Oxaliplatin Sandoz
Oxaliplatin 5 mg/ml – Concentrate for solution for infusion
Quick Facts about Oxaliplatin Sandoz
Key Takeaways about Oxaliplatin Sandoz
- Generic oxaliplatin from Sandoz: Bioequivalent to the originator product, approved by the European Medicines Agency (EMA) for the treatment of colorectal cancer
- Always given in combination: Administered together with 5-fluorouracil (5-FU) and folinic acid – part of the FOLFOX regimen, never used alone
- Cold-triggered peripheral neuropathy: Tingling and numbness in hands, feet and throat occurs in most patients and may become persistent with repeated cycles
- Hospital-only administration: Given by intravenous infusion under the supervision of a specialist oncology team, with regular blood tests between cycles
- Avoid cold exposure during treatment: Cold drinks, cold foods and cold air can trigger or worsen neuropathy symptoms – this is a unique characteristic of oxaliplatin
What Is Oxaliplatin Sandoz and What Is It Used For?
Oxaliplatin Sandoz 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 used in combination with 5-fluorouracil (5-FU) and folinic acid (leucovorin).
Oxaliplatin belongs to the group of platinum-based antineoplastic agents, a family of cytotoxic drugs that also includes cisplatin and carboplatin. Although the three drugs share a platinum atom as the active moiety, each has a distinct chemical structure that determines its clinical profile. Oxaliplatin has activity against colorectal cancer where cisplatin and carboplatin are ineffective, and it is now considered a cornerstone of systemic therapy for this disease worldwide.
At the molecular level, oxaliplatin enters the cell and undergoes rapid non-enzymatic transformation into reactive platinum species. These highly reactive complexes bind covalently to DNA, forming both intra-strand and inter-strand crosslinks. The resulting DNA damage blocks replication and transcription in dividing cells and triggers programmed cell death (apoptosis). Compared with cisplatin, oxaliplatin forms bulkier 1,2-diaminocyclohexane (DACH)-platinum adducts that are recognised differently by cellular DNA repair machinery, which partly explains why oxaliplatin works in tumours resistant to cisplatin and carboplatin.
Oxaliplatin Sandoz is the generic formulation manufactured by Sandoz, a division of Novartis and one of the world's leading producers of generic and biosimilar medicines. The product is bioequivalent to the originator oxaliplatin and is supplied in single-use vials of 10 ml (50 mg), 20 ml (100 mg) and 40 ml (200 mg), each at a concentration of 5 mg/ml. Before infusion, the concentrate must be diluted in 5% glucose (dextrose) solution. Chloride-containing diluents such as sodium chloride must never be used, because chloride ions destabilise the platinum complex and lead to rapid degradation of the active substance.
The approval of oxaliplatin for colorectal cancer was based on a series of landmark clinical trials conducted in the late 1990s and early 2000s. In Europe, the European Medicines Agency (EMA) has approved multiple generic oxaliplatin products including Oxaliplatin Sandoz after demonstration of pharmaceutical equivalence to the reference product. Regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) have approved similar generics, making high-quality oxaliplatin affordable and widely available for cancer patients globally.
Indications
Oxaliplatin Sandoz is indicated for the following conditions:
- Adjuvant treatment of stage III (Dukes C) colon cancer: Given after complete surgical resection of the primary tumour, with the aim of eliminating residual micrometastatic disease and reducing the risk of cancer recurrence. The MOSAIC trial (André et al., 2004) demonstrated that adding oxaliplatin to 5-FU/leucovorin significantly improved 3-year disease-free survival from 72.9% to 78.2%.
- Metastatic colorectal cancer: Used as first-line or subsequent therapy for colorectal cancer that has spread to other organs (most commonly liver, lungs, or peritoneum), in combination with 5-FU and folinic acid – the FOLFOX regimen. Oxaliplatin-based combinations have also been used in perioperative settings for patients with potentially resectable liver metastases.
