KENGREAL- cangrelor injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

The Medicines Company

INN (International Name):

CANGRELOR

Composition:

CANGRELOR 50 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 )] . Pregnancy Category C There are no adequate and well-controlled studies of KENGREAL in pregnant women. Cangrelor did not produce malformations in either the rat or rabbit reproductive studies, and is not considered to be a teratogen. In embryo-fetal development studies in rats, cangrelor produced dose-related fetal growth retardation characteri

Product summary:

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]. Distributed by: The Medicines Company Parsippany, NJ 07054 PN 1924-2

Authorization status:

New Drug Application

Summary of Product characteristics

KENGREAL- CANGRELOR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
THE MEDICINES COMPANY
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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, an oral P2Y platelet inhibitor should be
administered. (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 THE MEDICINES COMPANY
AT 1-888-977-6326 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: 8/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTR