Drug Interaction:
Clopidogrel: Do not administer during KENGREAL infusion.
Prasugrel: Do not administer during KENGREAL infusion.
Indication:
KENGREAL. (cangrelor) for injection, for intravenous use
Initial U.S. Approval: 2015
Proprietary Name- KENGREAL
Established Name- Cangrelor
Applicant- The Medicine Co
Indication- As an adjunct to percutaneous Coronary Intervention(PCI)
to reduce the risk of Pericrodural Myocardial Infarction(MI),
Repeat Coronary Revascularization, and Stent Thrombosis(ST)
in Patients who have been treated with a P2Y12 Platelet Inhibitor
and are not being given a Glycoprotein IIB/IIIA Inhibitor
Approval Date- 6/22/2015
Approved by U.S.FDA on 30-06-2015 (Ref- FDA approved List- 2015)
Adverse Reaction:
The most common adverse reaction is bleeding
Contra-Indications:
CONTRAINDICATIONS
Significant active bleeding
Hypersensitivity to KENGREAL or any component of the product
WARNINGS AND PRECAUTIONS
Bleeding: Like other drugs that inhibit platelet P2Y12 function, KENGREAL
can increase the risk of bleeding
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
KENGREAL is a P2Y12 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 P2Y12 platelet inhibitor and
are not being given a glycoprotein IIb/IIIa inhibitor
DOSAGE AND ADMINISTRATION
KENGREAL is intended for administration via a dedicated IV line, only after
reconstitution and dilution.
Administer 30 £gg/kg intravenous (IV) bolus prior to PCI followed immediately
by a 4 £gg/kg/min IV infusion for at least 2 hours or duration of procedure,
whichever is longer.
To maintain platelet inhibition after discontinuation of KENGREAL infusion,
an oral P2Y12 platelet inhibitor should be administered.
DOSAGE FORMS AND STRENGTHS
Single-use 10 mL vial containing 50 mg KENGREAL as a lyophilized powder
for reconstitution
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Cangrelor is a direct P2Y12 platelet receptor inhibitor that blocks ADP-induced platelet
activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y12
receptor to prevent further signaling and platelet activation.
2. Pharmacokinetics
KENGREAL administered intravenously has linear pharmacokinetics in both healthy
volunteers and patients. KENGREAL is rapidly distributed and metabolized,
reaching Cmax within 2 minutes after administration of an intravenous bolus
followed by infusion.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
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.
2. Nursing Mothers
It is not known whether KENGREAL is excreted in human milk.
3. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
4.Geriatric Use
In CHAMPION PHOENIX, 18% of patients were .75 years. No overall differences
in safety or effectiveness were observed between these patients and those
patients <75 years
Manufacturer Details