Oxaliplatin Teva
Platinum-based chemotherapy for colorectal cancer – oxaliplatin 5 mg/ml concentrate for solution for infusion
Oxaliplatin Teva is a platinum-based chemotherapy medication used to treat colorectal cancer. It is administered as an intravenous infusion in combination with 5-fluorouracil (5-FU) and leucovorin (folinic acid) as part of the FOLFOX regimen. Oxaliplatin works by damaging cancer cell DNA, preventing tumour growth and spread. This guide covers its uses, dosage, side effects, drug interactions, and storage, based on international clinical guidelines and regulatory data from the EMA and FDA.
Quick Facts
Key Takeaways
- Oxaliplatin Teva is a platinum-based chemotherapy drug used exclusively for colorectal cancer treatment, always in combination with 5-fluorouracil and leucovorin.
- Peripheral neuropathy (tingling, numbness in hands and feet) is the most characteristic side effect, often triggered or worsened by cold exposure – patients must avoid cold drinks and temperatures.
- The standard dose is 85 mg/m² body surface area administered every two weeks; adjuvant treatment typically lasts up to 6 months (12 cycles).
- Oxaliplatin must only be diluted in 5% glucose solution – never with saline or chloride-containing solutions, as these degrade the drug.
- Regular blood tests are essential to monitor blood cell counts, liver function, and kidney function throughout treatment.
What Is Oxaliplatin Teva and What Is It Used For?
Oxaliplatin is a third-generation platinum compound that belongs to the family of platinum-based antineoplastic agents, alongside cisplatin and carboplatin. Unlike its predecessors, oxaliplatin features a 1,2-diaminocyclohexane (DACH) carrier ligand that provides a distinct mechanism of action and a different spectrum of antitumour activity. This structural difference is clinically significant because it allows oxaliplatin to remain effective against certain tumour cell lines that are resistant to cisplatin and carboplatin.
The primary mechanism of action involves the formation of inter-strand and intra-strand cross-links in DNA. When oxaliplatin enters a cancer cell, it forms reactive platinum complexes that bind to DNA, creating bulky adducts that distort the DNA helix. This disruption prevents the cell from replicating its genetic material, ultimately leading to apoptosis (programmed cell death). Importantly, oxaliplatin is cytotoxic to both actively dividing and resting cancer cells, which contributes to its efficacy in treating slow-growing tumours.
Oxaliplatin Teva is indicated for two main clinical scenarios. First, it is used as adjuvant treatment of stage III (Dukes C) colon cancer following complete surgical removal (resection) of the primary tumour. In this setting, the MOSAIC trial demonstrated that adding oxaliplatin to 5-FU/leucovorin significantly improved disease-free survival compared with 5-FU/leucovorin alone, establishing the FOLFOX regimen as a standard of care for adjuvant chemotherapy. Second, it is used in the treatment of metastatic colorectal cancer, where the FOLFOX regimen has shown superior response rates and progression-free survival compared with 5-FU/leucovorin alone.
Oxaliplatin is never used as a single agent. It is always administered in combination with 5-fluorouracil and leucovorin (folinic acid), a combination known as the FOLFOX regimen. The synergistic interaction between oxaliplatin and 5-FU is well-established: oxaliplatin enhances the cytotoxic effect of 5-FU by inhibiting DNA repair mechanisms that would otherwise allow cancer cells to survive 5-FU-induced damage. Leucovorin further potentiates the activity of 5-FU by stabilising the ternary complex formed between 5-FU, thymidylate synthase, and folate.
The addition of oxaliplatin to the 5-FU/leucovorin backbone represented a major advance in colorectal cancer treatment. The MOSAIC trial showed that FOLFOX4 improved 5-year disease-free survival from 67.4% to 73.3% in stage III colon cancer, translating to a 20% relative reduction in the risk of recurrence. This benefit has been confirmed in multiple international trials and guidelines from ESMO, NCCN, and ASCO.
What Should You Know Before Receiving Oxaliplatin Teva?
Contraindications
You must not receive Oxaliplatin Teva if any of the following apply to you:
- Hypersensitivity to oxaliplatin or any of the other ingredients (lactose monohydrate, water for injections)
- Breastfeeding – oxaliplatin passes into breast milk and may harm the nursing infant
- Pre-existing myelosuppression – already reduced red blood cell counts (anaemia), white blood cell counts (neutropenia), or platelet counts (thrombocytopenia)
- Pre-existing peripheral neuropathy with functional impairment – tingling or numbness in fingers and toes with difficulty performing fine motor tasks such as buttoning a shirt
- Severe renal impairment – significantly reduced kidney function (creatinine clearance below 30 ml/min)
Warnings and Precautions
Tell your doctor before receiving Oxaliplatin Teva if you have ever experienced any of the following:
- An allergic reaction to platinum-containing drugs such as cisplatin or carboplatin – cross-reactivity is possible, and allergic reactions can occur during any infusion cycle, even after previous uneventful treatments
- Mild to moderate kidney problems – dose adjustments may be necessary, and kidney function should be monitored closely
- Liver problems or abnormal liver function test results – oxaliplatin may cause hepatic sinusoidal obstruction syndrome (veno-occlusive disease)
- Heart problems, including long QT syndrome, irregular heartbeat (arrhythmias), or a family history of cardiac disease – oxaliplatin may rarely cause QT prolongation
- Throat tightness or difficulty swallowing, especially during or after infusion
- Signs of severe allergic reaction: rash, hives, facial swelling, difficulty breathing, wheezing
- Headache, altered mental state, seizures, or vision changes (symptoms of posterior reversible encephalopathy syndrome)
- Extreme fatigue, shortness of breath, or very dark urine (signs of haemolytic anaemia or kidney failure)
- Fever of 38°C or above, which may indicate infection due to low white blood cell counts
- Unexpected bleeding or bruising – possible sign of disseminated intravascular coagulation
- Muscle pain with swelling, weakness, and dark urine (rhabdomyolysis)
- Severe abdominal pain with bloody stools (possible intestinal ischaemia or gastrointestinal perforation)
Pregnancy, Breastfeeding, and Fertility
Pregnancy: You should avoid becoming pregnant during treatment with oxaliplatin. Effective contraception must be used during treatment. Female patients should use appropriate contraception during treatment and for 4 months after the last dose. If you are pregnant or suspect you may be pregnant, inform your oncologist immediately before starting treatment. Oxaliplatin may cause harm to the developing foetus based on its mechanism of action.
Breastfeeding: Breastfeeding is contraindicated during treatment with oxaliplatin. The drug may pass into breast milk and cause serious harm to the nursing infant.
Fertility: Oxaliplatin may cause infertility, which can be permanent. Male patients should be counselled about sperm banking (cryopreservation) before starting treatment. Male patients are advised not to father a child during treatment and for up to 6 months after the last dose, and must use effective contraception during this period.
Driving and Operating Machinery
Treatment with oxaliplatin may increase the risk of dizziness, nausea, vomiting, and neurological symptoms that affect walking and balance. If you experience these effects, do not drive, operate machinery, or perform activities requiring alertness. Visual disturbances have also been reported. Patients should assess their ability to drive on an individual basis, considering all side effects experienced.
Vaccinations
During treatment with oxaliplatin, you should not receive live or attenuated vaccines (such as yellow fever vaccine). Your immune system is likely to be suppressed during chemotherapy, and live vaccines could cause serious or life-threatening infections. Inactivated vaccines may be given but may produce a reduced immune response. Discuss your vaccination needs with your oncologist before starting treatment.
How Does Oxaliplatin Teva Interact with Other Drugs?
Oxaliplatin has specific compatibility requirements and known drug interactions that healthcare providers must consider. Because it is administered intravenously in a hospital setting, most interactions relate to pharmaceutical incompatibilities during administration rather than traditional drug-drug interactions.
