CANGRELOR: 323 Adverse Event Reports & Safety Profile
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Drug Class: Decreased Platelet Aggregation [PE] · Route: INTRAVENOUS · Manufacturer: Gland Pharma Limited · FDA Application: 204958 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
Patent Expires: Nov 10, 2030 · First Report: 2010 · Latest Report: 20250826
What Are the Most Common CANGRELOR Side Effects?
All CANGRELOR Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 144 | 44.6% | 25 | 9 |
| Vascular stent thrombosis | 29 | 9.0% | 4 | 1 |
| Drug ineffective | 26 | 8.1% | 3 | 13 |
| Haemorrhage | 22 | 6.8% | 6 | 5 |
| Death | 19 | 5.9% | 19 | 0 |
| No adverse event | 19 | 5.9% | 0 | 0 |
| Inappropriate schedule of product administration | 18 | 5.6% | 5 | 3 |
| Cardiac arrest | 15 | 4.6% | 8 | 0 |
| Cardiogenic shock | 14 | 4.3% | 11 | 3 |
| Gastrointestinal haemorrhage | 12 | 3.7% | 2 | 6 |
| Intentional product use issue | 11 | 3.4% | 1 | 1 |
| Drug ineffective for unapproved indication | 9 | 2.8% | 2 | 0 |
| Dyspnoea | 9 | 2.8% | 1 | 0 |
| Haemorrhage intracranial | 9 | 2.8% | 3 | 2 |
| Vascular access site haemorrhage | 9 | 2.8% | 3 | 1 |
| Cardiac failure | 8 | 2.5% | 7 | 2 |
| Cerebral haemorrhage | 8 | 2.5% | 3 | 1 |
| Eosinophilia | 8 | 2.5% | 0 | 8 |
| Incorrect drug administration rate | 8 | 2.5% | 4 | 1 |
| Labelled drug-drug interaction medication error | 8 | 2.5% | 2 | 3 |
Who Reports CANGRELOR Side Effects? Age & Gender Data
Gender: 36.1% female, 63.9% male. Average age: 64.6 years. Most reports from: US. View detailed demographics →
Is CANGRELOR Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 0 | 0 |
| 2011 | 2 | 0 | 1 |
| 2012 | 1 | 1 | 0 |
| 2015 | 5 | 2 | 1 |
| 2016 | 11 | 5 | 0 |
| 2017 | 13 | 3 | 3 |
| 2018 | 14 | 4 | 3 |
| 2019 | 22 | 4 | 1 |
| 2020 | 8 | 2 | 1 |
| 2021 | 12 | 5 | 3 |
| 2022 | 11 | 4 | 1 |
| 2023 | 18 | 4 | 1 |
| 2024 | 15 | 1 | 1 |
| 2025 | 11 | 1 | 7 |
What Is CANGRELOR Used For?
CANGRELOR vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Decreased Platelet Aggregation [PE]
Official FDA Label for CANGRELOR
Official prescribing information from the FDA-approved drug label.
Drug Description
Cangrelor for injection is a direct-acting P2Y 12 platelet receptor inhibitor that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation. The chemical structure is similar to adenosine triphosphate (ATP). The chemical name of Cangrelor for injection is tetrasodium salt of N6-[2-(methylthio)ethyl]-2-[(3,3,3,trifluoropropyl)-5’-adenylic acid, monanhydride with (dichloromethylene) bisphosphonic acid. The empirical formula of Cangrelor tetrasodium is C 17 H 21 N 5 Cl 2 F 3 Na 4 O 12 P 3 S 2 and the molecular weight is 864.3 g/mol. The chemical structure is represented below: Cangrelor for Injection is a sterile white to off-white lyophilized powder for IV infusion. In addition to the active ingredient, Cangrelor, each single dose vial contains mannitol (158 mg), sorbitol (52 mg), and sodium hydroxide to adjust the pH. cangrelor-spl-structure
FDA Approved Uses (Indications)
AND USAGE Cangrelor for injection 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 P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor [see Clinical Studies (14.1) ]. Cangrelor for injection is a P2Y 12 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 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. ( 1 )
Dosage & Administration
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, administer an oral P2Y 12 platelet inhibitor. ( 2.2 )
2.1 Recommended Dosing 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.
2.2 Transitioning Patients to Oral P2Y 12 Therapy To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y 12 platelet inhibitor, as described below: Ticagrelor: 180 mg at any time during KENGREAL infusion or immediately after discontinuation <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.2 )]</span> . Prasugrel: 60 mg immediately after discontinuation of KENGREAL <span class="opacity-50 text-xs">[see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]</span> . Clopidogrel: 600 mg immediately after discontinuation of KENGREAL <span class="opacity-50 text-xs">[see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]</span> .
2.3 Preparation and Administration KENGREAL is intended for IV administration, after reconstitution and dilution.
Preparation
Reconstitute the vial prior to dilution in a bag. For each 50 mg/vial, reconstitute by adding 5 mL of Sterile Water for Injection. Swirl gently until all material is dissolved. Avoid vigorous mixing. Allow any foam to settle. Ensure that the contents of the vial are fully dissolved and the reconstituted material is a clear, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter after reconstitution. Before administration, each reconstituted vial must be diluted further with Normal Saline (Sodium Chloride Injection 0.9% USP) or 5% Dextrose Injection USP. Withdraw the contents from one reconstituted vial and add to one 250 mL saline bag. Mix the bag thoroughly. This dilution will result in a concentration of 200 mcg/mL and should be sufficient for at least 2 hours of dosing.
