KENGREAL- cangrelor injection, powder, lyophilized, for solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CANGRELOR (UNII: 6AQ1Y404U7) (CANGRELOR - UNII:6AQ1Y404U7)

Disponible desde:

Chiesi USA, Inc.

Designación común internacional (DCI):

CANGRELOR

Composición:

CANGRELOR 50 mg

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

KENGREAL is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor [see Clinical Studies ( 14.1 )]. KENGREAL is contraindicated in patients with significant active bleeding [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product [see Adverse Reactions ( 6.1 )] . Risk Summary There are no available data on cangrelor use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Untreated myocardial infarction can be fatal to the pregnant women and fetus (see Clinical Considerations ). In animal reproduction studies, continuous inf

Resumen del producto:

KENGREAL is supplied as a sterile lyophilized powder in single-use 10 mL vials. Vials of KENGREAL should be stored at USP Controlled Room Temperature, [20°C to 25°C (68°F to 77°F) with excursions between 15°C and 30°C (59°F and 86°F) permitted]. KENGREAL® is a registered trademeark of Chiesi Farmaceutici S.p.A. Distributed by: Chiesi USA, Inc. Cary, NC  27518 CTK-001-0720-01-SPL-1

Estado de Autorización:

New Drug Application

Ficha técnica

KENGREAL- CANGRELOR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CHIESI USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KENGREAL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KENGREAL.
KENGREAL
(CANGRELOR) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
KENGREAL is a P2Y
platelet inhibitor indicated as an adjunct to percutaneous coronary
intervention (PCI)
for reducing the risk of periprocedural myocardial infarction (MI),
repeat coronary revascularization, and
stent thrombosis (ST) in patients in who have not been treated with a
P2Y
platelet inhibitor and are not
being given a glycoprotein IIb/IIIa inhibitor. (1)
DOSAGE AND ADMINISTRATION
KENGREAL is intended for administration via a dedicated IV line, only
after reconstitution and dilution.
(2.3)
Administer 30 mcg/kg intravenous (IV) bolus prior to PCI followed
immediately by a 4 mcg/kg/min IV
infusion for at least 2 hours or duration of procedure, whichever is
longer. (2.1)
To maintain platelet inhibition after discontinuation of KENGREAL
infusion, administer an oral P2Y
platelet inhibitor. (2.2)
DOSAGE FORMS AND STRENGTHS
Single-use 10 mL vial containing 50 mg KENGREAL as a lyophilized
powder for reconstitution (3.0)
CONTRAINDICATIONS
Significant active bleeding (4.1)
Hypersensitivity to KENGREAL or any component of the product (4.2)
WARNINGS AND PRECAUTIONS
Bleeding: Like other drugs that inhibit platelet P2Y
function, KENGREAL can increase the risk of
bleeding (5.1)
ADVERSE REACTIONS
The most common adverse reaction is bleeding. (5.1, 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CHIESI USA, INC. AT
1-888-661-9260 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Clopidogrel: Do not administer during KENGREAL infusion. (7.1)
Prasugrel: Do not administer during KENGREAL infusion. (7.1)
REVISED: 9/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 RECOMMENDED