DEFITELIO- defibrotide sodium injection, solution

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

DEFIBROTIDE SODIUM (UNII: L7CHH2B2J0) (DEFIBROTIDE FREE ACID - UNII:568FY5I1YI)

থেকে পাওয়া:

Jazz Pharmaceuticals, Inc.

INN (International Name):

DEFIBROTIDE SODIUM

রচনা:

DEFIBROTIDE SODIUM 80 mg in 1 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). The use of DEFITELIO is contraindicated in the following conditions: Risk Summary There are no available data on DEFITELIO use in pregnant women. When administered to pregnant rabbits during the period of organogenesis at doses that were comparable to the recommended human dose based on body surface area, defibrotide sodium decreased the number of implantations and viable fetuses. Advise pregnant women of the potential risk of miscarriage. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Animal Data Embryo-Fetal tox

পণ্য সারাংশ:

DEFITELIO (defibrotide sodium) injection is supplied in a single-patient-use, clear glass vial as a clear, light yellow to brown, sterile, preservative-free solution for intravenous infusion. Each vial (NDC 68727-800-01) contains 200 mg/2.5 mL (at a concentration of 80 mg/mL) of defibrotide sodium. Each carton of DEFITELIO (defibrotide sodium) injection (NDC 68727-800-02) contains 10 vials. Store DEFITELIO (defibrotide sodium) injection at 20°C-25°C (68°F-77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) (see USP controlled room temperature).

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

DEFITELIO- DEFIBROTIDE SODIUM INJECTION, SOLUTION
JAZZ PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEFITELIO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEFITELIO.
DEFITELIO (DEFIBROTIDE SODIUM) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
DEFITELIO is indicated for the treatment of adult and pediatric
patients with hepatic veno-occlusive disease
(VOD), also known as sinusoidal obstruction syndrome (SOS), with renal
or pulmonary dysfunction
following hematopoietic stem-cell transplantation (HSCT). (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/2.5 mL (80 mg/mL) in a single-patient-use vial. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥10% and independent of
causality) with DEFITELIO
treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JAZZ PHARMACEUTICALS,
INC. AT 1-800-
520-5568 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
2.3 Treatment Modification
2.4 Preparation Instructions
3 DOSAGE FORMS AND STRENGTHS
Administer DEFITELIO 6.25 mg/kg every 6 hours given as a 2-hour
intravenous infusion. (2.1)
Treat for a minimum of 21 days. If after 21 days signs and symptoms of
VOD have not resolved,
continue treatment until resolution. (2.1)
Concomitant administration with systemic anticoagulant or fibrinolytic
therapy. (4)
Known hypersensitivity to DEFITELIO or to any of its excipients. (4)
Hemorrhage: Monitor patients for bleeding. Withhold or discontinue
DEFITELIO if significant bleeding
occurs. (2.3, 5.1)
Hypersensitivity Reactions: If severe or life threaten