Arodoxin 2 mg/ml (IV Infusion)

Indications

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

Pharmacology

• Cytotoxic anthracycline topoisomerase II inhibitor
• Nucleotide base intercalation and cell membrane lipid binding activities

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 or peripheral venous line
• Recommended discontinuation and dose reduction in certain medical conditions
• Management of suspected extravasation

Interaction

• Arodoxin is a major substrate of cytochrome P450 CYP3A4 and CYP2D6, and P-glycoprotein (P-gp)
• Avoid concurrent use with inhibitors and inducers of CYP3A4, CYP2D6, or P-gp
• Concurrent use of Trastuzumab and Arodoxin HCl increases risk of cardiac dysfunction
• Administer Arodoxin HCl prior to Paclitaxel if used concomitantly

Contraindications

• Severe myocardial insufficiency
• Recent (occurring within the past 4-6 weeks) myocardial infarction
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment
• Severe hypersensitivity reaction to Doxorubicin HCl

Side Effects

• Common adverse drug reactions include alopecia, nausea, and vomiting
• Other adverse reactions such as cardiomyopathy, arrhythmias, secondary malignancies, extravasation and tissue necrosis, myelosuppression, tumor lysis syndrome, radiation sensitization, and radiation recall

Pregnancy & Lactation

• Pregnancy Category D
• Potential fetal harm
• Need for highly effective contraception during treatment and for 6 months after
• Excretion in human milk

Use in Special Populations

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

Overdose Effects

• Symptoms likely to be an extension of Arodoxin's pharmacological action
• Single doses of 250 mg and 500 mg proven to be fatal
• Acute myocardial degeneration and severe myelosuppression
• Delayed cardiac failure

Therapeutic Class

• Cytotoxic Chemotherapy

Reconstitution

• Preparation with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP
• Visual inspection prior to administration
• Proper handling and disposal of anticancer drugs
• Caution during handling to minimize dermal exposure

Storage Conditions

• Store in a dry place at 2°-8°C temperature
• Protect from light and do not freeze
• Keep out of the reach of children

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