TOTECT- dexrazoxane hydrochloride injection, powder, lyophilized, for solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)

Disponibil de la:

Cumberland Pharmaceuticals Inc.

INN (nume internaţional):

DEXRAZOXANE HYDROCHLORIDE

Compoziție:

DEXRAZOXANE 500 mg

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. None. Risk Summary Based on findings from animal studies and its mechanism of action, Totect can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . Limited available data with Totect use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at maternal doses that were approximately 0.1 and 0.2 times, respectively, the human dose of 1000 mg/m². Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of ma

Rezumat produs:

Each Totect carton contains 1 single dose vial of Totect (dexrazoxane for injection) 500 mg as a sterile, pyrogen-free lyophilized powder. NDC 66220-110-01: Carton of 1 vial of Totect Store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from light. Keep vial in carton until ready for use. Follow special handling and disposal procedures [see Dosage and Administration (2.3)] .1

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

TOTECT- DEXRAZOXANE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
CUMBERLAND PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOTECT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TOTECT.
T O TE C T (DEXRAZOXANE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
Dosage and Administration (2.3) 11/2018
Warnings and Precautions (5.1) 02/2018
Warnings and Precautions (5.2) 02/2018
Warnings and Precautions (5.3) 02/2018
INDICATIONS AND USAGE
Totect is a cytoprotective agent indicated for the treatment of
extravasation resulting from intravenous anthracycline
chemotherapy. (1)
DOSAGE AND ADMINISTRATION
Reconstitute and further dilute Totect before use. (2.3)
Administer Totect by intravenous infusion over 1 to 2 hours once daily
for 3 consecutive days. (2.1, 2.4)
Initiate the first infusion as soon as possible and within the first
six hours after extravasation. (2.1)
Recommended doseMaximum daily dose
Day one: 1000 mg/m 2000 mg
Day two: 1000 mg/m 2000 mg
Day three: 500 mg/m 1000 mg
Reduce dose by 50% for patients with creatinine clearance < 40 mL/min.
(2.2)
DOSAGE FORMS AND STRENGTHS
For Injection: 500 mg as a sterile, pyrogen-free lyophilized powder in
a single dose vial for reconstitution. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Myelosuppression: Dexrazoxane is associated with leukopenia,
neutropenia, and thrombocytopenia. Perform
hematological monitoring. (5.1)
Anaphylactic/Hypersensitivity Reactions: Monitor for signs and
symptoms. Permanent treatment discontinuation
should be considered for severe hypersensitivity reactions. (5.2)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of
reproductive potential of the risk to a fetus and to use
effective contraception (5.3, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse reactions (≥15%) are nausea, pyrexia,
injection site pain, vomiting, and postoperative infection.
(6.1)
TO REPORT SUSPECTE