Oxaliplatin Vianex
Oxaliplatin 5 mg/ml – Powder for solution for infusion
Quick Facts about Oxaliplatin Vianex
Key Takeaways about Oxaliplatin Vianex
- Used for colorectal cancer: A cornerstone of the FOLFOX regimen for adjuvant stage III colon cancer and metastatic colorectal cancer treatment
- Supplied as a lyophilised powder: Must be reconstituted with water for injections or 5% glucose before further dilution in a 5% glucose infusion bag
- Always given in combination: Administered with 5-fluorouracil (5-FU) and folinic acid – never used as monotherapy
- Cold-triggered neuropathy is characteristic: Tingling and numbness in hands, feet and throat occurs in most patients and may become persistent with cumulative doses
- Avoid cold exposure during treatment: Cold drinks, cold foods and cold air should be avoided for several days after each infusion to reduce neuropathy symptoms
What Is Oxaliplatin Vianex and What Is It Used For?
Oxaliplatin Vianex is a platinum-based chemotherapy medicine supplied as a lyophilised powder containing oxaliplatin, which is reconstituted to 5 mg/ml before infusion. It is used to treat stage III colon cancer after surgical removal of the primary tumour (adjuvant treatment) and metastatic colorectal cancer, always in combination with 5-fluorouracil (5-FU) and folinic acid (leucovorin).
Oxaliplatin belongs to the class of platinum-based antineoplastic agents, which also includes the older compounds cisplatin and carboplatin. However, oxaliplatin possesses a distinct 1,2-diaminocyclohexane (DACH) ligand structure that confers unique clinical activity against colorectal cancers where older platinum compounds are ineffective. Since its approval by the European Medicines Agency (EMA) in the late 1990s and by the U.S. Food and Drug Administration (FDA) in 2002, oxaliplatin has become a global standard of care for colorectal cancer and is included on the WHO Model List of Essential Medicines.
The mechanism of action of oxaliplatin involves intracellular activation to reactive platinum complexes. These complexes form covalent bonds with DNA, creating inter-strand and intra-strand crosslinks, primarily at guanine-guanine and adenine-guanine sites. The resulting DNA lesions block replication and transcription, trigger the DNA damage response, and ultimately induce programmed cell death (apoptosis) in rapidly dividing cancer cells. Compared to cisplatin, oxaliplatin generates bulkier DNA adducts that are more resistant to repair by the mismatch repair system, which partly explains its efficacy in colorectal cancer.
Oxaliplatin Vianex is a generic formulation manufactured by Vianex S.A., one of the largest pharmaceutical companies in Greece. Unlike some oxaliplatin products that are supplied as a ready-to-use concentrate, the Vianex formulation is a lyophilised (freeze-dried) powder that must be reconstituted before use. This powder formulation offers improved stability and longer shelf life prior to reconstitution. Once reconstituted according to the instructions, the solution achieves the standard concentration of 5 mg oxaliplatin per ml and is further diluted in 250 to 500 ml of 5% glucose solution before intravenous administration. Crucially, sodium chloride or any chloride-containing solution must never be used, because chloride ions rapidly degrade oxaliplatin into inactive species.
Oxaliplatin Vianex is bioequivalent to the originator product and to other marketed generic forms. Regulatory approval by the EMA and national authorities is based on pharmaceutical equivalence and compliance with Good Manufacturing Practice (GMP). In clinical practice, the choice between oxaliplatin products is typically determined by hospital formulary, pricing, and availability, and therapeutic outcomes are expected to be identical across the different products.
Indications
Oxaliplatin Vianex 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 improved 3-year disease-free survival by approximately 23% compared with 5-FU/leucovorin alone.
- Metastatic colorectal cancer: Used as first-line or subsequent therapy for advanced colorectal cancer that has spread to other organs (liver, lung, peritoneum), in combination with 5-FU and folinic acid. Oxaliplatin-based regimens may also be combined with targeted agents such as bevacizumab, cetuximab, or panitumumab, depending on the tumour's molecular profile.
FOLFOX is the standard chemotherapy combination consisting of FOLinic acid (leucovorin), Fluorouracil (5-FU), and OXaliplatin. Several variations exist (FOLFOX4, FOLFOX6, mFOLFOX6), but all share the same three drugs, with differences in doses and infusion schedules. Treatment is typically administered 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.
