What Is Kengreal?
Kengreal (cangrelor) is antiplatelet agent used 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.
What Are Side Effects of Kengreal?
Common side effects of Kengreal include bleeding.
Dosage for Kengreal
Kengreal is administered in a 30 µg/kg intravenous (IV) bolus dose prior to PCI followed immediately by a 4 µg/kg/min IV infusion for at least 2 hours or duration of procedure, whichever is longer.
What Drugs, Substances, or Supplements Interact with Kengreal?
Kengreal may interact with clopidogrel and prasugrel. Tell your doctor all medications and supplements you use.
Kengreal During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before taking Kengreal. It is unknown if Kengreal passes into breast milk. Consult your doctor before breastfeeding.
Our Kengreal (cangrelor) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following adverse reactions are also discussed elsewhere in the labeling:
- Bleeding [see WARNINGS AND PRECAUTIONS]
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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of KENGREAL has been evaluated in 13,301 subjects in controlled trials, in whom, 5,529 were in the CHAMPION PHOENIX trial.
There was a greater incidence of bleeding with KENGREAL than with clopidogrel. No baseline demographic factor altered the relative risk of bleeding with KENGREAL (see Table 1 and Figure 1).
Table 1: Major Bleeding Results in the CHAMPION
PHOENIX Study (Non-CABG related Bleeding)a
|Any GUSTO bleeding, n (%)||857 (15.5)||602 (10.9)|
|Severe/life-threatening b||11 (0.2)||6 (0.1)|
|Moderate c||21 (0.4)||14 (0.3)|
|Mild d||825 (14.9)||582 (10.5)|
|Any TIMI bleeding, n (%)||45 (0.8)||17 (0.3)|
|Major e||12 (0.2)||6 (0.1)|
|Minor f||33 (0.6)||11 (0.2)|
|Abbreviations: GUSTO: Global
Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded
Arteries; TIMI: Thrombolysis in Myocardial Infarction
a Safety population is all randomized subjects who received at least one dose of study drug
b intracranial hemorrhage or bleeding resulting in substantial hemodynamic compromise requiring treatment
c requiring blood transfusion but not resulting in hemodynamic compromise
d all other bleeding not included in severe or moderate
e any intracranial hemorrhage, or any overt bleeding associated with a reduction in hemoglobin of ≥ 5 g/dL (or, when hemoglobin is not available, an absolute reduction in hematocrit ≥ 15%)
f any overt sign of bleeding (including observation by imaging techniques) that is associated with a reduction in hemoglobin of ≥ 3 g/dL and < 5 g/dL (or, when hemoglobin is not available, an absolute reduction in hematocrit of ≥ 9% and < 15%)
Figure 1: Bleeding Results in the CHAMPION PHOENIX
Studya (All Non-CABG related)
a Safety population is all randomized subjects who received at least one dose of study drug Note: The figure above presents effects in various subgroups most of which are baseline characteristics and most of which were pre-specified (patient presentation and weight were not pre-specified subgroups). The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.
In CHAMPION PHOENIX the rate of discontinuation for bleeding events was 0.3% for KENGREAL and 0.1% for clopidogrel. Discontinuation for non-bleeding adverse events was low and similar for KENGREAL (0.6%) and for clopidogrel (0.4%). Coronary artery dissection, coronary artery perforation, and dyspnea were the most frequent events leading to discontinuation in patients treated with KENGREAL.
Non-Bleeding Adverse Reactions
Serious cases of hypersensitivity were more frequent with KENGREAL (7/13301) than with control (2/12861). These included anaphylactic reactions, anaphylactic shock, bronchospasm, angioedema, and stridor.
Decreased renal function
Worsening renal function was reported in 3.2% of KENGREAL patients with severe renal impairment (creatinine clearance < 30 mL/min) compared to 1.4% of clopidogrel patients with severe renal impairment.
Dyspnea was reported more frequently in patients treated with KENGREAL (1.3%) than with control (0.4%).
Read the entire FDA prescribing information for Kengreal (Cangrelor for Injection)
© Kengreal Patient Information is supplied by Cerner Multum, Inc. and Kengreal Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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