Doxorub 2 mg/ml (IV Infusion)

Indications

• Component of multiagent adjuvant chemotherapy for women with axillary lymph node involvement
• 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
• Cytotoxic effect on malignant cells
• Toxic effects on various organs
• Nucleotide base intercalation
• Cell membrane lipid binding activities
• Inhibition of nucleotide replication
• Action of DNA and RNA polymerases
• Formation of DNA-cleavable complexes

Dosage & Administration

• Single agent dosage of 60 to 75 mg/m2 every 21 days
• Combination therapy dosage of 40 to 75 mg/m2 every 21 to 28 days
• Administration via intravenous injection or infusion
• Special management for suspected extravasation
• Incompatibility with other drugs
• Discontinuation and dose reduction in specific conditions

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 and Paclitaxel

Contraindications

• Severe myocardial insufficiency
• Recent myocardial infarction
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment
• Severe hypersensitivity reaction to Doxorubicin HCl

Side Effects

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

Pregnancy & Lactation

• Pregnancy Category D
• Potential fetal harm
• Need for effective contraception during treatment
• Potential excretion in human milk

Use in Special Populations

• Pediatric use risks and monitoring
• Geriatric use safety and effectiveness
• Dose adjustment in hepatic impaired patients

Overdose Effects

• Extension of pharmacological action
• Acute myocardial degeneration
• Severe myelosuppression
• Delayed cardiac failure

Therapeutic Class

• Cytotoxic Chemotherapy

Reconstitution

• Preparation with specific injection solutions
• Protection from light
• Visual inspection prior to administration
• Precautions during handling and disposal

Storage Conditions

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

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