Tumour Biology and Oxaliplatin Sensitivity
The efficacy of oxaliplatin is influenced by tumour molecular characteristics. Patients with microsatellite-stable (MSS) colorectal cancer typically respond better to oxaliplatin-based chemotherapy than those with high microsatellite instability (MSI-H), although MSI-H tumours often respond well to immunotherapy instead. Oxaliplatin is also integrated into the FOLFIRINOX regimen (adding irinotecan) for metastatic pancreatic cancer in some countries, although this is not a universally approved indication for all oxaliplatin products.
What Should You Know Before Receiving Oxaliplatin Vianex?
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.
Oxaliplatin is a powerful cytotoxic agent and its administration is preceded by a thorough clinical evaluation. Your oncology team will review your full medical history, perform a physical examination (including a baseline neurological assessment), order laboratory tests (complete blood count, renal function, liver function, electrolytes) and confirm the treatment indication. The decision to proceed with treatment always balances the expected benefit against the risk of toxicity for your individual clinical situation.
Contraindications
You must not receive Oxaliplatin Vianex in the following situations:
- Hypersensitivity to oxaliplatin or any excipient: If you have previously had an allergic reaction to oxaliplatin or to any of the ingredients listed in section 6 of the package leaflet
- Breastfeeding: Oxaliplatin and its metabolites may be excreted in breast milk and can harm the nursing infant. Breastfeeding must be stopped for the duration of treatment
- Pre-existing severe myelosuppression: If you already have a significantly reduced number of white blood cells (neutrophils <2.0 × 10&sup9;/L) or platelets (<100 × 10&sup9;/L) before starting the first cycle
- Pre-existing peripheral sensory neuropathy with functional impairment: If you already experience tingling, numbness or difficulty performing fine motor tasks such as buttoning clothes, oxaliplatin may substantially worsen these symptoms
- Severe renal impairment: Oxaliplatin is cleared through the kidneys, and severe kidney disease (creatinine clearance <30 ml/min) can lead to dangerous drug accumulation and increased toxicity
Warnings and Precautions
Talk to your oncologist before receiving Oxaliplatin Vianex if any of the following apply to you:
- You have had an allergic reaction to other platinum-based drugs (carboplatin, cisplatin), as cross-reactivity between platinum compounds can occur. The risk of hypersensitivity also increases after repeated oxaliplatin cycles, with anaphylactic reactions most frequent after cycles 6–12.
- You have mild to moderate kidney impairment – your doctor may decide to proceed at standard dose but monitor renal function more closely before each cycle
- You have any liver problems or abnormal liver function test results – oxaliplatin has been associated with hepatic sinusoidal obstruction syndrome (SOS) in some patients
- You have heart problems, including prolonged QT interval, bradycardia, irregular heartbeat, or a family history of sudden cardiac death – QT prolongation has rarely been reported with oxaliplatin
- You have recently received or plan to receive any vaccine – live attenuated vaccines (such as yellow fever vaccine) must be avoided for at least 3 months before and during oxaliplatin treatment
- You have a documented deficiency of dihydropyrimidine dehydrogenase (DPD) – this does not affect oxaliplatin metabolism directly but is highly relevant because it severely impacts safety of the co-administered 5-fluorouracil
An uncomfortable sensation in the throat or jaw (especially when swallowing cold liquids), 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 (possible rhabdomyolysis), or signs of severe allergic reaction (rash, swelling of face/lips/tongue, difficulty breathing).
Peripheral neuropathy is the most characteristic and dose-limiting toxicity of oxaliplatin. Two distinct forms occur:
- Acute neuropathy: Develops during or within hours of the infusion and is triggered or worsened by cold exposure. Typical symptoms include tingling in the hands, feet, and perioral region, jaw tightness, and a subjective sensation of difficulty breathing or swallowing (pharyngolaryngeal dysaesthesia). Despite its alarming nature, this form is usually transient and resolves within hours to days.
