DOXORUBICIN HYDROCHLORIDE injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Gland Pharma Limited

INN (Διεθνής Όνομα):

DOXORUBICIN HYDROCHLORIDE

Σύνθεση:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Doxorubicin Hydrochloride Injection, USP is supplied as follows: Protect from light. Retain in carton until time of use. Discard unused portion. Protect from light. Retain in carton until contents are used.  Doxorubicin Hydrochloride Injection, USP is a sterile parenteral, as a clear red isotonic solution, available in clear flip-top glass vials. Storage Conditions Store refrigerated between 2° and 8°C (36° and 46°F).   Storage of Doxorubicin Hydrochloride Injection 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 is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DOXORUBICIN HYDROCHLORIDE - DOXORUBICIN HYDROCHLORIDE INJECTION,
SOLUTION
GLAND PHARMA LIMITED
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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 lymph