DOXORUBICIN HYDROCHLORIDE injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Actavis Pharma, Inc.

INN (Tên quốc tế):

DOXORUBICIN HYDROCHLORIDE

Thành phần:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 - 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 - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma Doxorubicin Hydrochloride Injection 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

Tóm tắt sản phẩm:

Doxorubicin Hydrochloride Injection, USP is supplied in flip-top vials, as a clear, red solution containing doxorubicin hydrochloride USP, 2 mg/mL in the following package strengths: Single-Dose Vials NDC 45963-733-55: 10 mg/5 mL (2 mg/mL) NDC 45963-733-57: 20 mg/10 mL (2 mg/mL) NDC 45963-733-68: 50 mg/25 mL (2 mg/mL) Multiple-Dose Vial NDC 45963-733-60: 200 mg/100 mL (2 mg/mL) For the single dose vials: Store under refrigeration between 2° to 8°C (36° to 46°F). Protect from light. Retain in carton until time of use. Discard unused portion. For the multiple-dose vial: Store under refrigeration between 2° to 8°C (36° to 46°F). Protect from light. Retain in carton until contents are used. Storage Storage of Doxorubicin Hydrochloride Injection, USP 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 Doxorubicin Hydrochloride Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made with natural rubber latex.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
ACTAVIS PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXORUBICIN
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DOXORUBICIN HYDROCHLORIDE INJECTION.
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._
CARDIOMYOPATHY: MYOCARDIAL DAMAGE CAN OCCUR WITH DOXORUBICIN
HYDROCHLORIDE WITH
INCIDENCES FROM 1% TO 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)
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)
INDICATIONS AND USAGE
Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase
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, me