Eloxatin Side Effects

Generic name: oxaliplatin

Note: This document contains side effect information about oxaliplatin. Some of the dosage forms listed on this page may not apply to the brand name Eloxatin.

Some side effects of Eloxatin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to oxaliplatin: intravenous powder for injection, intravenous solution

Some people receiving a oxaliplatin (the active ingredient contained in Eloxatin) injection have had a reaction to the infusion within minutes after the medicine is injected into the vein. Tell your caregiver right away if you feel dizzy, short of breath, confused, sweaty, itchy, or have diarrhea, chest pain, warmth or redness in your face, or feel like you might pass out.

Get emergency medical help if you have any of these signs of an allergic reaction while taking oxaliplatin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• headache, confusion, change in mental status, vision problems, seizure (convulsions);

• numbness, tingling, or burning pain that interferes with daily activities;

• increased sensitivity to cold temperatures and cold objects;

• jaw or chest tightness, eye pain, strange feeling in your tongue, problems with speech or swallowing;

• fever, chills, sore throat, mouth and throat ulcers, cough with mucus;

• dry cough, wheezing, feeling short of breath on exertion;

• pain or burning when you urinate;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• pale skin, feeling weak or tired, rapid heart rate, trouble concentrating;

• pain, redness, swelling, or skin changes where the injection was given; or

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Other common side effects may include:

• nausea, vomiting, stomach pain, loss of appetite;

• diarrhea, constipation;

• weight gain;

• muscle pain; or

• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to oxaliplatin: intravenous powder for injection, intravenous solution

General

In general, side effects have been reported in 98% of patients, with 73% of those characterized as NCI CTC Grade 3/4 severity. The incidence of side effects given in the following sections refers to oxaliplatin (the active ingredient contained in Eloxatin) fluorouracil/leucovorin combination therapy.

The most common side effects include peripheral sensory neuropathies, neutropenia, nausea, emesis, and diarrhea. Thirteen percent of patients in the combination therapy group and 18% in the fluorouracil/leucovorin group discontinued treatment due to neuropathies, or gastrointestinal or hematologic side effects.

The incidence of death was 5% in the combination therapy group, 8% in the oxaliplatin monotherapy group, and 7% in the fluorouracil/leucovorin group within 30 days of treatment (regardless of causality).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (68% overall, 11% NCI CTC Grade 3/4), nausea (65% overall, 11% Grade 3/4), vomiting (40% overall, 9% Grade 3/4), stomatitis (37% overall, 3% Grade 3/4), abdominal pain (33% overall, 4% Grade 3/4), anorexia (29% overall, 3% Grade 3/4), and gastroesophageal reflux (5% overall, 2% Grade 3/4). Side effects with less than 1% incidence of Grade 3/4 severity have included constipation (32%), dyspepsia (14%), taste perversion (13%), mucositis (7%), and flatulence (5%). Additional side effects possibly related to treatment have been reported in 2% to 5% of patients and include dry mouth, melena, gingivitis, rectal hemorrhage, hemorrhoids, hemoptysis, proctitis, tenesmus, intestinal obstruction, and enlarged abdomen. Ileus, pancreatitis, and colitis (including Clostridium difficile diarrhea) have also been reported.

Nervous system

Acute neuropathy is reversible and primarily of a peripheral sensory nature. The onset occurs within hours to 2 days of dosing. It generally resolves within 2 weeks and frequently recurs with repeat doses. Exposure to cold temperature or cold objects may precipitate or exacerbate symptoms. Symptoms may include transient paresthesia, dysesthesia, and hypoesthesia in the hands, feet, perioral area, or throat. Jaw spasm, abnormal tongue sensation, dysarthria, eye pain, and chest pressure have also been reported. Ice should be avoided for mucositis prophylaxis. Acute pharyngolaryngeal dysesthesia with sensations of dysphagia and dyspnea but no laryngospasm or bronchospasm has been reported in 1% to 2% of patients.

Persistent neuropathy generally lasts for more than 2 weeks and is also primarily of a peripheral sensory nature. Symptoms included paresthesias, dysesthesias, hypoesthesias, and deficits in proprioception that may interfere with daily activities (e.g., writing, buttoning, swallowing, or walking). Persistent neuropathy may occur with no prior neuropathy event. Eighty percent of patients who developed Grade 3 persistent neuropathy progressed from Grade 1 or 2. The symptoms may improve in some patients when oxaliplatin (the active ingredient contained in Eloxatin) is discontinued.

Preventive measures include calcium and magnesium solutions, gabapentin, carbamazepine, amifostine, and glutathione. Treatment measures include calcium and magnesium solutions, gabapentin, and alpha-lipoic acid.

Nervous system side effects which have been most frequently reported include two types of neuropathy (74%) - acute and persistent, with an incidence of 56% and 48%, respectively. Six percent of patients experienced NCI CTC Grade 3/4 persistent neuropathy.