- Chronic cumulative neuropathy: Develops gradually over multiple treatment cycles and is related to the total cumulative dose received. Symptoms include persistent numbness, tingling, and difficulty with fine motor skills such as buttoning shirts, picking up small objects, or writing. This form can persist for months or years after treatment ends and may become permanent in a minority of patients. Your oncologist will carefully grade cumulative neuropathy at each visit using standardised scales (such as the NCI-CTCAE or the oxaliplatin-specific scale) and may reduce, delay, or discontinue treatment if symptoms become functionally impairing.
Pregnancy and Breastfeeding
Oxaliplatin is genotoxic and teratogenic in animal studies and must be avoided during pregnancy whenever possible. Women of childbearing potential must use effective contraception during treatment and for at least 15 months after the last dose. If pregnancy occurs during treatment, genetic counselling is recommended and the potential risks to the foetus should be discussed with a specialist in maternal–foetal medicine.
Male patients should use contraception during treatment and for up to 12 months after the last dose. Oxaliplatin may impair male fertility, potentially permanently, so sperm banking (cryopreservation) before starting treatment is strongly recommended for men who wish to father children in the future. Similarly, fertility preservation options such as oocyte or embryo cryopreservation should be discussed with women of reproductive age before initiating therapy.
Breastfeeding is strictly contraindicated during oxaliplatin treatment and for a period after the last dose (consult your oncologist for the specific recommendation). The drug and its metabolites may be excreted in breast milk and could cause serious harm to the nursing infant.
Driving and Operating Machinery
Oxaliplatin can cause dizziness, nausea, vomiting, visual disturbances and fatigue, particularly in the days following each infusion. If you experience any of these symptoms, you should not drive or operate heavy machinery. Cumulative peripheral neuropathy may also impair your balance, fine motor coordination, and the proprioceptive feedback required for safe driving. Discuss with your oncologist whether it is appropriate for you to drive during specific phases of your treatment course.
How Does Oxaliplatin Vianex Interact with Other Drugs?
Oxaliplatin interacts with several medications, including 5-fluorouracil (which is intentionally co-administered), erythromycin, paclitaxel, sodium valproate, salicylates, and live vaccines. Interactions can increase toxicity or alter effectiveness. Always inform your oncologist about every medicine and supplement you take.
Because oxaliplatin is administered in a hospital setting by specialist oncology teams, drug interactions are carefully managed by experienced pharmacists and clinicians. However, you should still disclose all medications you take, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins. Some interactions occur at the pharmacokinetic level (affecting drug levels) and others are pharmacodynamic (affecting the pharmacological effect).
Major Interactions
Certain combinations carry a substantial risk of increased toxicity or require careful monitoring:
| Drug | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| 5-Fluorouracil (5-FU) | Synergistic – intentional combination | Enhanced antitumour effect; increased toxicity (diarrhoea, myelosuppression, mucositis) | Standard FOLFOX protocol; close monitoring required |
| Erythromycin | QT prolongation risk | Both drugs may prolong QT interval, increasing cardiac arrhythmia risk | Avoid combination where possible or monitor ECG closely |
| Paclitaxel | Pharmacokinetic interaction | May alter clearance of oxaliplatin; overlapping myelosuppression and neuropathy | Caution; monitor blood counts and neurological status closely |
| Sodium Valproate | Pharmacodynamic interaction | Potential for increased neurotoxicity and altered seizure threshold | Monitor neurological symptoms; consider alternative anticonvulsants |
| Salicylates (aspirin) and NSAIDs | Increased bleeding risk | Antiplatelet effects combine with oxaliplatin-induced thrombocytopenia | Use with caution; monitor platelet count and bleeding signs |
| Live vaccines | Immunosuppression risk | Risk of disseminated vaccine infection in immunosuppressed patients | Contraindicated during and for months after treatment |
| Granisetron, Ondansetron | QT prolongation risk | Additive QT prolongation potential with 5-HT3 antagonists | Monitor ECG; commonly used as antiemetic in FOLFOX |
