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 Indications, Dosage, Storage, Stability - Rituximab
Rituxan Indications, Dosage, Storage, Stability - Rituximab
INDICATIONS
RITUXAN™(Rituximab) is indicated for the treatment
of patients with relapsed or refractory
low-grade or follicular,
CD20 positive, B-cell non-Hodgkin's lymphoma.
DOSAGE AND ADMINISTRATION
Usual Dose
The recommended dosage
of RITUXAN™(Rituximab) is 375 mg/m2
given as an IV infusion
once weekly for four doses (days 1, 8, 15, and 22). RITUXAN may
be administered in an outpatient
setting. DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR
BOLUS. (See Administration.)
Instructions for Administration
Preparation for Administration: Use appropriate
aseptic technique. Withdraw the necessary amount of RITUXAN and
dilute to a final concentration of 1 to 4 mg/mL into an infusion
bag containing either 0.9%
Sodium Chloride USP or 5% Dextrose in Water USP. Gently invert
the bag to mix
the solution. Discard any unused portion left
in the vial. Parenteral drug
products should be inspected visually for particulate
matter and discoloration
prior to administration.
RITUXAN solutions for infusion
are stable at 2°
to 8°C (36° to 46° F) for 24 hours and at room
temperature for
an additional 12 hours. No
incompatibilities between RITUXAN and polyvinylchloride or polyethlene
bags have been observed.
Administration: DO NOT ADMINISTER AS
AN INTRAVENOUS PUSH OR BOLUS.
Hypersensitivity reactions may occur (see WARNINGS).
Premedication, consisting of acetaminophen
and diphenhydramine, should be considered before each infusion
of RITUXAN. Premedication may attenuate infusion-related events.
Since transient hypotension
may occur during RITUXAN infusion, consideration should be given
to withholding anti-hypertensive medications 12 hours prior to RITUXAN
infusion.
First Infusion: The RITUXAN solution
for infusion should
be administered intravenously at an initial
rate of 50 mg/hr. RITUXAN
should not be mixed or diluted with other drugs. If hypersensitivity
or infusion-related events do not occur, escalate the infusion
rate in 50 mg/hr increments
every 30 minutes, to a maximum
of 400 mg/hr. If hypersensitivity
or an infusion-related event develops, the infusion
should be temporarily slowed or interrupted (see WARNINGS).
The infusion can continue
at one-half the previous rate
upon improvement of patient
symptoms.
Subsequent Infusions: Subsequent RITUXAN infusions can be administered
at an initial rate
of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute
intervals, to a maximum
of 400 mg/hr as tolerated.
Stability and Storage: RITUXAN vials are stable
at 2° to 8°C (36° to 46°F). Do not use beyond expiration
date stamped on carton. RITUXAN vials should be protected from direct
sunlight.
HOW SUPPLIED
RITUXAN™(Rituximab) is supplied as 100 mg
and 500 mg of sterile,
preservative-free, single-use vials.
Single unit 100 mg
carton: Contains one 10 mL vial
of RITUXAN (10 mg/mL). NDC 50242-051-21
Single unit 500 mg
carton: Contains one 50 mL vial
of RITUXAN (10 mg/mL). NDC 50242-053-06
REFERENCES
1. Valentine MA, Meier KE, Rossie S, et al. Phosphorylation
of the CD20 phosphoprotein
in resting B lymphocytes.
J. Biol. Chem. 1989 264(19): 11282-11287.
2. Einfeld DA, Brown JP, Valentine MA, et al. Molecular
cloning of the human B
cell CD20 receptor
predicts a hydrophobic protein with multiple
transmembrane domains. EMBO J. 1988 7(3):711-717.
3. Anderson KC, Bates MP, Slaughenhoupt BL, et
al. Expression of human
B cell-associated antigens on leukemias and lymphomas: A model of
human B cell
differentiation. Blood 1984 63(6):1424-1433.
4. Tedder TF, Boyd AW, Freedman AS, et al. The
B cell surface molecule
B1 is functionally linked with B cell
activation and differentiation.
J. Immunol. 1985 135(2):973-979.
5. Tedder TF, Zhou LJ, Bell PD, et al. The CD20
surface molecule of B lymphocytes functions as a calcium
channel. J. Cell. Biochem. 1990 14D:195.
6. Press OW, Applebaum F, Ledbetter JA, Martin
PJ, Zarling J, Kidd P, et al. Monoclonal antibody
1F5 (anti-CD20) serotherapy of human B-cell lymphomas. Blood 1987
69(2):584-591.
7. Reff ME, Carner C, Chambers KS, Chinn PC, Leonard
JE, Raab R, et al: Depletion of B Cells In
Vivo by a Chimeric Mouse Human Monoclonal Antibody to CD20. Blood
1994 83(2):435-445.
8. Demidem A, Lam T, Alas S, Hariharan K, Hanna
N, and Bonavida B. Chimeric Anti-CD20 (IDEC-C2B8) monoclonal
Antibody Sensitizes a B Cell Lymphoma Cell Line to Cell Killing
by Cytotoxic Drugs. Cancer Chemotherapy & Radiopharmaceuticals
1997 12(3):177-186.
9. Maloney DG, Liles TM, Czerwinski C, Waldichuk
J, Rosenberg J, Grillo-López A, et al. Phase I Clinical Trial
using escalating single-dose infusion
of chimeric anti-CD20 monoclonal
antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma.
Blood 1994 84(8):2457-2466.
10. Maloney DG, Grillo-López AJ, Bodkin
D, White CA, Liles T-M, Royston I, et al. IDEC-C2B8: Results of
a Phase I Multiple-Dose Trial in Patients with Relapsed Non-Hodgkin's
Lymphoma. J. Clin. Oncol. 1997 15(10):3266-3274.
11. Maloney DG, Grillo-López AJ, White CA,
Bodkin D, Schilder RJ, Neidhart JA, et al. IDEC-C2B8 (Rituximab)
Anti-CD20 Monoclonal Antibody Therapy in Patients with Relapsed
Low-Grade Hon-Hodgkin's Lymphoma. Blood 1997 90(6):2188-2195.
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