Doxorubicin PhaRes 2 mg/ml (IV Infusion)

Indications

• Adjuvant chemotherapy for 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
• Inhibition of nucleotide replication
• Inhibition of DNA and RNA polymerases
• Formation of DNA-cleavable complexes

Dosage & Administration

• Single agent dosage: 60-75 mg/m2 intravenously every 21 days
• Combination therapy dosage: 40-75 mg/m2 intravenously every 21-28 days
• Administration through central intravenous line
• Free-flowing peripheral venous line
• Administration over 3-10 minutes
• Intravenous infusion through central catheter
• Management of suspected extravasation
• Incompatibility with other drugs

Interaction

• Substrate of CYP3A4 and CYP2D6
• Substrate of P-glycoprotein (P-gp)
• Avoid concurrent use with inhibitors
• Avoid concurrent use with inducers
• Avoid concurrent administration with Trastuzumab
• Interaction with Paclitaxel

Contraindications

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

Side Effects

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

Pregnancy & Lactation

• Pregnancy Category D
• Potential fetal harm
• Use of contraception during treatment
• Excretion in human milk
• Serious adverse reactions in nursing infants

Use in Special Populations

• Pediatric use: Risk of late cardiovascular dysfunction
• Pediatric patients need long-term cardiovascular monitoring
• No overall differences in safety and effectiveness in geriatric use
• Reduced clearance in patients with elevated serum bilirubin levels

Overdose Effects

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

Therapeutic Class

• Cytotoxic Chemotherapy

Reconstitution

• Preparation for Administration with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP
• Protection from light following preparation
• Visual inspection prior to administration
• Proper handling and disposal procedures
• Caution in handling solution
• Use of impervious gloves

Storage Conditions

• Store at 2°C to 8°C temperature
• Protection from light
• No freezing
• Keep out of reach of children

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