Eloxatin Side Effects

Generic Name: Oxaliplatin

Please note - some side effects for Eloxatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Eloxatin - for the consumer

Eloxatin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Eloxatin:

Change in taste; constipation; diarrhea; dizziness; fatigue; hair loss; headache; heartburn; hiccups; nausea; pain; pain, redness, or swelling at the injection site; runny nose; sleeplessness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; blood in the urine; chest pain or pressure; decreased urination; difficulty swallowing; disorientation; dry cough; dry mouth; eye pain; fainting; fever or chills; flushing; groin or calf pain; itching; jaw tightness; loss of appetite; mouth sores; muscle cramps; nosebleeds; numbness, tingling, or pain of the hands, feet, or around the mouth or throat; odd feelings in the tongue; persistent sore throat; persistent stomach pain; sensitivity to cold temperatures or cold objects; severe diarrhea or vomiting; shortness of breath; slurred speech; sudden severe headache; thirst; trouble walking or performing activities of daily living; unusual bruising or bleeding; vision problems or changes; vomit that looks like coffee grounds; weakness; yellowing of the skin or eyes.

For the professional

Eloxatin

More than 1100 patients with stage II or III colon cancer and more than 4,000 patients with advanced colorectal cancer have been treated in clinical studies with Eloxatin either as a single agent or in combination with other medications. 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 previously untreated and treated patients were peripheral sensory neuropathies, fatigue, neutropenia, nausea, emesis, and diarrhea.

Combination Adjuvant Therapy with Eloxatin and infusional 5-FU/LV in Patients with Stage II or III Colon Cancer

One thousand one hundred and eight patients with stage II or III colon cancer, who had undergone complete resection of the primary tumor, have been treated in a clinical study with Eloxatin in combination with infusional 5-FU/LV. The incidence of grade 3 or 4 adverse events was 70% on the Eloxatin combination arm, and 31% on the infusional 5-FU/LV arm. The adverse reactions in this trial are shown in the tables below. Discontinuation of treatment due to adverse events occurred in 15% of the patients receiving Eloxatin and infusional 5-FU/LV. Both 5-FU/LV and Eloxatin are associated with gastrointestinal or hematologic adverse events. When Eloxatin is administered in combination with infusional 5-FU/LV, the incidence of these events is increased.

The incidence of death within 28 days of last treatment, regardless of causality, was 0.5% (n=6) in both the Eloxatin combination and infusional 5-FU/LV arms, respectively. Deaths within 60 days from initiation of therapy were 0.3% (n=3) in both the Eloxatin combination and infusional 5-FU/LV arms, respectively. On the Eloxatin combination arm, 3 deaths were due to sepsis/neutropenic sepsis, 2 from intracerebral bleeding and one from eosinophilic pneumonia. On the 5-FU/LV arm, one death was due to suicide, 2 from Steven-Johnson Syndrome (1 patient also had sepsis), 1 unknown cause, 1 anoxic cerebral infarction and 1 probable abdominal aorta rupture.

The following table provides adverse events reported in the adjuvant therapy colon cancer clinical trial by body system and decreasing order of frequency in the Eloxatin and infusional 5-FU/LV arm for events with overall incidences ≥ 5% and for NCI grade 3/4 events with incidences ≥ 1%. This table does not include hematologic and blood chemistry abnormalities; these are shown separately below.

The following table provides adverse events reported in the adjuvant therapy colon cancer clinical trial by body system and decreasing order of frequency in the Eloxatin and infusional 5-FU/LV arm for events with overall incidences ≥ 5% but with incidences <1% NCI grade 3/4 events.

Although specific events can vary, the overall frequency of adverse events was similar in men and women and in patients <65 and ≥65 years. However, the following grade 3/4 events were more common in females: diarrhea, fatigue, granulocytopenia, nausea and vomiting. In patients ≥65 years old, the incidence of grade 3/4 diarrhea and granulocytopenia was higher than in younger patients. Insufficient subgroup sizes prevented analysis of safety by race. The following additional adverse events, were reported in ≥2% and <5% of the patients in the Eloxatin and infusional 5-FU/LV combination arm (listed in decreasing order of frequency): pain, leukopenia, weight decrease, coughing.

Eloxatin Injection

More than 1100 patients with stage II or III colon cancer and more than 4,000 patients with advanced colorectal cancer have been treated in clinical studies with Eloxatin either as a single agent or in combination with other medications. 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 previously untreated and treated patients were peripheral sensory neuropathies, fatigue, neutropenia, nausea, emesis, and diarrhea.

Combination Adjuvant Therapy with Eloxatin and infusional 5-FU/LV in Patients with Stage II or III Colon Cancer

One thousand one hundred and eight patients with stage II or III colon cancer, who had undergone complete resection of the primary tumor, have been treated in a clinical study with Eloxatin in combination with infusional 5-FU/LV. The incidence of grade 3 or 4 adverse events was 70% on the Eloxatin combination arm, and 31% on the infusional 5-FU/LV arm. The adverse reactions in this trial are shown in the tables below. Discontinuation of treatment due to adverse events occurred in 15% of the patients receiving Eloxatin and infusional 5-FU/LV. Both 5-FU/LV and Eloxatin are associated with gastrointestinal or hematologic adverse events. When Eloxatin is administered in combination with infusional 5-FU/LV, the incidence of these events is increased.

The incidence of death within 28 days of last treatment, regardless of causality, was 0.5% (n=6) in both the Eloxatin combination and infusional 5-FU/LV arms, respectively. Deaths within 60 days from initiation of therapy were 0.3% (n=3) in both the Eloxatin combination and infusional 5-FU/LV arms, respectively. On the Eloxatin combination arm, 3 deaths were due to sepsis/neutropenic sepsis, 2 from intracerebral bleeding and one from eosinophilic pneumonia. On the 5-FU/LV arm, one death was due to suicide, 2 from Steven-Johnson Syndrome (1 patient also had sepsis), 1 unknown cause, 1 anoxic cerebral infarction and 1 probable abdominal aorta rupture.

The following table provides adverse events reported in the adjuvant therapy colon cancer clinical trial by body system and decreasing order of frequency in the Eloxatin and infusional 5-FU/LV arm for events with overall incidences ≥ 5% and for NCI grade 3/4 events with incidences ≥ 1%. This table does not include hematologic and blood chemistry abnormalities; these are shown separately below.

The following table provides adverse events reported in the adjuvant therapy colon cancer clinical trial by body system and decreasing order of frequency in the Eloxatin and infusional 5-FU/LV arm for events with overall incidences ≥ 5% but with incidences <1% NCI grade 3/4 events.

Although specific events can vary, the overall frequency of adverse events was similar in men and women and in patients <65 and ≥65 years. However, the following grade 3/4 events were more common in females: diarrhea, fatigue, granulocytopenia, nausea and vomiting. In patients ≥65 years old, the incidence of grade 3/4 diarrhea and granulocytopenia was higher than in younger patients. Insufficient subgroup sizes prevented analysis of safety by race. The following additional adverse events, were reported in ≥2% and <5% of the patients in the Eloxatin and infusional 5-FU/LV combination arm (listed in decreasing order of frequency): pain, leukopenia, weight decrease, coughing.

More resources:

Eloxatin

Eloxatin

Eloxatin - Includes detailed dosage instructions.

Eloxatin

Oxaliplatin

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