Cangrelor — Active Pharmaceutical Ingredient

Cangrelor is an active pharmaceutical ingredient found in 2 FDA-approved drug products. Forms: POWDER. Routes: INTRAVENOUS.

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Cangrelor (2 brand names, 1 dosage form, 1 route)

Available dosage forms: POWDER.

Routes of administration: INTRAVENOUS.

Brand Names

  • CANGRELOR
  • KENGREAL

Indications and Usage

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 )].

Dosage and Administration

The recommended dosage of KENGREAL is a 30 mcg/kg IV bolus followed immediately by a 4 mcg/kg/min IV infusion. Initiate the bolus infusion prior to PCI. The maintenance infusion should ordinarily be continued for at least 2 hours or for the duration of PCI, whichever is longer.

Contraindications

KENGREAL is contraindicated in patients with significant active bleeding [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )].

Warnings and Precautions

Drugs that inhibit platelet P2Y12 function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX bleeding events of all severities were more common with KENGREAL than with clopidogrel [see Adverse Reactions ( 6.1 )]. Bleeding complications with KENGREAL were consistent across a variety of clinically important subgroups (see Figure 1). Once KENGREAL is discontinued, there is no antiplatelet effect after an hour [see Clinical Pharmacology ( 12.3 )].

Adverse Reactions

The following adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Warnings and Precautions ( 5.1 )]

Drug Interactions

Clopidogrel or prasugrel administered during KENGREAL infusion will have no antiplatelet effect until the next dose is administered. Therefore, administer clopidogrel or prasugrel after KENGREAL infusion is discontinued [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

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.

Overdosage

There is no specific treatment to reverse the antiplatelet effect of KENGREAL but the effect is gone within one hour after the drug is discontinued. In clinical trials, 36 patients received an overdose of KENGREAL, ranging from 36 to 300 mcg/kg (bolus dose) or 4.8 to 13.7 mcg/kg/min (infusion dose). The maximum overdose received was 10 times the PCI bolus dose or 3.5 times the PCI infusion dose in 4 patients. No clinical sequela were noted as a result of overdose following completion of KENGREAL therapy.

⚠ Caution
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