Xorubin 2 mg/ml (IV Infusion)

Indications

• Adjuvant chemotherapy for axillary lymph node involvement following resection of primary breast cancer
• Treatment of acute lymphoblastic leukemia
• Treatment of acute myeloblastic leukemia
• Treatment of Hodgkin lymphoma
• Treatment of Non-Hodgkin lymphoma
• Treatment of metastatic breast cancer
• Treatment of metastatic Wilms' tumor
• Treatment of metastatic neuroblastoma
• Treatment of metastatic soft tissue sarcoma
• Treatment of metastatic bone sarcomas
• Treatment of metastatic ovarian carcinoma
• Treatment of metastatic transitional cell bladder carcinoma
• Treatment of metastatic thyroid carcinoma
• Treatment of metastatic gastric carcinoma
• Treatment of metastatic bronchogenic carcinoma

Pharmacology

• Cytotoxic anthracycline topoisomerase II inhibitor
• Nucleotide base intercalation
• Cell membrane lipid binding activities
• Inhibition of nucleotide replication
• Inhibition of DNA and RNA polymerases
• Formation of DNA-cleavable complexes

Dosage & Administration

• Single agent dosage: 60 to 75 mg/m2 intravenously every 21 days
• Combination therapy dosage: 40 to 75 mg/m2 intravenously every 21 to 28 days
• Administration through central intravenous line or peripheral venous line
• Intravenous infusion should be administered through a central catheter
• Management of suspected extravasation
• Incompatibility with other drugs

Interaction

• Substrate of cytochrome P450 CYP3A4 and CYP2D6
• Substrate of P-glycoprotein (P-gp)
• Concurrent use with inhibitors and inducers of CYP3A4, CYP2D6, or P-gp
• Concurrent use with Trastuzumab
• Concurrent use with Paclitaxel

Contraindications

• Severe myocardial insufficiency
• Recent myocardial infarction (within the past 4-6 weeks)
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment (Child Pugh Class C or serum bilirubin level >5 mg/dl)
• Severe hypersensitivity reaction to Doxorubicin HCl

Side Effects

• Alopecia
• Nausea
• Vomiting
• Cardiomyopathy
• Arrhythmias
• Secondary malignancies
• Extravasation and tissue necrosis
• Severe myelosuppression
• Tumor lysis syndrome
• Radiation sensitization
• Radiation recall

Pregnancy & Lactation

• Pregnancy Category D
• Potential fetal harm
• Recommendation for highly effective contraception
• Excretion in human milk

Use in Special Populations

• Pediatric use risk for late cardiovascular dysfunction
• Recommendation for long-term cardiovascular monitoring in pediatric patients
• No overall differences in safety and effectiveness in geriatric patients
• Reduced clearance in patients with elevated serum bilirubin levels

Overdose Effects

• Extension of pharmacological action
• Potential fatal doses of 250 mg and 500 mg
• Acute myocardial degeneration
• Severe myelosuppression
• Delayed cardiac failure

Therapeutic Class

• Cytotoxic Chemotherapy

Reconstitution

• Preparation for Administration with specific solutions
• Protection from light during infusion
• Precautions during handling and disposal

Storage Conditions

• Storage at 2°C-8°C temperature
• Protection from light
• Avoid freezing
• Keep out of the reach of children

Related Brands

• Doxorub 2 mg/ml (IV Infusion) - techno-drugs-ltd
• Doxorubicin SDZ 2 mg/ml (IV Infusion) - sandoz-a-novartis-division