{ "query": "ticagrelor", "ingredient": "ticagrelor", "slug": "ticagrelor", "rxcui": "1116632", "brands": [ "Brilinta" ], "names": [ "ticagrelor" ], "classes": [ { "id": "B01AC", "name": "Platelet aggregation inhibitors excl. heparin" } ], "alternatives": [ "abciximab", "aloxiprin", "aspirin", "cangrelor", "cilostazol", "clopidogrel", "dipyridamole", "epoprostenol", "eptifibatide", "iloprost", "indobufen", "prasugrel", "selexipag", "ticlopidine", "tirofiban", "treprostinil", "triflusal", "vorapaxar" ], "label": { "route_mode": "ORAL", "route_counts": { "ORAL": 32 }, "boxed_warning": "WARNING: BLEEDING RISK Ticagrelor tablets , like other antiplatelet agents, can cause significant, sometimes fatal bleeding (5.1, 6.1 ) . Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage ( 4.1, 4.2 ). Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG) ( 5.1, 6.1). If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events ( 5.2 ) . WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Ticagrelor tablets , like other antiplatelet agents, can cause significant, sometimes fatal bleeding. ( 5.1 , 6.1 ) Do not use ticagrelor tablets in patients with active pathological bleeding or a history of intracranial hemorrhage. ( 4.1 , 4.2 ) Do not start ticagrelor tablets in patients undergoing urgent coronary artery bypass graft surgery (CABG). ( 5.1, 6.1 ) If possible, manage bleeding without discontinuing ticagrelor tablets. Stopping ticagrelor tablets increases the risk of subsequent cardiovascular events. ( 5.2 )", "indications_and_usage": "Ticagrelor tablets are a P2Y 12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. (1.1) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor tablets were established in a population with type 2 diabetes mellitus (T2DM). (1.2) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score \u22645) or high-risk transient ischemic attack (TIA). (1.3) 1.1 Acute Coronary Syndrome or a History of Myocardial Infarction Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also red...", "contraindications": "History of intracranial hemorrhage. (4.1) Active pathological bleeding. (4.2) Hypersensitivity to ticagrelor or any component of the product. (4.3 ) 4.1 History of Intracranial Hemorrhage Ticagrelor tablets are contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical Studies (14.1), (14.2) ]. 4.2 Active Bleeding Ticagrelor tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. 4.3 Hypersensitivity Ticagrelor tablets are contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product.", "warnings_and_cautions": "Dyspnea was reported more frequently with ticagrelor tablets than with control agents in clinical trials. Dyspnea from ticagrelor tablets is self-limiting. (5.3 ) Severe Hepatic Impairment: Likely increase in exposure to ticagrelor. (5.5 ) Laboratory Test Interference: False negative platelet functional test results have been reported for Heparin Induced Thrombocytopenia (HIT). Ticagrelor tablets are not expected to impact PF4 antibody testing for HIT. (5.7 ) 5.1 Risk of Bleeding Drugs that inhibit platelet function including ticagrelor tablets increase the risk of bleeding [see Warnings and Precautions (5.2) and Adverse Reactions ( 6.1 )]. Patients treated for acute ischemic stroke or TIA Patients at NIHSS >5 and patients receiving thrombolysis were excluded from THALES and use of ticagrelor tablets in such patients is not recommended. 5.2 Discontinuation of Ticagrelor Tablets in Patients Treated for Coronary Artery Disease Discontinuation of ticagrelor tablets will increase the risk of myocardial infarction, stroke, and death in patients being treated for coronary artery disease. If ticagrelor tablets must be temporarily discontinued (e.g., to treat bleeding or for significant su...", "warnings": "", "adverse_reactions": "The following adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Warnings and Precautions (5.1) ] Dyspnea [see Warnings and Precautions (5.3) ] Most common adverse reactions (>5%) are bleeding and dyspnea. (5.1, 5.3, 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 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 reaction 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. Ticagrelor tablets have been evaluated for safety in more than 58,000 patients. Bleeding in PLATO (Reduction in risk of thrombotic events in ACS) Figure 1 is a plot of time to the first non-CABG major bleeding event. Figure 1 - Kaplan-Meier estimate of time to first non-CABG PLATO-defined major bleeding event (PLATO) Frequency of bleeding in PLATO is summarized in Tables 1 and 2. About half of the non-CABG major bleeding events were in the first 30 days. Table 1 \u2013 Non-CABG related bleeds (PLATO) Ticagrelor * N=9,235 Clopido...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "RECENT MAJOR CHANGES SECTION Dosage and Administration ( 2.2 , 2.4 ) 03/2024", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise patients daily doses of aspirin should not exceed 100 mg and to avoid taking any other medications that contain aspirin. Advise patients that they: Will bleed and bruise more easily Will take longer than usual to stop bleeding Should report any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine. Advise patients to contact their doctor if they experience unexpected shortness of breath, especially if severe. Advise patients to inform physicians and dentists that they are taking ticagrelor tablets before any surgery or dental procedure. Advise women that breastfeeding is not recommended during treatment with ticagrelor tablets [see Use in Specific Populations (8.2) ]. Dispense with Medication Guide available at https://www.apotex.com/products/us/mg.asp All registered trademarks in this document are the property of their respective owners. Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida. USA 33326 Rev. 3b Marketed by: GSMS, Inc. Camarillo, CA 93012 USA", "spl_medguide": "MEDICATION GUIDE Ticagrelor (tye ka\u2032 grel or) t ablets Medication Guide available at https://www.apotex.com/products/us/mg.asp What is the most important information I should know about ticagrelor tablets? Ticagrelor tablets are used to lower your chance of having, or dying from, a heart attack or stroke. Ticagrelor tablets (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. In cases of serious bleeding, such as internal bleeding, the bleeding may result in the need for blood transfusions or surgery. While you take ticagrelor tablets: you may bruise and bleed more easily you are more likely to have nose bleeds it will take longer than usual for any bleeding to stop Call your healthcare provider right away, if you have any of these signs or symptoms of bleeding while taking ticagrelor tablets: bleeding that is severe or that you cannot control pink, red or brown urine vomiting blood or your vomit looks like \u201ccoffee grounds\u201d red or black stools (looks like tar) coughing up blood or blood clots Do not stop taking ticagrelor tablets without talking to the healthcare provider who prescribes it for you. People who are treated with a stent, and stop tak...", "clinical_studies": "14.1 Acute Coronary Syndromes and Secondary Prevention after Myocardial Infarction PLATO PLATO (NCT00391872) was a randomized double-blind study comparing ticagrelor (N=9,333) to clopidogrel (N=9,291), both given in combination with aspirin and other standard therapy, in patients with acute coronary syndromes (ACS), who presented within 24 hours of onset of the most recent episode of chest pain or symptoms. The study\u2019s primary endpoint was the composite of first occurrence of cardiovascular death, non-fatal MI (excluding silent MI), or non-fatal stroke. Patients who had already been treated with clopidogrel could be enrolled and randomized to either study treatment. Patients with previous intracranial hemorrhage, gastrointestinal bleeding within the past 6 months, or with known bleeding diathesis or coagulation disorder were excluded. Patients taking anticoagulants were excluded from participating and patients who developed an indication for anticoagulation during the trial were discontinued from study drug. Patients could be included whether there was intent to manage the ACS medically or invasively, but patient randomization was not stratified by this intent. All patients randomi...", "brand_name": "Ticagrelor", "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC", "application_number": "ANDA208584", "pharm_class_epc": [ "P2Y12 Platelet Inhibitor [EPC]" ], "route": [ "ORAL" ], "effective_time": "20251124", "set_id": "41c5d35c-91de-a8a4-e063-6394a90ac5ff", "has_boxed_warning": true, "controlled": false, "mentions_rems": false }, "faers": { "total": 32882, "serious": 