Oxaliplatin

Oxaliplatin is a prescription medicine used to treat the symptoms of colorectal cancer.

• Oxaliplatin is available under the following different brand names: Eloxatin

Adult dosage

Powder for injectable solution

• 50mg/vial
• 100mg/vial
• 200mg/vial

Colorectal Cancer

Adult dosage

Advanced colorectal cancer

• Day 1: Oxaliplatin 85 mg/m² IV + leucovorin 200 mg/m² IV infused over 2 hours, THEN 
• 5-FU 400 mg/m² IV bolus over 2-4 minutes, THEN
• 5-FU 600 mg/m² IV infusion in D5W (500 mL) over 22 hours
• Day 2: Same regimen WITHOUT oxaliplatin
• Repeat every 2 weeks
• Adjuvant treatment for stage III colon cancer
• 12 cycles, every 2 weeks, according to the dosing schedule above, for a total of 6 months
• Adjuvant use follows tumor resection

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Oxaliplatin include:

• nausea,
• vomiting,
• diarrhea,
• numbness,
• tingling,
• burning pain,
• low blood cell counts,
• abnormal liver function tests,
• mouth sores, and
• tiredness.

Serious side effects of Oxaliplatin include:

• hives,
• swelling of the face, lips, tongue, or throat,
• shortness of breath,
• confusion,
• sweating,
• itching,
• chest pain,
• warmth or redness in the face,
• increased sensitivity to cold temperatures and cold objects,
• numbness, tingling, or burning pain that interferes with daily activities,
• severe or ongoing diarrhea or vomiting,
• change in mental status,
• vision problems,
• seizure,
• pain or burning while urinating,
• sudden chest pain or discomfort,
• wheezing,
• dry cough,
• pain, redness, swelling, or skin changes where the injection was given,
• feeling very thirsty or hot,
• being unable to urinate,
• heavy sweating,
• hot and dry skin,
• headache with chest pain,
• severe dizziness,
• fainting,
• fast or pounding heartbeats,
• upper stomach pain,
• tiredness,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes,
• unexplained muscle pain,
• weakness with a fever,
• unusual tiredness,
• jaw or chest tightness,
• eye pain,
• strange feeling in the tongue,
• problems with speech or swallowing,
• chills,
• tiredness,
• mouth sores,
• skin sores,
• easy bruising,
• unusual bleeding,
• pale skin,
• cold hands and feet, and
• lightheadedness,  

Rare side effects of Oxaliplatin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Oxaliplatin has severe interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • influenza virus vaccine quadrivalent, intranasal
  • measles (rubeola) vaccine
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella, and varicella vaccine, live
  • pimozide
  • rotavirus oral vaccine, live
  • rubella vaccine
  • smallpox (vaccinia) vaccine, live
  • typhoid polysaccharide vaccine
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Oxaliplatin has serious interactions with at least 45 other drugs.
• Oxaliplatin has moderate interactions with at least 206 other drugs.
• Oxaliplatin has minor interactions with the following drugs:
  • colistin
  • entecavir
  • isavuconazonium sulfate
  • maitake
  • methoxyflurane
  • taurine
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to oxaliplatin, other platinum compounds
• Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Oxaliplatin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Oxaliplatin?”

Cautions

• Caution in renal impairment, elderly, neuropathy, neurotoxic agents
• For 3-4 days, avoid contact with ice/cold food/objects, avoid breathing cold air
• Avoid contact with aluminum needles or equipment
• Avoid pregnancy
• Pulmonary fibrosis may occur
• Concomitant use with fluorouracil may increase gastrointestinal effects
• Grade 3 or 4 neutropenia reported in patients with colorectal cancer treated in combination with 5-fluorouracil (5-FU) and leucovorin; delay oxaliplatin therapy until neutrophils are at 1.5 x 10^9/L; withhold oxaliplatin for sepsis or septic shock; reduce the dose after recovery from Grade 4 neutropenia or febrile neutropenia
• Cardiovascular toxicity reported; ECG monitoring recommended if therapy initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities; correct hypokalemia or hypomagnesemia before initiating oxaliplatin and monitor these electrolytes periodically during therapy; avoid oxaliplatin in patients with congenital long QT syndrome
• Reversible posterior leukoencephalopathy syndrome (RPLS, also known as PRES, Posterior Reversible Encephalopathy Syndrome) reported in clinical trials and postmarketing experience
• Rhabdomyolysis, including fatal cases, reported; discontinue oxaliplatin if any signs or symptoms of rhabdomyolysis occur

Pregnancy and Lactation

• Based on direct interaction with DNA, therapy can cause fetal harm when administered to a pregnant woman; available human data do not establish the presence or absence of major birth defects or miscarriage related to use of the drug; advise a pregnant woman of the potential hazard to the fetus
• Verify pregnancy status in females of reproductive potential before initiating therapy
• Therapy can cause embryo-fetal harm when administered to a pregnant woman
• Advise females of reproductive potential to use effective contraception while receiving therapy and for 9 months after the final dose
• Based on mechanism acts as a genotoxic drug, advise males with female partners of reproductive potential to use effective contraception while receiving the drug and for 6 months after the final dose
• Lactation
  • There are no data on the presence of drugs or their metabolites in human or animal milk, effects on the breastfed infant or milk production; because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 3 months after the final dose