OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml) Infusion/Concentrate for

What is OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml) is a prescription cytotoxic (anticancer) medication used as part of chemotherapy regimens. It contains the active substance Oxaliplatin, a platinum-based compound, formulated as a concentrate for solution for infusion. Supplied in a 40 ml glass vial, each vial contains 200 mg of Oxaliplatin.

• Indication: Oxaliplatin is used in the treatment of advanced and metastatic colorectal cancer, and also as an adjuvant therapy following surgery for colon cancer.
• Drug Class: Platinum coordination compound – similar to cisplatin and carboplatin, but with a unique side effect profile.
• Formulation: Supplied as a sterile, clear solution requiring further dilution before intravenous infusion.
• Combination Therapy: Commonly used in combination with 5-Fluorouracil (5-FU) and leucovorin in regimens like FOLFOX.
• Objective: To kill rapidly dividing cancer cells by interfering with DNA replication and transcription.
• Clinical Benefit: Demonstrated to improve survival rates and reduce recurrence in colorectal cancer when used appropriately.

How to use OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

OXALIPLATIN HOSPIRA must be administered only by trained medical professionals in a controlled hospital or oncology clinic setting. This drug requires precise preparation and careful infusion protocols.

• Preparation: Dilute the required volume in 250–500 ml of 5% dextrose solution. Avoid using saline or chloride-containing solutions due to instability.
• Administration Route: Intravenous infusion over a period of 2 to 6 hours, depending on the prescribed regimen.
• Cycle Frequency: Usually administered every 2 weeks in combination protocols (e.g., FOLFOX), depending on tolerance and treatment goals.
• Pre-Infusion Testing: Baseline blood counts, renal, and liver function must be evaluated before each cycle.
• Special Considerations: Monitor for signs of neurotoxicity, especially cold-induced symptoms during or after infusion. Gloves or warm drinks may be recommended.
• Use with Other Agents: Often given on the same day as leucovorin and 5-FU as part of combination therapy. The timing and order of administration are important.

Mode of Action OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

Oxaliplatin’s mechanism of action is centered around its ability to bind and damage DNA within cancer cells, ultimately triggering their death. It differs slightly from other platinum agents in terms of both efficacy and toxicity profile.

• DNA Crosslinking: After entering the cell, oxaliplatin forms covalent bonds with DNA, creating intra- and inter-strand crosslinks.
• Inhibits DNA Functions: These crosslinks prevent DNA replication and transcription, halting cell division.
• Cell Cycle Arrest: Cells that are unable to replicate DNA or repair damage undergo apoptosis (programmed cell death).
• Unique Carrier Ligand: Oxaliplatin contains a diaminocyclohexane (DACH) carrier ligand, which contributes to its unique activity and resistance profile compared to cisplatin or carboplatin.
• Selective Cytotoxicity: While the drug targets rapidly dividing cancer cells, it can also affect fast-dividing normal cells (e.g., bone marrow, GI mucosa), leading to side effects.
• Synergy with 5-FU: Its combination with fluorouracil enhances the effectiveness against colorectal cancer by attacking DNA from multiple angles.

OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml) Interactions OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

OXALIPLATIN HOSPIRA may interact with a range of medications and substances, influencing its efficacy or increasing toxicity. Healthcare providers must assess all concurrent medications before and during treatment.

• 5-Fluorouracil (5-FU): Commonly used together. The combination enhances cytotoxic effects but increases risk of neutropenia and mucositis.
• Capecitabine: An oral prodrug of 5-FU, used alternatively in combination regimens. Monitor for gastrointestinal and hematologic toxicity.
• Neurotoxic Drugs: Caution with other neurotoxic agents like paclitaxel, vincristine – may worsen peripheral neuropathy.
• Nephrotoxic Agents: Drugs like aminoglycosides or NSAIDs may impair renal function, affecting oxaliplatin clearance.
• Live Vaccines: Should be avoided due to immunosuppression during chemotherapy, which can increase infection risks.
• Anticoagulants: Increased risk of bleeding when platelet counts are low; regular coagulation monitoring is advised.

Dosage of OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

Dosage must be personalized based on the patient’s body surface area (BSA), treatment protocol, and tolerance. Close monitoring is essential to adjust doses as needed and manage side effects effectively.

• Standard Adult Dose: 85 mg/m² IV infusion every two weeks, in combination with leucovorin and 5-FU (FOLFOX regimen).
• Dose Adjustment: May be required for renal impairment, hepatic dysfunction, or severe hematologic toxicity.
• Duration of Treatment: Commonly given for 6–12 cycles. Treatment duration depends on cancer stage, response, and patient tolerance.
• Pre-treatment Tests: Include complete blood count (CBC), serum creatinine, liver function tests before each dose cycle.
• Missed Dose: Management should be supervised by the oncologist; treatment may be postponed or resumed at adjusted doses.
• Pediatric Use: Safety and effectiveness in children have not been established. Use in pediatric oncology is off-label and based on limited data.

Possible side effects of OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

While effective, OXALIPLATIN HOSPIRA can cause a range of side effects. These vary in severity and frequency, and patients should be informed and monitored closely throughout treatment.

• Neuropathy: Tingling, numbness, or pain in the hands and feet. Acute symptoms can be triggered by cold temperatures. Chronic exposure may lead to permanent nerve damage.
• Hematologic Effects: Includes neutropenia, thrombocytopenia, and anemia – which may result in infections, bruising, or fatigue.
• Gastrointestinal: Nausea, vomiting, diarrhea, and mucositis are common but often manageable with supportive care.
• Hypersensitivity Reactions: Rash, itching, fever, or in rare cases, anaphylaxis. These may occur during infusion or in later cycles.
• Respiratory Symptoms: Dyspnea, cough, and rarely interstitial lung disease or pulmonary fibrosis.
• Fatigue: Generalized weakness or tiredness may persist between cycles.
• Liver and Kidney Impact: Mild, transient increases in liver enzymes or serum creatinine can occur and are usually reversible.

OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml) Contraindications OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

OXALIPLATIN HOSPIRA should not be administered in patients with known contraindications. Identifying and respecting these limits is vital to ensure patient safety and treatment success.

• Allergy to Oxaliplatin or Platinum Compounds: Any history of hypersensitivity to platinum-based drugs is an absolute contraindication.
• Severe Renal Impairment: Use is contraindicated in patients with significant renal dysfunction (creatinine clearance <30 ml/min).
• Pregnancy and Breastfeeding: Contraindicated due to teratogenic effects and potential excretion in breast milk. Effective contraception is required during and after treatment.
• Peripheral Neuropathy: Patients with pre-existing severe neuropathy should not receive oxaliplatin due to risk of worsening symptoms.
• Severe Bone Marrow Suppression: Use is contraindicated if baseline blood counts are critically low, until recovery is confirmed.

Storage of OXALIPLATIN HOSPIRA 5mg/ml (200mg/40ml)

Proper storage and handling are essential to maintain drug stability and safety. As a cytotoxic agent, OXALIPLATIN HOSPIRA must be stored and disposed of according to specific protocols.

• Storage Temperature: Store between 2°C and 8°C (in a refrigerator). Do not freeze as freezing may compromise the product's integrity.
• Light Protection: Keep in original packaging to protect from light exposure, which may degrade the active compound.
• Dilution: Once diluted in 5% dextrose, the infusion solution should ideally be used immediately. If necessary, it may be stored up to 24 hours at 2–8°C, depending on local guidelines.
• Handling Precautions: Only trained professionals should prepare or administer the drug. Use gloves and protective clothing to avoid accidental exposure.
• Disposal: Follow institutional protocols for disposal of cytotoxic waste. Do not dispose in regular waste streams.
• Shelf Life: Refer to the manufacturer's expiration date on the packaging. Do not use after expiry.