Introduction

Rubitor 50 mg contains Epirubicin Hydrochloride, a potent anthracycline compound with proven cytotoxic properties. As an essential component in adjuvant therapy for breast cancer patients with axillary node tumor involvement after primary cancer resection, Rubitor delivers effective treatment through its multi-faceted mechanism of action.

How Rubitor Works

Epirubicin Hydrochloride works through several complementary mechanisms:

• Intercalates between DNA base pairs creating steric obstruction
• Triggers DNA cleavage via topoisomerase II inhibition
• Inhibits DNA helicase activity
• Generates cytotoxic free radicals

This comprehensive approach targets cancer cells effectively while following a predictable pharmacokinetic profile:

• Distribution: Rapidly and widely distributes into tissues after IV administration
• Protein Binding: Approximately 77% binding to plasma proteins, primarily albumin
• Metabolism: Undergoes extensive liver metabolism and processing in other organs including red blood cells
• Excretion: Primarily eliminated through biliary excretion with some urinary elimination
• Half-life: Terminal elimination half-life of 30-40 hours

Dosage and Administration

Rubitor is administered via intravenous infusion in repeated 3-to-4-week cycles. The recommended dosage ranges from 100 to 120 mg/m², which can be administered either as a full dose on day 1 or divided equally between days 1 and 8 of each cycle.

Recommended Regimens:

CEF-120 Protocol:

• Cyclophosphamide: 75 mg/m² PO Days 1-14
• Epirubicin: 60 mg/m² IV Days 1, 8
• 5-Fluorouracil: 500 mg/m² IV Days 1, 8
• Repeated every 28 days for 6 cycles

FEC-100 Protocol:

• 5-Fluorouracil: 500 mg/m² IV Day 1
• Epirubicin: 100 mg/m² IV Day 1
• Cyclophosphamide: 500 mg/m² IV Day 1
• Repeated every 21 days for 6 cycles

Patients receiving the higher 120-mg/m² regimen should be provided with prophylactic antibiotic therapy to prevent potential infections during treatment.

Important Precautions and Monitoring

Before initiating Rubitor therapy, healthcare professionals should ensure:

• Patient recovery from any acute toxicities from prior cytotoxic treatments
• Baseline assessment of blood counts
• Evaluation of serum levels (total bilirubin, AST, creatinine)
• Assessment of cardiac function via left ventricular ejection fraction (LVEF)

During treatment, careful monitoring is essential for:

• Myelosuppression complications
• Potential cardiotoxicity, especially with cumulative exposure
• Hepatic and renal function

Special Population Considerations

Hepatic Impairment:

• 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 recommended for patients with severe renal impairment (serum creatinine >5 mg/dL)

Geriatric Use:

• Special monitoring needed for female patients ≥70 years of age

Pediatric Use:

• Safety and effectiveness not established in pediatric patients
• Higher risk for acute cardiotoxicity and chronic CHF in pediatric populations

Drug Interactions

Rubitor may interact with:

• Cardioactive compounds (calcium channel blockers) – monitor cardiac function
• Cimetidine – should be discontinued during Rubitor treatment
• Other cytotoxic drugs – potential for additive toxicity
• Paclitaxel and Docetaxel – altered systemic exposure
• Radiation therapy – potential inflammatory recall reaction

Contraindications

Rubitor is contraindicated in patients with:

• Hypersensitivity to Epirubicin
• Hypersensitivity to other anthracyclines or anthracenediones
• Hypersensitivity to any components of the product

Common Side Effects

Patients may experience:

• Myelosuppression (decreased blood cell counts)
• Cardiotoxicity
• Alopecia (hair loss)
• Gastrointestinal effects (nausea, vomiting, diarrhea)
• Hyperpyrexia and lethargy
• Amenorrhea
• Anorexia
• Temporary reddish discoloration of urine (1-2 days)

Pregnancy and Lactation

• Pregnancy Category D: Use only if potential benefit justifies potential risk to the fetus
• Lactation: Consider discontinuing either nursing or the drug based on importance to the mother

Storage and Handling

• Store in refrigerator at 2-8°C
• Do not freeze
• Protect from light
• Keep out of reach of children
• Note: Refrigeration may cause gel formation, which will return to normal after 2-4 hours at room temperature (15-25°C)

Rubitor 50 mg (Epirubicin) Injection, manufactured by Eskayef Pharmaceuticals Ltd. and supplied by Orio Pharma, represents a crucial component in modern breast cancer treatment protocols. With its powerful cytotoxic action and established efficacy in adjuvant therapy settings, healthcare providers can confidently incorporate Rubitor into their treatment strategies for patients with axillary node involvement following breast cancer resection.