BRILINTA

Ticagrelor demonstrates dose proportional pharmacokinetics, which are similar in patients and healthy volunteers. Absorption BRILINTA can be taken with or without food. Absorption of ticagrelor occurs with a median t max of 1.5 h (range 1.0–4.0). The formation of the major circulating metabolite AR-C124910XX (active) from ticagrelor occurs with a median t max of 2.5 h (range 1.5-5.0). The mean absolute bioavailability of ticagrelor is about 36% (range 30%-42%). Ingestion of a high-fat meal had n...

14.1 Acute Coronary Syndromes and Secondary Prevention after Myocardial Infarction PLATO PLATO (NCT00391872) was a randomized double-blind study comparing BRILINTA (N=9333) to clopidogrel (N=9291), 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’s 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 c...

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 AstraZeneca at 1-800-236-9933 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 rat...

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 BRILINTA is 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 BRILI...

Dyspnea was reported more frequently with BRILINTA than with control agents in clinical trials. Dyspnea from BRILINTA is self-limiting. (5.3) Severe Hepatic Impairment: Likely increase in exposure to ticagrelor. (5.6) Laboratory Test Interference: False negative platelet functional test results have been reported for Heparin Induced Thrombocytopenia (HIT). BRILINTA is not expected to impact PF4 antibody testing for HIT. (5.8) 5.1 Risk of Bleeding Drugs that inhibit platelet function including BR...

7 DRUG INTERACTIONS Avoid use with strong CYP3A inhibitors or CYP3A inducers. (7.1 , 7.2) Opioids: Decreased exposure to ticagrelor. Consider use of parenteral anti-platelet agent. ( 7.3 ) Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse effects. ( 7.4 ) Monitor digoxin levels with initiation of or any change in BRILINTA. ( ...