OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml) Infusion/Concentrate for

What is OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

OXALIPLATIN HOSPIRA 5mg/ml is a prescription-only antineoplastic (anticancer) agent used in chemotherapy. It contains the active substance Oxaliplatin and is provided in a 20 ml glass vial containing 100 mg of the drug as a concentrate for solution for infusion. It is administered intravenously and belongs to the platinum-based chemotherapy class.

• Therapeutic Use: Primarily indicated for the treatment of advanced colorectal cancer, often in combination with 5-fluorouracil (5-FU) and leucovorin.
• Classification: Platinum coordination complex – it interferes with the replication of DNA in rapidly dividing cancer cells.
• Form: Concentrate for infusion, meaning it must be diluted before being administered via an intravenous drip.
• Target: Designed to treat solid tumors, particularly in the gastrointestinal tract, by damaging cancer cell DNA.
• Approval: Widely approved for use globally as part of first-line and adjuvant therapy in colorectal cancer treatment protocols.
• Benefits: Demonstrated effectiveness in prolonging survival and delaying cancer progression when used as part of combination chemotherapy.

How to use OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

OXALIPLATIN HOSPIRA must be used strictly under the supervision of a qualified oncologist or medical professional experienced in chemotherapy administration. The medication requires careful handling and preparation before administration.

• Preparation: The concentrate must be diluted with a 5% dextrose solution. It is incompatible with sodium chloride and other chloride-containing solutions.
• Infusion Process: Administered as an intravenous infusion over 2 to 6 hours, depending on the treatment protocol and patient tolerance.
• Use in combination therapy: Commonly used with 5-FU and leucovorin in the FOLFOX regimen. It can be part of both adjuvant and metastatic treatment plans.
• Cycle Frequency: Treatment is usually given every two to three weeks, with rest periods in between to allow the body to recover.
• Monitoring: Close monitoring of blood cell counts, liver and kidney function, and neurological symptoms is essential during treatment cycles.
• Administration setting: Only in hospital or oncology centers with facilities for handling cytotoxic drugs due to the potential for severe side effects and complications if misused.

Mode of Action OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

OXALIPLATIN HOSPIRA exerts its antitumor effects by interfering with DNA synthesis and repair mechanisms in cancer cells. Its mechanism of action is distinct yet shares similarities with other platinum-based agents like cisplatin and carboplatin.

• DNA Binding: Oxaliplatin enters cancer cells and binds covalently to DNA, forming platinum-DNA adducts.
• Crosslink Formation: It induces both intra-strand and inter-strand crosslinks in DNA, thereby disrupting the normal structure and function of the DNA molecule.
• Inhibition of Cell Functions: These crosslinks prevent essential processes such as DNA replication and transcription, halting cell proliferation.
• Induction of Apoptosis: Accumulated DNA damage triggers programmed cell death (apoptosis), particularly in rapidly dividing tumor cells.
• Cytotoxic Effect: The overall result is the selective killing of malignant cells, though some normal rapidly dividing cells (e.g., bone marrow, GI tract) are also affected.
• Unique Profile: Oxaliplatin’s DACH (diaminocyclohexane) carrier ligand is believed to contribute to its distinct efficacy and side effect profile, notably neurotoxicity rather than nephrotoxicity (seen with cisplatin).

OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml) Interactions OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

OXALIPLATIN HOSPIRA may interact with a variety of other drugs, necessitating careful management and coordination by the treating physician. These interactions can influence drug efficacy, safety, or increase toxicity.

• 5-Fluorouracil (5-FU): Commonly co-administered. The combination enhances antitumor activity but also requires increased vigilance for gastrointestinal and hematologic toxicity.
• Other Chemotherapy Agents: When used with irinotecan or capecitabine, the cumulative side effect profile can become significant and should be monitored closely.
• Neurotoxic Agents: Drugs such as paclitaxel or vincristine may exacerbate oxaliplatin-induced peripheral neuropathy.
• Nephrotoxic Drugs: Co-use with drugs that impair renal function (e.g., aminoglycosides, NSAIDs) should be approached with caution as oxaliplatin is partially cleared by the kidneys.
• Live Vaccines: Should be avoided due to immunosuppression caused by chemotherapy, which can increase the risk of infection from live attenuated vaccines.
• Anticoagulants: As oxaliplatin can affect platelet counts, using blood thinners concurrently may elevate bleeding risk, requiring monitoring of coagulation parameters.

Dosage of OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

The dosage of OXALIPLATIN HOSPIRA depends on individual patient factors, including body surface area (BSA), renal function, and co-administered therapies. It is critical to follow the oncologist’s guidance for safe and effective dosing.

• Standard Dose: Typically, 85 mg/m² of BSA is administered via intravenous infusion once every 2 weeks, often in combination with 5-FU and leucovorin.
• Modified Doses: Patients with renal impairment or elderly patients may require dose adjustments to reduce toxicity risk.
• Cumulative Dose Limit: Neuropathy is dose-dependent, and total cumulative exposure should be carefully tracked to prevent irreversible nerve damage.
• Cycle Duration: Most treatment regimens involve repeated cycles over several months. A typical course may last for 6 to 12 cycles, depending on patient response and tolerance.
• Pre-treatment Testing: Routine blood tests, including complete blood counts and kidney/liver function panels, must be done before each cycle to ensure patient safety.
• Missed Doses: Should only be managed by the prescribing oncologist. Delays or dose reductions may be needed based on toxicity levels or patient recovery.

Possible side effects of OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

Possible Side Effects of OXALIPLATIN HOSPIRA 5mg/ml

As with all chemotherapy drugs, OXALIPLATIN HOSPIRA is associated with a variety of side effects. These may range from mild to severe and often depend on individual tolerance and treatment duration.

• Neurological: Peripheral sensory neuropathy is the most common. Acute symptoms may be cold-induced (dysesthesia, paresthesia), while chronic exposure can lead to lasting nerve damage.
• Gastrointestinal: Includes nausea, vomiting, diarrhea, constipation, and mucositis. These can usually be managed with supportive medications.
• Hematologic: Anemia, neutropenia, and thrombocytopenia can occur, increasing the risk of fatigue, infection, and bleeding, respectively.
• Respiratory: Rare cases of interstitial lung disease and pulmonary fibrosis have been reported.
• Allergic Reactions: Rashes, fever, hypotension, and rarely anaphylaxis, especially with repeated infusions.
• Fatigue and General Weakness: Common during chemotherapy cycles and may persist for several days post-infusion.
• Renal and Hepatic Changes: Mild elevations in serum creatinine or liver enzymes may occur, typically reversible.

OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml) Contraindications OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

Contraindications of OXALIPLATIN HOSPIRA 5mg/ml

OXALIPLATIN HOSPIRA should not be used in certain populations or clinical situations where the risk outweighs the benefit. Identifying contraindications is critical before initiating therapy.

• Hypersensitivity: Patients with known hypersensitivity to oxaliplatin, platinum compounds, or any excipients in the formulation must not use this medication.
• Pregnancy and Lactation: Contraindicated during pregnancy due to potential harm to the fetus. Breastfeeding is not recommended while undergoing treatment.
• Severe Renal Impairment: Patients with significantly reduced renal function (creatinine clearance <30 mL/min) should not receive oxaliplatin due to accumulation and increased toxicity.
• Severe Myelosuppression: Patients with very low blood cell counts should delay treatment until recovery due to the risk of severe complications.
• Peripheral Neuropathy: Pre-existing significant peripheral neuropathy may worsen with oxaliplatin and is a relative contraindication for ongoing use.

Storage of OXALIPLATIN HOSPIRA 5mg/ml (100mg/20ml)

Proper storage is essential to maintain the chemical integrity and therapeutic efficacy of OXALIPLATIN HOSPIRA. Special handling precautions are necessary given its cytotoxic nature.

• Temperature: Store at 2°C to 8°C (36°F to 46°F) in a refrigerator. Do not freeze.
• Packaging: Keep the vial in the original carton to protect from light, which can degrade the active ingredient.
• Handling Instructions: Use aseptic technique during dilution. Trained professionals should prepare and handle the solution in designated areas.
• Post-Dilution Stability: The diluted solution should be used immediately. If storage is necessary, refer to local guidelines (generally stable for up to 24 hours at 2–8°C).
• Disposal: Unused medicine and waste should be disposed of following hospital protocols for hazardous cytotoxic drugs.
• Shelf Life: Always check the expiration date before use. Do not use beyond the manufacturer’s indicated shelf life.