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, and discontinuation of ELOXATIN therapy may be required.
Continued below
Reasons to Choose Eloxatin-Based Chemotherapy...
For Stage III Colon Cancer:
Eloxatin, combined with infusional (given through bloodstream) administration of
2 other chemotherapy drugs, 5-fluorouracil/leucovorin (5-FU/LV), is approved by
the Food and Drug Administration (FDA) for the treatment of people with stage III
colon cancer who have had their primary (original) tumors surgically removed. This
approval was based on evidence of an improvement in
disease-free survival
after 4 years.
In clinical studies, of people with stage III colon cancer who had their primary
tumors surgically removed, Eloxatin plus 5-FU/LV has been shown to:
- Significantly increase
disease-free survival
when the recommended dose of 12 cycles of therapy is completed
- Reduce the risk of colon cancer coming back
For Advanced Colorectal Cancer (Also Known as Stage IV or Metastatic Cancer):
Eloxatin, combined with the chemotherapy regimen of 5-FU/LV, is approved by the
FDA for the treatment of advanced colorectal cancer (cancer of the colon and/or
rectum).
Eloxatin plus 5-FU/LV showed the following benefits in clinical trials of patients
with advanced colorectal cancer:
- Significantly prolonged survival
- Significantly shrank tumors
- Significantly delayed cancer progression
Safety of Eloxatin
For patients with advanced colorectal cancer, Eloxatin has been proven as safe and effective in patients over age 65 as it is
in younger patients. The incidence of diarrhea, dehydration, hypokalemia, leukopenia,
fatigue and syncope were higher in patients over age 65.
Learn more about Eloxatin
colorectal cancer treatment.
INDICATIONS
ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for:
- Adjuvant treatment of stage Ill colon cancer patients who have undergone complete
resection of the primary tumor
- Treatment of advanced carcinoma of the colon or rectum
Important Safety Information
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, and discontinuation of ELOXATIN therapy may
be required.
- 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-FULV 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 Ill colon cancer, paresthesia was seen in 92% (all grades) and
13% (grade 3/4) of patients; 21% (all grades) and 0.5% (grade 3/4) of patients 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
was 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 Ill 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
Click here for additional important information for
Eloxatin.
