A CHANGING TREATMENT PARADIGM

SUPPORT FOR BRILINTA AS A STANDARD OF CARE IN THE TREATMENT OF ACS HAS GROWN

BRILINTA IS THE #1 INITIATED ORAL ANTIPLATELET FOR STEMI PATIENTS UNDERGOING PCI1*

FDA

Indication: BRILINTA is superior to clopidogrel for at least the first 12 months following ACS2

  • The FDA-approved indication states that for at least the first 12 months following ACS, BRILINTA is superior to clopidogrel in reducing the rate of CV death, MI, and stroke

ACC/AHA

BRILINTA is preferred over clopidogrel in ACS in the 2016 ACC/AHA DAPT guideline3

  • According to the 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy (DAPT), BRILINTA is preferred over clopidogrel in ACS (Class IIa; LOE B-R)
    • First time preferred in patients with STEMI who have received a coronary stent (Class IIa; LOE B-R)
    • Preferred in patients with NSTE-ACS who have received a coronary stent or are managed with medical therapy alone (Class IIa; LOE B-R)

Class I recommendation (LOE B-R)

  • Use of dual antiplatelet therapy for at least 12 months in patients with ACS
  • BRILINTA as a treatment option in patients with ACS who undergo stent implantation or who are managed with medical therapy alone

Real-world evidence

45,000 patients studied from a real-world registry confirmed the significant reductions in CV events for BRILINTA vs clopidogrel seen in the PLATO trial4,5

  • The trial was conducted only in Sweden, and there may be differences between Swedish and US populations and treatment practices4

*Among P2Y12 inhibitors. Based on monthly market share performance in the STEMI PCI subsegment of ACS patient OAP initiation data for all hospitals within the IMS dataset, as of November 2016. Source: IMS: Charge Data Master (CDM) OAP Patient Data, November 2016.

Class of recommendation and level of evidence

  • Class I recommends that the procedure/treatment should be performed/administered
  • Class IIa states that it is reasonable to perform procedure/administer treatment
  • Level B-R is moderate-quality evidence from 1 or more RCTs or meta-analyses of moderate-quality RCTs

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

CONTRAINDICATIONS

  • 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
  • Ticagrelor can cause ventricular pauses. Bradyarrhythmias including AV block have been reported in the post-marketing setting. PLATO and PEGASUS excluded patients at increased risk of bradyarrhythmias not protected by a pacemaker, and they may be at increased risk of developing bradyarrhythmias with ticagrelor
  • 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

ADVERSE REACTIONS

  • 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%)

DRUG INTERACTIONS

  • 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
  • As with other oral P2Y12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of ticagrelor. Consider use of a parenteral anti-platelet in ACS patients requiring co-administration
  • 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

INDICATIONS

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.

DOSING

In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily. Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.

Please read Medication Guide and Prescribing Information, including Boxed WARNINGS, for BRILINTA.