CANGRELOR

Cangrelor administered intravenously has linear pharmacokinetics in both healthy volunteers and patients. Cangrelor is rapidly distributed and metabolized, reaching C max within 2 minutes after administration of an intravenous bolus followed by infusion.

DistributionIn a study in healthy volunteers, cangrelor administration at a dose of 30 mcg/kg bolus plus 4 mcg/kg/min showed a volume of distribution of 3.9 L. Plasma protein binding of cangrelor is about 97 to 98%.

MetabolismCangrelor is deac...

14.1 CHAMPION PHOENIX Trial The CHAMPION PHOENIX trial was intended to test whether faster platelet inhibition with cangrelor at the time of PCI would reduce the rate of periprocedural thrombotic events compared to a drug with a slower antiplatelet effect, clopidogrel, given at about the time of PCI. It was a randomized, double-blind study in which patients with coronary artery disease (stable angina, UA/NSTEMI, STEMI) requiring PCI and receiving standard therapy including aspirin and heparin or bivalirudin were randomized 1:1 to cangrelor (n=5472) or to clopidogrel 300 or 600 mg (n=5470). Pat...

The following adverse reactions are also discussed elsewhere in the labeling:

• Bleeding [see Warnings and Precautions (5.1) ] The most common adverse reaction is bleeding ( 5.1 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be d...

• Significant active bleeding ( 4.1 )
• Hypersensitivity to cangrelor or any component of the product ( 4.2 ) 4.1 Significant Active Bleeding Cangrelor is contraindicated in patients with significant active bleeding [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. 4.2 Hypersensitivity Cangrelor is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cang...

• Bleeding: Like other drugs that inhibit platelet P2Y 12 function, cangrelor can increase the risk of bleeding ( 5.1 ) 5.1 Bleeding Drugs that inhibit platelet P2Y 12 function, including cangrelor, increase the risk of bleeding. In CHAMPION PHOENIX bleeding events of all severities were more common with cangrelor than with clopidogrel [see Adverse Reactions (6.1) ]. Bleeding complications with cangrelor were consistent across a variety of clinically important subgroups (see Figure 1). Once cang...

7 DRUG INTERACTIONS

• Clopidogrel: Do not administer during cangrelor infusion. ( 7.1 )
• Prasugrel: Do not administer during cangrelor infusion. ( 7.1 ) 7.1 Thienopyridines Clopidogrel or prasugrel administered during cangrelor infusion will have no antiplatelet effect until the next dose is administered. Therefore, administer Clopidogrel or prasugrel after cangrelor infusion is discontinued [see...