Oxator 50 mg (Oxaliplatin) Injection

Oxator 50 mg (Oxaliplatin) Injection – Advanced Platinum Chemotherapy for Colorectal Cancer

Overview

Oxator 50 mg is a premium formulation of Oxaliplatin, a platinum-based chemotherapeutic agent specifically designed for the treatment of colorectal cancer. Manufactured by Eskayef Pharmaceuticals Ltd., this injectable medication has become a cornerstone in the management of both early-stage and advanced colorectal malignancies.

Available through Saif Pharma, a leading global supplier of oncology medications since 2014, Oxator represents the gold standard in accessible cancer treatments. This medication has revolutionized colorectal cancer management by providing enhanced survival benefits when used in combination regimens, offering patients improved outcomes and quality of life compared to older chemotherapy options.

Mechanism of Action

Oxator works through a sophisticated biological mechanism as a platinum-containing alkylating agent. Unlike many conventional chemotherapeutic agents, Oxator’s mode of action involves:

• Formation of platinum-DNA adducts after intracellular hydrolysis
• Creation of cross-links within and between DNA strands
• Inhibition of DNA replication and transcription processes
• Disruption of cell division leading to programmed cell death
• Activity against both dividing and quiescent (resting) tumor cells

This targeted cellular damage mechanism makes Oxator particularly effective against colorectal cancer cells while demonstrating a different toxicity profile from other platinum compounds such as cisplatin.

Therapeutic Indications

Oxator 50 mg is indicated for two primary clinical scenarios in colorectal cancer management:

Adjuvant Treatment

• For patients with stage III colon cancer who have undergone complete surgical resection of the primary tumor
• Used in combination with infusional 5-fluorouracil/leucovorin (5-FU/LV)
• Demonstrated significant improvement in disease-free survival compared to surgery alone

Advanced Disease

• For patients with advanced or metastatic colorectal cancer
• Used in combination with infusional 5-fluorouracil/leucovorin (5-FU/LV)
• Provides meaningful prolongation of progression-free and overall survival in this patient population

These indications represent the standard of care in colorectal cancer management, with Oxator serving as an essential component of modern therapeutic regimens.

Dosage and Administration

Oxator features precise dosing regimens tailored to specific clinical scenarios:

Adjuvant Therapy in Stage III Colon Cancer

• Standard Dose: 85 mg/m² intravenously every 2 weeks for 12 cycles
• Administration: Intravenous infusion over 2-6 hours
• Diluent: Dissolved in 250-500 ml of 5% glucose solution
• Dose Reduction: After recovery from toxicity, reduce to 75 mg/m² if necessary
• Sequence: Administer before fluoropyrimidines

Advanced Colorectal Cancer

• Standard Dose: 85 mg/m² intravenously every 2 weeks until disease progression or unacceptable toxicity
• Administration: Intravenous infusion over 2-6 hours
• Diluent: Dissolved in 250-500 ml of 5% glucose solution
• Dose Reduction: After recovery from toxicity, reduce to 65 mg/m² if necessary
• Sequence: Administer before fluoropyrimidines

Important Administration Guidelines

• Requires appropriate reconstitution and dilution before administration
• Must be administered under the supervision of an experienced cancer chemotherapy physician
• Avoid aluminum-containing needles or IV administration sets that may contact Oxator, as aluminum can degrade platinum compounds

Reconstitution and Preparation

Proper handling and preparation of Oxator are essential for safety and efficacy:

1. Reconstitution: Reconstitute with 10 ml (for 50 mg vial) of water for injection or 5% dextrose injection
2. Further Dilution: Reconstituted solution must be further diluted with 250-500 ml of 5% dextrose injection before administration
3. Storage After Reconstitution: Reconstituted solution may be stored at 2-8°C for up to 24 hours
4. Storage After Dilution: Diluted solutions are stable for up to 6 hours at 20-25°C or up to 24 hours under refrigeration at 2-8°C

Clinical Safety Profile

Drug Interactions

Healthcare providers should be aware of potential interactions:

• May decrease plasma levels of digoxin
• May increase risk of toxicity when used with nephrotoxic drugs
• When administered with taxane derivatives (docetaxel, paclitaxel), Oxator should be administered after these agents to limit myelosuppression and enhance efficacy

Contraindications

Oxator is contraindicated in:

• Pregnancy
• Patients with peripheral neuropathy with functional impairment
• Severe renal impairment

Adverse Effects

While generally manageable, patients may experience various side effects:

Common effects include:

• Fatigue and fever
• Gastrointestinal disturbances (nausea, diarrhea, vomiting, constipation)
• Peripheral neuropathy (often presenting as cold sensitivity)
• Myelosuppression (anemia, thrombocytopenia, leukopenia)
• Elevated liver enzymes (AST, ALT, bilirubin)

Less common effects include:

• Allergic reactions
• Respiratory symptoms (dyspnea, cough)
• Infusion site reactions
• Electrolyte disturbances (particularly hypokalemia)
• Pharyngolaryngeal dysesthesia

Special Warnings and Precautions

Careful monitoring is essential during Oxator therapy:

• Neurological Status: Monitor regularly and reduce dose if symptoms are prolonged or severe
• Blood Counts: Check before each cycle; treatment should not be repeated until recovery
• Elderly Patients: Use with caution due to potentially increased risk of toxicity
• Renal Function: Caution in moderate renal impairment; contraindicated in severe impairment
• Handling Precautions: Use appropriate precautions for handling and disposal of cytotoxics

Special Populations

Pregnancy and Lactation

Oxator carries FDA Pregnancy Category D classification:

• Positive evidence of human fetal risk exists
• Use may be acceptable despite risk if needed for life-threatening situations
• Breastfeeding is not recommended during treatment

Renal Impairment

Dose adjustments may be necessary for patients with renal impairment:

• Contraindicated in severe renal impairment
• Dosage adjustments recommended for moderate impairment
• Regular monitoring of renal function advised during treatment

Management of Overdosage

In case of overdose, patients may experience:

• Enhanced adverse reactions (thrombocytopenia, myelosuppression)
• Severe nausea and vomiting
• Increased neurotoxicity
• Respiratory symptoms

Treatment is primarily supportive, focusing on symptom management and maintenance of vital functions.

Product Quality and Availability

Oxator 50 mg is manufactured by Eskayef Pharmaceuticals Ltd., a leading pharmaceutical company in Bangladesh with over 31 years of experience producing world-class medications. As part of the respected Transcom Group, Eskayef maintains stringent quality standards throughout production.

Saif Pharma distributes Oxator to more than 60 countries globally, including the United States, Canada, Saudi Arabia, UAE, China, India, and Pakistan. As a specialized oncology medicine platform established in 2014, Saif Pharma is dedicated to providing high-quality, affordable cancer treatments to patients worldwide.

Storage Recommendations

To maintain optimal efficacy and safety, Oxator should be:

• Stored in intact vials at 15-30°C
• Protected from freezing
• Handled according to reconstitution and dilution guidelines for prepared solutions
• Used within the stability timeframes specified for reconstituted and diluted solutions

Conclusion

Oxator 50 mg (Oxaliplatin) Injection represents a significant advancement in colorectal cancer treatment, offering patients an effective therapeutic option with established survival benefits. Its unique mechanism of action, well-defined dosing regimens, and established efficacy make it an essential component of modern oncology practice.

Through the combined expertise of Eskayef Pharmaceuticals in manufacturing and Saif Pharma in global supplier, Oxator is accessible to patients worldwide who require this life-extending medication. For healthcare providers and patients seeking effective treatment options for colorectal cancer, Oxator 50 mg provides a well-researched, clinically proven solution backed by extensive clinical experience.

For more information about Oxator 50 mg or to place an order, visit Saif Pharma at www.saifpharma.com or contact Eskayef Pharmaceuticals at www.skfbd.com.