MARQIBO- vincristine sulfate kit

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

VINCRISTINE SULFATE (UNII: T5IRO3534A) (VINCRISTINE - UNII:5J49Q6B70F)

Dostupné z:

Acrotech Biopharma LLC

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Marqibo® is indicated for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti leukemia therapies. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Marqibo is contraindicated in patients with demyelinating conditions, including Charcot-Marie-Tooth syndrome. Marqibo is contraindicated in patients with hypersensitivity to vincristine sulfate or any of the other components of Marqibo (vinCRIStine sulfate LIPOSOME injection). Marqibo is contraindicated for intrathecal administration Risk Summary Based on findings from nonclinical studies and its mechanism of action, Marqibo can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1 ),

Prehľad produktov:

The Marqibo Kit (NDC # 72893-008-03) contains: The prepared liposome product should be administered within 12 hours of the initiation of Marqibo preparation. Store the Marqibo Kit in the refrigerator at 2°C to 8°C. Do Not Freeze Marqibo is a hazardous drug. Follow applicable special handling and disposal procedures.1

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

MARQIBO- VINCRISTINE SULFATE
ACROTECH BIOPHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MARQIBO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MARQIBO.
MARQIBO® (VINCRISTINE SULFATE LIPOSOME INJECTION), FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 2012
WARNING: FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
_ _MARQIBO IS FOR INTRAVENOUS USE ONLY AND IS FATAL IF GIVEN BY OTHER
ROUTES. DEATH HAS
OCCURRED WITH INTRATHECAL USE. (5.1)
MARQIBO (VINCRISTINE SULFATE LIPOSOME INJECTION) HAS DIFFERENT DOSAGE
RECOMMENDATIONS THAN VINCRISTINE SULFATE INJECTION. VERIFY DRUG NAME
AND DOSE
PRIOR TO PREPARATION AND ADMINISTRATION TO AVOID OVERDOSAGE. (2.1,
5.1)
INDICATIONS AND USAGE
Marqibo is a vinca alkaloid indicated for the treatment of adult
patients with Philadelphia chromosome-
negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater
relapse or whose disease has
progressed following two or more anti-leukemia therapies.
This indication is approved under accelerated approval based on
overall response rate. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory
trial(s).(1.1).
DOSAGE AND ADMINISTRATION
INTRAVENOUS USE ONLY. DO NOT ADMINISTER BY ANY OTHER ROUTE (2.1)
Administer Marqibo at a dose of 2.25 mg/m intravenously over 1 hour
once every 7 days (2.2)
DOSAGE FORMS AND STRENGTHS
Kit for Injection: After preparation, each single-dose vial of Marqibo
(vinCRIStine sulfate LIPOSOME
injection) contains 5 mg/31 mL (0.16 mg/mL) vincristine sulfate. (3)
CONTRAINDICATIONS
Demyelinating conditions including Charcot-Marie-Tooth syndrome (4)
Hypersensitivity to vincristine sulfate or any of the other components
of Marqibo (vinCRIStine sulfate
LIPOSOME injection) (4)
For intrathecal administration (4)
WARNINGS AND PRECAUTIONS
Extravasation Tissue Injury: Extravasation causes tissue