How ELOXATIN Treatment is Given
How ELOXATIN Treatment is Given
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
You are about to begin your treatment with Eloxatin, a chemotherapy
drug. Eloxatin is given together with 2 other drugs: 5-fluorouracil (5-FU)
and leucovorin. This combination is given to treat adults with stage III colon cancer
after surgery to remove the tumor, or to treat adults with advanced colorectal cancer.1
- Your treatment will be given through one of your veins. This is called an intravenous,
or IV, infusion1,2
- Before your first treatment, your doctor may insert a soft, flexible tube into a
large vein and attach a port
- A port is a tiny disk with an opening, completely hidden
under your skin, that will remain in place during the course of your treatment2
- Every time you receive a treatment, the IV will be inserted into that port
- This means fewer needle sticks
- It also helps protect your skin from direct exposure to
the chemotherapy
In most cases, chemotherapy with Eloxatin is given every 2 weeks. This is called
a cycle of treatment. Your doctor will determine the best approach
to your treatment.1
What happens during your 14-day treatment cycle?
You will be given Eloxatin and leucovorin by IV infusion over a 2-hour period.
After that, you will receive 2 doses of 5-FU. The first dose is given by IV infusion
as soon as the leucovorin infusion is over. The second dose is given as a steady,
slow drip over the next 22 hours, using a pump device.
1,2
You will not be given Eloxatin on Day 2. That day you will receive an IV infusion
of leucovorin for 2 hours. After that, you will receive 2 doses of 5-FU. The first
dose is given by IV infusion as soon as the leucovorin infusion is over. The second
dose is given as a steady, slow drip over the next 22 hours, using a pump device.
1,2
Your pump device will be disconnected.
1
No treatments or procedures are scheduled.
1
If you have questions about how your treatment is given, speak to your
doctor or nurse.2
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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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