FOLFOX is the standard chemotherapy combination consisting of FOLinic acid (leucovorin), Fluorouracil (5-FU), and OXaliplatin. This protocol is one of the most widely used chemotherapy regimens 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. Variations of the regimen exist (FOLFOX4, mFOLFOX6, FOLFOX7) that differ slightly in dose and schedule; your oncologist will choose the most appropriate variant based on your individual disease characteristics and overall health.
What Should You Know Before Receiving Oxaliplatin Sandoz?
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, myelosuppression, and during breastfeeding.
Starting oxaliplatin therapy is a significant medical decision that should always be made jointly between you and your oncology team. The drug is highly effective but also carries important toxicities, and careful pre-treatment evaluation is essential to minimise risk. Baseline investigations typically include a complete blood count, serum creatinine with estimated glomerular filtration rate, liver function tests, electrolytes, an electrocardiogram (ECG) in patients with cardiac risk factors, and a thorough neurological examination.
Contraindications
You must not receive Oxaliplatin Sandoz in the following situations:
- Allergy to oxaliplatin or any excipient: If you have previously experienced an allergic or anaphylactic reaction to oxaliplatin or any other ingredient in the formulation, including water for injections
- Breastfeeding: Oxaliplatin or its metabolites can be excreted in breast milk and cause harm to the nursing infant. Breastfeeding must be discontinued during treatment
- Pre-existing myelosuppression: If you already have significantly reduced red blood cells (haemoglobin <9 g/dL), white blood cells (neutrophils <1.5 × 10&sup9;/L), or platelets (<100 × 10&sup9;/L)
- Pre-existing peripheral neuropathy with functional impairment: If you already experience tingling, numbness, or difficulty with fine motor tasks such as buttoning clothes, oxaliplatin is likely to worsen these symptoms significantly
- Severe renal impairment: Creatinine clearance below 30 ml/min. Oxaliplatin is cleared through the kidneys, and severe kidney disease can lead to dangerous drug accumulation and systemic toxicity
Warnings and Precautions
Talk to your oncologist before receiving Oxaliplatin Sandoz 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 in up to 25% of patients
- You have mild to moderate kidney problems – your doctor may need to adjust the dose or monitor kidney function more closely during treatment
- You have any liver problems or abnormal liver function test results
- You have heart problems, including prolonged QT interval, irregular heartbeat, heart failure, or a family history of sudden cardiac death
- You have received or plan to receive any vaccine – live or attenuated vaccines (such as yellow fever, oral polio, MMR, BCG) must not be given during oxaliplatin treatment or for several months afterwards
- You have a history of hearing loss or tinnitus, because all platinum compounds carry a small risk of ototoxicity
- You are planning to undergo major surgery, dental extractions, or any procedures that could be complicated by low blood counts
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 a severe allergic reaction (rash, swelling of face/lips/tongue, difficulty breathing, low blood pressure).
Peripheral neuropathy is the most characteristic toxicity of oxaliplatin. Two distinct forms occur and it is important to recognise them:
- 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 disturbing sensation of difficulty breathing or swallowing. Pharyngolaryngeal dysaesthesia is a specific form in which patients feel that they cannot breathe, even though oxygen saturation and airway calibre are normal. This form is usually transient and reversible within hours to days.
- Chronic cumulative neuropathy: Develops gradually over multiple treatment cycles, typically after total cumulative doses of 540 mg/m² or more. Symptoms include persistent numbness, tingling, and difficulty with fine motor skills such as buttoning a shirt, writing, or picking up small objects. Walking may become unsteady. This form can persist for months or years after treatment ends and may become permanent in approximately 10–15% of patients. Your oncologist will grade neuropathy at each visit and may reduce or stop treatment if symptoms become functionally impairing.
Pregnancy and Breastfeeding
Oxaliplatin can cause serious harm to a developing foetus and is classified as teratogenic based on animal studies. Women of childbearing potential must use highly effective contraception during treatment and for at least 15 months after the last dose. Male patients should use effective contraception during treatment and for at least 12 months after the last dose, because oxaliplatin may damage sperm and theoretically increase the risk of congenital abnormalities in a subsequently conceived child.
Men are advised not to father children during treatment and should seriously consider sperm banking before starting therapy, as oxaliplatin may impair fertility – potentially permanently. Female patients who wish to preserve fertility should consult a reproductive specialist before treatment to discuss options such as oocyte or embryo cryopreservation. Genetic counselling is recommended for patients who wish to have children after completing treatment.
Breastfeeding is strictly contraindicated during oxaliplatin treatment. Excretion of platinum and its metabolites into human breast milk has not been fully characterised, but any exposure in a nursing infant could cause serious adverse effects including myelosuppression and developmental abnormalities.
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 heavy machinery. Peripheral neuropathy may also affect your balance, coordination, and ability to feel pedals or controls. Discuss with your doctor whether it is safe for you to drive during treatment. Some patients find that it takes several days after each infusion before driving feels comfortable again.
How Does Oxaliplatin Sandoz Interact with Other Drugs?
Oxaliplatin interacts with several medications, including 5-fluorouracil (intentionally co-administered), erythromycin, paclitaxel, sodium valproate, and live vaccines. Drug interactions may increase toxicity or reduce effectiveness. Always inform your oncologist about all prescription medicines, over-the-counter drugs, herbal supplements, and vitamins 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 everything you take, including medicines prescribed by other specialists, over-the-counter products, traditional or herbal remedies, and nutritional supplements. Herbal products such as St John's wort can induce cytochrome P450 enzymes and may theoretically alter the metabolism of co-administered cytotoxic drugs; grapefruit juice can affect drug transporters in the gut. 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, mucositis, myelosuppression) | Standard FOLFOX protocol; close clinical monitoring required |
| Folinic acid (leucovorin) | Pharmacodynamic – intentional combination | Potentiates antitumour effect of 5-FU; does not directly interact with oxaliplatin | Must use formulation without trometamol; typically given simultaneously with oxaliplatin via Y-connector |
| Erythromycin | QT prolongation risk | Both drugs may prolong QT interval, increasing the risk of cardiac arrhythmia including torsades de pointes | Avoid combination or monitor ECG closely; use alternative antibiotics where possible |
| Paclitaxel | Pharmacokinetic / pharmacodynamic interaction | May alter clearance of oxaliplatin; overlapping neuropathy and myelosuppression | Caution; monitor blood counts and neurological symptoms closely |
| Sodium valproate | Pharmacodynamic interaction | Potential for increased neurotoxicity and altered seizure threshold | Monitor neurological symptoms; consider alternative anticonvulsants where appropriate |
| Salicylates (aspirin, NSAIDs) | Increased bleeding risk | Combined antiplatelet effect with oxaliplatin-induced thrombocytopenia | Use with caution; monitor platelet count and clinical signs of bleeding |
| Live attenuated vaccines | Immunosuppression risk | Risk of disseminated vaccine-related infection due to treatment-induced immunosuppression | Contraindicated during and for several months after treatment; inactivated vaccines including annual influenza and COVID-19 boosters are generally safe and recommended |
| Granisetron / ondansetron | QT prolongation risk | Additive QT prolongation potential, especially with electrolyte imbalance | Monitor ECG when indicated; these are commonly used as antiemetics in FOLFOX |
| Warfarin and other anticoagulants | Increased INR and bleeding risk | Oxaliplatin-induced thrombocytopenia plus anticoagulation can cause severe haemorrhage | More frequent INR monitoring; consider dose adjustment of anticoagulant |
Important Notes on Compatibility
Oxaliplatin Sandoz has strict physical and chemical compatibility requirements that must be respected by the pharmacy and the oncology nursing team:
- Never use aluminium-containing equipment: Aluminium degrades oxaliplatin on contact, reducing its effectiveness and potentially forming toxic precipitates. Needles, syringes and infusion systems used to prepare and administer the drug must be aluminium-free
- Only dilute with 5% glucose solution: Sodium chloride (saline) and other chloride-containing solutions cause rapid degradation of oxaliplatin into inactive or potentially toxic species
- Do not mix with alkaline solutions: Alkaline drugs or solutions, including certain formulations of folinic acid that contain trometamol, are incompatible with oxaliplatin and must not be combined in the same infusion bag or line
- 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 to prevent precipitation and ensure chemical stability
What Is the Correct Dosage of Oxaliplatin Sandoz?
The standard dose of Oxaliplatin Sandoz 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 during previous cycles.
Oxaliplatin Sandoz is exclusively administered by trained healthcare professionals in a hospital or specialist cancer treatment centre. It cannot be given at home, by injection, or in any community pharmacy setting. 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. Infusion is administered through a central venous catheter or a large peripheral vein, preferably using a volumetric infusion pump for precise rate control.
Before each cycle, your oncologist will review your recent blood counts, kidney function, and clinical status. Treatment may be delayed or the dose reduced if specific toxicity thresholds are exceeded. This individualised approach helps balance the need for effective treatment against the risks of cumulative toxicity.
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
- Pre-medication: Standard antiemetics such as ondansetron or granisetron, often combined with dexamethasone
The same dose applies regardless of age in adults who have adequate organ function. Older patients (aged 65 and above) do not routinely require a dose reduction based on age alone, but they may have reduced bone marrow reserve, impaired renal function, and higher baseline neuropathy from other conditions such as diabetes, so the threshold for dose adjustment is lower.
| Setting | Dose | Duration | Cycles |
|---|---|---|---|
| Adjuvant (stage III) | 85 mg/m² every 2 weeks | 3–6 months | 6–12 cycles |
| Metastatic (first-line) | 85 mg/m² every 2 weeks | Until progression or toxicity | Variable |
| Metastatic (subsequent line) | 85 mg/m² every 2 weeks | Until progression or toxicity | Variable |
| Perioperative (resectable liver metastases) | 85 mg/m² every 2 weeks | Typically 6 cycles before and 6 cycles after surgery | 12 cycles total (EORTC protocol) |
Children and Adolescents
Oxaliplatin Sandoz 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 such as the EMA or FDA. Clinical trials in children have shown no meaningful activity in paediatric tumours evaluated so far.
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. Recurrent severe neutropenia or thrombocytopenia may require a permanent dose reduction
- Peripheral neuropathy: For persistent paraesthesia lasting more than 7 days, or any functionally impairing symptoms, the dose is typically reduced to 75 mg/m² or 65 mg/m². Treatment may be discontinued entirely if symptoms are severe, disabling, or if they significantly impair daily activities
- Gastrointestinal toxicity: Severe diarrhoea (grade 3–4) or mucositis may require dose reduction of oxaliplatin and/or 5-FU
- Renal impairment: In patients with mild to moderate kidney impairment (creatinine clearance 30–80 ml/min), dosing is at the standard level with close monitoring. Oxaliplatin is contraindicated in severe renal impairment (CrCl <30 ml/min)
- Hepatic impairment: In patients with liver dysfunction, oxaliplatin can generally be given at the standard dose because it is primarily cleared by the kidneys, but liver function should be monitored throughout treatment
Missed Dose
Because Oxaliplatin Sandoz is administered in hospital at scheduled appointments, missed doses are uncommon. If you cannot attend a scheduled cycle due to illness, infection, or personal circumstances, contact your oncology team as soon as possible. The team will reschedule the infusion, usually with a delay of 1–2 weeks. Small delays generally do not compromise treatment efficacy, but long interruptions (more than 4 weeks) may affect the overall therapeutic plan and will be carefully evaluated.
Overdose
As Oxaliplatin Sandoz is administered by healthcare professionals in a controlled hospital setting, overdose is very unlikely. However, if an overdose were to occur, it could lead to more severe forms of the known adverse effects, particularly severe myelosuppression with risk of infection and bleeding, and accelerated neurotoxicity. There is no specific antidote for oxaliplatin overdose. Treatment would be supportive and symptom-directed, including haematological support (blood transfusions, granulocyte colony-stimulating factors), management of infections, hydration, electrolyte correction, and close monitoring of organ function in an intensive or high-dependency unit.
What Are the Side Effects of Oxaliplatin Sandoz?
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 widely between patients. Your oncology team will monitor you closely throughout treatment and can provide a range of supportive treatments to manage many of these effects – antiemetics for nausea, loperamide and fluids for diarrhoea, growth factors for low white cell counts, and transfusions for severe anaemia or thrombocytopenia. It is essential to report any new or worsening symptoms to your doctor before your next treatment cycle, as early intervention can often prevent serious complications.
Signs of an allergic or anaphylactic reaction (rash, itching, swelling of face/lips/tongue, difficulty breathing, wheezing, loss of consciousness); abnormal bruising or bleeding, or signs of infection such as sore throat and fever above 38°C; persistent or severe diarrhoea or vomiting leading to dehydration; blood or dark brown particles in vomit; symptoms of stroke (sudden severe headache, confusion, visual difficulties, one-sided weakness, slurred speech); extreme fatigue with reduced urination (possible kidney failure); chest pain or sudden severe breathlessness.
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 at the injection site during infusion
- Elevated liver enzymes (ALT, AST)
Common
- Infections due to low white blood cell count
- 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 or low blood pressure
- Depression, insomnia
- Conjunctivitis and visual disturbances
- Decreased blood calcium levels
- Falls due to balance disturbance
Uncommon
- Severe bloodstream infection (sepsis) – can be life-threatening
- Bowel obstruction or swelling
- Severe allergic or anaphylactic reactions requiring immediate intervention
- Nervousness, anxiety
- Immune-related haemolytic anaemia
Rare and Very Rare
- Hearing impairment and tinnitus
- Interstitial lung disease (scarring and thickening of the lungs) – can be fatal
- Temporary or permanent 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, 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)
- Secondary leukaemia (when used with certain other agents)
- Focal nodular hyperplasia of the liver
- Posterior reversible encephalopathy syndrome (PRES)
Posterior Reversible Encephalopathy Syndrome (PRES)
In 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 cortical blindness. If you experience any of these symptoms, contact your doctor immediately or go to the nearest emergency department. PRES is usually reversible with appropriate management – blood pressure control, discontinuation of the causative agent, and supportive care – but prompt recognition is essential to avoid long-term neurological damage.
Reporting Side Effects
If you experience 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 to the appropriate national pharmacovigilance system (for example, the Yellow Card scheme in the United Kingdom, the FDA MedWatch programme in the United States, or EudraVigilance in the European Union). By reporting side effects, you contribute to providing more information on the safety of this medicine.
How Should Oxaliplatin Sandoz Be Stored?
Oxaliplatin Sandoz 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 Sandoz is administered in a hospital or clinical setting, storage is managed by healthcare professionals and hospital pharmacies. Patients do not handle or store this medicine at home. However, the following storage conditions apply and are useful to understand:
- Store the vial in the original outer carton to protect from light, at temperatures not above 25°C
- Do not freeze – freezing causes precipitation of the active substance
- Do not use after the expiry date printed on the carton and vial label (EXP MM/YYYY)
- 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 time and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2–8°C, unless dilution took place under controlled and validated aseptic conditions
- Only clear, colourless solutions without visible particles should be used. If the solution is discoloured or contains precipitate, it must be discarded
- The medicine is for single use only – discard any unused solution according to local cytotoxic waste regulations
Avoid contact with eyes and skin. In case of accidental splashing or spillage, wash the area with plenty of water immediately and contact a healthcare professional. Oxaliplatin is a cytotoxic substance and must be handled with appropriate personal protective equipment including gloves, gowns, protective eyewear and, where indicated, respiratory protection. Pregnant staff should not prepare or handle oxaliplatin. Unused medicine and any contaminated material must not be disposed of via household waste or wastewater but must be handled as cytotoxic waste according to local regulations and national guidelines.
What Does Oxaliplatin Sandoz 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 Sandoz has a simple formulation designed to maintain the stability of the platinum complex and minimise the risk of excipient-related adverse effects:
- Active substance: Oxaliplatin – 5 mg per ml of concentrate
- Excipient: Water for injections (no preservatives, stabilisers or colourings)
The medicine is supplied as a clear, colourless concentrate in Type I glass vials with rubber stoppers and aluminium seals fitted with plastic flip-off caps. Each carton contains one vial. The simple, single-excipient formulation means that allergic reactions to oxaliplatin itself are the primary allergenic concern; there are no common excipient sensitivities to worry about (such as lactose, soy, or sulphites found in some other injectable products).
| 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 Sandoz A/S or its regional affiliates, which are part of the Novartis group. Sandoz is a global leader in generic and biosimilar medicines and operates manufacturing and quality-control facilities accredited to European Good Manufacturing Practice (GMP) standards.
Frequently Asked Questions about Oxaliplatin Sandoz
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, typically delivered via 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/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, particularly voltage-gated sodium 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 frightening 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 or taking things out of the freezer, cover your mouth and nose in cold weather with a scarf, and use lukewarm water for washing and dishwashing.
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 approximately 10–15% of patients it may become permanent. Your oncologist will monitor for cumulative neuropathy at each visit using standardised grading 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 of oxaliplatin received, particularly above 540 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, some oncologists may recommend a shorter 3-month course (6 cycles) based on the IDEA collaboration data showing that shorter treatment may be equally effective in certain lower-risk patients (T1–T3, N1 disease). For metastatic colorectal cancer, treatment continues until the disease progresses or side effects become unacceptable. In practice, many oncologists use a "stop-and-go" strategy (OPTIMOX protocol), pausing oxaliplatin after a set number of cycles while continuing 5-FU/leucovorin as maintenance, and then reintroducing oxaliplatin if the disease progresses. Your oncologist will determine the optimal treatment duration for your specific situation based on tumour staging, response, and tolerance.
Oxaliplatin Sandoz is a generic version of oxaliplatin manufactured by Sandoz, a division of Novartis. 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 and other generics such as Oxaliplatin Accord, Oxaliplatin Teva, and Oxaliplatin Fresenius Kabi. 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 Sandoz has been approved by the European Medicines Agency (EMA) and other national regulators after demonstrating pharmaceutical equivalence and compliance with Good Manufacturing Practice (GMP) standards. The therapeutic effects, safety profile and side effects are the same as for any other approved oxaliplatin product. The choice between generic brands is usually made by the hospital pharmacy based on supply, price and procurement contracts.
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, blood urea nitrogen) since oxaliplatin is cleared through the kidneys; liver function tests (ALT, AST, alkaline phosphatase, bilirubin) to detect hepatotoxicity including hepatic sinusoidal obstruction syndrome; and electrolytes, particularly potassium, magnesium and calcium. 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, typically using a standardised grading scale (CTCAE or the oxaliplatin-specific Levi scale).
Many patients continue to work, study, or care for their families during oxaliplatin treatment, particularly if their job is not physically demanding and they can take time off for infusion days and occasional sick days. However, side effects such as fatigue, neuropathy affecting fine motor skills, cold sensitivity, and risk of infection may require workplace adjustments. Talk to your employer about flexible working hours, the ability to work from home, and reduced exposure to people with infections. Occupational health professionals or patient navigators in your cancer centre can help with practical advice and, where available, assist with documentation for sick leave or disability benefits. Listen to your body – fatigue may become more pronounced later in treatment due to cumulative effects and anaemia.
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.
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