Oxaliplatin Accord
Oxaliplatin 5 mg/ml – Concentrate for solution for infusion
Quick Facts about Oxaliplatin Accord
Key Takeaways about Oxaliplatin Accord
- Used for colorectal cancer: Oxaliplatin is a cornerstone of the FOLFOX regimen for both adjuvant and metastatic colorectal cancer treatment
- Always given in combination: Administered together with 5-fluorouracil (5-FU) and folinic acid – never used alone
- Peripheral neuropathy is the key side effect: Cold-triggered tingling and numbness in hands, feet and throat occurs in most patients and may become persistent
- Monitored by specialists: Regular blood tests are essential to check blood cell counts and organ function throughout treatment
- Avoid cold exposure: During treatment, avoid cold drinks, cold foods and cold air to reduce neuropathy symptoms
What Is Oxaliplatin Accord and What Is It Used For?
Oxaliplatin Accord is a platinum-based chemotherapy medicine containing oxaliplatin 5 mg/ml as concentrate for solution for infusion. It is used to treat stage III colon cancer after surgical removal of the primary tumour (adjuvant treatment) and metastatic colorectal cancer. It is always used in combination with 5-fluorouracil (5-FU) and folinic acid (leucovorin).
Oxaliplatin belongs to the group of platinum-based antineoplastic agents, a class of cancer-fighting drugs that includes cisplatin and carboplatin. However, oxaliplatin has a distinct chemical structure that gives it activity against colorectal cancers where older platinum compounds are not effective. The drug was initially approved by the European Medicines Agency (EMA) and subsequently by the U.S. Food and Drug Administration (FDA), and is now considered a standard of care for colorectal cancer treatment worldwide.
The mechanism of action of oxaliplatin involves the formation of reactive platinum complexes inside cells. These complexes bind to DNA strands, creating inter-strand and intra-strand crosslinks that disrupt DNA replication and transcription. This DNA damage triggers programmed cell death (apoptosis) in rapidly dividing cancer cells. Unlike cisplatin, oxaliplatin forms bulkier DNA adducts that are more difficult for cancer cells to repair, which contributes to its effectiveness in colorectal cancer.
Oxaliplatin Accord is the generic formulation manufactured by Accord Healthcare. It is bioequivalent to the originator product and is available in 10 ml (50 mg), 20 ml (100 mg), and 40 ml (200 mg) vials, each containing 5 mg/ml oxaliplatin. The solution must be diluted in 5% glucose (dextrose) before intravenous administration. Importantly, sodium chloride or any chloride-containing solution must never be used for dilution, as chloride ions degrade oxaliplatin.
Indications
Oxaliplatin Accord is indicated for the following conditions:
- Adjuvant treatment of stage III (Dukes C) colon cancer: Given after complete surgical resection of the primary tumour to reduce the risk of cancer recurrence. The landmark MOSAIC trial demonstrated that adding oxaliplatin to 5-FU/leucovorin significantly improved disease-free survival.
- Metastatic colorectal cancer: Used as first-line or subsequent therapy for advanced colorectal cancer that has spread to other organs, in combination with 5-FU and folinic acid (the FOLFOX regimen).
FOLFOX is the standard chemotherapy combination consisting of FOLinic acid (leucovorin), Fluorouracil (5-FU), and OXaliplatin. This regimen is one of the most widely used chemotherapy protocols for colorectal cancer worldwide. Treatment is typically given every two weeks (a "cycle") and may continue for 6 months in the adjuvant setting or until disease progression or unacceptable toxicity in the metastatic setting.
What Should You Know Before Receiving Oxaliplatin Accord?
Before starting oxaliplatin treatment, your oncologist must assess your kidney function, blood counts, neurological status, and allergy history. Oxaliplatin is contraindicated in patients with pre-existing peripheral neuropathy, severe kidney impairment, known allergy to platinum compounds, and during breastfeeding.
