Zuvidox 50mg(Doxorubicin Hydrochloride Injection)

ProductName : Zuvidox 50mg

GenericName : Doxorubicin Hydrochloride Injection

Manufacturer: Zuvius

Doxorubicin Hydrochloride Injection, USP is a clear, red,sterile, isotonic aqueous solution provided in vials containing 10 mg/5 mL, 20mg/10 mL, 50 mg/25 mL, 150 mg/75 mL, or 200 mg/100 mL of doxorubicin HCl. Thedrug product has demonstrated inherent antimicrobial activitysuitable for a multiple dose presentation. Each milliliter of solution contains2 mg of doxorubicin HCl. Inactive ingredients include sodium chloride 0.9%,USP, and water for injection, USP, quantity sufficient. The pH of the solutionis adjusted to 3.0 with hydrochloric acid, USP.

DOSAGE AND ADMINISTRATION

RecommendedDose

AdjuvantBreast Cancer

Therecommended dose of doxorubicin HCl is 60 mg/m administered as an intravenousbolus on day 1 of each 21-day treatment cycle, in combination withcyclophosphamide, for a total of four cycles [see Clinical Studies].

MetastaticDisease, Leukemia, Or Lymphoma

• The recommended dose of doxorubicin HCl when used as a single agent is 60 to 75 mg/m intravenously every 21 days.
• The recommended dose of doxorubicin HCl, when administered in combination with other chemotherapydrugs, is 40 to 75 mg/m² intravenously every 21 to 28 days.
• Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.

PreparationAnd Administration

PreparationOf Doxorubicin HCl For injection

Reconstitutedoxorubicin hydrochloride for injection with 0.9% Sodium Chloride Injection,USP to obtain a final concentration of 2 mg per mL as follows:

• 5 mL 0.9% Sodium Chloride Injection, USP to reconstitute 10 mg doxorubicin HCl vial
• 10 mL 0.9% Sodium Chloride Injection, USP to reconstitute 20 mg doxorubicin HCl vial

SIDEEFFECTS

Thefollowing adverse reactions are discussed in more detail in other sections ofthe labeling.

• Cardiomyopathy and Arrhythmias [see WARNINGS AND PRECAUTIONS]
• Secondary Malignancies [see WARNINGS AND PRECAUTIONS]
• Extravasation and Tissue Necrosis [see WARNINGS AND PRECAUTIONS]
• Severe Myelosuppression [see WARNINGS AND PRECAUTIONS]

PRECAUTIONS

Cardiomyopathy And Arrhythmias

Cardiomyopathy

DoxorubicinHCl can result in myocardial damage, including acuteleft ventricular failure. The risk of cardiomyopathy isgenerally proportional to the cumulative exposure. Include prior doses of otheranthracyclines or anthracenediones in calculations of total cumulative dosagefor doxorubicin HCl. Cardiomyopathy may develop during treatment or up toseveral years after completion of treatment and can include decrease in LVEFand signs and symptoms of congestive heart failure (CHF).