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Coping Suggestions for ELOXATIN Patients

As with any drug, reactions to ELOXATIN vary from person to person. Here you will find ideas for managing some of the most common side effects.

The information here is provided for educational purposes only. Please consult with your healthcare professional if you experience these or any other side effects while on treatment.

Chemotherapy and gastrointestinal side effects

It is important to try to manage any gastrointestinal side effects of chemotherapy, such as nausea, vomiting, and diarrhea. These side effects can rob the body of valuable nutrients. They can also cause too much water loss (dehydration). In very rare cases, certain side effects from ELOXATIN may be life threatening. The following suggestions may help you better manage side effects:

Suggestions for managing nausea and vomiting:

Eating:

  • Do not eat for at least 1 to 2 hours before treatment. Otherwise eat a light meal before treatment.
  • 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 smaller snacks more frequently before hunger sets in.
  • Avoid foods that have a strong odor, are high in fat, are fried, or are very sweet or spicy.
  • 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.

Drinking:

  • Drink fewer liquids with meals. Drinking liquids can cause a full, bloated feeling.
  • Drink slowly, with a straw if it helps to make you drink more slowly.
  • Drink room-temperature, clear, unsweetened juices or flat light-colored sodas without caffeine.

Suggestions for managing diarrhea:

  • Drink room temperature liquids frequently, in small amounts.
  • Try a diet of clear liquids (such as water, clear broth, and apple juice).
  • Eat small meals frequently.
  • Eat foods or drink beverages rich in potassium (such as bananas, apricots, potatoes, and sports drinks).
  • Try eating small amounts of low-fiber food when diarrhea starts to improve (such as white rice and noodles).
  • Do not drink beverages containing caffeine or milk.
  • Do not eat greasy, fried, or spicy foods.

Foods that are easy on your stomach:

  • Clear liquids: Sports drinks, clear soda – such as ginger ale, tea, broth, or water.
  • Full liquids: Sodas, liquid meal replacements, milk shakes, vegetable juice.
  • Other foods: Canned fruit, cooked cereal, rice, noodles, potatoes.

ELOXATIN and stomatitis

Stomatitis means inflammation of the mucous membranes of the mouth. This can lead to soreness of the tongue, gums, and the soft areas inside the cheeks and lips.

Chemotherapy often affects these areas because the cells there grow rapidly. This side effect is temporary. It will go away after chemotherapy treatments are completed. Here are some things to remember in the meantime:

  • Brush teeth after eating, using a soft-bristle toothbrush.
  • Avoid mouthwash that contains alcohol.
  • Rinse the mouth frequently with warm salt water.
  • Avoid eating or drinking anything that could irritate the mouth (spicy food, citrus fruits or juices [orange, lemon, or grapefruit], nuts, and pretzels).
  • Avoid tobacco products.
  • Be sure to report any mouth sores to the doctor or nurse.

ELOXATIN and neuropathy

ELOXATIN may cause nervous system side effects, including a nerve condition called neuropathy. Neuropathy can cause tingling or numbness in the extremities, muscle weakness, or other altered sensations.

Exposure to cold during treatment is one of the most common triggers of neuropathy symptoms. The following ideas may help you limit your exposure to cold and better manage neuropathy.

Suggestions for managing neuropathy:

  • Avoid drinking cold beverages and eating cold foods.
  • Try to stay inside during cold days. If you need to go outside, make sure you dress warmly, and cover your extremities with mittens and warm socks.
  • During your chemotherapy treatments, avoid sucking on ice and going straight out into the cold weather or a cold automobile.
  • When handling frozen items, wear a pair of gloves.

Get questions to ask your doctor.

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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