When choosing an OAP, consider these select differences

PRODUCT PRESCRIBING INFORMATION

BRILINTA1

Clopidogrel2

Prasugrel3

In patients with ACS: Reduction in CV death without qualifications

According to the prasugrel label, the difference in the composite efficacy endpoint between prasugrel and clopidogrel was driven predominantly by MI, with no difference on strokes, and little difference on CV death.3

✔

✖

✖

Indicated in NSTE-ACS for patients who are managed with medical therapy alone*

✔

✔

✖

Indicated in STEMI PCI

BRILINTA is indicated to reduce the risk of thrombotic CV events and stent thrombosis in patients with ACS who have been stented. Since 2016, clopidogrel is no longer indicated for STEMI patients who are managed with PCI.2,4

✔

✖

✔

Indicated for patients with ACS or with a history of MI

Prasugrel is only indicated for patients with ACS who are to be managed with PCI.3

✔

✔

✖

Indicated to reduce the risk of a first MI or stroke in patients with CAD at high risk for such events

While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes.1

✔

✖

✖

Indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIHSS score ≤5) or high-risk TIA

After acute ischemic stroke (NIHSS ≤5) or high-risk TIA, BRILINTA is the only P2Y12 inhibitor indicated for early initiation within 24 hours in the acute setting.1,2†

✔

✖

✖

Not impacted by genetic variability‡

Up to 1 in 7 patients is a poor CYP2C19 metabolizer.§ Poor metabolizers of clopidogrel have diminished antiplatelet effect, therefore another P2Y12 inhibitor should be considered.2

✔

✖

✔

PRODUCT PRESCRIBING INFORMATION

In patients with ACS: Reduction in CV death without qualifications

According to the prasugrel label, the difference in the composite efficacy endpoint between prasugrel and clopidogrel was driven predominantly by MI, with no difference on strokes, and little difference on CV death.3

BRILINTA1

Clopidogrel2

Prasugrel3

✔

✖

✖

Indicated in NSTE-ACS for patients who are managed with medical therapy alone*

BRILINTA1

Clopidogrel2

Prasugrel3

✔

✔

✖

Indicated in STEMI PCI

BRILINTA is indicated to reduce the risk of thrombotic CV events and stent thrombosis in patients with ACS who have been stented. Since 2016, clopidogrel is no longer indicated for STEMI patients who are managed with PCI.2,4

BRILINTA1

Clopidogrel2

Prasugrel3

✔

✖

✔

Indicated for patients with ACS or with a history of MI

Prasugrel is only indicated for patients with ACS who are to be managed with PCI.3

BRILINTA1

Clopidogrel2

Prasugrel3

✔

✔

✖

Indicated to reduce the risk of a first MI or stroke in patients with CAD at high risk for such events

While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes.1

BRILINTA1

Clopidogrel2

Prasugrel3

✔

✖

✖

Indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIHSS score ≤5) or high-risk TIA

After acute ischemic stroke (NIHSS ≤5) or high-risk TIA, BRILINTA is the only P2Y12 inhibitor indicated for early initiation within 24 hours in the acute setting.1,2†

BRILINTA1

Clopidogrel2

Prasugrel3

✔

✖

✖

Not impacted by genetic variability‡

Up to 1 in 7 patients is a poor CYP2C19 metabolizer.§ Poor metabolizers of clopidogrel have diminished antiplatelet effect, therefore another P2Y12 inhibitor should be considered.2

BRILINTA1

Clopidogrel2

Prasugrel3

✔

✖

✔

Additional important considerations in patients with ACS

BRILINTA IS NOT RESTRICTED BY:

  • Previous clopidogrel loading or maintenance dose
  • Patient age or weight
  • Medical or invasive management*
  • Prior TIA/ischemic stroke
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OTHER IMPORTANT TREATMENT CONSIDERATIONS

include contraindications, patient bleeding risk, comorbid conditions, other concomitant medications, and overall health status

*PLATO included both medical and invasive (PCI or CABG) treatment approaches. Patients who received fibrinolytic therapy within the previous 24 hours or who had a need for chronic oral anticoagulation therapy were excluded.5

†Clopidogrel is not indicated in patients with acute ischemic stroke. Clopidogrel is only indicated in patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke.2

‡CYP3A4 is the major enzyme responsible for ticagrelor metabolism and the formation of its major active metabolite.1

§CYP2C19 poor metabolizers are defined as patients who are homozygous for nonfunctional alleles (ie, 2 loss-of-function alleles) of the CYP2C19 gene. In a genetic substudy cohort of PLATO, the risk of thrombotic CV events in the BRILINTA arm did not depend on CYP2C19 loss of function status.1

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FDA narrowed the ACS indication for clopidogrel4

  • FDA has removed the reduction of CV death and death from the ACS indication for Plavix® (clopidogrel bisulfate) tablets
  • Plavix is not indicated in patients with STEMI undergoing PCI

2016 revisions to Plavix ACS indications‖

Plavix is indicated to reduce the rate of myocardial infarction and stroke For in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Plavix should be administered in conjunction with aspirin. Plavix has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.

