DOXIL- doxorubicin hydrochloride injection, suspension, liposomal

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

doxorubicin hydrochloride (UNII: 82F2G7BL4E) (doxorubicin - UNII:80168379AG)

제공처:

Janssen Products, LP

INN (국제 이름):

doxorubicin hydrochloride

구성:

doxorubicin hydrochloride 2 mg in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

DOXIL is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. DOXIL is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. DOXIL, 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. DOXIL 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, DOXIL can cause fetal harm when administered to a pregnant woman; avoid the use of DOXIL during the 1st trimester. In animal reproduction studies, DOXIL was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at dos

제품 요약:

DOXIL is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. The following individually cartoned vials are available: Refrigerate unopened vials of DOXIL at 2°C– 8°C (36°F– 46°F). Do not freeze. Discard unused portion. DOXIL is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

승인 상태:

New Drug Application

제품 특성 요약

DOXIL- DOXORUBICIN HYDROCHLORIDE INJECTION, SUSPENSION, LIPOSOMAL
JANSSEN PRODUCTS, LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXIL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DOXIL.
DOXIL (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._
DOXIL 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
DOXIL, 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
DOXIL FOR INFUSION-RELATED
REACTIONS AND RESUME AT A REDUCED RATE. DISCONTINUE DOXIL INFUSION FOR
SERIOUS OR LIFE-THREATENING
INFUSION-RELATED REACTIONS (5.2).
INDICATIONS AND USAGE
DOXIL is an anthracycline topoisomerase inhibitor indicated for:
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 DOXIL 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 to complete administration over 1
hour. Do not administer as bolus injection or undiluted
solution (2).
OVARIAN CANCER: 50 mg/m IV every 4 weeks (2.2)
AIDS-RELATED KAPOSI'S SARCOMA: 20 mg/m IV every 3 weeks (2.3)
MULTIPLE MYELOMA: 30 mg/m IV on day 4 following bortezomib (2.4)
DOSAGE FORMS AND STRENGTHS
Doxorubicin