Side effects with less than 1% incidence of Grade 3/4 severity have included headache, dizziness, and insomnia. Additional side effects possibly related to treatment have been reported in 2% to 5% of patients and include anxiety, depression, ataxia, nervousness, and somnolence. Deafness, loss of deep tendon reflexes, dysarthria, Lhermitte sign, cranial nerve palsies, and fasciculations have also been reported.

Hematologic

Hematologic side effects have included thrombocytopenia (68% all grades; 4% NCI CTC Grade 3/4), neutropenia (73% all grades; 44% Grade 3/4), leukopenia (76% all grades; 19% Grade 3/4), anemia (81% all grades, 2% Grade 3/4), thromboembolism (9% overall, 8% Grade 3/4), and febrile neutropenia (6% overall, 6% Grade 3/4). Immunoallergic thrombocytopenia, immunoallergic hemolytic anemia, and hemolytic uremic syndrome have also been reported. One case of fatal hemolytic anemia has been reported.

Other

Side effects affecting the body as a whole have included fatigue (68% overall, 7% NCI CTC Grade 3/4), fever (29% overall, 1% Grade 3/4), back pain (19% overall, 3% Grade 3/4), edema (15% overall, 1% Grade 3/4), pain (15% overall, 2% Grade 3/4), chest pain (8% overall, 1% Grade 3/4), flushing (10%), peripheral edema (10%), rigors (10%), hot flashes (2% to 5%), and angioedema.

Respiratory

Respiratory side effects have included dyspnea (20% overall, 4% NCI CTC Grade 3/4) and coughing (19% overall, 1% Grade 3/4). Side effects with a less than 1% incidence of Grade 3/4 severity have included rhinitis (15%), upper respiratory tract infection (10%), pharyngitis (9%), epistaxis (9%), and hiccup (5%). Pulmonary fibrosis and other interstitial lung diseases (sometimes fatal) have also been reported (0.7%). A case of cryptogenic organizing pneumonitis has been reported.

Hypersensitivity

Patients who develop mild to moderate hypersensitivity to oxaliplatin (the active ingredient contained in Eloxatin) may be pretreated with steroids as well as type 1 and type 2 histamine receptor antagonists. However, patients who develop severe reactions are unlikely to tolerate further therapy.

Hypersensitivity reactions of an anaphylactoid and anaphylactic nature with symptoms of rash, urticaria, erythema, pruritus, and rarely, bronchospasm, and hypotension have been reported. Anaphylactic shock has also been reported. Less than 1% of hypersensitivity reactions were characterized as NCI CTC Grade 3/4. Other platinum compounds have been associated with fatal hypersensitivity reactions. Epinephrine, corticosteroids, and antihistamines have been used to manage symptoms.

Hepatic

Hepatic side effects have included elevations in ALT (31% overall, 0% NCI CTC Grade 3/4), AST (47% overall, 0% Grade 3/4), and total bilirubin (13% overall, 1% Grade 3/4). Veno-occlusive disease of the liver (also known as sinusoidal obstruction syndrome) and perisinusoidal fibrosis (which rarely may progress) have also been reported.

Dermatologic

Dermatologic side effects with a less than 1% incidence of NCI CTC Grade 3/4 severity have included hand-foot syndrome (11%), rash (9%), and alopecia (7%). Erythematous rash and purpura have been reported in 2% to 5% of patients.

Local

Local side effects (injection site reactions) have been reported in 10% of patients (3%, NCI CTC Grade 3/4), including redness, swelling, and pain. Extravasation may result in severe pain and inflammation and cause complications such as necrosis.

Renal

Renal side effects have included serum creatinine elevations (10% overall, 1% NCI CTC Grade 3/4).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (10% overall, less than 1% Grade 3/4). Involuntary muscle contractions and muscle weakness have been reported in 2% to 5% of patients. Six cases of involuntary masticatory spasms induced by continuous infusion of oxaliplatin (the active ingredient contained in Eloxatin) have also been reported.

Metabolic

Metabolic side effects have included hypokalemia (9% overall, 4% NCI CTC Grade 3/4) and dehydration (8% overall, 3% Grade 3/4). Weight decrease (2% to 5%) and metabolic acidosis have also been reported.

Ocular

Ocular side effects have included abnormal lacrimation (7% overall, less than 1% NCI CTC Grade 3/4), conjunctivitis (2% to 5%), decrease of visual acuity, visual field disturbance, transient vision loss (reversible following therapy discontinuation), and optic neuritis. A case of acute bilateral abducens paralysis due to oxaliplatin (the active ingredient contained in Eloxatin) has also been reported.

Genitourinary

Genitourinary side effects that have been reported with a less than 1% incidence of NCI CTC Grade 3/4 severity include hematuria (6%) and dysuria (6%). Additional side effects possibly related to treatment have been reported in 2% to 5% of patients and include abnormal micturition frequency, vaginal hemorrhage, and urinary incontinence.

Cardiovascular

Cardiovascular side effects have included tachycardia (2% to 5%).

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