Adribin 2 mg/ml (IV Infusion)

Indications

• Treatment of primary breast cancer 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
• Nucleotide base intercalation
• Cell membrane lipid binding activities
• Inhibition of nucleotide replication
• Interaction with topoisomerase II to form 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 secure peripheral venous line
• Discontinuation and dose reduction based on cardiomyopathy and hepatic impairment
• Management of suspected extravasation

Interaction

• Substrate of cytochrome P450 CYP3A4 and CYP2D6
• Substrate of P-glycoprotein (P-gp)
• Avoid concurrent use with inhibitors and inducers of CYP3A4, CYP2D6, or P-gp
• Increased risk of cardiac dysfunction with concurrent use of Trastuzumab
• Increased plasma concentrations when used concomitantly 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 including anaphylaxis

Side Effects

• Adverse reactions: alopecia, nausea, vomiting, cardiomyopathy, arrhythmias, secondary malignancies, extravasation, tissue necrosis, severe myelosuppression, tumor lysis syndrome, radiation sensitization, radiation recall

Pregnancy & Lactation

• Pregnancy Category D
• Potential fetal harm
• Use of highly effective contraception during treatment
• Excretion in human milk
• Consideration for discontinuation of nursing

Use in Special Populations

• Pediatric use: Risk for developing late cardiovascular dysfunction
• Periodic cardiovascular monitoring for pediatric patients
• No significant differences in safety and effectiveness for geriatric patients
• Reduction of dose in hepatic impaired patients with elevated serum bilirubin levels

Overdose Effects

• Symptoms likely to be an extension of pharmacological action
• Fatal doses of 250 mg and 500 mg
• Acute myocardial degeneration
• Severe myelosuppression
• Delayed cardiac failure
• Supportive treatment and observation

Therapeutic Class

• Cytotoxic Chemotherapy

Reconstitution

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

Storage Conditions

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

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