DOXORUBICIN HYDROCHLORIDE injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Pfizer Laboratories Div Pfizer Inc

INN (الاسم الدولي):

DOXORUBICIN HYDROCHLORIDE

تركيب:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Doxorubicin Hydrochloride Injection 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. Doxorubicin Hydrochloride Injection is indicated for the treatment of Doxorubicin Hydrochloride Injection are contraindicated in patients with: Risk Summary Based on findings in animals and its mechanism of action, Doxorubicin Hydrochloride Injection can cause fetal harm when administered to a pregnant woman; avoid the use of Doxorubicin Hydrochloride Injection during the 1st trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2nd and 3rd trimesters. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 (see

ملخص المنتج:

Doxorubicin Hydrochloride Injection Doxorubicin Hydrochloride Injection is a sterile, isotonic solution, available in polypropylene (CYTOSAFE)® vials in single vial packs as: Retain in carton until time of use. Discard unused portion. Retain in carton until contents are used. Storage Store all vials at 2° to 8°C (36° to 46°F). Protect from light. Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15° to 30°C (59° to 86°F)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Handling and Disposal Doxorubicin Hydrochloride Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

الوضع إذن:

New Drug Application

خصائص المنتج

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
PFIZER LABORATORIES DIV PFIZER 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.
DOXORUBICIN HYDROCHLORIDE INJECTION, 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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RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.8)
12/2019
INDICATIONS AND USAGE
Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase
inhibitor indicated:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection:
CARDIOMYOPATHY: MYOCARDIAL DAMAGE CAN OCCUR WITH DOXORUBICIN
HYDROCHLORIDE
WITH INCIDENCES FROM 1% – 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
women with axillary lymph
node invo