Oxaliplatin Injection

Oxaliplatin Injection is always used as part of a combination chemotherapy regimen — never as a standalone treatment.

• Adjuvant treatment of stage III colon cancer: Used with infusional fluorouracil and leucovorin in patients who have had their tumor completely removed by surgery, to reduce the risk of cancer returning. Treatment continues for up to 12 cycles.
• Advanced colorectal cancer: Used with infusional fluorouracil and leucovorin to treat colorectal cancer that has spread or progressed. Treatment continues until the disease progresses or side effects become unacceptable.

Oxaliplatin is a platinum-based drug that works by damaging the DNA inside cancer cells. Once in the body, it forms chemical bonds that create cross-links in the DNA strand — essentially locking the cancer cell's genetic material so it can no longer replicate or make the proteins it needs to survive. This effect is not limited to a specific point in the cell's life cycle, so it can act on cancer cells at various stages of growth. When paired with fluorouracil, the combination disrupts cancer cell survival through complementary pathways, making it more effective than either drug alone.

Oxaliplatin Injection is given intravenously (into a vein) by a trained healthcare provider in a clinical setting — it is not self-administered. It is infused over 2 hours alongside leucovorin (in a separate IV bag) on Day 1 of a 14-day (2-week) cycle, followed by fluorouracil. Fluorouracil and leucovorin are also given on Day 2.

• For adjuvant (post-surgery) treatment: up to 12 cycles, or until side effects require stopping
• For advanced colorectal cancer: continued until disease progresses or side effects become unacceptable
• Your doctor may slow the infusion rate or adjust the dose if you develop side effects such as nerve symptoms or low blood counts

The most common side effects of oxaliplatin (occurring in 40% or more of patients) include:

• Peripheral sensory neuropathy — tingling, numbness, or pain in hands, feet, or around the mouth, often triggered by cold
• Neutropenia — dangerously low white blood cells, raising infection risk
• Thrombocytopenia — low platelets, raising bleeding risk
• Anemia — low red blood cells, causing fatigue and weakness
• Nausea and vomiting
• Diarrhea
• Elevated liver enzymes (transaminases and alkaline phosphatase)
• Mouth sores (stomatitis) and fatigue

Serious reactions to act on immediately include signs of allergic reaction (hives, swelling, difficulty breathing), fever or chills suggesting infection, sudden confusion or vision changes (possible PRES), new or severe breathing problems, unusual muscle pain with dark urine (possible rhabdomyolysis), or irregular heartbeat.

• Severe allergic reactions (anaphylaxis): Can occur within minutes of any infusion and can be fatal. Patients with a prior reaction to any platinum drug must not receive oxaliplatin.
• Peripheral nerve damage (neuropathy): Very common — affects up to 92% of adjuvant patients. Cold exposure makes it worse. Can become permanent. Dose reduction or discontinuation may be required.
• Severe low blood counts (myelosuppression): Grade 3–4 neutropenia occurs in 41–44% of patients. Sepsis and septic shock, including fatal cases, have occurred.
• Heart rhythm problems (QT prolongation): Can cause dangerous or fatal arrhythmias. Patients with congenital long QT syndrome should not use oxaliplatin. ECG monitoring is needed in high-risk patients.
• Lung damage (pulmonary toxicity): Rare but can be fatal. New unexplained cough or shortness of breath requires investigation before continuing treatment.
• PRES (posterior reversible encephalopathy syndrome): A rare brain condition causing headache, confusion, seizures, or vision loss. Confirmed PRES requires permanent discontinuation.
• Rhabdomyolysis (severe muscle breakdown): Rare but potentially fatal. Requires permanent discontinuation.
• Embryo-fetal harm: Can cause serious harm to a developing fetus. Effective contraception is required during and for months after treatment.

Oxaliplatin Injection has a few important drug interactions to be aware of:

• QT-prolonging drugs (including Class Ia and III antiarrhythmics): Increases risk of dangerous heart rhythm problems, including potentially fatal torsade de pointes. Avoid combining if possible.
• Nephrotoxic drugs (medications that can harm the kidneys): Since oxaliplatin is eliminated mainly through the kidneys, drugs that reduce kidney function can cause platinum to accumulate and worsen toxicity. Avoid if possible.
• Oral anticoagulants (blood thinners such as warfarin): Combining with oxaliplatin/fluorouracil/leucovorin can prolong clotting time (elevated INR) and increase bleeding risk. More frequent blood monitoring is needed.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• History of allergic reaction to oxaliplatin or other platinum drugs (such as cisplatin or carboplatin): This is a contraindication — you must not receive oxaliplatin.
• Severe kidney disease: The drug accumulates more in patients with severely reduced kidney function; a lower dose is required.
• Heart conditions or medications affecting heart rhythm: Risk of QT prolongation is higher; ECG monitoring is needed.
• Pregnancy: Oxaliplatin can cause serious fetal harm. Women of childbearing potential must use effective contraception during treatment and for 9 months after the last dose.
• Breastfeeding: Not recommended during treatment or for 3 months after the final dose, due to potential risk to the infant.
• Males with partners who could become pregnant: Use effective contraception during treatment and for 6 months after the last dose.
• Fertility: Oxaliplatin may impair fertility in both men and women — discuss with your doctor before starting if this is a concern.
• Older adults (65+): May be more susceptible to diarrhea, dehydration, low potassium, fatigue, and more severe low blood counts.
• Children: Safety and effectiveness in pediatric patients have not been established for the approved indications.

Oxaliplatin overdose has been reported and can cause severe reactions including very low platelet counts, serious nerve symptoms (such as tingling, facial muscle spasms, and voice/throat changes), severe nausea and vomiting, serious bowel problems, extreme dehydration, breathing difficulties, dangerous slowing of the heart rate, and in some cases death.

If an overdose is suspected, close medical monitoring and supportive treatment in a clinical setting are required immediately. There is no specific antidote.

A direct relationship between the measurable level of platinum in the blood and how well oxaliplatin works — or how toxic it is — has not been firmly established in clinical studies. The drug's effects on cancer cells are not tied to a specific phase of the cell cycle, meaning it can act on cancer cells at various stages of growth and division.

After a 2-hour IV infusion, oxaliplatin rapidly converts into active forms that spread throughout the body — about 85% distributes into tissues or is eliminated by the kidneys almost immediately, while only about 15% remains circulating in the blood. The drug binds tightly and irreversibly to blood proteins (mainly albumin) and red blood cells. It is broken down through a non-enzymatic process (not through the liver's cytochrome P450 system), and the majority of platinum is eliminated through the urine over several days. The final phase of clearance from the body is very slow, with a terminal half-life of about 391 hours, meaning platinum can persist in the body for a long time after a dose. In patients with severely reduced kidney function, platinum exposure is significantly increased, which is why a dose reduction is required.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Do not freeze and protect from light (keep in original outer carton).