DOXORUBICIN HYDROCHLORIDE injectable, liposomal

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

اشتر الآن

تأكيد الحساب خصائص المنتج (SPC)
30-06-2022

العنصر النشط:

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

متاح من:

Sun Pharmaceutical Industries, 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 liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. Doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions (5.2)]. Risk Summary Based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the

ملخص المنتج:

Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10 mL or 25 mL glass, single-dose vials. The following individually cartoned vials are available: Refrigerate unopened vials of doxorubicin hydrochloride liposome injection at 2° to 8°C (36° to 46°F). Do not freeze. Discard unused portion. Doxorubicin hydrochloride liposome injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1 .

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

                                DOXORUBICIN HYDROCHLORIDE - DOXORUBICIN HYDROCHLORIDE INJECTABLE,
LIPOSOMAL
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXORUBICIN
HYDROCHLORIDE LIPOSOME INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION.
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION,
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
WARNING: CARDIOMYOPATHY AND INFUSION-RELATED REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION CAN CAUSE MYOCARDIAL
DAMAGE,
INCLUDING ACUTE LEFT VENTRICULAR FAILURE. THE RISK OF CARDIOMYOPATHY
WAS 11% WHEN
THE CUMULATIVE ANTHRACYCLINE DOSE WAS BETWEEN 450 MG/M TO 550 MG/M .
ASSESS
LEFT VENTRICULAR CARDIAC FUNCTION PRIOR TO INITIATION OF DOXORUBICIN
HYDROCHLORIDE
LIPOSOME INJECTION, DURING TREATMENT, AND AFTER TREATMENT (5.1).
SERIOUS, LIFE-THREATENING, AND FATAL INFUSION-RELATED REACTIONS CAN
OCCUR. ACUTE
INFUSION-RELATED REACTIONS OCCURRED IN 11% OF PATIENTS WITH SOLID
TUMORS. WITHHOLD
DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION FOR INFUSION-RELATED
REACTIONS AND
RESUME AT A REDUCED RATE. DISCONTINUE DOXORUBICIN HYDROCHLORIDE
LIPOSOME INJECTION
INFUSION FOR SERIOUS OR LIFE-THREATENING INFUSION-RELATED REACTIONS
(5.2).
INDICATIONS AND USAGE
Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor
indicated for: (1)
OVARIAN CANCER: After failure of platinum-based chemotherapy (1.1).
AIDS-RELATED KAPOSI’S SARCOMA: After failure of prior systemic
chemotherapy or intolerance to
such therapy (1.2).
MULTIPLE MYELOMA: In combination with bortezomib in patients who have
not previously received
bortezomib and have received at least one prior therapy (1.3).
DOSAGE AND ADMINISTRATION
Administer doxorubicin hydrochloride liposome injection at an initial
rate of 1 mg/min to minimize the risk
of infusion reactions. If no infusion related reactions occur,
increase rate of infusion 
                                
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