Important Safety
Information Including
Boxed Warning
Anaphylactic-like reactions to ELOXATIN have been reported and may occur within minutes
of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines have
been employed to alleviate symptoms.
Continue below
Preparation & Handling
- Eloxatin IS NOT INTERCHANGEABLE WITH OTHER PLATINUMS. PLEASE VERIFY
CORRECT DRUG AND DOSAGE PRIOR TO PREPARATION
- Concentrated solution should not be frozen and should be protected from light.
- A FINAL DILUTION MUST NEVER BE PERFORMED WITH A SODIUM
CHLORIDE SOLUTION OR OTHER CHLORIDE-CONTAINING SOLUTIONS
- The solution must be further diluted in an infusion solution of 250-500 mL of 5% Dextrose Injection, USP
- After 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])
- After final dilution, protection from light is not required.
When administering Eloxatin, remember:
- 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
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Do not freeze, and protect from light (keep it in original outer carton).
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, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient
NDC 0024-0590-10: 50-mg single-use vial with green flip-off seal individually
packaged in a carton.
NDC 0024-0591-20: 100-mg single-use vial with dark blue flip-off seal individually
packaged in a carton.
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.
INDICATIONS
Eloxatin® (oxaliplatin injection), used in combination with infusional
5-FU/LV, is
indicated for
- Adjuvant treatment of stage III colon cancer patients who have undergone complete
resection of the primary tumor.
- Treatment of advanced carcinoma of the colon or rectum.
Clinical Safety Considerations
Anaphylactic-like reactions to ELOXATIN have been reported and may occur within
minutes of ELOXATIN administration. Epinephrine, corticosteroids, and antihistamines
have been employed to alleviate symptoms.
- ELOXATIN should not be administered to patients with a history of known allergy
to ELOXATIN or other platinum compounds. Hypersensitivity and anaphylactic/anaphylactoid
reactions to ELOXATIN have been reported and were similar in nature and severity
to those reported with other platinum compounds (ie, rash, urticaria, erythema,
pruritus, and, rarely, bronchospasm and hypotension). These reactions occur within
minutes of administration and should be managed with appropriate supportive therapy.
Drug-related deaths from this reaction have been reported.
- ELOXATIN may cause fetal harm when administered to a pregnant woman. Women of childbearing
potential should be advised not to become pregnant while receiving ELOXATIN. It
is not known whether ELOXATIN or its derivatives are excreted in human milk.
- ELOXATIN has been associated with pulmonary fibrosis (<1% of study patients),
which may be fatal. The combined incidence of cough and dyspnea was 7.4% (<1%
grade 3, no grade 4) in the ELOXATIN plus 5-FU/LV arm compared to 4.5% (no grade
3, 0.1% grade 4) in the 5-FU/LV alone arm in the adjuvant colon cancer study. In
this study, one patient died from eosinophilic pneumonia in the ELOXATIN combination
arm. The combined incidence of cough, dyspnea, and hypoxia was 43% (7% grade 3 and
4) in the ELOXATIN plus 5-FU/LV arm compared to 32% (5% grade 3 and 4) in the irinotecan
plus 5-FU/LV arm in patients with previously untreated colorectal cancer. In case
of unexplained respiratory symptoms, ELOXATIN should be discontinued until pulmonary
investigation excludes interstitial lung disease or pulmonary fibrosis.
- ELOXATIN is associated with two types of primarily peripheral sensory neuropathy:
an acute, reversible type of early onset and a persistent type (>14 days). In
patients with advanced colorectal cancer paresthesias occurred in 77% (all grades)
and 18% (grade 3/4) of previously untreated patients. In previously treated patients,
acute neuropathy occurred in 56% (all grades) and 2% (grade 3/4) of patients; persistent
neuropathy occurred in 48% (all grades) and 6% (grade 3/4) of patients. In patients
with stage II and III colon cancer, paresthesia was seen in 92% (all grades) and
13% (grade 3/4) of patients; 21% (all grades), 0.5% (grade 3/4) had residual paresthesia
at 18-month follow-up.
- Hepatotoxicity, as evidenced in the adjuvant study by increase in transaminases
and alkaline phosphatase was observed more commonly in the ELOXATIN combination
arm. The incidence of increased bilirubin was similar on both arms. Changes noted
on liver biopsies include: peliosis, nodular regenerative hyperplasia or sinusoidal
alterations, perisinusoidal fibrosis and veno-occlusive lesions. Hepatic vascular
disorders should be considered and, if appropriate, investigated in case of abnormal
liver function test results or portal hypertension not explained by liver metastases.
- Monitoring of white blood cell count with differential, hemoglobin, platelet count
and blood chemistries (including ALT, AST, bilirubin and creatinine) is recommended
before each ELOXATIN cycle.
- The safety and effectiveness of ELOXATIN plus 5-FU/LV in patients with renal impairment
have not been evaluated. Since the primary route of platinum elimination is renal,
this combination should be used with caution in patients with preexisting renal
impairment. Clearance of these products may be decreased by coadministration of
potentially nephrotoxic compounds, although this has not been specifically studied.
- The incidence of diarrhea, dehydration, hypokalemia, leukopenia, fatigue and syncope
were higher in patients ≥65 years old.
- Extravasation may result in local pain and inflammation that may be severe and lead
to complications, including necrosis. Injection site reaction, including redness,
swelling and pain, has been reported.
- There have been reports of prolonged prothrombin time and INR occasionally associated
with hemorrhage in patients receiving ELOXATIN plus 5-FU/LV while on anticoagulants.
Patients receiving ELOXATIN plus 5-FU/LV and requiring oral anticoagulants may require
closer monitoring.
- The most common adverse reactions in patients with stage II or III colon cancer
receiving adjuvant therapy were peripheral sensory neuropathy, neutropenia, thrombocytopenia,
anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis,
fatigue, and stomatitis. The most common adverse reactions in patients with advanced
colorectal cancer were peripheral sensory neuropathy, fatigue, neutropenia, nausea,
emesis, and diarrhea.
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