Oxaliplatin Side Effects

Brand Names: Eloxatin

Please note - some side effects for Oxaliplatin 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 Oxaliplatin - for the Consumer

Oxaliplatin

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 Oxaliplatin:

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.

Oxaliplatin Side Effects - for the Professional

Oxaliplatin

Most common adverse reactions (incidence ≥ 40%) were peripheral sensory neuropathy, neutropenia, thrombocytopenia, anemia, nausea, increase in transaminases and alkaline phosphatase, diarrhea, emesis, Fatigue and stomatitis. Other adverse reactions, including serious adverse reactions, have been reported. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact CARACO Pharmaceutical Laboratories Ltd. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System

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/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 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 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 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 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%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.