Tuesday, 29 September 2015
BRILINTA 60 mg available for long-term use in patients with a history of heart attack
AstraZeneca (NYSE: AZN) announced today that BRILINTA® (ticagrelor) 60-mg tablets are now available in US pharmacies. On September 3, 2015, the US Food and Drug Administration (FDA) approved a new 60-mg dosage strength for BRILINTA to be used in patients with a history of heart attack beyond the first year. BRILINTA is approved to reduce the rate of cardiovascular (CV) death, myocardial infarction ([MI], also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, BRILINTA is superior to clopidogrel. BRILINTA is the first and only FDA approved oral antiplatelet to demonstrate superior reductions in CV death vs clopidogrel at 12 months.
“Patients continue to be at risk for a second heart attack, even if their first heart attack was more than a year ago and they continue on the recommended therapies prescribed to them,” said Tonous Silfani, PhD, Executive Director, CV Thrombosis, US Head of Marketing, AstraZeneca. “We wanted to make this new 60-mg dosage strength available as quickly as possible so that healthcare providers can consider adding BRILINTA 60 mg to the treatment regimen for patients with a history of heart attack beyond the first year.
The dosing of BRILINTA in the management of ACS is 90 mg twice daily during the first year after an ACS event. After one year, patients with a history of heart attack can now be treated with 60 mg twice daily. BRILINTA must be used with a daily maintenance dose of aspirin of 75-100mg.
AstraZeneca is committed to supporting patient access to BRILINTA and connecting patients with the information and support they need. For patients who have been prescribed BRILINTA, AstraZeneca offers the BRILINTA Patient Support Service (BPSS) tool that provides resources and support to help patients and caregivers from hospital discharge throughout the ACS treatment journey. To help loved ones, the program offers important patient education and coaching in addition to savings offers, refill reminders, personal pharmacy locator, co-pay calculator, and coverage verification and information. To enroll in BPSS, call 1-888-512-7454 or enroll online at www.BRILINTA.com.
IMPORTANT SAFETY INFORMATION FOR BRILINTA (ticagrelor) 60-MG AND 90-MG TABLETS
WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
A. BLEEDING RISK
- BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding
- Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
- Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery
- If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events
B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
- Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided
- BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with hypersensitivity (eg, angioedema) to ticagrelor or any component of the product
WARNINGS AND PRECAUTIONS
- Dyspnea was reported in about 14% of patients treated with BRILINTA, more frequently than in patients treated with control agents. Dyspnea resulting from BRILINTA is often self-limiting
- Discontinuation of BRILINTA will increase the risk of MI, stroke, and death. When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. If BRILINTA must be temporarily discontinued, restart as soon as possible
- Avoid use of BRILINTA in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients
- The most common adverse reactions associated with the use of BRILINTA included bleeding and dyspnea: In PLATO, for BRILINTA vs clopidogrel, non-CABG PLATO-defined major bleeding (3.9% vs 3.3%) and dyspnea (14% vs 8%); in PEGASUS, BRILINTA vs aspirin alone, TIMI Total Major bleeding (1.7% vs 0.8%) and dyspnea (14% vs 6%)
- Avoid use with strong CYP3A inhibitors and strong CYP3A inducers. BRILINTA is metabolized by CYP3A4/5. Strong inhibitors substantially increase ticagrelor exposure and so increase the risk of adverse events. Strong inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor
- Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse events
- Monitor digoxin levels with initiation of, or change in, BRILINTA therapy
BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
Patients can find out more information about BRILINTA at www.BRILINTA.com or by calling 1-888-412-7454.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
NOTES TO EDITORS
About PEGASUS-TIMI 54
PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) is AstraZeneca’s largest outcomes trial with more than 21,000 patients from over 1,100 sites in 31 countries. The study assessed BRILINTA® (ticagrelor) tablets at either 60 mg twice daily or 90 mg twice daily plus once daily low-dose aspirin compared to placebo plus once daily low-dose aspirin for the secondary prevention of atherothrombotic events in patients ≥ 50 years of age who had experienced a heart attack one to three years prior to study start and had at least 1 risk factor for thrombotic cardiovascular events ( age ≥ 65 years, Diabetes mellitus requiring medication, at least one other prior MI, evidence of multivessel coronary artery disease or a creatinine clearance < 60 ml/min). The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke at 36 months. Patients were treated for at least 12 months and up to 48 months with a median follow-up time of 33 months. Only the 60 mg dose is approved for use in patients with a history of MI beyond 12 months. The study was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA).
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca-us.com.
BRILINTA is a registered trademark of the AstraZeneca group of companies.
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