DOXORUBICIN HYDROCHLORIDE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)

Available from:

Mylan Institutional LLC

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxorubicin hydrochloride, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14)]. Doxorubicin hydrochloride, USP is indicated for the treatment of Doxorubicin hydrochloride is contraindicated in patients with: Pregnancy Category D Doxorubicin hydrochloride can cause fetal harm when administered to a pregnant woman. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and rabbits at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. Doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats. Tera

Product summary:

Doxorubicin Hydrochloride for Injection, USP is supplied as a sterile red-orange lyophilized powder for intravenous use only, is available in single dose flip-top vials in the following package strengths: NDC 67457-478-10: 10 mg vial; individually boxed. NDC 67457-436-50: 50 mg vial; individually boxed. Store unreconstituted vial at controlled room temperature, between 20°C to 25°C (68°F to 77°F). [See USP.] Protect vials from light. Retain in carton until time of use. Discard unused portion. Reconstituted Solution Stability After adding the diluent, the vial should be shaken and the contents allowed to dissolve. The reconstituted solution is stable for 7 days at room temperature and under normal room light (100 foot-candles) and 15 days under refrigeration (2° to 8°C). It should be protected from exposure to sunlight. Discard any unused solution from the 10 mg and 50 mg single dose vials. Handling and Disposal Handle and dispose of Doxorubicin Hydrochloride for Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs.1  

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXORUBICIN HYDROCHLORIDE FOR INJECTION,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DOXORUBICIN HYDROCHLORIDE FOR INJECTION, USP.
DOXORUBICIN HYDROCHLORIDE FOR INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1974
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND
TISSUE
NECROSIS, AND SEVERE MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE Doxorubicin hydrochloride, USP is an anthracycline topoisomerase II
inhibitor indicated:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
CARDIOMYOPATHY: MYOCARDIAL DAMAGE CAN OCCUR WITH DOXORUBICIN
HYDROCHLORIDE WITH INCIDENCES
FROM 1% TO 20% FOR CUMULATIVE DOSES FROM 300 MG/M TO 500 MG/M WHEN
DOXORUBICIN
HYDROCHLORIDE IS ADMINISTERED EVERY 3 WEEKS. THE RISK OF
CARDIOMYOPATHY IS FURTHER INCREASED WITH
CONCOMITANT CARDIOTOXIC THERAPY. ASSESS LEFT VENTRICULAR EJECTION
FRACTION (LVEF) BEFORE AND
REGULARLY DURING AND AFTER TREATMENT WITH DOXORUBICIN HYDROCHLORIDE.
(5.1).
2
2
SECONDARY MALIGNANCIES: SECONDARY ACUTE MYELOGENOUS LEUKEMIA (AML) AND
MYELODYSPLASTIC
SYNDROME (MDS) OCCUR AT A HIGHER INCIDENCE IN PATIENTS TREATED WITH
ANTHRACYCLINES, INCLUDING
DOXORUBICIN HYDROCHLORIDE. (5.2).
EXTRAVASATION AND TISSUE NECROSIS: EXTRAVASATION OF DOXORUBICIN
HYDROCHLORIDE CAN RESULT IN SEVERE
LOCAL TISSUE INJURY AND NECROSIS REQUIRING WIDE EXCISION AND SKIN
GRAFTING. IMMEDIATELY TERMINATE THE
DRUG, AND APPLY ICE TO THE AFFECTED AREA. (5.3).
SEVERE MYELOSUPPRESSION RESULTING IN SERIOUS INFECTION, SEPTIC SHOCK,
REQUIREMENT FOR TRANSFUSIONS,
HOSPITALIZATION, AND DEATH MAY OCCUR. (5.4).
as a component of multiagent adjuvant chemotherapy for treatment of
w