Contraindications
You must not receive Oxaliplatin Accord in the following situations:
- Allergy to oxaliplatin or any excipient: If you have previously had an allergic reaction to oxaliplatin or any other ingredient in the formulation, including water for injections
- Breastfeeding: Oxaliplatin is excreted in breast milk and can harm the nursing infant. Breastfeeding must be stopped during treatment
- Pre-existing myelosuppression: If you already have a significantly reduced number of red blood cells (anaemia), white blood cells (neutropenia), or platelets (thrombocytopenia)
- Pre-existing peripheral neuropathy: If you already experience tingling, numbness, or difficulty with fine motor tasks such as buttoning clothes, oxaliplatin may worsen these symptoms significantly
- Severe renal impairment: Oxaliplatin is cleared through the kidneys, and severe kidney disease can lead to dangerous drug accumulation
Warnings and Precautions
Talk to your oncologist before receiving Oxaliplatin Accord if any of the following apply to you:
- You have had an allergic reaction to other platinum-based drugs (carboplatin, cisplatin), as cross-reactivity can occur
- You have mild to moderate kidney problems – your doctor may need to adjust the dose or monitor kidney function more closely
- You have any liver problems or abnormal liver function test results
- You have heart problems, including prolonged QT interval, irregular heartbeat, or a family history of cardiac conditions
- You have recently received or plan to receive any vaccine – live or attenuated vaccines (such as yellow fever vaccine) must not be given during oxaliplatin treatment
An uncomfortable sensation in the throat (especially when swallowing), shortness of breath, persistent or severe diarrhoea, unexplained bleeding or bruising, fever above 38°C, headache with vision changes or confusion, chest pain, muscle pain with swelling and dark urine, or signs of severe allergic reaction (rash, swelling of face/lips/tongue, difficulty breathing).
Peripheral neuropathy is the most characteristic toxicity of oxaliplatin. Two distinct forms occur:
- Acute neuropathy: Occurs during or within hours of infusion, triggered by cold exposure. Symptoms include tingling in the hands, feet, and around the mouth, jaw tightness, and a sensation of difficulty breathing. This form is usually transient and reversible.
- Chronic cumulative neuropathy: Develops gradually over multiple treatment cycles. Symptoms include persistent numbness, tingling, and difficulty with fine motor skills. This form can persist for months or years after treatment ends and may become permanent in some patients. Your oncologist will carefully monitor for this and may reduce or stop treatment if symptoms become functionally impairing.
Pregnancy and Breastfeeding
Oxaliplatin can cause serious harm to a developing foetus. Women of childbearing potential must use effective contraception during treatment and for 15 months after the last dose. Male patients should use contraception during treatment and for 12 months after the last dose.
Men are advised not to father children during treatment and should consider sperm banking before starting therapy, as oxaliplatin may impair fertility – potentially permanently. Genetic counselling is recommended for patients who wish to have children after completing treatment.
Breastfeeding is strictly contraindicated during oxaliplatin treatment. The drug and its metabolites may be excreted in breast milk and could harm the infant.
Driving and Operating Machinery
Oxaliplatin can cause dizziness, nausea, vomiting, and visual disturbances. If you experience any of these symptoms, you should not drive or operate machinery. Peripheral neuropathy may also affect your balance and coordination. Discuss with your doctor whether it is safe for you to drive during treatment.
How Does Oxaliplatin Accord Interact with Other Drugs?
Oxaliplatin interacts with several medications including 5-fluorouracil (which is intentionally co-administered), erythromycin, paclitaxel, sodium valproate, and live vaccines. Drug interactions may increase toxicity or reduce effectiveness. Always inform your oncologist about all medications you are taking.
Because oxaliplatin is administered in a hospital setting by specialist oncologists, drug interactions are carefully managed by the medical team. However, it is essential that your doctor knows about all medications you take, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins. Some key interactions to be aware of include:
| Drug | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| 5-Fluorouracil (5-FU) | Synergistic – intentional combination | Enhanced antitumour effect; increased toxicity (diarrhoea, myelosuppression) | Standard FOLFOX protocol; close monitoring required |
| Erythromycin | QT prolongation risk | Both drugs may prolong QT interval, increasing cardiac arrhythmia risk | Avoid combination or monitor ECG closely |
| Paclitaxel | Pharmacokinetic interaction | May alter clearance of oxaliplatin; combined myelosuppression | Caution; monitor blood counts closely |
| Sodium Valproate | Pharmacodynamic interaction | Potential for increased neurotoxicity and altered seizure threshold | Monitor neurological symptoms; consider alternatives |
| Salicylates (aspirin) | Increased bleeding risk | Combined antiplatelet effect with oxaliplatin-induced thrombocytopenia | Use with caution; monitor platelet count |
| Live vaccines | Immunosuppression risk | Risk of disseminated vaccine infection due to immunosuppression | Contraindicated during treatment |
| Granisetron | QT prolongation risk | Additive QT prolongation potential | Monitor ECG; commonly used as antiemetic in FOLFOX |
Important Notes on Compatibility
Oxaliplatin has strict physical and chemical compatibility requirements:
- Never use aluminium-containing equipment: Aluminium degrades oxaliplatin on contact, reducing its effectiveness and potentially forming toxic precipitates
- Only dilute with 5% glucose solution: Sodium chloride (saline) and other chloride-containing solutions cause rapid degradation of oxaliplatin
- Do not mix with alkaline solutions: Alkaline drugs or solutions, including certain formulations of folinic acid containing trometamol, are incompatible with oxaliplatin
- Administer before 5-FU: In the FOLFOX regimen, oxaliplatin must always be infused before 5-fluorouracil. The infusion line must be flushed between the two drugs
What Is the Correct Dosage of Oxaliplatin Accord?
The standard dose of Oxaliplatin Accord is 85 mg/m² body surface area, administered as an intravenous infusion over 2 to 6 hours every two weeks. The dose is calculated based on your height and weight. Your oncologist may adjust the dose based on blood test results, kidney function, and side effects experienced.
Oxaliplatin Accord is exclusively administered by trained healthcare professionals in a hospital or specialist cancer treatment centre. The medication must be diluted in 250–500 ml of 5% glucose solution before infusion, achieving a final concentration between 0.2 mg/ml and 0.7 mg/ml.
Adults (including Elderly)
Standard Dosing Protocol
- Dose: 85 mg/m² body surface area per cycle
- Route: Intravenous infusion in 250–500 ml 5% glucose
- Duration: Infused over 2 to 6 hours
- Frequency: Every 2 weeks (one cycle)
- Timing: Given simultaneously with folinic acid (via Y-connector) and before 5-FU
| Setting | Dose | Duration | Cycles |
|---|---|---|---|
| Adjuvant (stage III) | 85 mg/m² every 2 weeks | Up to 6 months | Up to 12 cycles |
| Metastatic (first-line) | 85 mg/m² every 2 weeks | Until progression or toxicity | Variable |
Children and Adolescents
Oxaliplatin is not recommended for use in children and adolescents under 18 years of age. There is insufficient evidence of safety and efficacy in the paediatric population, and no paediatric indications have been approved by regulatory authorities.
Dose Adjustments
Your oncologist may reduce the dose or delay treatment based on several factors:
- Haematological toxicity: If blood counts are too low (neutrophils <1.5 × 10&sup9;/L or platelets <75 × 10&sup9;/L), treatment will be delayed until recovery
- Peripheral neuropathy: For persistent (lasting >7 days) or functionally impairing symptoms, the dose is typically reduced to 75 mg/m². Treatment may be discontinued if symptoms are severe or disabling
- Gastrointestinal toxicity: Severe diarrhoea (grade 3–4) or mucositis may require dose reduction
- Renal impairment: In patients with mild to moderate kidney impairment, dosing is at the standard level with close monitoring. Oxaliplatin is contraindicated in severe renal impairment
Overdose
As oxaliplatin is administered by healthcare professionals in a controlled setting, overdose is very unlikely. However, if an overdose were to occur, it could lead to more severe forms of the known side effects, particularly myelosuppression (dangerously low blood cell counts) and severe neurotoxicity. There is no specific antidote for oxaliplatin overdose. Treatment would be supportive, addressing individual symptoms as they arise. Blood cell counts would be monitored closely, and supportive measures such as blood transfusions or growth factor injections may be needed.