Critical Administration Incompatibilities
The following substances must never be co-administered or mixed with oxaliplatin:
- Sodium chloride (saline) and all chloride-containing solutions – chloride ions degrade oxaliplatin, reducing its potency
- Alkaline solutions – these destabilise the drug and reduce efficacy
- Aluminium-containing equipment – aluminium reacts with platinum compounds, causing degradation
- 5-Fluorouracil – while used in the same treatment regimen, the two drugs must never be mixed in the same infusion bag; they are administered sequentially through a Y-line with a glucose flush between them
- Leucovorin preparations containing trometamol – trometamol is alkaline and incompatible with oxaliplatin
Drug Interactions
| Interacting Drug | Type | Effect | Clinical Advice |
|---|---|---|---|
| Nephrotoxic drugs (e.g. aminoglycosides, NSAIDs, contrast agents) | Pharmacokinetic | Increased risk of kidney damage | Monitor renal function closely; avoid if possible |
| Other myelosuppressive agents | Pharmacodynamic | Additive bone marrow suppression | Monitor blood counts more frequently |
| Live vaccines (e.g. yellow fever, MMR, varicella) | Immunological | Risk of serious vaccine-strain infection | Contraindicated during treatment |
| Anticoagulants (e.g. warfarin) | Pharmacodynamic | Increased bleeding risk due to thrombocytopenia | Monitor INR and platelet counts closely |
| Phenytoin / Fosphenytoin | Pharmacokinetic | Reduced phenytoin absorption; increased toxicity risk | Monitor phenytoin levels; consider alternative anticonvulsant |
Always inform your oncologist about all medications you are taking, including prescription drugs, over-the-counter medicines, herbal remedies, and dietary supplements. Some interactions may not yet be fully characterised, and your healthcare team needs a complete medication list to ensure safe treatment.
What Is the Correct Dosage of Oxaliplatin Teva?
Oxaliplatin Teva is intended exclusively for adult patients. The dosage is calculated based on body surface area (BSA), which is determined by the patient's height and weight. This individualised dosing approach ensures appropriate drug exposure while minimising the risk of excessive toxicity.
Adults (Standard Dosing)
FOLFOX Regimen – Standard Dose
Dose: 85 mg/m² body surface area
Route: Intravenous infusion in 250–500 ml of 5% glucose solution
Duration: Infused over 2 to 6 hours
Frequency: Once every two weeks (Day 1 of each 14-day cycle)
Treatment duration: Up to 6 months (approximately 12 cycles) in the adjuvant setting; duration determined by the oncologist for metastatic disease based on response and tolerability
The infusion is administered in a specific sequence. Oxaliplatin is infused simultaneously with leucovorin through a Y-connector (with leucovorin in a separate bag of 5% glucose), followed by a line flush, and then the 5-fluorouracil infusion. The two drugs must never be mixed in the same bag.
Elderly Patients
No specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly neuropathy and gastrointestinal toxicity. Kidney function tends to decline with age, and the oncologist will assess renal function before each cycle and adjust dosing accordingly. Close monitoring of blood counts and organ function is particularly important in this age group.
Patients with Renal Impairment
Oxaliplatin is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml/min). For patients with mild to moderate renal impairment, the recommended starting dose remains 85 mg/m², but kidney function must be monitored closely, and dose reductions should be made if renal function deteriorates during treatment.
Dose Modifications
Your oncologist may reduce your dose, delay treatment, or discontinue oxaliplatin based on the severity of side effects:
- Grade 2 peripheral neuropathy (persistent): Reduce dose to 65 mg/m²
- Grade 3 peripheral neuropathy: Discontinue oxaliplatin
- Severe neutropenia or thrombocytopenia: Delay until recovery; reduce dose for subsequent cycles
- Severe gastrointestinal toxicity (Grade 3–4 diarrhoea or mucositis): Delay treatment; dose reduction upon recovery
Missed Dose
Since oxaliplatin is administered in a clinical setting by healthcare professionals, missed doses are uncommon. If you miss an appointment, contact your oncology team as soon as possible to reschedule. Do not attempt to make up for a missed dose by receiving a double dose – your doctor will determine the appropriate timing for your next treatment.
Overdose
Because oxaliplatin is prepared and administered by trained healthcare professionals, overdose is unlikely. However, in the event of an overdose, side effects may be amplified, including severe myelosuppression (dangerously low blood cell counts), severe neuropathy, nausea, vomiting, and diarrhoea. There is no specific antidote for oxaliplatin overdose. Treatment is supportive: monitoring blood counts, providing platelet or red blood cell transfusions as needed, managing infections with antibiotics, and treating other symptoms as they arise.
What Are the Side Effects of Oxaliplatin Teva?
Like all chemotherapy drugs, oxaliplatin can cause side effects, although not everyone experiences them. The nature and severity of side effects depend on the dose, the number of treatment cycles, and individual patient factors. It is important to report all side effects to your oncology team, as many can be managed effectively with dose adjustments or supportive medications.
