BRILINTATM (ticagrelor) Tablets Now Available in U.S. Pharmacies for Patients with Acute Coronary Syndrome
Also New BRILINTA Savings Card Program Will Offer Savings to Eligible Patients
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca (NYSE: AZN) today announced that BRILINTATM (ticagrelor) tablets, a new oral antiplatelet therapy, is now available in pharmacies in the United States.
BRILINTA received approval from the U.S. Food & Drug Administration (FDA) on July 20, 2011, and is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS) (unstable angina [UA], non--ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis. BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.
Initial steps in the launch process following the U.S. FDA approval of BRILINTA include working with distribution partners and pharmacy customers to ensure BRILINTA is available to order for use in hospital-based patients, and also for patients to fill by prescription in U.S. pharmacies.
Now that BRILINTA is available in the U.S., AstraZeneca will continue to work with hospitals, government and managed care reimbursement bodies to ensure BRILINTA is reimbursed, and listed on hospital formularies and treatment protocols. Navigating these steps, which are necessary before BRILINTA will be available to a substantial number of incident ACS patients, will be a key focus for the next 12 months.
"Every year, more than one million Americans are hospitalized with ACS. The U.S. approval and launch of BRILINTA means that physicians now have access to a new treatment option for patients with ACS that is proven to be more effective than clopidogrel at reducing heart attack and cardiovascular death when taken with low-dose aspirin (less than 100mg)," said Alex Gold, MD, Executive Director of Clinical Development, BRILINTA, AstraZeneca.
A savings card program for BRILINTA is available for eligible patients. Commercially insured and cash-paying patients may be eligible for one free prescription and will get up to $75 off (after the first $25) on each of their next 11 refills. Patients covered through Medicare, Medicaid or a resident of Massachusetts may be eligible for one month free prescription. Patients can find out more at www.BRILINTAtouchpoints.com or by calling 1-888-412-7454.
Additionally, AstraZeneca also offers a U.S. patient assistance program for BRILINTA through its AZ&METM Prescription Savings Program. To determine eligibility, patients can visit www.AZandMe.com or call 1-800-AZandMe (292-6363).
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA (TICAGRELOR) TABLETS
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 planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery.
Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA.
If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events.
ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75-100 mg per day.
Risk factors for bleeding include older age, a history of bleeding disorders, performance of percutaneous invasive procedures and concomitant use of medications that increase the risk of bleeding.
If BRILINTA must be temporarily discontinued, it should be restarted as soon as possible.
The use of BRILINTA is also contraindicated in severe hepatic impairment. BRILINTA has not been studied in patients with moderate hepatic impairment. Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients treated with clopidogrel. If dyspnea is determined to be related to BRILINTA, no specific treatment is required; continue BRILINTA without interruption.
BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers.
Avoid simvastatin and lovastatin doses greater than 40 mg. BRILINTA will result in higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4.
Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy, because of inhibition of the P-glycoprotein transporter.
There is limited clinical experience in patients at increased risk of symptomatic bradycardic events. In PLATO, syncope, presyncope, and loss of consciousness were reported by 1.7% and 1.5% of BRILINTA and clopidogrel patients, respectively. In a Holter substudy of about 3,000 patients in PLATO, more patients had ventricular pauses with BRILINTA (6%) than with clopidogrel (3.5%), in the acute phase; rates were 2.2% and 1.6% respectively after one month.
The most commonly observed adverse reactions associated with the use of BRILINTA vs. clopidogrel were bleeding (11.6% vs.11.2%) and dyspnea (14% vs. 8%).
Please see full US Full Prescribing Information including Boxed Warnings and Medication Guide at www1.astrazeneca-us.com/pi/brilinta.pdf.
NOTES TO EDITORS:
About BRILINTA (ticagrelor)
BRILINTA is an oral antiplatelet treatment for acute coronary syndrome (ACS) in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA works by helping to prevent the formation of new blood clots to help reduce a patient's risk of another cardiovascular event (called atherothrombotic events) such as a heart attack or cardiovascular death. BRILINTA is a reversibly-binding oral adenosine diphosphate (ADP) receptor antagonist.
BRILINTA is available in 90-mg tablets to be administered with a single 180-mg oral loading dose (two 90-mg tablets) followed by a twice daily, 90-mg maintenance dose. Following an initial loading dose of aspirin, BRILINTA should be used with a maintenance dose of 75 mg-100 mg aspirin once daily, 81-mg aspirin dose in the U.S.
BRILINTA are trademarks of the AstraZeneca group of companies.
About Acute Coronary Syndrome (ACS)
ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina (unremitting chest pain that threatens a heart attack) to heart attack.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the US or our AZ&MeTM Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
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