Introduction

Rubitor 10 mg (Epirubicin) Injection is a potent anthracycline chemotherapy agent indicated for the adjuvant treatment of breast cancer in patients with axillary node involvement post-resection. Manufactured by Eskayef Pharmaceuticals Ltd. and supplied globally by Onco Solution, Rubitor 10 mg (Epirubicin) Injection inhibits DNA and RNA synthesis, disrupting tumor cell proliferation. With its proven efficacy and manageable safety profile, Rubitor 10 mg (Epirubicin) Injection is a cornerstone in modern oncology protocols.

Indications

Rubitor 10 mg (Epirubicin) Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

Pharmacology

Rubitor 10 mg (Epirubicin) Injection exerts its cytotoxic effects by:

• Intercalating between DNA base pairs, inhibiting DNA and RNA synthesis.
• Triggering DNA cleavage via topoisomerase II inhibition.
• Generating cytotoxic free radicals that damage cellular components.

Pharmacokinetics:

• Distribution: Rapid and widespread tissue distribution (77% plasma protein binding).
• Metabolism: Extensively metabolized by the liver and red blood cells.
• Excretion: Primarily biliary, with a terminal half-life of 30–40 hours.

Dosage & Administration

Rubitor 10 mg (Epirubicin) Injection is administered intravenously under the supervision of an oncology specialist.

Recommended Dosage:

• CEF-120 Regimen:
  • Cyclophosphamide: 75 mg/m² PO on Days 1–14.
  • Epirubicin: 60 mg/m² IV on Days 1 and 8.
  • 5-Fluorouracil: 500 mg/m² IV on Days 1 and 8.
  • Repeat every 28 days for 6 cycles.
• FEC-100 Regimen:
  • 5-Fluorouracil: 500 mg/m² IV on Day 1.
  • Epirubicin: 100 mg/m² IV on Day 1.
  • Cyclophosphamide: 500 mg/m² IV on Day 1.
  • Repeat every 21 days for 6 cycles.

Precautions:

• Delay administration if prior cardiotoxic agents (e.g., trastuzumab) are not cleared from circulation.
• Monitor cardiac function regularly.

Drug Interactions

• Cimetidine: Increases epirubicin exposure; discontinue during treatment.
• Paclitaxel/Docetaxel: Alters systemic exposure of epirubicin metabolites.
• Radiation Therapy: May induce inflammatory recall reactions.
• Hepatic Impairment: Alters metabolism and toxicity; dose adjustment required.

Contraindications

• Hypersensitivity to epirubicin, anthracyclines, or anthracenediones.
• Severe hepatic or renal impairment.

Side Effects

Common Adverse Reactions:

• Hematologic: Myelosuppression (neutropenia, thrombocytopenia).
• Cardiac: Cardiotoxicity (acute or chronic).
• Gastrointestinal: Nausea, vomiting, diarrhea.
• Dermatologic: Alopecia, rash.

Serious Risks:

• Congestive heart failure (CHF).
• Severe infections due to neutropenia.

Pregnancy & Lactation

• Pregnancy Category D: Rubitor 10 mg (Epirubicin) Injection may cause fetal harm. Use only if benefits outweigh risks.
• Lactation: Discontinue breastfeeding during treatment and for 1 week after the final dose.

Precautions & Warnings

• Monitor blood counts, liver function, and cardiac function regularly.
• Use with caution in elderly patients and those with pre-existing cardiac conditions.
• Avoid extravasation during administration to prevent tissue necrosis.

Use in Special Populations

• Hepatic Impairment: Reduce dose by 50% for bilirubin 1.2–3 mg/dL or AST 2–4x ULN; reduce by 75% for bilirubin >3 mg/dL or AST >4x ULN.
• Renal Impairment: Lower doses recommended for severe impairment (serum creatinine >5 mg/dL).
• Pediatric Use: Safety and efficacy not established.
• Geriatric Use: Monitor closely for toxicity in patients ≥70 years.

Overdose Management

No specific antidote exists. Provide supportive care, including antibiotics, blood transfusions, and colony-stimulating factors. Monitor for delayed cardiotoxicity.

Storage Conditions

Store at 2–8°C (refrigerated); do not freeze.

• Protect from light and keep out of reach of children.

Manufacturing Excellence

Rubitor 10 mg (Epirubicin) Injection is manufactured by Eskayef Pharmaceuticals Ltd., a WHO-GMP-certified company with over 30 years of expertise in oncology therapeutics. Their state-of-the-art facilities ensure:

• Rigorous quality control.
• Compliance with international standards.

Global Supply Network

Onco Solution, the global supplier of Rubitor 10 mg (Epirubicin) Injection, guarantees:

• Reliable, temperature-controlled logistics.
• Compliance with global regulatory requirements.

Clinical Value Proposition

Rubitor 10 mg (Epirubicin) Injection offers:

• Proven efficacy in adjuvant breast cancer therapy.
• Targeted DNA and RNA synthesis inhibition.
• Enhanced safety with dose adjustments for toxicity.

Conclusion

Rubitor 10 mg (Epirubicin) Injection is a vital therapeutic option for adjuvant breast cancer treatment, combining clinical efficacy with a manageable safety profile. Backed by Eskayef Pharmaceuticals Ltd.’s manufacturing excellence and Onco Solution’s global distribution network, Rubitor 10 mg (Epirubicin) Injection ensures reliable access to life-saving oncology care.