Peripheral Neuropathy – The Hallmark Side Effect
Oxaliplatin causes two distinct forms of peripheral neuropathy that patients and clinicians must understand:
Acute neurotoxicity occurs during or within hours of the infusion in up to 85–95% of patients. It is characterised by transient cold-triggered symptoms: tingling and numbness in fingers, toes, around the mouth, and in the throat; jaw tightness; muscle cramps; and an unpleasant sensation when touching cold objects or drinking cold beverages. Some patients describe an electric shock-like sensation running down the arms or trunk when bending the neck. A characteristic but alarming symptom is throat tightness with a sensation of difficulty breathing – although this is not true bronchospasm, it can be distressing. These acute symptoms typically resolve within hours to days and can be minimised by avoiding cold exposure.
Cumulative chronic neuropathy develops with repeated treatment cycles, typically becoming clinically significant after 6–8 cycles. Symptoms include persistent tingling and numbness in the fingers and toes, difficulty with fine motor tasks (buttoning clothes, writing, picking up small objects), and impaired balance. Unlike the acute form, cumulative neuropathy may persist for months or even years after treatment completion, and in some patients it may be permanent. The incidence of Grade 3 persistent neuropathy (functionally limiting) is approximately 10–15% with the standard 12-cycle adjuvant regimen.
Very Common (affects more than 1 in 10 patients)
- Peripheral neuropathy (tingling, numbness, cold sensitivity)
- Nausea and vomiting
- Diarrhoea
- Stomatitis and mucositis (mouth sores)
- Fatigue and asthenia (weakness)
- Anaemia (low red blood cells)
- Neutropenia (low white blood cells)
- Thrombocytopenia (low platelets)
- Abdominal pain
- Loss of appetite and taste changes
- Constipation
- Headache and back pain
- Fever, rigors, and body pain
- Cough and shortness of breath
- Nosebleeds and abnormal bleeding
- Skin rash and mild hair loss
- Abnormal liver function tests
- Injection site reactions
Common (affects 1 to 10 in 100 patients)
- Infection due to low white blood cell counts
- Neutropenic sepsis (life-threatening blood infection)
- Febrile neutropenia (fever with low white blood cells)
- Indigestion, heartburn, hiccups
- Dizziness, flushing
- Chest pain
- High blood pressure
- Blood clots (deep vein thrombosis, pulmonary embolism)
- Increased sweating, nail disorders, skin peeling
- Joint and bone pain
- Depression, insomnia
- Eye inflammation (conjunctivitis), vision problems
- Blood in urine, painful urination
- Dehydration, low blood calcium
- Falls
Uncommon (affects 1 to 10 in 1,000 patients)
- Severe blood infection (sepsis), potentially fatal
- Bowel obstruction or swelling
- Nervousness
Rare and Very Rare (affects fewer than 1 in 1,000 patients)
- Hearing loss
- Interstitial lung disease (scarring of the lungs), potentially fatal
- Temporary vision loss
- Disseminated intravascular coagulation (DIC), potentially fatal
- Posterior reversible encephalopathy syndrome (PRES)
- Haemolytic-uraemic syndrome (HUS), potentially fatal
- QT prolongation (abnormal heart rhythm), potentially fatal
- Rhabdomyolysis (muscle breakdown), potentially fatal
- Gastrointestinal perforation or haemorrhage
- Intestinal ischaemia (reduced blood flow to bowel), potentially fatal
- Acute kidney failure
- Hepatic vascular disorders
- Allergic vasculitis (blood vessel inflammation)
- Autoimmune pancytopenia
- Laryngospasm (throat spasm causing breathing difficulty)
- Secondary leukaemia after treatment completion
- Myocardial infarction (heart attack), angina
- Oesophagitis (inflammation of the food pipe)
Cold-triggered neuropathy is the most distinctive side effect of oxaliplatin. To minimise symptoms: avoid cold drinks and ice for at least 5 days after each infusion; do not breathe cold air without covering your nose and mouth; wear gloves when handling cold objects or reaching into the refrigerator; avoid air conditioning directly on your skin. These precautions should be followed during and for several days after each treatment cycle.
How Should You Store Oxaliplatin Teva?
Proper storage of Oxaliplatin Teva is essential to maintain drug stability and ensure patient safety. In most cases, storage is handled by hospital pharmacies and oncology units, but understanding the requirements helps ensure quality throughout the supply chain.
