Oxaliplatin Eugia
Oxaliplatin 5 mg/ml – Concentrate for solution for infusion
Quick Facts about Oxaliplatin Eugia
Key Takeaways about Oxaliplatin Eugia
- Generic oxaliplatin for colorectal cancer: Bioequivalent to the originator product and to other approved generics, with the same 5 mg/ml concentration and identical clinical indications
- Always given in combination: Oxaliplatin Eugia is administered together with 5-fluorouracil (5-FU) and folinic acid as part of the FOLFOX regimen – never used as monotherapy
- Peripheral neuropathy is the hallmark toxicity: Cold-triggered tingling and numbness in hands, feet and throat occurs in most patients and can become persistent over multiple cycles
- Hospital-only administration: Given as a 2–6 hour intravenous infusion by qualified oncology staff, with regular blood monitoring before each cycle
- Avoid cold exposure: Patients should avoid cold drinks, cold foods and cold air for several days after each infusion to reduce neuropathy symptoms
What Is Oxaliplatin Eugia and What Is It Used For?
Oxaliplatin Eugia is a platinum-based chemotherapy medicine containing oxaliplatin 5 mg/ml as a 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 given in combination with 5-fluorouracil (5-FU) and folinic acid (leucovorin).
Oxaliplatin belongs to the group of platinum-based antineoplastic agents, a class of cytotoxic drugs that also includes cisplatin and carboplatin. However, oxaliplatin has a distinct chemical structure – with a diaminocyclohexane (DACH) carrier ligand – that gives it activity against colorectal cancers where older platinum compounds are not effective. The compound was first approved for clinical use in Europe, followed by approval from the U.S. Food and Drug Administration (FDA), and is now considered standard of care for colorectal cancer treatment worldwide. It is included on the World Health Organization (WHO) Model List of Essential Medicines.
The mechanism of action of oxaliplatin involves the formation of reactive platinum complexes inside cells. Once inside the cell, the chloride-based leaving groups of oxaliplatin are replaced by water molecules (aquation), producing highly reactive species that bind covalently to DNA. These complexes form inter-strand and intra-strand crosslinks, particularly between adjacent guanine residues, disrupting DNA replication and transcription. The resulting DNA damage triggers programmed cell death (apoptosis) in rapidly dividing cancer cells. Unlike cisplatin, oxaliplatin forms bulkier DNA adducts that are recognised poorly by the DNA mismatch repair system, which contributes to its particular effectiveness in colorectal cancer.
Oxaliplatin Eugia is a generic formulation manufactured by Eugia Pharma Specialities. It is bioequivalent to the originator product and to other generic oxaliplatin products, and is authorised on the basis of pharmaceutical equivalence and compliance with Good Manufacturing Practice (GMP) standards. The product is supplied as a clear, colourless ready-to-dilute solution at 5 mg/ml strength and is available in three vial sizes: 10 ml (50 mg), 20 ml (100 mg) and 40 ml (200 mg). The solution must be diluted in 5% glucose (dextrose) before intravenous administration. Crucially, sodium chloride or any chloride-containing infusion fluid must never be used for dilution, as chloride ions rapidly degrade oxaliplatin.
Indications
Oxaliplatin Eugia 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 compared with 5-FU/leucovorin alone.
- Metastatic colorectal cancer: Used as first-line therapy or in subsequent lines for advanced colorectal cancer that has spread to distant organs such as the liver, lung or peritoneum, in combination with 5-FU and folinic acid (the FOLFOX regimen). It may also be combined with biologic agents such as bevacizumab or cetuximab where clinically appropriate.
FOLFOX is the standard chemotherapy combination consisting of FOLinic acid (leucovorin), Fluorouracil (5-FU), and OXaliplatin. It is one of the most widely used chemotherapy protocols for colorectal cancer worldwide. Treatment is typically given every two weeks (one "cycle") and may continue for 6 months in the adjuvant setting, or until disease progression or unacceptable toxicity in the metastatic setting. Common sub-protocols include FOLFOX4, mFOLFOX6 and FOLFOX7, which differ mainly in the dose and duration of 5-FU administration.
What Should You Know Before Receiving Oxaliplatin Eugia?
Before starting oxaliplatin treatment, your oncologist must evaluate your kidney function, blood counts, neurological status and allergy history. Oxaliplatin Eugia is contraindicated in patients with pre-existing severe peripheral neuropathy, significant kidney impairment, known allergy to platinum compounds, during pregnancy without strict medical oversight, and during breastfeeding.
Contraindications
You must not receive Oxaliplatin Eugia in the following situations:
- Allergy to oxaliplatin or any excipient: If you have previously experienced an allergic reaction to oxaliplatin or any other ingredient in the formulation, including water for injections
- Breastfeeding: Oxaliplatin may be excreted in breast milk and could 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 <2 × 10&sup9;/L), or platelets (thrombocytopenia <100 × 10&sup9;/L) before starting treatment
- Pre-existing peripheral sensory neuropathy with functional impairment: If you already have persistent tingling, numbness, or difficulty with fine motor tasks such as buttoning clothes, oxaliplatin may worsen these symptoms significantly
- Severe renal impairment: Oxaliplatin and its metabolites are cleared primarily through the kidneys. Severe kidney disease can lead to drug accumulation and dangerous toxicity
Warnings and Precautions
Talk to your oncologist before receiving Oxaliplatin Eugia if any of the following apply to you:
- You have had an allergic reaction to other platinum-based drugs (cisplatin, carboplatin), as cross-reactivity can occur and may be severe
- You have mild to moderate kidney problems – your doctor may need to adjust the dose or monitor kidney function more closely
- You have liver disease or abnormal liver function test results – liver enzymes and bilirubin will be monitored during treatment
- You have any heart conditions, including long QT syndrome, arrhythmias, or a family history of sudden cardiac death
- You have recently received or plan to receive any vaccine – live or attenuated vaccines (such as yellow fever, MMR, or oral polio) must not be given during oxaliplatin treatment and for several months afterwards
- You are taking anticoagulants (warfarin, direct oral anticoagulants) – bleeding risk may be increased due to thrombocytopenia
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 subjective sensation of difficulty breathing or swallowing. Unlike allergic reactions, this is a peripheral nerve hyperexcitability phenomenon and is usually transient and reversible within a few days.
- Chronic cumulative neuropathy: Develops gradually over multiple treatment cycles, typically after a cumulative dose of 600–850 mg/m². Symptoms include persistent numbness, tingling, and difficulty with fine motor skills such as fastening buttons, writing, or handling small objects. This form can persist for months or years after treatment ends and may become permanent in some patients. Your oncologist will carefully grade neuropathy at each visit using the NCI CTCAE scale and may reduce or stop treatment if symptoms become functionally impairing.
Long-term oxaliplatin therapy has been associated with vascular liver injury known as sinusoidal obstruction syndrome (also called "blue liver" syndrome). This presents with splenomegaly, thrombocytopenia, elevated liver enzymes and occasionally portal hypertension. It is particularly relevant for patients receiving preoperative chemotherapy before liver metastasectomy, as it can increase surgical morbidity. Your hepatobiliary surgeon and oncologist will take this into account when planning treatment duration.
Pregnancy and Breastfeeding
Oxaliplatin can cause serious harm to a developing foetus. Animal studies have demonstrated embryotoxicity and teratogenicity, and the compound is genotoxic. Women of childbearing potential must use effective contraception during treatment and for at least 15 months after the last dose. Male patients should use reliable contraception during treatment and for at least 6 to 12 months after the final dose, according to the most recent regulatory guidance.
Men are advised not to father children during treatment and should consider sperm banking before starting therapy, as oxaliplatin may impair fertility – potentially permanently. Women who wish to preserve fertility should discuss options such as ovarian tissue cryopreservation or oocyte retrieval with a fertility specialist before initiating therapy where time allows. Genetic counselling is recommended for patients who plan to conceive after completing cancer treatment.
Breastfeeding is strictly contraindicated during oxaliplatin treatment. The drug and its platinum-containing metabolites may be excreted in breast milk and could cause serious harm to the infant. Expressed milk produced during treatment must be discarded.
Driving and Operating Machinery
Oxaliplatin can cause dizziness, nausea, vomiting, fatigue, and visual disturbances. If you experience any of these symptoms, you should not drive or operate machinery. Peripheral neuropathy can also affect your balance, coordination and ability to perform fine motor tasks such as operating pedals or gear levers. Discuss with your doctor whether it is safe for you to drive during treatment, particularly in the days immediately after each infusion.
How Does Oxaliplatin Eugia Interact with Other Drugs?
Oxaliplatin interacts with several medications including 5-fluorouracil (which is intentionally co-administered), erythromycin, paclitaxel, sodium valproate, nephrotoxic drugs, and live vaccines. Drug interactions may increase toxicity, alter clearance, or compromise effectiveness. Always inform your oncologist about every medication, supplement and herbal product you are taking.
Because Oxaliplatin Eugia 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 and pharmacist know about all medications you take, including prescription drugs, over-the-counter medicines, herbal supplements (such as St John's wort), and vitamins. Below is an overview of the most clinically relevant interactions.
Major Interactions
Major interactions are those that may produce serious clinical consequences and typically require dose modification, additional monitoring or avoidance of the combination entirely.
| Drug | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| 5-Fluorouracil (5-FU) | Synergistic – intentional combination | Enhanced antitumour effect; increased risk of diarrhoea, mucositis, myelosuppression | Standard FOLFOX protocol; close monitoring required |
| Erythromycin / clarithromycin | QT prolongation risk | Both drugs may prolong QT interval, increasing cardiac arrhythmia risk including torsade de pointes | Avoid combination if possible or monitor ECG and electrolytes |
| Paclitaxel / docetaxel | Pharmacokinetic interaction | May alter clearance of oxaliplatin; combined myelosuppression and neuropathy | Caution; monitor blood counts and nerve symptoms closely |
| Sodium valproate | Pharmacodynamic interaction | Potential for increased neurotoxicity and altered seizure threshold | Monitor neurological symptoms; consider alternative anticonvulsant |
| Salicylates (aspirin, high-dose NSAIDs) | Increased bleeding risk | Combined antiplatelet effect with oxaliplatin-induced thrombocytopenia | Use with caution; monitor platelet count and for bleeding |
| Live vaccines (yellow fever, MMR, oral polio, BCG) | Immunosuppression risk | Risk of disseminated vaccine-strain infection due to chemotherapy-induced immunosuppression | Contraindicated during treatment and for at least 3–6 months afterwards |
| Granisetron / ondansetron | QT prolongation risk | Additive QT prolongation potential | Monitor ECG; these antiemetics are commonly used in FOLFOX but need electrolyte correction |
| Aminoglycosides / loop diuretics | Additive nephrotoxicity | May impair renal clearance of oxaliplatin and increase systemic exposure | Monitor renal function; adjust dose of concomitant nephrotoxins if possible |
| Warfarin / direct oral anticoagulants | Increased bleeding risk | Thrombocytopenia combined with anticoagulation can cause clinically significant bleeding | Intensify INR monitoring; hold or dose-adjust anticoagulant as advised |
Minor Interactions and Compatibility Notes
Beyond the major interactions above, several practical compatibility issues are important for nursing staff and pharmacists preparing Oxaliplatin Eugia infusions.
- Never use aluminium-containing equipment: Aluminium in needles, syringes or administration sets degrades oxaliplatin on contact, reducing its effectiveness and potentially forming toxic precipitates. Use only PVC, polyethylene or polyurethane devices
- Only dilute with 5% glucose solution: Sodium chloride (saline) and other chloride-containing solutions cause rapid hydrolysis and degradation of oxaliplatin
- Do not mix with alkaline solutions: Alkaline drugs or solutions, including certain formulations of folinic acid containing trometamol, are chemically incompatible with oxaliplatin. When folinic acid is co-administered, a Y-connector with separate lines or line flushing must be used
- Administer before 5-FU: In the FOLFOX regimen, oxaliplatin must always be infused before 5-fluorouracil. The infusion line must be flushed with 5% glucose between the two drugs
- Protect from light where possible: Although the diluted solution is reasonably stable in normal room lighting, prolonged exposure to direct sunlight should be avoided
What Is the Correct Dosage of Oxaliplatin Eugia?
The standard adult dose of Oxaliplatin Eugia is 85 mg/m² body surface area, administered as an intravenous infusion over 2 to 6 hours every two weeks. The dose is calculated from your height and weight and may be adjusted based on blood test results, kidney function, and side effects experienced during previous cycles.
Oxaliplatin Eugia is administered exclusively 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, to achieve a final concentration between approximately 0.2 mg/ml and 0.7 mg/ml. The preparation should be performed in a biological safety cabinet by trained personnel using personal protective equipment, as oxaliplatin is a cytotoxic substance.
Adults
Standard Adult Dosing Protocol
- Dose: 85 mg/m² body surface area per cycle
- Route: Intravenous infusion in 250–500 ml of 5% glucose
- Duration: Infused over 2 to 6 hours (typically 2 hours in mFOLFOX6)
- Frequency: Every 2 weeks (one cycle)
- Timing: Given simultaneously with folinic acid via Y-connector and before 5-FU
- Pre-medication: Antiemetic cover with a 5-HT3 antagonist and corticosteroid
| Setting | Dose | Duration | Cycles |
|---|---|---|---|
| Adjuvant (stage III colon cancer) | 85 mg/m² every 2 weeks | 3 or 6 months | 6 or 12 cycles |
| Metastatic colorectal cancer (first-line) | 85 mg/m² every 2 weeks | Until progression or toxicity | Variable |
| Metastatic colorectal cancer (maintenance "stop-and-go") | 85 mg/m² reintroduced after pause | Guided by tolerability and response | Individualised |
Children and Adolescents
Oxaliplatin Eugia 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 the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA). Paediatric oncology protocols use oxaliplatin only in specific clinical trial contexts.
Elderly Patients
Older adults (65 years and above) can be treated with Oxaliplatin Eugia at the standard dose, but close monitoring is required as they may experience a higher rate of severe diarrhoea, dehydration, myelosuppression and cumulative neuropathy than younger patients. Comprehensive geriatric assessment before starting therapy helps identify patients at higher risk of serious toxicity. Dose adjustments or shorter treatment durations may be appropriate for frail elderly patients, particularly those aged 75 and older.
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 is delayed until recovery, and the dose may be reduced to 65–75 mg/m² for subsequent cycles
- Peripheral neuropathy: For persistent (lasting >7 days) or functionally impairing symptoms (grade 2 or higher), the dose is typically reduced to 65–75 mg/m². Treatment is usually discontinued if neuropathy becomes severe (grade 3–4) or disabling
- Gastrointestinal toxicity: Severe diarrhoea (grade 3–4) or mucositis may require dose reduction and supportive treatment including intravenous rehydration
- Renal impairment: In patients with mild to moderate kidney impairment (creatinine clearance 30–80 ml/min), dosing is generally at the standard level with close monitoring. Oxaliplatin is contraindicated in severe renal impairment (creatinine clearance <30 ml/min)
- Allergic reactions: Mild reactions may be managed with pre-medication for subsequent cycles; moderate or severe reactions require immediate discontinuation
Missed Dose
Because Oxaliplatin Eugia is given by scheduled hospital appointment rather than self-administration, missed doses as such do not occur. However, cycles may be postponed due to illness, low blood counts, or severe side effects. If you miss a scheduled appointment or your treatment is delayed, contact your oncology team to arrange rescheduling. Delays of up to one or two weeks generally do not compromise treatment efficacy, but longer interruptions should be discussed with your oncologist.
Overdose
As Oxaliplatin Eugia is administered by healthcare professionals in a strictly controlled setting with weight- and surface area-based dosing calculations, clinical overdose is very unusual. However, if an overdose were to occur – for example through administration error – it could result in more severe forms of the known side effects, particularly profound and prolonged myelosuppression (dangerously low blood cell counts), severe neurotoxicity, and serious gastrointestinal toxicity.
There is no specific antidote for oxaliplatin overdose. Treatment is entirely supportive, addressing individual symptoms as they arise. Close monitoring of blood cell counts, renal and hepatic function is essential. Supportive measures may include blood transfusions, granulocyte colony-stimulating factor (G-CSF), platelet transfusions, intravenous fluids, antiemetics and broad-spectrum antibiotics for febrile neutropenia. Patients who have received an overdose should be admitted to a specialist oncology unit for ongoing care.
What Are the Side Effects of Oxaliplatin Eugia?
Like all chemotherapy drugs, Oxaliplatin Eugia 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 every side effect, and their severity varies considerably between patients. Your oncology team will monitor you closely throughout treatment and can provide supportive treatments to manage many adverse effects. It is essential to report any new or worsening symptoms to your doctor or clinical nurse specialist before your next treatment cycle, so that pre-emptive dose adjustments or additional supportive care can be considered.
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 above 38°C; persistent or severe diarrhoea or vomiting preventing oral intake; 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 generalised weakness
- Fever, chills, body pain
- Loss of appetite and weight changes
- Taste changes (dysgeusia)
- Abdominal pain and constipation
- Nosebleeds and abnormal bleeding
- Mild hair thinning (alopecia)
- Discomfort, redness or burning near the injection site during infusion
- Inflammation of mouth and throat lining (mucositis)
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, dry or peeling skin
- Chest pain
- Lung problems including shortness of breath and runny nose
- Joint and bone pain, muscle pain
- Pain when urinating, dehydration
- Blood in urine or stool, swollen veins
- Blood clots in the lungs (pulmonary embolism) or deep veins (DVT)
- High blood pressure
- Depression, insomnia
- Conjunctivitis and visual disturbances
- Decreased blood calcium and magnesium levels
- Falls and impaired balance
Uncommon
- Severe bloodstream infection (sepsis) – can be fatal
- Bowel obstruction or swelling
- Nervousness and anxiety
- Abnormal kidney function
- Hearing changes
Rare and Very Rare
- Permanent 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 small 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)
Posterior Reversible Encephalopathy Syndrome (PRES)
In very rare cases, oxaliplatin may cause a neurological condition called posterior reversible encephalopathy syndrome (PRES). Symptoms include severe headache, altered mental status, seizures, and visual disturbances ranging from blurred vision to complete vision loss. If you experience any of these symptoms, contact your oncology team or the emergency department immediately. PRES is usually reversible with appropriate management including blood pressure control and discontinuation of the offending drug, but prompt recognition is essential to prevent permanent neurological injury.
Reporting Side Effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this article. You can also report side effects directly via your national pharmacovigilance reporting system – for example, the Yellow Card Scheme (UK), the MedWatch programme (U.S.), or the EudraVigilance system (European Union). Reporting side effects helps provide more information on the safety of this medicine.
How Should Oxaliplatin Eugia Be Stored?
Oxaliplatin Eugia should be stored in its original outer carton at room temperature to protect from light. Do not freeze. After dilution in 5% glucose, the solution is chemically and physically 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 Eugia is administered in a hospital or clinical setting, storage and handling are managed by pharmacy and nursing staff following cytotoxic handling procedures. The following storage conditions apply to the unopened vial and reconstituted product:
- Store the vial in the original outer carton to protect from light
- Do not freeze – freezing and thawing can cause precipitation and loss of potency
- 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, protected from light
- From a microbiological standpoint, the diluted solution should be used immediately. If not used immediately, storage conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2–8°C
- Only clear, colourless solutions without visible particles should be used – any vial with discoloured solution, precipitate or particulate matter must be discarded
- The medicine is for single use only – any unused portion must be discarded as cytotoxic waste
Avoid contact with eyes and skin. In case of accidental splashing or spillage, wash the affected area immediately with copious water and contact a healthcare professional. Oxaliplatin is a cytotoxic substance and must be handled with appropriate personal protective equipment including nitrile gloves, protective gown, face shield and respirator where aerosolisation is possible. Preparation should take place in a Class II biological safety cabinet or an isolator dedicated to cytotoxic preparation. Unused medicine and contaminated waste must be disposed of as cytotoxic waste in accordance with local regulations.
What Does Oxaliplatin Eugia Contain?
The active substance is oxaliplatin (5 mg per ml of concentrate). The only other ingredient is water for injections. The product is a clear, colourless solution available in 10 ml, 20 ml and 40 ml single-use vials containing 50 mg, 100 mg and 200 mg of oxaliplatin respectively.
Oxaliplatin Eugia has a simple formulation, consistent with most contemporary oxaliplatin generics:
- 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 Type I glass vials with chlorobutyl rubber stoppers and aluminium flip-off seals. Each outer carton contains a single vial. The product is intended for professional use only and is not dispensed directly to patients.
| 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, and availability is subject to local regulatory approval and pharmacy procurement decisions. The marketing authorisation holder is Eugia Pharma Specialities. Further country-specific information, including the most recent Summary of Product Characteristics (SmPC) and patient information leaflet, can be obtained from your hospital pharmacy or the relevant national medicines authority.
Frequently Asked Questions about Oxaliplatin Eugia
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 delivered through a portable pump. 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 with 5-FU and 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 sodium and potassium 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 describe a sensation of difficulty swallowing cold drinks or a tight, "choking" feeling in the throat. These symptoms typically begin during or shortly after infusion and can last several days. To minimise discomfort, avoid cold drinks and foods for at least five days after each treatment, wear gloves when handling cold items or opening the fridge, cover your mouth and nose with a scarf in cold weather, and use lukewarm water for washing.
Yes, in some patients. While the 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, writing or handling small coins. Studies indicate that clinically significant neuropathy can persist for over two years in roughly one-third of patients, and in a small minority it may become permanent. Your oncologist will assess for cumulative neuropathy at each visit using standardised scales and may reduce the dose or discontinue oxaliplatin if symptoms become functionally impairing. The risk of persistent neuropathy increases with the total cumulative dose received, which is why total treatment duration is carefully planned.
For adjuvant treatment (after surgery for stage III colon cancer), the traditional duration has been 6 months – typically 12 cycles given every 2 weeks. However, many oncologists now recommend a shorter 3-month course (6 cycles) for certain lower-risk patients, based on data from the international IDEA collaboration showing that the shorter course has similar efficacy with substantially less neuropathy. For metastatic colorectal cancer, treatment continues until the disease progresses or side effects become unacceptable. In practice, a "stop-and-go" strategy is often used – pausing oxaliplatin after a set number of cycles while continuing 5-FU to manage cumulative neuropathy, and then reintroducing oxaliplatin if disease progresses. Your oncologist will determine the optimal treatment duration for your specific clinical situation, tumour biology, and tolerance.
Oxaliplatin Eugia is a generic version of oxaliplatin manufactured by Eugia Pharma Specialities. It contains the same active ingredient (oxaliplatin) at the same concentration (5 mg/ml) and is administered in exactly the same way as the originator product. Generic medicines must meet strict regulatory standards to demonstrate pharmaceutical equivalence, meaning they deliver the same amount of active drug to the body at the same rate. Oxaliplatin Eugia has been authorised after demonstrating compliance with Good Manufacturing Practice (GMP) standards and the same quality specifications as other approved oxaliplatin products. The therapeutic effects and side effect profile are the same as for brand-name oxaliplatin or other generics such as Oxaliplatin Accord, Oxaliplatin Teva and Oxaliplatin Fresenius Kabi.
Regular blood tests are essential throughout oxaliplatin treatment. Before each cycle your doctor will typically check: a complete blood count (CBC) to ensure adequate white blood cells, red blood cells, and platelets; kidney function tests (creatinine, urea) since oxaliplatin is cleared through the kidneys; liver function tests (ALT, AST, alkaline phosphatase, bilirubin) to detect hepatotoxicity; and serum electrolytes including magnesium, potassium and calcium. Treatment may be delayed if blood counts are too low – 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 using a formal grading scale, and for some regimens will check tumour markers such as CEA and imaging findings.
Many patients continue to work in some capacity during oxaliplatin treatment, but this depends greatly on the type of work, individual tolerance, and side effects experienced. Patients with desk-based or sedentary jobs may be able to maintain part-time or flexible hours. Work that requires fine motor skills (for example, musicians, surgeons, or precision assembly) may be difficult due to peripheral neuropathy. Jobs involving outdoor cold exposure are particularly challenging during the first week after each infusion. Fatigue is typically worst in the first 3–5 days after each cycle. Discuss with your oncology team, occupational health service and employer about reasonable adjustments, reduced hours or temporary medical leave. Many countries recognise colorectal cancer treatment as qualifying for disability protections and short-term work absence.
References
This article is based on the following peer-reviewed sources and international guidelines:
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