DOXORUBICIN HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DOXOrubicin hydrochloride injection, USP is indicated as a c omponent of multi-a gent adjuvant chemotherapy for treat ment of wo men with axillary lymph node involve ment following resection of pri mary breast cancer [see Clinical Studies (14.1 ) ]. DOXOrubicin hydrochloride injection, USP is indicated for the treat ment of - acute ly mphoblastic leu ke mia - acute m yeloblastic leuke mia - Hodgkin lympho ma - non-Hodgkin ly mpho ma (NHL) - metastatic breast cancer - metastatic Wil ms’ tumor - metastatic neurobla stoma - metastatic s oft tissue sa rco ma - metastatic bone sarco ma - metastatic o varian car cino ma - metastatic t ransitional c ell bladder carcino ma - metastatic t hyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma Doxorubicin hydrochloride is contraindicated in patients with: - Severe myocardial insufficiency [see Warnings and Precautions (5.1)] - Recent (occurring within the past 4 to 6 weeks) myocardial infarction [see Warnings and Precautions

Product summary:

DOXOrubicin hydrochloride injection, USP is supplied in single-dose, colorless molded vial, with teflon coated gray chlorobutyl rubber stopper sealed with light blue flip-off aluminum seal, as a red-orange solution containing doxorubicin hydrochloride, USP 2 mg/mL in the following package strength: NDC 62756-826-40: 50 mg in a 25 mL vial; individually boxed. Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect from light. Retain in carton until time of use. Contains no preservative. Discard unused portion. DOXOrubicin hydrochloride injection, USP is supplied in a sterile, multiple dose, colorless molded vial with gray chlorobutyl rubber stopper sealed with light blue flip-off aluminum seal, as a red-orange solution containing doxorubicin hydrochloride, USP 2 mg/mL in the following package strength: NDC 62756-827-40: 200 mg in a 100 mL vial; individually boxed. Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect from light. Retain in carton until contents are used. Contains no preservative. Storage of doxorubicin hydrochloride injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Handling and Disposal Handle and dispose of doxorubicin hydrochloride injection 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,
SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXORUBICIN
HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR DOXORUBICIN
HYDROCHLORIDE INJECTION.
DOXORUBICIN HYDROCHLORIDE 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._
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)
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)
INDICATIONS AND USAGE
Doxorubicin hydrochloride (HCl) is an anthracycline topoisomerase II
inhibitor indicated: (1)
as a component of multiagent adjuvant chemotherapy for treatment of
women with axillary lymph node
involvement following resection of primary breast cancer (1.1).
for the treatment of: acute lymphoblastic leukemia, acute myeloblastic
leukemia, Hodgkin lymphoma,
Non-Hodgkin ly