DOXORUBICIN HYDROCHLORIDE injectable, liposomal

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Doxorubicin Hydrochloride (UNII: 82F2G7BL4E) (Doxorubicin - UNII:80168379AG)

Available from:

NorthStar RxLLC

INN (International Name):

Doxorubicin Hydrochloride

Composition:

Doxorubicin Hydrochloride 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials.   Each 10-mL vial contains 20 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL. Each 30-mL vial contains 50 mg doxorubicin hydrochloride, USP at a concentration of 2 mg/mL. The following individually cartoned vials are available: Table 14 Refrigerate unopened vials of doxorubicin hydrochloride liposome injection at 2°C to 8°C (36°F to 46°F). Do not freeze. Discard unused portion. Doxorubicin hydrochloride liposome injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTABLE,
LIPOSOMAL
NORTHSTAR RXLLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXORUBICIN
HYDROCHLORIDELIPOSOME INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DOXORUBICIN HYDROCHLORIDELIPOSOME
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 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,
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 FOR INFUSION-RELATED REACTIONS AND RESUME AT
A REDUCED
RATE. DISCONTINUE DOXORUBICIN HYDROCHLORIDE INFUSION FOR SERIOUS OR
LIFE-THREATENING
INFUSION-RELATED REACTIONS 5.2).
INDICATIONS AND USAGE
Doxorubicin hydrochloride liposome injection is an anthracycline
topoisomerase II 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.Doxorubicin hydrochloride is an
anthracycline topoisomerase inhibitor
indicated for: (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 o