Black Box Warning And Important Safety Information

Coping With Nausea, Vomiting, and Diarrhea

Coping With Nausea, Vomiting, and
Diarrhea

Nausea, with or without vomiting, is a common side effect of chemotherapy. Before treatments, a nurse may give you 1 or more antinausea drugs. This type of drug prevents or reduces the severity of nausea and vomiting which can occur right after treatment, or a day or more after.¹^,²

If you experience vomiting, avoid eating or drinking until it’s under control. Then you can try small amounts of clear liquids, and work up to a full-liquid diet or a soft diet. Ask a registered dietician for information about a soft diet. If you have diarrhea, drink plenty of fluids and avoid foods high in fiber, like raw vegetables and whole grains. If you have nausea, vomiting, or diarrhea that is severe or lasts more than a day, or you can’t keep liquids down, contact your doctor, who may suggest antinausea medication or other treatment.¹^,²

Guidelines for managing nausea and vomiting

Eating¹^,²

If your treatment causes nausea, do not eat for at least 1 to 2 hours before treatment.Otherwise, eat a light meal prior
Eat what appeals to you and don’t force yourself to eat unappealing foods
Eat foods that are at room temperature and eat them slowly
In place of larger meals, eat more frequent and smaller meals and snacksbefore hunger sets in. Hunger feelings worsen nausea
Avoid foods that have a strong odor, are high in fat or fried, are verysweet, or are spicy. Rest after eating, while sitting up rather than lying down
If you have morning nausea, try eating dry foods like cereal, toast, or crackers, unless you have sores in your throat or mouth, or very little saliva

Drinking¹^,²

Drink liquids at least an hour before or after eating to prevent feeling bloated
Drink slowly, with a straw if it helps to make you drink more slowly
Drink room temperature liquids frequently, in small amounts
Drink cool, clear, unsweetened juices or flat light-colored sodas without caffeine

Foods that are easy on your stomach²

Clear liquids: Sports drinks, clear soda—like ginger ale, tea, broth, water

Full liquids: Sodas, liquid meal replacements, milk shakes, vegetable juice

Other foods: Canned fruit, cooked cereal, rice, noodles, potatoes

Try to keep track of when you have nausea and what seems to cause it. Some nausea, vomiting, and diarrhea can be expected during chemotherapy, and you should tell your doctor or nurse when symptoms occur so they can monitor them. If vomiting or diarrhea persists, your body can lose too much water.²

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Note: The Eloxatin Nurse's Guide is intended for use by health care professionals in the United States only.

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Lab Tests

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.

References:

National Cancer Institute, National Institutes of Health, US Department of Health and Human Services. Chemotherapy and You. Bethesda, MD: National Institutes of Health; 2003. NIH publication 03-1136.
National Cancer Institute, National Institutes of Health, US Department of Health and Human Services. Eating Hints for Cancer Patients. Bethesda, MD: National Institutes of Health; 2003. NIH publication 03-2079.

Eloxatin.com Registration | Colorectal Cancer Symptoms | Colorectal Cancer Treatment | Colorectal Cancer Side Effects

ELOXATIN, 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. The indication is based on an improvement in disease-free survival, with no demonstrated benefit in overall survival after a median follow-up of 4 years
Treatment of advanced carcinoma of the colon or rectum

Clinical Safety Considerations

ELOXATIN should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.

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) 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 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