ADRIAMYCIN- 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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DOXORUBICIN HYDROCHLORIDE

Composition:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adriamycin (DOXOrubicin HCl) Injection, USP and Adriamycin (DOXOrubicin HCl) for 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 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 Doxorubicin 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 [see Warnings and Precautions (5.4)] - Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level gr

Product summary:

Adriamycin (DOXOrubicin HCI) Injection, USP is supplied in single-dose, fl ip-top vials, as a red-orange solution containing Doxorubicin Hydrochloride, USP 2 mg/mL in the following package strengths: NDC 0143-9549-01 : 10 mg in 5 mL; individually boxed. NDC 0143-9548-01 : 20 mg in 10 mL; individually boxed. NDC 0143-9547-01 : 50 mg in 25 mL; individually boxed. Store refrigerated, 2° to 8°C (36° to 46°F). Protect from light. Retain in carton until time of use. Discard unused portion. Adriamycin (DOXOrubicin HCI) Injection, USP is supplied in a sterile, multiple dose, flip-top vial, as a red-orange solution containing Doxorubicin Hydrochloride, USP 2 mg/mL in the following package strength: NDC 0143-9546-01 : 200 mg in 100 mL; individually boxed. Store refrigerated, 2° to 8°C (36° to 46°F). Protect from light. Retain in carton until contents are used. Storage of vials of Adriamycin (DOXOrubicin HCl) Injection, USP following reconstitution 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 Adriamycin (DOXOrubicin HCl) Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADRIAMYCIN- DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADRIAMYCIN
(DOXORUBICIN HCL) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ADRIAMYCIN
(DOXORUBICIN HCL).
ADRIAMYCIN (DOXORUBICIN HCL) 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 WITH
INCIDENCES
FROM 1% TO 20% FOR CUMULATIVE DOSES FROM 300 MG/M TO 500 MG/M WHEN
DOXORUBICIN 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. (5.2)
EXTRAVASATION AND TISSUE NECROSIS: EXTRAVASATION OF DOXORUBICIN 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 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 cancer, metastatic Wilms’
tumor, metastatic
neuroblastoma, metastatic soft tissue s