- Unopened vials: Store at or below 25°C. Keep the vial in its outer carton to protect from light. Oxaliplatin is a light-sensitive compound, and prolonged exposure to light can degrade the active substance.
- Shelf life: Do not use after the expiry date printed on the carton and vial label. The expiry date refers to the last day of the stated month.
- After dilution: Once diluted in 5% glucose solution (50 mg/ml), the prepared infusion solution has demonstrated chemical and physical stability for 24 hours at 2–8°C and for 6 hours at room temperature (25°C). From a microbiological standpoint, the solution should be used immediately. If not used immediately, the storage time and conditions are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless dilution was performed under controlled and validated aseptic conditions.
- Visual inspection: Before use, the solution should be visually inspected. Only clear, colourless to almost colourless solutions without particles should be used.
- Single use only: Each vial is for single use. Any remaining solution after the infusion must be discarded in accordance with local regulations for cytotoxic waste.
- Safety: Oxaliplatin must not come into contact with the eyes or skin. If accidental spillage occurs, wash the affected area immediately and thoroughly with water and notify healthcare staff.
Keep all medicines out of the sight and reach of children. Hospital staff will handle the disposal of any unused product in accordance with established protocols for hazardous pharmaceutical waste.
What Does Oxaliplatin Teva Contain?
Active Substance
The active substance is oxaliplatin. Each millilitre of concentrate for solution for infusion contains 5 mg of oxaliplatin.
Inactive Ingredients (Excipients)
- Lactose monohydrate (45 mg/ml) – used as a stabiliser
- Water for injections – the solvent
Available Pack Sizes
Oxaliplatin Teva is a clear, colourless or almost colourless solution supplied in colourless glass vials with a bromobutyl rubber stopper, aluminium seal, and polypropylene snap-off cap. The following presentations are available:
| Vial Volume | Oxaliplatin Content | Concentration |
|---|---|---|
| 4 ml | 20 mg | 5 mg/ml |
| 10 ml | 50 mg | 5 mg/ml |
| 20 ml | 100 mg | 5 mg/ml |
| 40 ml | 200 mg | 5 mg/ml |
Each carton contains one vial. Not all pack sizes may be marketed in all countries.
Marketing Authorisation Holder
Teva Pharmaceutical Industries Ltd. The product is manufactured by Pharmachemie B.V., Haarlem, the Netherlands.
Frequently Asked Questions About Oxaliplatin Teva
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Oxaliplatin – Summary of Product Characteristics. European Public Assessment Report. Updated 2024.
- U.S. Food and Drug Administration (FDA). Eloxatin (oxaliplatin) – Prescribing Information. FDA Approved Drug Products. Updated 2023.
- André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. New England Journal of Medicine. 2004;350(23):2343–2351. doi:10.1056/NEJMoa032709
- André T, Boni C, Navarro M, et al. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. Journal of Clinical Oncology. 2009;27(19):3109–3116. doi:10.1200/JCO.2008.20.6771
- de Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. Journal of Clinical Oncology. 2000;18(16):2938–2947. doi:10.1200/JCO.2000.18.16.2938
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Argyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Critical Reviews in Oncology/Hematology. 2012;82(1):51–77. doi:10.1016/j.critrevonc.2011.04.012
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Colon Cancer. Annals of Oncology. 2024.
- British National Formulary (BNF). Oxaliplatin. National Institute for Health and Care Excellence (NICE). Updated 2024.
- Grothey A, Sobrero AF, Shields AF, et al. Duration of adjuvant chemotherapy for stage III colon cancer (IDEA collaboration). New England Journal of Medicine. 2018;378(13):1177–1188. doi:10.1056/NEJMoa1713709
Medical Editorial Team
This article has been written and reviewed by qualified medical professionals following international clinical guidelines and the GRADE evidence framework.
iMedic Medical Editorial Team – specialists in oncology and clinical pharmacology with documented academic background and clinical experience in cancer treatment.
iMedic Medical Review Board – independent panel of board-certified oncologists and pharmacologists who review all content according to EMA, FDA, WHO, and ESMO guidelines.
Evidence standard: Level 1A – based on systematic reviews and meta-analyses of randomised controlled trials. All medical claims are supported by peer-reviewed literature and international clinical guidelines.
Conflict of interest: None. iMedic receives no pharmaceutical company funding, sponsorship, or advertising revenue.
Last reviewed: