Introduction

Rubitor 10 mg (Epirubicin) Injection represents a cornerstone in modern breast cancer treatment protocols, offering oncologists an effective anthracycline-based option for adjuvant therapy following primary breast cancer surgery. Manufactured by the renowned Eskayef Pharmaceuticals Ltd. and distributed globally by Orio Pharma, this premium-quality injection contains Epirubicin Hydrochloride, a potent cytotoxic agent with proven efficacy in preventing cancer recurrence and improving survival outcomes.

Each vial of Rubitor contains 10 mg of Epirubicin Hydrochloride, precisely formulated under stringent quality control measures to ensure maximum therapeutic efficacy, stability, and safety. This specialized oncology medication is designed for intravenous administration by qualified healthcare professionals in clinical settings, forming an integral component of comprehensive breast cancer management strategies.

Therapeutic Applications

Rubitor is specifically indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. This targeted approach helps eliminate residual cancer cells that may remain after surgery, significantly reducing the risk of disease recurrence and metastasis.

The medication is particularly valuable in combination chemotherapy regimens, where it synergizes with other anticancer agents such as cyclophosphamide and 5-fluorouracil to create powerful treatment protocols like CEF-120 and FEC-100, which have demonstrated significant clinical benefits in breast cancer patients with lymph node involvement.

Mechanism of Action

Rubitor works through multiple complementary mechanisms that effectively disrupt cancer cell proliferation and survival:

1. DNA Intercalation: Epirubicin intercalates between DNA base pairs, creating a steric obstruction that prevents DNA and RNA synthesis, a critical process for rapidly dividing cancer cells.
2. Topoisomerase II Inhibition: The medication triggers DNA cleavage by inhibiting topoisomerase II, an essential enzyme for DNA replication, transcription, and repair.
3. DNA Helicase Inhibition: By inhibiting DNA helicase, Epirubicin prevents the unwinding of the DNA double helix, further disrupting DNA replication.
4. Free Radical Generation: The compound generates cytotoxic free radicals that cause oxidative damage to cellular components, including DNA, proteins, and cell membranes.

This multi-targeted approach makes Epirubicin particularly effective against aggressive breast cancer cells while demonstrating a more favorable cardiotoxicity profile compared to older anthracyclines.

Pharmacokinetic Profile

Following intravenous administration, Rubitor demonstrates a sophisticated pharmacokinetic profile:

• Distribution: Epirubicin is rapidly and widely distributed throughout body tissues. It exhibits approximately 77% binding to plasma proteins, predominantly albumin, which remains consistent across various drug concentrations.
• Metabolism: The medication undergoes extensive hepatic metabolism and is also processed by other organs and cells, including red blood cells, resulting in various metabolites with different activity profiles.
• Excretion: Elimination occurs primarily through biliary excretion and, to a lesser extent, via urinary excretion, with a terminal elimination half-life of 30-40 hours, allowing for convenient dosing schedules.

This pharmacokinetic profile supports the effective delivery of Epirubicin to target tissues while maintaining manageable systemic exposure.

Dosage and Administration Guidelines

Rubitor should be administered exclusively by healthcare professionals experienced in cytotoxic therapy management. The medication is administered through intravenous infusion according to specific treatment protocols:

Recommended Dosage Range: 100-120 mg/m² body surface area

Common Administration Schedules:

• The total dose may be given on day 1 of each 3-4 week cycle
• Alternatively, the dose may be divided equally and given on days 1 and 8 of each cycle

Standard Combination Regimens:

1. CEF-120 Protocol:
   • Cyclophosphamide: 75 mg/m² orally, days 1-14
   • Epirubicin (Rubitor): 60 mg/m² IV, days 1 and 8
   • 5-Fluorouracil: 500 mg/m² IV, days 1 and 8
   • Repeated every 28 days for 6 cycles
2. FEC-100 Protocol:
   • 5-Fluorouracil: 500 mg/m² IV, day 1
   • Epirubicin (Rubitor): 100 mg/m² IV, day 1
   • Cyclophosphamide: 500 mg/m² IV, day 1
   • Repeated every 21 days for 6 cycles

Patients receiving higher-dose regimens (120 mg/m²) should receive prophylactic antibiotic therapy to mitigate infection risks associated with myelosuppression.

Before initiating treatment, patients should have recovered from any acute toxicities from prior treatments, and baseline assessments of blood counts, liver and kidney function, and cardiac status (LVEF) should be performed.

