Oxator 100 mg (Oxaliplatin) Injection

Oxator 100 mg (Oxaliplatin) Injection: Advanced Colorectal Cancer Treatment

Introduction to Oxator

Oxator 100 mg Injection represents a significant advancement in colorectal cancer treatment, delivering the platinum-complex agent oxaliplatin in a professionally formulated injectable solution. This premium oncology medication, manufactured by Eskayef Pharmaceuticals Ltd. and distributed globally by Saif Pharma, plays a crucial role in both adjuvant therapy for stage III colon cancer and in the management of advanced colorectal cancer.

As a cornerstone of modern colorectal cancer treatment protocols, Oxator 100 mg provides oncologists with a powerful therapeutic tool supported by extensive clinical evidence. Its strategic incorporation into combination chemotherapy regimens has contributed to improved survival rates and disease outcomes for colorectal cancer patients worldwide.

Therapeutic Indications

Oxator 100 mg (Oxaliplatin) Injection is specifically indicated for:

Adjuvant Treatment of Stage III Colon Cancer

Following complete surgical resection of the primary tumor, Oxator® serves as a critical adjuvant therapy component in combination with infusional 5-fluorouracil/leucovorin. This post-surgical treatment strategy aims to eliminate microscopic disease and reduce recurrence risk, significantly improving long-term survival prospects for patients with stage III colon cancer.

Treatment of Advanced Colorectal Cancer

For patients with metastatic or locally advanced colorectal cancer, Oxator® provides an essential therapeutic option when combined with infusional 5-fluorouracil/leucovorin. This combination approach has demonstrated meaningful improvements in progression-free survival and overall response rates compared to earlier treatment standards.

The specific approval for these indications reflects the robust clinical evidence supporting oxaliplatin’s efficacy in colorectal cancer management, making Oxator® a vital component of evidence-based oncology practice.

Mechanism of Action

Oxator® contains oxaliplatin, a third-generation platinum-containing complex with structural similarities to cisplatin but a distinct activity profile. Its anticancer effects occur through several sophisticated mechanisms:

1. DNA Cross-linking: After intracellular hydrolysis, active platinum compounds form intra- and inter-strand cross-links within DNA molecules.
2. Replication Inhibition: These cross-links physically prevent DNA polymerase from proceeding during DNA replication, blocking cellular division.
3. Transcription Interference: The structural changes in DNA disrupt RNA transcription processes, preventing the synthesis of essential proteins.
4. Apoptosis Induction: The accumulated DNA damage triggers programmed cell death (apoptosis) pathways, particularly in rapidly dividing cancer cells.

Unlike earlier platinum compounds, oxaliplatin demonstrates a unique resistance profile and activity against colorectal cancers that traditionally showed limited response to platinum-based therapies. This distinctive mechanism makes Oxator® particularly valuable in colorectal cancer treatment regimens.

Pharmaceutical Formulation

Each vial of Oxator 100 mg contains oxaliplatin for intravenous administration as a freeze-dried powder requiring reconstitution before use. The formulation is specifically designed to ensure stability, potency, and proper delivery of the active ingredient to target tissues.

The product is manufactured under stringent quality control standards by Eskayef Pharmaceuticals Ltd., a company with over three decades of pharmaceutical excellence. Founded in 1990 when Bangladesh operations of SK&F USA were acquired by the respected Transcom Group, Eskayef has established itself as a premier provider of world-class medicines.

Dosage and Administration Guidelines

Oxator 100 mg (Oxaliplatin) Injection requires administration by qualified healthcare professionals in settings equipped for chemotherapy delivery and monitoring. The recommended dosing regimens are:

• Standard dose: 85 mg/m² administered intravenously every 2 weeks for 12 cycles
• Administration method: Intravenous infusion over 2-6 hours, 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 in the combination regimen

For Advanced Colorectal Cancer

• Standard dose: 85 mg/m² administered intravenously every 2 weeks until disease progression or unacceptable toxicity
• Administration method: Intravenous infusion over 2-6 hours, 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 in the combination regimen

Reconstitution Process

1. Reconstitute the 100 mg vial with 20 ml of water for injection or 5% dextrose injection
2. Further dilute the reconstituted solution with 250-500 ml of 5% dextrose injection before administration
3. Avoid using aluminum-containing needles or IV administration sets that may contact the solution, as aluminum can degrade platinum compounds

Clinical Pharmacology

Oxaliplatin demonstrates a complex pharmacokinetic profile following intravenous administration. The drug undergoes rapid distribution to tissues followed by elimination primarily through renal excretion. The platinum from oxaliplatin becomes irreversibly bound to plasma proteins and erythrocytes, with the remaining unbound platinum being available for anti-tumor activity.

Understanding these pharmacokinetic properties helps clinicians optimize dosing strategies and monitoring protocols, particularly for patients with renal impairment or other factors that might affect drug clearance.

Safety and Tolerability Profile

As with all potent cytotoxic agents, Oxator 100 mg can produce various adverse effects that require careful monitoring and management. Common adverse events include:

Neurological Effects

• Peripheral neuropathy (acute and persistent forms)
• Pharyngolaryngeal dysesthesia (particularly during infusion)

Gastrointestinal Effects

• Nausea and vomiting (often preventable with modern antiemetic protocols)
• Diarrhea
• Stomatitis and mucositis

Hematological Effects

• Neutropenia
• Thrombocytopenia
• Anemia

Constitutional Symptoms

• Fatigue
• Fever
• Pain

Healthcare providers should implement appropriate monitoring protocols and supportive care measures to manage these effects while maximizing therapeutic benefits.

Important Precautions and Contraindications

Oxator® requires careful consideration of several important precautions:

Administration Setting

• Should be administered under the supervision of an experienced cancer chemotherapy physician
• Requires appropriate facilities for monitoring and managing potential adverse reactions

Monitoring Requirements

• Regular assessment of neurological status
• Periodic blood count monitoring
• Liver and kidney function evaluation

Contraindications

• Pregnancy (Category D)
• Pre-existing peripheral neuropathy with functional impairment
• Severe renal impairment

Special Populations

• Elderly patients may require careful monitoring
• Dose adjustments may be necessary for patients with moderate renal impairment

Global Access Through Saif Pharma

Saif Pharma, established in 2014, has developed extensive distribution networks to make Oxator 100 mg available to healthcare facilities across more than 60 countries worldwide. As a specialized oncology medicine platform, Saif Pharma ensures consistent supply of this essential medication to major markets including:

• North America (United States and Canada)
• Middle East (Saudi Arabia, UAE)
• Asia (China, India, Pakistan)
• And numerous additional regions

This global reach reflects Saif Pharma’s commitment to expanding access to high-quality, affordable oncology medications worldwide. By maintaining reliable supply chains and competitive pricing structures, we help healthcare systems overcome barriers to providing optimal colorectal cancer treatment.

Storage and Stability Information

To maintain the potency and safety of Oxator 100 mg:

• Store intact vials at 15-30°C; do not freeze
• Reconstituted solution may be stored at 2-8°C for up to 24 hours
• Diluted solutions remain stable for up to 6 hours at 20-25°C or up to 24 hours under refrigeration at 2-8°C

Healthcare facilities should follow these storage recommendations to ensure product stability until administration.

Conclusion

Oxator 100 mg (Oxaliplatin) Injection represents a significant advancement in colorectal cancer treatment, offering healthcare providers a powerful therapeutic option supported by extensive clinical evidence. Manufactured by Eskayef Pharmaceuticals Ltd. and distributed globally by Saif Pharma, this premium oncology medication continues to improve outcomes for patients with both early-stage and advanced colorectal cancer.

Our commitment to quality manufacturing, reliable distribution, and affordable access aligns with global efforts to enhance cancer care standards worldwide. Through strategic partnerships with healthcare providers across more than 60 countries, we contribute to better treatment outcomes and improved quality of life for patients facing colorectal cancer.

For detailed prescribing information, technical specifications, or supply inquiries regarding Oxator 100 mg Injection, please contact our specialized oncology team through www.saifpharma.com or visit the manufacturer’s website at www.skfbd.com.