What Are the Side Effects of Oxaliplatin Accord?
Like all chemotherapy drugs, oxaliplatin can cause side effects. The most common include peripheral neuropathy (tingling and numbness triggered by cold), nausea, vomiting, diarrhoea, fatigue, and low blood cell counts. Some side effects are serious and require immediate medical attention.
Not everyone will experience side effects, and their severity varies between patients. Your oncology team will monitor you closely throughout treatment and can provide supportive treatments to manage many of these effects. It is essential to report any new or worsening symptoms to your doctor before your next treatment cycle.
Signs of allergic or anaphylactic reaction (rash, itching, swelling of face/lips/tongue, difficulty breathing, wheezing); abnormal bruising or bleeding or signs of infection such as sore throat and fever; persistent or severe diarrhoea or vomiting; blood or dark brown particles in vomit; symptoms of stroke (sudden severe headache, confusion, visual difficulties, one-sided weakness); extreme fatigue with reduced urination (signs of kidney failure).
Very Common
- Peripheral neuropathy (tingling, numbness in fingers, toes, around the mouth or throat, often triggered by cold)
- Nausea and vomiting
- Diarrhoea
- Low white blood cell count (neutropenia) – increased infection risk
- Low platelet count (thrombocytopenia) – increased bleeding risk
- Anaemia (low red blood cell count)
- Fatigue and weakness
- Fever, chills, body pain
- Loss of appetite and weight changes
- Taste changes (dysgeusia)
- Abdominal pain and constipation
- Nosebleeds and abnormal bleeding
- Mild hair loss (alopecia)
- Discomfort near or at the injection site during infusion
Common
- Infections due to low white blood cell count
- Severe bloodstream infection (neutropenic sepsis) – can be fatal
- Febrile neutropenia (low white cells with fever)
- Indigestion, heartburn, hiccups
- Hot flushes, dizziness
- Increased sweating, nail disorders, skin peeling
- Chest pain
- Lung problems, runny nose
- Joint and bone pain
- Pain when urinating, dehydration
- Blood in urine or stool, swollen veins
- Blood clots in the lungs (pulmonary embolism)
- High blood pressure
- Depression, insomnia
- Conjunctivitis and visual disturbances
- Decreased blood calcium levels
- Falls
Uncommon
- Severe bloodstream infection (sepsis) – can be fatal
- Bowel obstruction or swelling
- Nervousness
Rare and Very Rare
- Hearing impairment
- Interstitial lung disease (scarring and thickening of the lungs) – can be fatal
- Temporary vision loss
- Disseminated intravascular coagulation (DIC) – can be fatal
- Vascular liver disease (hepatic sinusoidal obstruction syndrome)
- Allergic vasculitis (inflammation of blood vessels)
- Seizures (convulsions)
- Laryngospasm (throat spasm causing breathing difficulty)
- Abnormal heart rhythm (QT prolongation) – can be fatal
- Rhabdomyolysis (muscle breakdown) – can be fatal
- Gastrointestinal bleeding or perforation – can be fatal
- Intestinal ischaemia (reduced blood flow to intestines) – can be fatal
- Heart attack, angina pectoris
- Oesophagitis (inflammation of the oesophagus)
- Secondary leukaemia (when used with certain other drugs)
- Focal nodular hyperplasia of the liver
Posterior Reversible Encephalopathy Syndrome (PRES)
In rare cases, oxaliplatin may cause a neurological condition called posterior reversible encephalopathy syndrome (PRES). Symptoms include headache, altered mental status, seizures, and visual disturbances ranging from blurred vision to vision loss. If you experience any of these symptoms, contact your doctor immediately. This condition is usually reversible with appropriate management, but prompt recognition is important.
