Oxaliplat5 mg/ml

Oxaliplat 5 mg/ml is a platinum-based chemotherapy medicine, used in combination with 5-fluorouracil and leucovorin (the FOLFOX regimen), indicated for:

• Adjuvant treatment of stage III colon cancer, in patients who have undergone complete resection of the primary tumour
• Treatment of advanced (metastatic) colorectal cancer

Contains Oxaliplat 5 mg/ml as the active ingredient, supplied as a solution for intravenous infusion, commonly in 50 mg and 100 mg single-dose vials (5 mg/mL).

Oxaliplat 5 mg/ml is a third-generation platinum chemotherapy medicine, used together with other chemotherapy drugs (5-fluorouracil and leucovorin) to treat colon and colorectal cancer, both after surgical removal of the tumour and in more advanced, metastatic disease. It works, like other platinum agents, by binding to and cross-linking DNA within cancer cells, preventing them from dividing. Oxaliplat 5 mg/ml has a very distinctive and well-recognized side effect: a peripheral neuropathy that is characteristically triggered or worsened by exposure to cold - even touching a cold drink, cold air, or cold objects can bring on tingling, numbness, or throat/jaw discomfort within hours of an infusion. It also carries a risk of serious and sometimes fatal hypersensitivity reactions, including anaphylaxis, which can occur within minutes of any infusion.

Therapeutic Class: Antineoplastic (Chemotherapy) Agent

Oxaliplat 5 mg/ml undergoes rapid, nonenzymatic conversion in the body to active derivatives that bind to DNA. It has a narrow therapeutic index, and its most distinctive toxicity - an acute, cold-triggered sensory neuropathy affecting the hands, feet, mouth, and throat - occurs in more than 90% of patients to some degree, typically appearing during or within hours of an infusion and resolving within days, though it tends to recur and intensify with further cycles. A separate, delayed (chronic) peripheral neuropathy, persisting beyond 14 days, develops in about 48% of patients and is related to cumulative dose.

• Given only by intravenous infusion, by trained oncology healthcare professionals, typically over 2-6 hours depending on the specific protocol
• Avoid exposure to cold during and for several days after each infusion - do not drink cold beverages, touch cold objects, or go outside in cold weather without protection, given the characteristic cold-triggered acute neuropathy
• Avoid topical application of ice (such as for mucositis prevention), since cold temperature can worsen acute neurological symptoms
• The infusion site is monitored closely, since extravasation can cause tissue injury
• Blood counts are checked before each cycle; treatment is delayed until neutrophils and platelets recover to specified thresholds

The following should be assessed and managed by the treating oncology team:

• Other nephrotoxic or neurotoxic drugs (such as aminoglycosides): may increase the risk of kidney or nerve-related toxicity when combined with Oxaliplat 5 mg/ml.
• 5-fluorouracil and leucovorin: given together as part of the standard FOLFOX combination regimen; dosing and sequencing are specifically coordinated by the treating oncology team.
• Live vaccines: should generally be avoided during and for a period after Oxaliplat 5 mg/ml treatment, given significant immune suppression.
• Other chemotherapy or myelosuppressive agents: combined use increases the risk and severity of low blood counts; dosing is carefully coordinated within combination regimens.

Common side effects

• Acute, cold-triggered peripheral sensory symptoms: tingling, numbness, or discomfort in the hands, feet, mouth, or throat, usually appearing during or shortly after infusion and resolving within days
• Nausea, vomiting, diarrhoea
• Fatigue
• Myelosuppression: reduced blood cell counts
• Loss of appetite

Serious side effects (require prompt medical attention)

• Serious and fatal hypersensitivity reactions, including anaphylaxis: can occur within minutes of administration and during any cycle, not just the first; Oxaliplat 5 mg/ml must be immediately and permanently discontinued if this occurs.
• Acute pharyngolaryngeal dysesthesia: a subjective sensation of difficulty breathing or swallowing, without actual airway obstruction, occurring in 1-2% of patients, typically triggered by cold - avoiding cold drinks, food, and air helps minimize this; anti-anxiety medicines may be used if needed once oxygen levels are confirmed normal.
• Delayed (chronic) peripheral sensory neuropathy: persistent (beyond 14 days) numbness, tingling, or reduced sensation that can interfere with daily activities such as writing, buttoning clothes, or walking; occurs in about 48% of patients and may require dose reduction or discontinuation based on severity.
• Severe myelosuppression: treatment is delayed until neutrophil and platelet counts recover to specified thresholds; withhold for sepsis or septic shock.
• Signs of infection during periods of low blood counts: fever, chills.
• Severe or persistent diarrhoea or vomiting, which can lead to dehydration and electrolyte imbalance.

Pregnancy

Oxaliplat 5 mg/ml can cause fetal harm based on its mechanism of action and platinum-class effects. Effective contraception is recommended for patients of reproductive potential during treatment and for a defined period afterward, as advised by the treating oncologist.

Breastfeeding

Breastfeeding is not recommended during Oxaliplat 5 mg/ml treatment and for a period afterward, given the potential for serious adverse effects in a nursing infant.

• Cold avoidance: avoid cold drinks, cold objects, and cold air exposure during and for several days after each infusion, given the characteristic cold-triggered acute neuropathy; avoid ice application for mucositis prevention or other purposes.
• Hypersensitivity monitoring: serious, sometimes fatal, reactions can occur within minutes of any infusion, not only the first; monitor closely, particularly during and shortly after each dose.
• Peripheral neuropathy monitoring: assess neurological symptoms regularly; dose reduction or discontinuation is required based on severity, since chronic neuropathy can significantly affect quality of life and daily function.
• Myelosuppression: monitor blood counts before each cycle; do not administer if sepsis or septic shock is present.
• This medicine should only be administered under constant supervision by physicians experienced in the use of cancer chemotherapeutic agents, in facilities equipped to manage complications.

Overdose would be expected to cause exaggerated known toxicities, particularly severe myelosuppression, peripheral neuropathy, and gastrointestinal toxicity. There is no specific antidote; management is supportive, provided in a specialist facility, including blood count monitoring, transfusion support, and treatment of any resulting infection or severe neurological symptoms, under the direct management of the oncology treatment team.

Store unopened vials at controlled room temperature, protected from light, as directed by the specific manufacturer. Diluted infusion solutions should be used within the manufacturer's specified time frame; never mix with sodium chloride solutions or other chloride-containing solutions, since chloride can degrade Oxaliplat 5 mg/ml - use only the diluent (commonly dextrose solution) specified in the product's instructions. Dispose of unused cytotoxic medicine according to institutional protocols for hazardous pharmaceutical waste.

• Renal impairment: Dose reduction is required in severe impairment (creatinine clearance below 30 mL/min); Oxaliplat 5 mg/ml is predominantly eliminated by the kidneys.
• Elderly: Used with the same weight/BSA-based dosing approach, with careful monitoring given increased likelihood of comorbidities.
• Women who seem more likely than men to experience severe cold-triggered neurotoxicity based on clinical observation: monitored with the same care as other patients, with dose modification per protocol as needed.

For adjuvant treatment of stage III colon cancer, Oxaliplat 5 mg/ml combined with 5-FU/leucovorin is typically given for 12 cycles (approximately 6 months). For advanced/metastatic colorectal cancer, treatment continues until disease progression or unacceptable toxicity, as determined by the treating oncologist through periodic reassessment of disease response and neuropathy severity.

Oxaliplat 5 mg/ml must be diluted only in 5% dextrose solution (D5W) before infusion - never with sodium chloride or other chloride-containing solutions, which can degrade the drug. Reconstituted and diluted solutions should be used within the manufacturer's specified stability window, following the specific product's instructions.

Drug Class: Third-generation platinum-based alkylating-like agent

Once inside the body, Oxaliplat 5 mg/ml forms reactive platinum complexes that bind to DNA within cells, creating cross-links both within and between DNA strands. These cross-links prevent DNA replication and transcription, which triggers programmed cell death, particularly in rapidly dividing cancer cells. Oxaliplat 5 mg/ml's specific platinum "arm" structure allows it to retain activity against some cancer cells that have developed resistance to other platinum agents like cisplatin.

There is no established pediatric indication for Oxaliplat 5 mg/ml; it is used in adult oncology practice for colon and colorectal cancer as described under indications.