25986, "death": 3657, "hospitalization": 13329, "primary_suspect": 32524, "top_reactions": [ [ "Dyspnoea", 3771 ], [ "Myocardial Infarction", 2707 ], [ "Death", 1736 ], [ "Fatigue", 1568 ], [ "Off Label Use", 1464 ], [ "Chest Pain", 1450 ], [ "Dizziness", 1239 ], [ "Drug Interaction", 1143 ], [ "Contusion", 1078 ], [ "Asthenia", 943 ], [ "Acute Kidney Injury", 916 ], [ "Malaise", 898 ], [ "Nausea", 873 ], [ "Drug Ineffective", 855 ], [ "Vascular Stent Thrombosis", 824 ] ], "by_year": { "2019": 3014, "2020": 2780, "2021": 2395, "2022": 1876, "2023": 2099, "2024": 2173, "2025": 1700, "2026": 792 }, "by_year_primary": { "2019": 3008, "2020": 2772, "2021": 2361, "2022": 1812, "2023": 2010, "2024": 2121, "2025": 1622, "2026": 771 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20210315", "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.", "firm": "Cardinal Health Inc.", "status": "Terminated" }, { "class": "Class I", "date": "20170525", "reason": "Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.", "firm": "AstraZeneca Pharmaceuticals, LP", "status": "Terminated" } ], "recall_total": 2, "drugsfda": { "applications": 22, "nda": 1, "anda": 21, "first_approval": "20110720", "rems": false, "rems_last": "20131030", "labeling_supplements": 15, "labeling_recent": 4, "sponsors": [ "ALEMBIC", "ALKEM LABS LTD", "AMNEAL", "APOTEX", "ASTRAZENECA", "CHANGZHOU PHARM", "DR REDDYS", "HISUN PHARM HANGZHOU" ], "unapproved": false, "first_approval_fmt": "07/20/2011" }, "trials": { "total": 623, "completed": 343, "terminated": 47, "with_results": 109, "industry": 182, "phase3": 105, "results_share": 0.3177842565597668, "terminated_share": 0.0754414125200642 }, "pubmed": { "rct": 487, "meta": 122, "recent_rct": 149, "cochrane": [] }, "payments": { "year": "2024", "usd": 84320.89, "records": 2495, "by_name": [ [ "Brilinta", 84320.89 ] ], "names_checked": [ "ticagrelor", "Brilinta" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 1029007, "beneficiaries": 242931, "spend": 685497436.89, "by_brand": [ { "brand": "Brilinta", "claims": 1029007, "per_claim": 666.17373535, "is_generic": false } ], "per_claim": 666.1737353487391 }, "mdl": [], "dsc": [ { "date": "20160502", "title": "FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm497942.htm", "kind": "drug", "matched": "ticagrelor" }, { "date": "20150730", "title": "FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor)", "url": "https://www.fda.gov/Drugs/DrugSafety/ucm456341.htm", "kind": "drug", "matched": "ticagrelor" } ], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "ApplicationRejected", "name": "ticagrelor", "matched": "ticagrelor", "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 4514, "fills": 1029007, "per_million": 4386.753442882313, "ratio": 1.584266177772726, "median": 2768.949753790441 }, "scores": { "safety": { "score": 35, "letter": "F", "why": [ "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)", "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-16)", "4,387 FDA reports naming it as the suspect drug per million Medicare fills, 1.6x the median drug on this site (-4)", "Death share in reports is near or below the FAERS average (1.2x)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)", "1 Class I recall(s): reasonable probability of serious harm (-10)" ], "weight": 0.35 }, "evidence": { "score": 68, "letter": "C", "why": [ "487 randomized trials and 122 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 32% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 73, "letter": "C", "why": [ "Recalls since 2016: 1 Class I, 1 Class II, 0 Class III across 21 generic makers (-18)", "4 label changes approved since 2021 (-4)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $84,321 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (21 applications)", "18 same-class alternatives exist" ], "weight": 0.1 } }, "total": 65, "grade": "C", "questions": [ "In 2016 the FDA issued a safety communication about this drug (FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antip). Does that risk apply to me?", "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?", "The most-reported problems in FDA's adverse event data are dyspnoea, myocardial infarction, death, fatigue. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over abciximab, aloxiprin, aspirin? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }