensitivity
reactions which may respond to adjustments in the infusion
rate. Hypotension, bronchospasm, and angioedema
have occurred in association
with RITUXAN infusion
as part of an infusion-related symptom
complex. RITUXAN infusion
should be interrupted for severe reactions and can be resumed at
a 50% reduction in
rate (e.g., from 100 mg/hr
to 50 mg/hr) when symptoms have completely resolved. Treatment of
these symptoms with diphenhydramine and acetaminophen
is recommended; additional treatment
with bronchodilators or IV
saline may be indicated.
In most cases, patients who have experienced non-life-threatening
reactions have been able to complete the full course of therapy.
(See DOSAGE AND ADMINISTRATION.)
Medications for the treatment
of hypersensitivity reactions, e.g., epinephrine, antihistamines
and corticosteroids should be available for immediate
use in the event of a reaction
during administration.
Cardiovascular
Infusions should be discontinued in the event of serious
or life-threatening cardiac arrhythmias. Patients who develop clinically
significant arrhythmias
should undergo cardiac
monitoring during and after subsequent infusions of RITUXAN. Patients
with preexisting cardiac
conditions including arrhythmias and angina
have had recurrences of these events during RITUXAN therapy and
should be monitored throughout the infusion
and immediate post-infusion
period.
Tumor Lysis Syndrome
RITUXAN™(Rituximab) rapidly decreases benign
and malignant CD20
positive cells. Tumor lysis
syndrome has been reported
to occur within 12 to 24 hours after the first RITUXAN infusion
in patients with high numbers of circulating malignant
lymphocytes. Patients with high tumor
burden (bulky lesions) may also be at risk. Patients at risk
of developing tumor lysis
syndrome should be followed closely and appropriate
laboratory monitoring
performed. Appropriate medical
therapy should be provided
for patients who develop tumor
lysis syndrome. Following
treatment for and
resolution of tumor lysis
syndrome, subsequent
RITUXAN therapy was
administered in conjunction with prophylactic
therapy for this syndrome
in a limited number of cases.
PRECAUTIONS
Laboratory Monitoring
Complete blood counts
(CBC) and platelet counts should be obtained at regular
intervals during RITUXAN™(Rituximab) therapy and more frequently
in patients who develop cytopenias (see ADVERSE
REACTIONS).
Drug/Laboratory Interactions
There have been no formal
drug interaction studies performed with RITUXAN.
HAMA/HACA Formation
Human anti-murine antibody
(HAMA) was not detected in 67 patients evaluated. Less than 1.0%
(3/355) of patients evaluated for human
anti-chimeric antibody
(HACA) were positive. Patients who develop HAMA/HACA titers may
have allergic or hypersensitivity
reactions when treated with this or other murine
or chimeric monoclonal
antibodies.
Immunization
The safety of immunization
with any vaccine, particularly
live viral vaccines, following
RITUXAN therapy has
not been studied. The ability to generate a primary
or anamnestic humoral
response to any vaccine
has also not been studied.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies
have been performed to establish the carcinogenic
or mutagenic potential of RITUXAN, or to determine its effects on
fertility in males
or females. Individuals of childbearing
potential should use
effective contraceptive methods during treatment
and for up to 12 months following RITUXAN therapy.
Pregnancy Category C
Animal reproduction
studies have not been conducted with RITUXAN. It is not known whether
RITUXAN can cause fetal
harm when administered to a pregnant
woman or whether it can
affect reproductive capacity.
Human IgG is known to pass
the placental barrier,
and thus may potentially cause
fetal B-cell depletion;
therefore, RITUXAN should be given to a pregnant
woman only if clearly
needed.
Nursing Mothers
It is not known whether RITUXAN is excreted in human
milk. Because human IgG
is excreted in human milk
and the potential for absorption
and immunosuppression
in the infant is unknown,
women should be advised to discontinue nursing
until circulating drug
levels are no longer detectable. (See CLINICAL
PHARMACOLOGY.)
Pediatric Use
The safety and effectiveness
of RITUXAN in pediatric patients have not been established.
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