How Should Oxaliplatin Accord Be Stored?
Oxaliplatin Accord should be stored in its original outer carton to protect from light. Do not freeze. After dilution, the solution is stable for up to 48 hours at 2–8°C and 24 hours at 25°C. The medicine is for single use only.
As Oxaliplatin Accord is administered in a hospital or clinical setting, storage is managed by healthcare professionals. However, the following storage conditions apply:
- Store the vial in the original outer carton to protect from light
- Do not freeze
- Do not use after the expiry date printed on the carton and vial label
- After dilution in 5% glucose solution: chemically and physically stable for up to 48 hours at 2–8°C and 24 hours at 25°C
- From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, storage should not normally exceed 24 hours at 2–8°C
- Only clear solutions without visible particles should be used
- The medicine is for single use only – discard any unused solution
Avoid contact with eyes and skin. In case of accidental splashing or spillage, contact a healthcare professional immediately. Oxaliplatin is a cytotoxic substance and must be handled with appropriate protective equipment. Unused medicine should not be disposed of via household waste or wastewater but must be handled as cytotoxic waste according to local regulations.
What Does Oxaliplatin Accord Contain?
The active substance is oxaliplatin (5 mg/ml). The only other ingredient is water for injections. The solution is a clear, colourless liquid without visible particles, available in 10 ml, 20 ml and 40 ml single-use vials.
Oxaliplatin Accord has a simple formulation:
- Active substance: Oxaliplatin – 5 mg per ml of concentrate
- Excipient: Water for injections
The medicine is supplied as a clear, colourless solution for infusion concentrate in siliconised Type I glass vials with rubber stoppers and aluminium seals with lavender-blue flip-off caps. Each carton contains one vial.
| Vial Volume | Oxaliplatin Content | Concentration |
|---|---|---|
| 10 ml | 50 mg | 5 mg/ml |
| 20 ml | 100 mg | 5 mg/ml |
| 40 ml | 200 mg | 5 mg/ml |
Not all pack sizes may be marketed in every country. The marketing authorisation holder is Accord Healthcare B.V., Utrecht, Netherlands. Manufacturing takes place at Accord Healthcare facilities in Poland and Greece.
Frequently Asked Questions about Oxaliplatin Accord
FOLFOX is a standard chemotherapy combination used to treat colorectal cancer. The name comes from its three components: FOLinic acid (leucovorin), Fluorouracil (5-FU), and OXaliplatin. The regimen is administered intravenously every two weeks. Oxaliplatin and folinic acid are given first (oxaliplatin over 2–6 hours, often simultaneously with folinic acid via a Y-connector), followed by 5-FU as a bolus injection and then a 46-hour continuous infusion. FOLFOX has been shown in large clinical trials, including the landmark MOSAIC trial, to significantly improve outcomes in both adjuvant and metastatic colorectal cancer compared to 5-FU/leucovorin alone.
Cold exposure triggers acute peripheral neuropathy in patients receiving oxaliplatin. This unique sensitivity to cold is caused by oxaliplatin's effect on nerve cell ion channels, making them hyperexcitable at lower temperatures. Patients may experience painful tingling or numbness in the hands, feet, face, and throat when touching cold objects, drinking cold liquids, or breathing cold air. Some patients describe a choking sensation or difficulty swallowing cold drinks. These symptoms typically begin during or shortly after infusion and can last several days. To minimise discomfort, avoid cold drinks and foods for several days after each treatment, wear gloves when handling cold items, cover your mouth and nose in cold weather, and use lukewarm water for washing.