Clinical Considerations and Patient Monitoring

Comprehensive patient monitoring is essential during Rubitor therapy to ensure safety and optimize treatment outcomes:

• Hematological Monitoring: Regular complete blood count assessments to detect and manage myelosuppression
• Cardiac Evaluation: Baseline and periodic cardiac function assessments to monitor for potential cardiotoxicity
• Hepatic Function: Regular liver function tests to guide dosing and detect toxicity
• Renal Function: Assessment of kidney function to ensure appropriate drug clearance

Dose modifications may be necessary based on hematological parameters, with specific adjustments recommended for patients with:

• Platelet counts <50,000/mm³
• Absolute neutrophil counts <250/mm³
• Neutropenic fever
• Grade 3/4 non-hematological toxicities

Safety Profile and Management of Adverse Effects

While Rubitor is generally well-tolerated within its therapeutic dosage range, healthcare providers should be vigilant for potential adverse effects:

• Myelosuppression: The most common dose-limiting toxicity, requiring close monitoring and possible supportive care
• Cardiotoxicity: Both acute and chronic forms may occur, necessitating cardiac function monitoring throughout treatment
• Alopecia: Reversible hair loss commonly associated with treatment
• Gastrointestinal Effects: Nausea, vomiting, and diarrhea may occur and can be managed with appropriate supportive care
• Dermatological Reactions: Various skin reactions can develop during treatment
• Red Urine Coloration: A harmless effect lasting 1-2 days after administration

Proactive management strategies, including antiemetics, colony-stimulating factors, and appropriate hydration, can significantly improve patient comfort and treatment adherence.

Special Population Considerations

Hepatic Impairment: Dose adjustments are recommended based on bilirubin and AST levels:

• Bilirubin 1.2-3 mg/dL or AST 2-4 times ULN: Reduce to 50% of starting dose
• Bilirubin >3 mg/dL or AST >4 times ULN: Reduce to 25% of starting dose

Renal Impairment: Lower doses should be considered for patients with severe renal impairment (serum creatinine >5 mg/dL)

Geriatric Use: Particular care and monitoring are recommended for female patients ≥70 years of age

Pediatric Use: Safety and effectiveness have not been established in pediatric populations

Storage and Handling Requirements

Rubitor requires specific storage conditions to maintain potency and stability:

• Store in refrigerator at 2-8°C (36-46°F)
• Do not freeze
• Protect from light
• Keep out of reach of children

If the solution appears gelled after refrigeration, it will return to a mobile solution after 2-4 hours at controlled room temperature (15-25°C). Always inspect for particulate matter or discoloration before administration.

As a cytotoxic agent, Rubitor requires special handling procedures during preparation and administration. Healthcare professionals should follow established guidelines for the safe handling, preparation, administration, and disposal of anticancer medications.

Quality Assurance and Manufacturing Excellence

As a product of Eskayef Pharmaceuticals Ltd., Rubitor 10 mg undergoes rigorous quality control throughout its manufacturing process. Eskayef maintains state-of-the-art production facilities that comply with international Good Manufacturing Practice (GMP) standards, ensuring consistent product quality, potency, and safety.

Each batch of Rubitor undergoes comprehensive analysis for purity, stability, sterility, and endotoxin levels before release, guaranteeing that oncology patients receive only the highest quality medication for their cancer treatment.

Global Availability Through Orio Pharma

Orio Pharma proudly serves as a global distributor of Rubitor 10 mg, making this essential breast cancer treatment accessible to patients worldwide. Understanding the time-sensitive nature of cancer treatment, Orio Pharma offers expedited worldwide delivery, ensuring that healthcare providers and patients receive this crucial medication within 3 to 7 working days, regardless of location.

Conclusion

The availability of Rubitor 10 mg represents the shared commitment of Eskayef Pharmaceuticals and Orio Pharma to advancing cancer care globally. By providing consistent access to high-quality oncology medications, these organizations contribute significantly to improving treatment outcomes and offering hope to patients battling breast cancer.

Healthcare professionals choosing Rubitor for their patients can do so with confidence, knowing they’re prescribing a medication manufactured with precision, distributed with care, and backed by organizations dedicated to fighting cancer through pharmaceutical excellence.

For additional information about Rubitor 10 mg or to place an order, please visit www.oriopharma.com or contact our dedicated oncology specialists who provide comprehensive support for healthcare providers and institutions worldwide.Retry