Overview
Rubitor 10 mg (Epirubicin Hydrochloride Injection) is a high-quality anthracycline cytotoxic chemotherapy medication manufactured by Eskayef Pharmaceuticals Ltd and distributed globally by Saif Pharma. This premium oncology medicine is specifically indicated as a component of adjuvant therapy for patients with evidence of axillary node tumor involvement following primary breast cancer resection.
Therapeutic Applications
Rubitor Injection has established itself as an essential component in breast cancer treatment protocols worldwide. As an adjuvant therapy following surgical resection, Rubitor helps target remaining cancer cells, significantly reducing the risk of recurrence in patients with node-positive breast cancer. The active ingredient, Epirubicin Hydrochloride, belongs to the anthracycline class of antibiotics with potent cytotoxic properties, making it effective against rapidly dividing cancer cells.
Mechanism of Action
Epirubicin works through multiple mechanisms to combat cancer cells:
- Intercalates between DNA base pairs, causing steric obstruction
- Triggers DNA cleavage by inhibiting topoisomerase II
- Inhibits DNA helicase activity
- Generates cytotoxic free radicals
This multifaceted approach effectively disrupts DNA and RNA synthesis, preventing cancer cell replication and promoting cancer cell death.
Pharmacokinetic Profile
Understanding the pharmacokinetics of Rubitor 10 mg helps healthcare providers optimize treatment:
- Distribution: Following intravenous administration, Epirubicin rapidly distributes throughout body tissues. Approximately 77% binds to plasma proteins, primarily albumin, independent of drug concentration.
- Metabolism: The liver extensively metabolizes Epirubicin, with additional metabolism occurring in other organs and cells, including red blood cells.
- Excretion: Elimination occurs primarily through biliary excretion, with urinary excretion playing a secondary role. The terminal elimination half-life ranges from 30-40 hours.
Dosage and Administration Guidelines
Rubitor 10 mg Injection must be administered intravenously under the supervision of qualified physicians experienced in cytotoxic therapy. The recommended dosage ranges from 100 to 120 mg/m², administered in repeated 3-4 week cycles. The total dose may be given on day 1 of each cycle or divided equally between days 1 and 8.
Established regimens include:
CEF-120 Protocol:
- Cyclophosphamide: 75 mg/m² PO D 1-14
- Epirubicin (Rubitor): 60 mg/m² IV D 1, 8
- 5-Fluorouracil: 500 mg/m² IV D 1, 8
- Repeated every 28 days for 6 cycles
FEC-100 Protocol:
- 5-Fluorouracil: 500 mg/m²
- Epirubicin (Rubitor): 100 mg/m²
- Cyclophosphamide: 500 mg/m²
- All drugs administered intravenously on day 1
- Repeated every 21 days for 6 cycles
Patients receiving the higher 120-mg/m² regimen should also receive prophylactic antibiotic therapy to prevent potential complications.
Special Population Considerations
Dosage adjustments are necessary for certain patient populations:
Hematologic Toxicities:
- For nadir platelet counts <50,000/mm³, ANC <250/mm³, neutropenic fever, or Grades 3/4 nonhematologic toxicity, reduce subsequent cycle doses to 75% of the current cycle’s Day 1 dose.
- Delay treatment until platelet counts are ≥100,000/mm³, ANC ≥1500/mm³, and nonhematologic toxicities have recovered to ≤Grade 1.
Hepatic Impairment:
- For patients with bilirubin 1.2-3 mg/dL or AST 2-4 times upper limit of normal: administer 50% of recommended starting dose
- For patients with bilirubin >3 mg/dL or AST >4 times upper limit of normal: administer 25% of recommended starting dose
Renal Impairment:
- Lower doses recommended for patients with severe renal impairment (serum creatinine >5 mg/dL)
Geriatric Patients:
- Close monitoring for toxicity is particularly important in female patients ≥70 years of age
Drug Interactions
Healthcare providers should be aware of important drug interactions with Rubitor:
- Cardioactive Compounds: Close cardiac function monitoring required when used with calcium channel blockers and other medications that could cause heart failure
- Cimetidine: Increases Rubitor exposure; should be discontinued during Rubitor treatment
- Other Cytotoxic Drugs: May cause additive toxicity, especially hematologic and gastrointestinal effects
- Paclitaxel: Prior or subsequent administration increases systemic exposure to Rubitor and its metabolites
- Docetaxel: Prior or subsequent administration increases systemic exposure to Rubitorol and 7-deoxydoxorubicin aglycone
- Radiation Therapy: May induce inflammatory recall reaction at irradiation sites
Safety Profile and Contraindications
Rubitor is contraindicated in patients with known hypersensitivity to Epirubicin, other anthracyclines or anthracenediones, or any components of the formulation.
Common adverse effects include:
- Myelosuppression
- Cardiotoxicity
- Alopecia
- Hyperpyrexia
- Lethargy
- Amenorrhea
- Gastrointestinal disturbances (nausea, vomiting, diarrhea)
- Fever and rash
- Anorexia
- Harmless reddish discoloration of urine for 1-2 days
Pregnancy and Lactation
Rubitor carries Pregnancy Category D classification. There are no adequate well-controlled studies in pregnant women. Use during pregnancy only when potential benefits justify potential fetal risks. Since Epirubicin may be excreted in breast milk and cause serious adverse reactions in nursing infants, breastfeeding should be discontinued during therapy.
Quality Assurance
As a product of Eskayef Pharmaceuticals Ltd., one of Bangladesh’s leading pharmaceutical companies, Rubitor 10 mg maintains the highest quality standards. With over 31 years of experience, Eskayef has established itself as a producer of world-class medicines distributed globally by Saif Pharma since 2014.
Storage and Handling
Rubitor should be stored in a refrigerator at 2-8°C. Do not freeze. Protect from light and keep out of reach of children. If refrigerated solution forms a gel, it will return to a mobile solution after 2-4 hours at controlled room temperature (15-25°C). Always inspect for particulate matter and discoloration before administration.
Global Availability
Through Saif Pharma’s extensive distribution network, Rubitor 10 mg is available in over 60 countries worldwide, including the United States, Canada, Saudi Arabia, UAE, China, India, and Pakistan. Saif Pharma’s commitment to providing affordable, high-quality oncology medications ensures that patients globally can access this essential breast cancer treatment.
For more information about Rubitor 10 mg or other oncology medications, visit www.saifpharma.com or contact the manufacturer at www.skfbd.com.