| Warfarin and direct oral anticoagulants | Altered coagulation | Increased bleeding risk in combination with thrombocytopenia | Monitor INR or specific anticoagulant levels more frequently |
Minor Interactions and Special Considerations
Oxaliplatin has minimal interactions with the cytochrome P450 enzyme system, as it is not primarily metabolised by hepatic enzymes. Most of its clearance occurs by non-enzymatic hydrolysis and renal elimination. This differs from many other chemotherapy drugs and simplifies co-administration with drugs that strongly induce or inhibit CYP enzymes (such as certain antiepileptics, rifampicin or azole antifungals). However, minor interactions that warrant awareness include:
- Nephrotoxic drugs: Concurrent use of aminoglycoside antibiotics, vancomycin, or NSAIDs may worsen renal function and indirectly increase oxaliplatin exposure
- Ototoxic drugs: Although oxaliplatin is less ototoxic than cisplatin, combination with aminoglycosides or loop diuretics may still increase the risk of hearing impairment
- Herbal preparations: St John's Wort, echinacea, and high-dose antioxidants may theoretically interfere with chemotherapy; discuss all herbal products with your oncologist
Important Notes on Compatibility
Oxaliplatin has strict physical and chemical compatibility requirements that apply across all oxaliplatin products, including the Vianex formulation:
- Never use aluminium-containing equipment: Aluminium in needles, syringes, catheters or administration sets reacts with oxaliplatin, causing degradation and potential precipitate formation
- Only reconstitute with water for injections or 5% glucose: Further dilution is in 5% glucose solution. Sodium chloride (saline) and other chloride-containing solutions cause rapid degradation
- Do not mix with alkaline solutions: Alkaline drugs or solutions are incompatible with oxaliplatin, including certain formulations of folinic acid containing trometamol
- 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
What Is the Correct Dosage of Oxaliplatin Vianex?
The standard dose of Oxaliplatin Vianex 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 Vianex is exclusively administered by trained healthcare professionals in a hospital or specialist cancer treatment centre. Before each cycle, the dose is calculated based on your current body surface area (BSA), usually using the Mosteller or Du Bois formula. After reconstitution of the lyophilised powder, the resulting solution is further diluted in 250–500 ml of 5% glucose solution, achieving a final concentration between 0.2 mg/ml and 0.7 mg/ml before infusion.
Adults (including Elderly)
Standard Dosing Protocol
- Dose: 85 mg/m² body surface area per cycle (may be reduced to 65 mg/m² or 75 mg/m² based on toxicity or clinical context)
- Route: Intravenous infusion via peripheral or central venous line, diluted in 250–500 ml 5% glucose
- Duration: Infused over 2 to 6 hours (typically 2 hours in standard FOLFOX protocols)
- Frequency: Every 2 weeks (one cycle)
- Timing: Administered simultaneously with folinic acid (via a Y-connector) and always before 5-FU
- Premedication: Antiemetics (typically a 5-HT3 antagonist plus dexamethasone) are given before each dose
| Setting / Patient Group | Dose | Duration | Cycles |
|---|---|---|---|
| Adjuvant (stage III colon cancer) | 85 mg/m² every 2 weeks | Typically 6 months | Up to 12 cycles |
| Adjuvant (abbreviated "IDEA" schedule) | 85 mg/m² every 2 weeks | 3 months (select low-risk stage III) | 6 cycles |
| Metastatic (first-line) | 85 mg/m² every 2 weeks | Until progression or unacceptable toxicity | Variable (often 6–12 before "maintenance" strategy) |
| Elderly (age ≥ 70) | Standard 85 mg/m² with close monitoring; consider 65–75 mg/m² if comorbidities | Individualised | Individualised |
| Mild–moderate renal impairment | Standard 85 mg/m² with monitoring | Standard | Standard |
| Severe renal impairment (CrCl < 30 ml/min) | Contraindicated | — | — |
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. Clinical trials in paediatric solid tumours have not demonstrated clear benefit, and the drug should only be used in children within the setting of a dedicated clinical trial.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, older patients are more likely to have reduced renal function, comorbid conditions, concurrent medications, and may be more vulnerable to neurotoxicity and cumulative fatigue. A comprehensive geriatric assessment is recommended before initiating chemotherapy in patients aged 70 years or older, and dose reductions may be considered on a case-by-case basis.
Dose Adjustments
Your oncologist may reduce the dose or delay treatment based on several factors observed during the treatment cycle:
- Haematological toxicity: If blood counts are too low (neutrophils <1.5 × 10&sup9;/L or platelets <75 × 10&sup9;/L) on the planned day of treatment, the cycle will be delayed until recovery, typically by one week
- Peripheral neuropathy: For persistent symptoms lasting >7 days or functionally impairing symptoms (grade 2–3), the dose is typically reduced to 75 mg/m². Treatment may be discontinued for grade 3 neuropathy persisting between cycles or for any grade 4 neuropathy
- Gastrointestinal toxicity: Severe diarrhoea or mucositis (grade 3–4) usually requires dose reduction of both oxaliplatin and 5-FU
- Hepatic impairment: Patients with mild to moderate liver dysfunction can receive standard doses with monitoring; severe liver impairment requires individualised assessment
- Hypersensitivity reactions: Mild reactions may be managed with premedication and slower infusion; moderate to severe reactions require permanent discontinuation
Missed or Delayed Dose
Because oxaliplatin is administered exclusively in a clinical setting, patients do not self-administer doses and cannot miss a dose in the traditional sense. If a scheduled cycle is delayed due to toxicity, logistical issues or intercurrent illness, it is simply rescheduled by your oncology team. A delay of 1–2 weeks between cycles generally does not compromise effectiveness. If delays exceed 2 weeks repeatedly, your oncologist may reassess the treatment plan.
Overdose
As oxaliplatin is administered by healthcare professionals in a controlled setting, true overdose is extremely rare. However, if an overdose were to occur, it could lead to more severe forms of known toxicities, particularly myelosuppression (dangerously low blood counts), severe and potentially irreversible neurotoxicity, and severe gastrointestinal symptoms. There is no specific antidote for oxaliplatin. Management is supportive: close monitoring in hospital, correction of fluid and electrolyte imbalances, transfusion of blood products if needed, growth factor support for neutropenia (G-CSF) and symptomatic treatment of individual manifestations.
What Are the Side Effects of Oxaliplatin Vianex?
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 considerably between patients. Your oncology team will monitor you closely throughout treatment and can provide supportive treatments (antiemetics, antidiarrhoeals, growth factors, analgesics) to manage many of these effects. It is essential to report any new or worsening symptoms to your doctor or chemotherapy nurse before your next treatment cycle, and to immediately report urgent symptoms such as fever, severe bleeding, or allergic reactions.
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; 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); chest pain or sudden shortness of breath.
Very Common
- Peripheral sensory 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 general weakness (asthenia)
- Fever, chills, generalised body pain
- Loss of appetite and weight changes
- Taste changes (dysgeusia), sometimes described as metallic taste
- Abdominal pain and constipation
- Nosebleeds (epistaxis) and minor abnormal bleeding
- Mild hair thinning (alopecia)
- Discomfort at or near the infusion site
- Inflammation of the mouth and gums (stomatitis, mucositis)
Common
- Infections due to low white blood cell count (respiratory, urinary, skin)
- Febrile neutropenia (low white cells with fever) – oncological emergency
- Severe bloodstream infection (neutropenic sepsis) – can be fatal
- Indigestion, heartburn, hiccups
- Hot flushes, dizziness
- Increased sweating, nail disorders, dry or peeling skin
- Chest pain (non-cardiac in most cases)
- Respiratory tract inflammation, runny nose
- Joint and bone pain, back pain
- Pain when urinating, dehydration
- Blood in urine or stool, swollen veins
- Blood clots (deep vein thrombosis, pulmonary embolism)
- High blood pressure
- Depression, insomnia, anxiety
- Conjunctivitis and visual disturbances
- Decreased blood calcium levels (hypocalcaemia)
- Abnormal liver function tests
- Falls (related to neuropathy and fatigue)
Uncommon
- Severe bloodstream infection (sepsis) – can be fatal
- Bowel obstruction or swelling (ileus)
- Nervousness, agitation
- Mild immune-mediated haemolytic anaemia
- Reduced vision or blurred vision that persists
Rare and Very Rare
- Hearing impairment or tinnitus
- Interstitial lung disease (scarring and thickening of the lungs) – can be fatal
- Temporary vision loss (reversible cortical blindness)
- 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, torsades de pointes) – 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)
- Posterior reversible encephalopathy syndrome (PRES)
- Secondary leukaemia (when combined with certain other cytotoxic drugs)
- Focal nodular hyperplasia of the liver
Managing Common Side Effects
Most side effects can be partly mitigated with supportive interventions. Nausea and vomiting are prevented with antiemetic premedication (typically a 5-HT3 antagonist such as ondansetron plus dexamethasone, with an NK1 antagonist added in higher-emetogenic settings). Diarrhoea is managed with loperamide and adequate hydration, but severe or persistent diarrhoea always requires urgent medical review. Peripheral neuropathy is minimised by avoiding cold exposure for 3–5 days after each infusion, wearing gloves when handling cold objects, using lukewarm water, and covering the nose and mouth in cold weather. Fatigue is often relieved by gentle exercise, adequate sleep, and balanced nutrition.
Posterior Reversible Encephalopathy Syndrome (PRES)
In rare cases, oxaliplatin may cause posterior reversible encephalopathy syndrome (PRES), a neurological condition characterised by rapidly evolving symptoms of headache, altered mental status, seizures, and visual disturbances ranging from blurred vision to cortical blindness. Hypertension frequently accompanies PRES. Diagnosis is confirmed by MRI showing characteristic oedema in the posterior cerebral regions. If you experience any of these symptoms during or after oxaliplatin treatment, contact emergency medical services immediately. PRES is usually reversible with appropriate blood pressure management and discontinuation of the causative drug, but delayed recognition may result in permanent neurological damage.
How Should Oxaliplatin Vianex Be Stored?
Unreconstituted Oxaliplatin Vianex powder should be stored below 25°C in its original outer carton to protect from light. Do not refrigerate or freeze the powder. After reconstitution and dilution in 5% glucose, the solution is chemically and physically stable for up to 24 hours at 2–8°C. The product is for single use only.
As Oxaliplatin Vianex is administered in a hospital or clinical setting, storage and handling are managed by trained healthcare professionals. However, the following storage conditions apply and reflect the standard requirements for lyophilised oxaliplatin powder formulations:
- Store the unopened vial at room temperature (below 25°C) in the original outer carton to protect from light
- Do not refrigerate or freeze the unreconstituted powder
- Do not use after the expiry date printed on the carton and vial label
- After reconstitution with water for injections or 5% glucose: the resulting concentrated solution (5 mg/ml) should be further diluted immediately
- After dilution in 250–500 ml of 5% glucose solution: chemically and physically stable for up to 24 hours at 2–8°C
- From a microbiological standpoint, the diluted solution should be used immediately; if not used immediately, in-use storage times and conditions 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
- The medicine is for single use only – any unused reconstituted or diluted solution must be discarded
Oxaliplatin is a cytotoxic substance and must be handled according to local policies for hazardous drugs. Preparation must take place in a vertical laminar airflow cabinet or biological safety cabinet by trained pharmacy staff wearing appropriate personal protective equipment (gown, double gloves, eye protection). Avoid contact with eyes, skin, and mucous membranes; in case of accidental splashing or spillage, follow institutional spill procedures and decontaminate affected skin with copious water. Pregnant or breastfeeding staff should not handle oxaliplatin. Unused medicine and contaminated waste must be disposed of as cytotoxic waste according to local regulations, never via household waste or wastewater.
What Does Oxaliplatin Vianex Contain?
The active substance is oxaliplatin. The powder for solution for infusion contains lactose monohydrate as an excipient. After reconstitution and dilution, the solution provides 5 mg/ml oxaliplatin for intravenous infusion. It is supplied in single-use vials containing 50 mg or 100 mg of oxaliplatin.