Plavix is indicated to reduce the rate of myocardial infarction and stroke For in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Plavix should be administered in conjunction with aspirin. Plavix has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown. The optimal duration of Plavix therapy in ACS is unknown.

||Additions are shown as underlined text; deletions are shown as strikethrough text.

Plavix is a registered trademark of sanofi-aventis.

See complete information on changes to the Plavix Prescribing Information.

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ACC=American College of Cardiology; ACS=acute coronary syndrome; AHA=American Heart Association; CABG=coronary artery bypass graft; CAD=coronary artery disease; CV=cardiovascular; DAPT=dual antiplatelet therapy; FDA=Food and Drug Administration; MI=myocardial infarction; NIHSS=National Institutes of Health Stroke Scale; NSTE-ACS=non–ST-elevation acute coronary syndrome; OAP=oral antiplatelet; PCI=percutaneous coronary intervention; PLATO=PLATelet inhibition and patient Outcomes; STEMI=ST-elevation myocardial infarction; TIA=transient ischemic attack.

References
  1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
  2. Plavix® (clopidogrel bisulfate) [package insert]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; 2022.
  3. Effient® (prasugrel) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.
  4. Department of Health and Human Services. US Food and Drug Administration. Revised Plavix labeling. Published September 16, 2016. Accessed April 25, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020839Orig1s062,s064ltr.pdf
  5. Wallentin L, Becker RC, Budaj A, et al; PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-1057 and Supplementary Appendix.
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IMPORTANT SAFETY INFORMATION FOR BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

WARNING: 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

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 more frequently with BRILINTA than in patients treated with control agents. Dyspnea from BRILINTA is often self-limiting
  • In patients being treated for coronary artery disease, 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. Clinical trials excluded patients at increased risk of bradyarrhythmias not protected by a pacemaker, and they may be at increased risk of developing bradyarrhythmias
  • 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
  • Central sleep apnea (CSA) including Cheyne-Stokes respiration (CSR) has been reported in the post-marketing setting in patients taking ticagrelor, including recurrence or worsening of CSA/CSR following rechallenge
  • In patients with Heparin Induced Thrombocytopenia (HIT): False-negative results for HIT-related platelet functional tests, including the heparin-induced platelet aggregation (HIPA) assay, have been reported with BRILINTA. BRILINTA is not expected to impact PF4 antibody testing for HIT

ADVERSE REACTIONS

  • The most common adverse reactions (>5%) associated with the use of BRILINTA included bleeding and dyspnea

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 delays and reduces the absorption of ticagrelor. Consider the 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
  • Rosuvastatin plasma concentrations may increase because rosuvastatin is a breast cancer resistance protein (BCRP) substrate. Monitor for statin-related adverse effects
  • Monitor digoxin levels with initiation of, or change in, BRILINTA therapy

SPECIAL POPULATIONS

  • Lactation: Breastfeeding is not recommended

INDICATIONS

BRILINTA is indicated to reduce the risk 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 risk of stent thrombosis in patients who have been stented for the treatment of ACS.

BRILINTA is indicated 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 was established in a population with type 2 diabetes.

BRILINTA is indicated to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale Score ≤5) or high-risk transient ischemic attack (TIA).

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. However, in patients who have undergone PCI, consider single antiplatelet therapy with BRILINTA based on the evolving risk for thrombotic versus bleeding events.

In patients with CAD but no prior stroke or MI, administer 60 mg twice daily. Generally, use BRILINTA with a daily maintenance dose of aspirin of 75 mg to 100 mg.

In patients with acute ischemic stroke or high-risk TIA, initiate treatment with a 180-mg loading dose of BRILINTA and then continue with 90 mg twice daily for up to 30 days. Use BRILINTA with a loading dose of aspirin (300 mg to 325 mg) and a daily maintenance dose of aspirin of 75 mg to 100 mg.

Please read full Prescribing Information, including Boxed WARNING, and Medication Guide.

You may report side effects related to AstraZeneca products.

 

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