Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Cangrelor
- Drug class
- P2y12 Platelet Inhibitor
- Form
- Injectable
- Strength
- Cangrelor 50MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Chiesi
- FDA application
- NDA204958
What is Kengreal?
From the FDA label:KENGREAL 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 KENGREAL 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 KENGREAL is C 17 H 21 N 5 C l2 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 use vial contains mannitol (158 mg), sorbitol (52 mg), and sodium hydroxide to adjust the pH. chemical structure
How to use
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 [see Clinical Pharmacology ( 12.2 )] . Prasugrel: 60 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . Clopidogrel: 600 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . 2.3 Preparation and Administration KENGREAL is intended for IV administration,…
Side effects
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…
Warnings
Important safety information
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 [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 )] . 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 [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 )] .
Who should not take Kengreal
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 [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . 4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product [see Adverse Reactions ( 6.1 )] . 4.1 Significant Active Bleeding KENGREAL is contraindicated in patients with significant active bleeding [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . 4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product [see Adverse Reactions ( 6.1 )] .
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Clopidogrel: Do not administer during KENGREAL infusion. ( 7.1 ) Prasugrel: Do not administer during KENGREAL infusion. ( 7.1 ) 7.1 Thienopyridines 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 )]. 7.1 Thienopyridines 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 )].
Storing Kengreal, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Diluted KENGREAL is stable for up to 12 hours in 5% Dextrose Injection and 24 hours in Normal Saline at Room Temperature.”
Drug class
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- How is Kengreal rated?
- pharmaranks gives Kengreal a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Kengreal?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Kengreal. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Kengreal?
- Kengreal is marketed by Chiesi. You can see Chiesi's full profile, rating, and other products on pharmaranks.
- Is Kengreal a brand-name or generic drug?
- Kengreal is a brand-name product with the active ingredient Cangrelor. Lower-cost generic equivalents containing Cangrelor are available — ask your pharmacist.
- Is Kengreal available over the counter?
- No. Kengreal is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Kengreal come in?
- Kengreal is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Kengreal?
- Kengreal is classified as p2y12 platelet inhibitor, per the FDA's Established Pharmacologic Class.
- Is Kengreal FDA-registered?
- Kengreal is on record with the U.S. FDA under application number NDA204958. You can verify this on its official FDA label.
- Has Kengreal been recalled by the FDA?
- Kengreal has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Kengreal safe?
- There's no single safe-or-not verdict. pharmaranks gives Kengreal a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Kengreal?
- Kengreal's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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70/100