Rubitor 2 mg/ml (IV Infusion)

Therapeutic Class

• Cytotoxic Chemotherapy

Indications

• Component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Pharmacology

• Anthracycline with cytotoxic properties
• Inhibits DNA and RNA synthesis
• Generates cytotoxic free radicals
• Distribution into tissues
• Metabolized by the liver
• Eliminated through biliary and urinary excretion
• Terminal elimination half-life is 30-40 hrs

Dosage & Administration

• Administered by intravenous infusion
• Given in repeated 3-to 4-week cycles
• Total dose may be given on day 1 or divided and given on days 1 and 8 of each cycle
• Recommended dose is 100 to 120 mg/m²
• Specific regimens recommended
• Prophylactic antibiotic therapy recommended for certain regimen

Interaction

• Close monitoring with concomitant use of cardioactive compounds
• Cimetidine increases exposure
• Additive toxicity with other cytotoxic drugs
• Increased systemic exposure with Paclitaxel and Docetaxel
• Inflammatory recall reaction with previous radiation therapy
• Metabolism affected by concomitant therapies

Contraindications

• Known hypersensitivity to Epirubicin or other anthracyclines or anthracenediones or any other components

Side Effects

• Myelosuppression
• Cardiotoxicity
• Alopecia
• Nausea
• Vomiting
• Diarrhea
• Fever
• Rash
• Anorexia
• Harmless reddish appearance of urine for 1-2 days

Pregnancy & Lactation

• Pregnancy Category D
• No adequate and well-controlled studies in pregnant women
• Potential risk to the fetus
• Potential serious adverse reactions in nursing infants

Precautions & Warnings

• Gelling when stored at refrigerated conditions
• Careful visual inspection prior to administration
• Administration under supervision of qualified physicians
• Recovery from acute toxicities of prior cytotoxic treatment before beginning Rubitor
• Baseline assessment of blood counts, serum levels, and cardiac function
• Monitoring for myelosuppression and cardiotoxicity

Use in Special Populations

• Dosage adjustments based on toxicities within a cycle of treatment
• Considerations for bone marrow dysfunction, hepatic impairment, renal impairment, pediatric use, and geriatric use

Overdose Effects

• Supportive treatment if overdose occurs
• Observation for delayed CHF

Storage Conditions

• Store in refrigerator or at 2-8°C
• Do not freeze
• Protect from light
• Keep out of the reach of children

Related Brands

• Epirubin 2 mg/ml (IV Infusion) - healthcare-pharmaceuticals-ltd