Long-term Nerve-related Side Effects:Persistent Neuropathy
Long-term Nerve-related Side
Effects:Persistent Neuropathy
Another form of neuropathy that can happen while taking Eloxatin is long-term,
persistent neuropathy. This form lasts longer than 2 weeks, unlike acute (short-term)
neuropathy.
Symptoms can feel much like the symptoms of acute neuropathy:1
- Tingling sensations or numbness, usually in the feet or hands
- A feeling that it’s hard to breathe or swallow
Choose higher-calorie foods that contain a lot of protein. You may have to eat less
fiber. Some high fiber foods, like raw vegetables and whole grain crackers, can
trigger diarrhea and mouth sores.
These symptoms can happen if you’ve never had acute neuropathy, and they may start
even after you’ve had several treatments; they can last weeks or months before going
away. Cold does not trigger this form of neuropathy.
Chronic, long-term neuropathy may include:
- Constant pain, tingling, or numbness in your hands, feet, or around your mouth or
throat
- Trouble with walking (stumbling, loss of balance)
- Trouble with activities of daily living such as writing or buttoning a shirt
Because the symptoms of persistent neuropathy do not lessen between treatments and
can interfere with daily life, your doctor may choose to alter your treatment with
Eloxatin.
Your doctor may change your treatment in any or all of these ways during a cycle:1
- Give Eloxatin for a longer treatment time
- A lower dose of Eloxatin
- Doses of calcium and magnesium put through your IV before and after Eloxatin2
Usually the other part of your chemotherapy, called 5-FU/LV, will remain at the
same dose, with the same infusion time as before. If your symptoms are very severe,
your doctor may choose to give you another form of chemotherapy.
As with acute neuropathy, let your family, friends, and caregivers know that you
may experience the above symptoms of persistent neuropathy. Always let your doctors
and nurses know of any symptoms you may have during and between treatments so they
can decide if and how to adjust your chemotherapy.
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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
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