Yes, in some patients. While acute cold-triggered neuropathy usually resolves within hours to days, chronic cumulative neuropathy can develop after multiple cycles of treatment and may persist long after treatment ends. This persistent neuropathy manifests as ongoing numbness, tingling, and difficulty with fine motor tasks such as buttoning clothes or writing. Studies indicate that significant neuropathy can persist for over two years in some patients, and in a small percentage it may become permanent. Your oncologist will monitor for cumulative neuropathy at each visit and may reduce the dose or discontinue oxaliplatin if symptoms become functionally impairing. The risk of persistent neuropathy increases with the total cumulative dose of oxaliplatin received.
For adjuvant treatment (after surgery for stage III colon cancer), the standard duration is 6 months, which typically means 12 cycles given every 2 weeks. However, some oncologists may recommend a shorter 3-month course (6 cycles) based on recent clinical trial data (the IDEA collaboration) showing that shorter treatment may be equally effective in certain lower-risk patients. For metastatic colorectal cancer, treatment continues until the disease progresses or side effects become unacceptable. In practice, some oncologists use a "stop-and-go" strategy, pausing oxaliplatin after a set number of cycles while continuing 5-FU to manage cumulative neuropathy, and then reintroducing oxaliplatin if needed. Your oncologist will determine the optimal treatment duration for your specific situation.
Oxaliplatin Accord is a generic version of oxaliplatin. It contains the same active ingredient (oxaliplatin) at the same concentration (5 mg/ml) and is administered in the same way as the originator product. Generic medicines must meet strict regulatory standards to demonstrate bioequivalence, meaning they deliver the same amount of active drug to the body at the same rate. Oxaliplatin Accord has been approved by the European Medicines Agency (EMA) after demonstrating pharmaceutical equivalence and compliance with Good Manufacturing Practice (GMP) standards. The therapeutic effects and side effect profile are the same as for any other approved oxaliplatin product. Other generic brands include Oxaliplatin Fresenius Kabi.
Regular blood tests are essential throughout oxaliplatin treatment. Before each cycle, your doctor will check: complete blood count (CBC) to ensure adequate white blood cells, red blood cells, and platelets; kidney function tests (creatinine, BUN) since oxaliplatin is cleared through the kidneys; liver function tests (ALT, AST, bilirubin) to detect hepatotoxicity; and electrolytes. Treatment may be delayed if blood counts are too low. For example, neutrophils must typically be above 1.5 × 10&sup9;/L and platelets above 75 × 10&sup9;/L before proceeding with the next cycle. Your doctor will also clinically assess for neuropathy symptoms at each visit.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Oxaliplatin – Summary of Product Characteristics. Available at: www.ema.europa.eu
- André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer (MOSAIC trial). N Engl J Med. 2004;350(23):2343–2351. doi:10.1056/NEJMoa032709
- Grothey A, Sobrero AF, Shields AF, et al. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer (IDEA Collaboration). N Engl J Med. 2018;378(13):1177–1188. doi:10.1056/NEJMoa1713709
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Colon Cancer. Version 1.2026.
- Argyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Crit Rev Oncol Hematol. 2012;82(1):51–77.
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List. 2023.
- European Society for Medical Oncology (ESMO). Clinical Practice Guidelines: Metastatic Colorectal Cancer. Ann Oncol. 2024.
- U.S. Food and Drug Administration (FDA). Oxaliplatin Prescribing Information. Available at: www.fda.gov
- Cassidy J, Misset JL. Oxaliplatin-related side effects: characteristics and management. Semin Oncol. 2002;29(5 Suppl 15):11–20.
- British National Formulary (BNF). Oxaliplatin monograph. Available at: bnf.nice.org.uk
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, which includes board-certified specialists in oncology, clinical pharmacology, and evidence-based medicine. Our team follows international editorial standards and the GRADE evidence framework to ensure that all medical information is accurate, up-to-date, and based on the highest quality of evidence.
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