Introduction
The Carbotor 450 mg (Carboplatin) Injection is a potent platinum-based alkylating chemotherapy agent specifically formulated for advanced ovarian carcinoma treatment. Manufactured by Eskayef Pharmaceuticals Ltd., a globally recognized leader in pharmaceutical innovation, and supplied by Onco Solution, a trusted international oncology medicine provider, this high-dose formulation offers robust tumor suppression with minimized renal toxicity. Designed for both initial combination therapy and palliative care in recurrent cases, the Carbotor 450 mg (Carboplatin) Injection ensures precision in dosing, improved patient compliance, and enhanced therapeutic outcomes.
Key Benefits
- High-Dose Efficacy: Delivers 450 mg of carboplatin per vial, optimizing tumor suppression while maintaining safety.
- Reduced Renal Toxicity: Unlike cisplatin, Carbotor minimizes kidney damage, eliminating the need for aggressive hydration protocols.
- Versatile Application: Effective for initial treatment (combined with cyclophosphamide) and secondary treatment of recurrent ovarian carcinoma.
- Global Accessibility: Supplied by Onco Solution, ensuring reliable, affordable access to advanced oncology therapies worldwide.
Indications
1. Initial Treatment of Advanced Ovarian Carcinoma
The Carbotor 450 mg (Carboplatin) Injection is indicated for the initial treatment of advanced ovarian carcinoma as part of a combination regimen with other chemotherapeutic agents, such as cyclophosphamide. Clinical studies, including randomized trials conducted by the NCIC and SWOG, have demonstrated equivalent overall survival outcomes compared to cisplatin-based therapies.
Key Study Insights:
- Equivalent survival rates between Carbotor (carboplatin) and cisplatin groups in combination with cyclophosphamide.
- Limited statistical power to confirm equivalence in pathologic complete response rates or long-term survival (≥3 years) due to small subgroup sizes.
2. Secondary Treatment of Recurrent Ovarian Carcinoma
Carbotor 450 mg is also indicated for palliative care in patients with recurrent ovarian carcinoma, including those previously treated with cisplatin. Note that patients who developed progressive disease during prior cisplatin therapy may exhibit reduced response rates.
Pharmacology
Mechanism of Action:
Carboplatin, the active ingredient in Carbotor 450 mg (Carboplatin) Injection, is an alkylating agent that covalently binds to DNA. This interaction disrupts DNA replication and repair mechanisms, inducing apoptosis (programmed cell death) in rapidly dividing cancer cells.
Key Advantages Over Cisplatin:
- Reduced Nephrotoxicity: Eliminates the need for forced diuresis or hydration protocols.
- Improved Tolerability: Lower incidence of severe nausea, vomiting, and kidney damage.
Dosage & Administration
Previously Untreated Patients
- Recommended Dose: 400 mg/m² administered as a single intravenous infusion over 15–60 minutes.
- Dosing Interval: Repeat every 4 weeks, provided:
- Neutrophil count ≥ 2,000 cells/mm³.
- Platelet count ≥ 100,000 cells/mm³.
Patients with Prior Myelosuppressive Therapy or Poor Performance Status
- Adjusted Dose: Reduce initial dose by 20–25% (300–320 mg/m²) to mitigate risks of bone marrow suppression.
Renal Impairment Adjustments (Non-AUC Dosing)
- Creatinine Clearance 41–59 mL/min: Reduce dose to 250 mg/m².
- Creatinine Clearance 16–40 mL/min: Reduce dose to 200 mg/m².
Administration Guidelines:
- Administer via IV infusion using sterile techniques.
- Do not mix with aluminum-containing equipment, as carboplatin may degrade.
Drug Interactions
- Live Vaccines: Avoid concurrent use due to immunosuppressive effects of chemotherapy.
- Nephrotoxic Agents (e.g., aminoglycosides, NSAIDs): Enhanced risk of kidney damage; monitor renal function closely.
- CYP3A4 Inducers/Inhibitors: Limited interaction data; exercise caution.
Contraindications
- Severe bone marrow depression (neutrophils < 1,500 cells/mm³ or platelets < 50,000 cells/mm³).
- Active bleeding or history of severe allergic reactions to cisplatin or platinum-based compounds.
Side Effects
Common Adverse Reactions:
- Bone Marrow Suppression: Anemia, thrombocytopenia, neutropenia.
- Gastrointestinal Effects: Nausea, vomiting, mucositis.
- Hair Loss: Alopecia (usually reversible post-treatment).
Serious Risks:
- Nephrotoxicity: Monitor serum creatinine and electrolytes regularly.
- Ototoxicity: Hearing loss or tinnitus (rare but irreversible).
- Hypersensitivity Reactions: Rash, bronchospasm, anaphylaxis (premedicate with antihistamines/corticosteroids).
Pregnancy & Lactation
- Pregnancy Category D: Carbotor 450 mg may cause fetal harm. Use only if maternal benefits outweigh fetal risks. Effective contraception is mandatory during and for 6 months post-treatment.
- Lactation: Discontinue breastfeeding due to potential infant toxicity from drug excretion in milk.
Precautions & Warnings
- Bone Marrow Suppression:
- Monitor complete blood counts (CBC) before each cycle. Delay therapy if counts are suboptimal.
- Consider growth factor support for severe neutropenia.
- Renal Function Monitoring:
- Assess creatinine clearance before initiating treatment and periodically thereafter.
- Avoid concurrent nephrotoxic medications.
- Hypersensitivity Management:
- Premedicate with dexamethasone (20 mg IV) and diphenhydramine (50 mg IV) 30 minutes before infusion.
- Have emergency equipment (e.g., epinephrine) readily available.
- Secondary Malignancies: Long-term use may increase leukemia risk.
Why Choose Carbotor 450 mg (Carboplatin) Injection?
- High-Dose Precision: Each vial contains 450 mg of carboplatin, enabling flexible dosing for diverse patient needs.
- Trusted Manufacturer: Produced by Eskayef Pharmaceuticals Ltd., a pioneer in Bangladesh’s pharmaceutical sector with over three decades of expertise in oncology formulations.
- Global Supplier Network: Supplied by Onco Solution, ensuring seamless access to life-saving therapies across Asia, Africa, Europe, and beyond.
- Patient-Centric Design: Reduced renal toxicity and simplified administration enhance treatment adherence.
Technical Specifications
- Active Ingredient: Carboplatin (450 mg/vial).
- Storage: Store at controlled room temperature (20–25°C). Protect from light.
- Packaging: Sterile, single-dose vials with tamper-evident seals.
- Shelf Life: 24 months from the date of manufacture.
Commitment to Excellence
Eskayef Pharmaceuticals Ltd., part of Bangladesh’s Transcom Group, combines cutting-edge research with stringent quality control to deliver world-class oncology solutions. Partnering with Onco Solution, they bridge healthcare disparities by providing affordable, high-efficacy treatments to underserved regions.
Conclusion
The Carbotor 450 mg (Carboplatin) Injection is a vital therapeutic asset in advanced ovarian carcinoma management, offering a strategic balance of potency, safety, and accessibility. By integrating this high-dose formulation into treatment regimens, healthcare providers empower patients with a clinically validated option backed by Eskayef Pharmaceuticals Ltd. and Onco Solution – global leaders in compassionate cancer care.