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
Eloxatin Indications, Dosage, Storage, Stability - Oxaliplatin
Eloxatin Indications, Dosage, Storage, Stability - Oxaliplatin
INDICATIONS AND USAGE
ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for the
treatment of patients with metastatic carcinoma of the colon or rectum whose
disease has recurred or progressed during or within 6 months of completion of
first-line therapy with the combination of bolus 5-FU/LV and irinotecan.
The approval of ELOXATIN is based on response rate and an interim analysis
showing improved time to radiographic progression. No results are available
at this time that demonstrate a clinical benefit, such as improvement of disease-related
symptoms or increased survival (see CLINICAL
STUDIES).
DOSAGE AND ADMINISTRATION
The recommended dose schedule given every two weeks is as follows:
| Day 1: |
ELOXATIN 85 mg/m2 IV infusion in 250-500 mL D5W
and leucovorin 200 mg/m2 IV infusion in D5W both given over 120
minutes at the same time in separate bags using a Y-line, followed by 5-FU
400 mg/m2 IV bolus given over 2-4 minutes, followed by 5-FU 600
mg/m2 IV infusion in 500 mL D5W (recommended) as a 22-hour continuous
infusion.
|
| Day 2: |
Leucovorin 200 mg/m2 IV infusion over 120 minutes,
followed by 5-FU 400 mg/m2 IV bolus given over 2-4 minutes, followed
by 5-FU 600 mg/m2 IV infusion in 500 mL D5W (recommended) as
a 22-hour continuous infusion. |
Repeat cycle every 2 weeks.
The administration of ELOXATIN does not require prehydration.
Premedication with antiemetics, including 5-HT3 blockers with or
without dexamethasone, is recommended.
For information on 5-fluorouracil and leucovorin, see the respective package
inserts.
Dose Modification Recommendations
Prior to subsequent therapy cycles, patients should be evaluated for clinical
toxicities and laboratory tests. Neuropathy was graded using a study-specific
neurotoxicity scale (see PRECAUTIONS,
Neuropathy). Other toxicities were graded by the NCI CTC, Version 2.0.
Prolongation of infusion time for ELOXATIN from 2 hours to 6 hours decreases
the Cmax by an estimated 32% and may mitigate acute toxicities. The
infusion time for infusional 5-FU and leucovorin do not need to be changed.
For patients who experience persistent Grade 2 neurosensory events that do
not resolve, a dose reduction of ELOXATIN to 65 mg/m2 should be considered.
For patients with persistent Grade 3 neurosensory events, discontinuing therapy
should be considered.
The infusional 5-FU/LV regimen need not be altered.
A dose reduction of ELOXATIN to 65 mg/m2 and infusional 5-FU by
20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is
recommended for patients after recovery from Grade 3/4 gastrointestinal (despite
prophylactic treatment) or Grade 3/4 hematologic toxicity (neutrophils <1.5
x 109/L, platelets <100 x 109/L).
Preparation of Infusion Solution
RECONSTITUTION OR FINAL DILUTION MUST NEVER BE PERFORMED WITH A SODIUM CHLORIDE
SOLUTION OR OTHER CHLORIDE-CONTAINING SOLUTIONS.
The lyophilized powder is reconstituted by adding 10 mL (for the 50 mg vial)
or 20 mL (for the 100 mg vial) of Water for Injection, USP or 5% Dextrose Injection,
USP. Do not administer the reconstituted solution without further dilution.
The reconstituted solution must be further diluted in an infusion solution of
250-500 mL of 5% Dextrose Injection, USP.
After reconstitution in the original vial, the solution may be stored up to
24 hours under refrigeration (2-8°C [36-46°F]). After final dilution with 250-500
mL of 5% Dextrose Injection, USP, the shelf life is 6 hours at room temperature
(20-25°C [68-77°F]) or up to 24 hours under refrigeration (2-8°C [36-46°F]).
ELOXATIN is not light sensitive.
ELOXATIN is incompatible in solution with alkaline medications or media (such
as basic solutions of 5-FU) and must not be mixed with these or administered
simultaneously through the same infusion line. The infusion line should be flushed
with D5W prior to administration of any concomitant medication.
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration and discarded if present.
Needles or intravenous administration sets containing aluminum parts that may
come in contact with ELOXATIN should not be used for the preparation or mixing
of the drug. Aluminum has been reported to cause degradation of platinum compounds.
HOW SUPPLIED
ELOXATIN is supplied in clear, glass, single-use vials with gray elastomeric
stoppers and aluminum flip-off seals containing 50 mg or 100 mg of oxaliplatin
as a sterile, preservative-free lyophilized powder for reconstitution. Lactose
monohydrate is also present as an inactive ingredient.
NDC 0024-0596-02: 50 mg single-use vial with green flip-off seal individually
packaged in a carton.
NDC 0024-0597-04: 100 mg single-use vial with dark blue flip-off seal individually
packaged in a carton.
Storage
Store under normal lighting conditions at 25°C (77°F); excursions permitted
to 15-30°C (59-86°F) (see USP controlled room temperature).
Handling and Disposal
As with other potentially toxic anticancer agents, care should be exercised
in the handling and preparation of infusion solutions prepared from ELOXATIN.
The use of gloves is recommended. If a solution of ELOXATIN contacts the skin,
wash the skin immediately and thoroughly with soap and water. If ELOXATIN contacts
the mucous membranes, flush thoroughly with water.
Procedures for the handling and disposal of anticancer drugs should be considered.
Several guidelines on the subject have been published [1-8]. There is no general
agreement that all of the procedures recommended in the guidelines are necessary
or appropriate.
REFERENCES
1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations
for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
2. Recommendations for the safe handling of parenteral antineoplastic drugs.
NIH Publication No. 83-2621. For sale by the Superintendent of Documents,
U.S. Government Printing Office, Washington, D.C. 20402.
3. AMA Council Report. Guidelines for handling parenteral antineoplastics.
JAMA 1985;253(11):1590-1592.
4. National Study Commission on Cytoxic Exposure. Recommendations for handling
cytoxic agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National
Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy
and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
5. Clinical Oncological Society of Australia. Guidelines and recommendations
for safe handling of antineoplastic agents. Med J Australia 1983;1:426-428.
6. Jones RB, et al. Safe handling of chemotherapeutic agents: a report from
the Mount Sinai Medical Center. Ca – A Cancer Journal for Clinicians.
Sept./Oct. 1983:258-263.
7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin
on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 1990;47:1033-1049.
8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice
Guidelines). Am J Hosp Pharm 1996;53:1669-1685.
Distributed by Sanofi-Synthelabo Inc.
New York, NY 10016
Manufactured for Sanofi-Synthelabo Inc. by Ben Venue Laboratories
Bedford, Ohio 44146-0568
ESS-5 Rev. 8/02
top
