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:

Teva Parenteral Medicines, 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 component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14.1)]. Doxorubicin Hydrochloride Injection USP is indicated for the treatment of - acute lymphoblastic leukemia - acute myeloblastic leukemia - Hodgkin lymphoma - non-Hodgkin lymphoma (NHL) - metastatic breast cancer - metastatic Wilms’ tumor - metastatic neuroblastoma - metastatic soft tissue sarcoma - metastatic bone sarcoma - metastatic ovarian carcinoma - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma Doxorubicin HCl 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 (5.1)] - Severe persistent drug-induced myelosuppression

Product summary:

Doxorubicin Hydrochloride Injection USP is a sterile parenteral, isotonic solution, available as follows: Contains no preservative. For the sterile single dose vials: Store under refrigeration between 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT AND RETAIN IN CARTON UNTIL TIME OF USE. Discard unused portion. For the sterile multiple dose vial: Store under refrigeration between 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT AND RETAIN IN CARTON UNTIL CONTENTS ARE USED. Storage of Doxorubicin Hydrochloride Injection USP 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 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,
SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXORUBICIN HYDROCHLORIDE INJECTION
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DOXORUBICIN HYDROCHLORIDE INJECTION USP.
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 HCL WITH
INCIDENCES FROM 1% TO
20% FOR CUMULATIVE DOSES FROM 300 MG/M TO 500 MG/M WHEN DOXORUBICIN
HCL 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 HCL. (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 HCL. (5.2)
EXTRAVASATION AND TISSUE NECROSIS: EXTRAVASATION OF DOXORUBICIN HCL
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) Injection USP is an anthracycline
topoisomerase II inhibitor indicated:
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
lymphoma, metastatic breast c