Oxaliplatin Vianex has a simple lyophilised formulation typical of powder-based oxaliplatin products:
- Active substance: Oxaliplatin
- Excipient: Lactose monohydrate (as bulking agent for lyophilisation)
The product is supplied as a white or off-white lyophilised cake or powder in Type I colourless glass vials sealed with chlorobutyl rubber stoppers and aluminium flip-off caps. Each carton contains one single-use vial. After reconstitution with water for injections or 5% glucose solution (10 ml for the 50 mg vial; 20 ml for the 100 mg vial), the solution appears clear and colourless. Any solution that is cloudy, discoloured, or contains visible particles must not be used.
| Vial | Oxaliplatin Content | Reconstitution Volume | Final Concentration |
|---|---|---|---|
| 50 mg vial | 50 mg powder | 10 ml water for injections or 5% glucose | 5 mg/ml |
| 100 mg vial | 100 mg powder | 20 ml water for injections or 5% glucose | 5 mg/ml |
Not all pack sizes may be marketed in every country. The marketing authorisation holder is Vianex S.A., a Greek pharmaceutical company that manufactures a wide range of generic medicines for the European market. Manufacturing takes place at Vianex facilities certified under European Good Manufacturing Practice (EU-GMP) standards. The product is registered through national procedures and, where applicable, mutual recognition across the European Economic Area.
Frequently Asked Questions about Oxaliplatin Vianex
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 thought to result from oxaliplatin's effect on voltage-gated sodium and potassium channels in peripheral nerves, 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 choking sensation or difficulty swallowing cold drinks (pharyngolaryngeal dysaesthesia). These symptoms typically begin during or shortly after infusion and can last several days. To minimise discomfort: avoid cold drinks and foods for 3–5 days after each treatment, wear gloves when handling cold items, cover your mouth and nose in cold weather, use lukewarm water for washing hands, and do not open the freezer without protection.
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, typically becoming clinically relevant after cumulative doses above 780 mg/m².
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, recent data from the IDEA collaboration have shown that a shorter 3-month course (6 cycles) may be equally effective in certain lower-risk patients, while substantially reducing the risk of chronic neuropathy. For metastatic colorectal cancer, treatment continues until the disease progresses or side effects become unacceptable. Many oncologists use a "stop-and-go" strategy in the metastatic setting, pausing oxaliplatin after 6–8 cycles to manage cumulative neuropathy while continuing 5-FU-based maintenance, and then reintroducing oxaliplatin if needed. Your oncologist will determine the optimal treatment duration for your specific situation based on response, tolerability, and tumour biology.
Oxaliplatin Vianex is a generic version of oxaliplatin manufactured by Vianex S.A. in Greece. It contains the same active ingredient (oxaliplatin) as all other oxaliplatin products, and when reconstituted and diluted it achieves the same 5 mg/ml concentration and is administered in the same way as any other approved oxaliplatin. The most visible difference is the formulation: Oxaliplatin Vianex is supplied as a lyophilised (freeze-dried) powder that must be reconstituted, while some other brands (such as Oxaliplatin Accord or Oxaliplatin Fresenius Kabi) are supplied as a ready-to-use aqueous concentrate. Both formulations deliver identical clinical activity. Generic medicines must meet strict EMA regulatory standards to demonstrate pharmaceutical equivalence and compliance with Good Manufacturing Practice (GMP). Therapeutic outcomes and side-effect profiles are the same across approved oxaliplatin products.
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, bilirubin, alkaline phosphatase) to detect hepatotoxicity; and electrolytes including sodium, potassium, magnesium and calcium. Tumour marker CEA (carcinoembryonic antigen) is often monitored to track disease response. Treatment may be delayed if blood counts are too low. For example, neutrophils must typically be ≥1.5 × 10&sup9;/L and platelets ≥75 × 10&sup9;/L before proceeding with the next cycle. Your doctor will also clinically assess for neuropathy symptoms at every visit using standardised grading scales.
Many patients continue to work during oxaliplatin treatment, but the feasibility depends on the nature of the work, the severity of side effects, and individual circumstances. In the first few days after each infusion (days 1–5), fatigue, nausea and cold sensitivity are usually most pronounced, so many patients schedule treatment on Thursdays or Fridays to allow for recovery over the weekend. Desk-based work is generally more manageable than physically demanding or outdoor work (the latter may be restricted by cold-triggered neuropathy). Occupations requiring fine motor skills may become more difficult if cumulative neuropathy develops. Discuss with your oncologist and occupational health services to find a schedule that works for your situation, and consider the possibility of part-time work or sick leave during the most difficult periods.
References
This article is based on the following peer-reviewed sources and international guidelines:
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