Patients
100 kg and over will require a minimum of 2 bags. Reconstituted KENGREAL should be diluted immediately. Diluted KENGREAL is stable for up to 12 hours in 5% Dextrose Injection and 24 hours in Normal Saline at Room Temperature. Discard any unused portion of reconstituted solution remaining in the vial.
Administration
Administer KENGREAL via a dedicated IV line. Administer the bolus volume rapidly (<1 minute), from the diluted bag via manual IV push or pump. Ensure the bolus is completely administered before the start of PCI. Start the infusion immediately after administration of the bolus [see Dosage and Administration ( 2.1 )] .
2.1 Recommended Dosing 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.
2.2 Transitioning Patients to Oral P2Y 12 Therapy To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y 12 platelet inhibitor, as described below: Ticagrelor: 180 mg at any time during KENGREAL infusion or immediately after discontinuation <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.2 )]</span> . Prasugrel: 60 mg immediately after discontinuation of KENGREAL <span class="opacity-50 text-xs">[see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]</span> . Clopidogrel: 600 mg immediately after discontinuation of KENGREAL <span class="opacity-50 text-xs">[see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]</span> .
2.3 Preparation and Administration KENGREAL is intended for IV administration, after reconstitution and dilution.
Preparation
Reconstitute the vial prior to dilution in a bag. For each 50 mg/vial, reconstitute by adding 5 mL of Sterile Water for Injection. Swirl gently until all material is dissolved. Avoid vigorous mixing. Allow any foam to settle. Ensure that the contents of the vial are fully dissolved and the reconstituted material is a clear, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter after reconstitution. Before administration, each reconstituted vial must be diluted further with Normal Saline (Sodium Chloride Injection 0.9% USP) or 5% Dextrose Injection USP. Withdraw the contents from one reconstituted vial and add to one 250 mL saline bag. Mix the bag thoroughly. This dilution will result in a concentration of 200 mcg/mL and should be sufficient for at least 2 hours of dosing.
Patients
100 kg and over will require a minimum of 2 bags. Reconstituted KENGREAL should be diluted immediately. Diluted KENGREAL is stable for up to 12 hours in 5% Dextrose Injection and 24 hours in Normal Saline at Room Temperature. Discard any unused portion of reconstituted solution remaining in the vial.
Administration
Administer KENGREAL via a dedicated IV line. Administer the bolus volume rapidly (<1 minute), from the diluted bag via manual IV push or pump. Ensure the bolus is completely administered before the start of PCI. Start the infusion immediately after administration of the bolus [see Dosage and Administration ( 2.1 )] .
Contraindications
Significant active bleeding ( 4.1 ) Hypersensitivity to KENGREAL or any component of the product ( 4.2 )
4.1 Significant Active Bleeding KENGREAL is contraindicated in patients with significant active bleeding <span class="opacity-50 text-xs">[see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]</span> .
4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> .
4.1 Significant Active Bleeding KENGREAL is contraindicated in patients with significant active bleeding <span class="opacity-50 text-xs">[see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]</span> .
4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> .
Known Adverse Reactions
REACTIONS 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 Chiesi USA, Inc. at 1-888-661-9260 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 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.
Bleeding
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 CHAMPION PHOENIX KENGREAL (N=5529) Clopidogrel (N=5527) 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 Study a (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.
Drug
Discontinuation 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 Hypersensitivity 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
Dyspnea was reported more frequently in patients treated with KENGREAL (1.3%) than with control (0.4%).
Figure
1: Bleeding Results in the CHAMPION PHOENIX Studya (All Non-CABG related)
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 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.
Bleeding
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 CHAMPION PHOENIX KENGREAL (N=5529) Clopidogrel (N=5527) 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 Study a (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.
Drug
Discontinuation 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 Hypersensitivity 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
Dyspnea was reported more frequently in patients treated with KENGREAL (1.3%) than with control (0.4%).
Figure
1: Bleeding Results in the CHAMPION PHOENIX Studya (All Non-CABG related)
Warnings
AND PRECAUTIONS Bleeding: Like other drugs that inhibit platelet P2Y 12 function, KENGREAL can increase the risk of bleeding ( 5.1 )
5.1 Bleeding Drugs that inhibit platelet P2Y 12 function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX bleeding events of all severities were more common with KENGREAL than with clopidogrel <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> . 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 <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.3 )]</span> .
5.1 Bleeding Drugs that inhibit platelet P2Y 12 function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX bleeding events of all severities were more common with KENGREAL than with clopidogrel <span class="opacity-50 text-xs">[see Adverse Reactions ( 6.1 )]</span> . 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 <span class="opacity-50 text-xs">[see Clinical Pharmacology ( 12.3 )]</span> .
Drug Interactions
INTERACTIONS Clopidogrel: Do not administer during KENGREAL infusion. ( 7.1 ) Prasugrel: Do not administer during KENGREAL infusion. ( 7.1 )