Indicated for:

Acute Coronary Syndrome or a History of Myocardial Infarction:

• To reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. 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 treatment of ACS.

Use BRILINTA with a daily maintenance dose of aspirin of 75 to 100 mg.

Initiate treatment with a 180 mg loading dose of BRILINTA. Administer 90 mg of BRILINTA twice daily during the first year after an ACS event. After one year, administer 60 mg of BRILINTA twice daily.

Coronary Artery Disease but No Prior Stroke or Myocardial Infarction:

• 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 BRILINTA was established in a population with type 2 diabetes mellitus (T2DM).

Administer 60 mg of BRILINTA twice daily. For all patients with ACS.

Use BRILINTA with a daily maintenance dose of aspirin of 75 to 100 mg.

Acute Ischemic Stroke or Transient Ischemic Attack (TIA):

To reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high risk transient ischemic attack (TIA).

Initiate treatment with a 180 mg loading dose of BRILINTA and then continue with 90 mg twice daily for up to 30 days. The treatment effect accrued early in the course of therapy

Use BRILINTA with a loading dose of aspirin (300 to 325 mg) and a daily maintenance dose of aspirin of 75 to 100 mg.

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 (CABG).

If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events.

If BRILINTA must be temporarily discontinued (e.g., to treat bleeding or for significant surgery), restart it as soon as possible. When possible, interrupt therapy with BRILINTA for five days prior to surgery that has a major risk of bleeding. Resume BRILINTA as soon as hemostasis is achieved.

Discontinuation of BRILINTA will increase the risk of myocardial infarction, stroke, and death in patients being treated for coronary artery disease. If BRILINTA must be temporarily discontinued (e.g., to treat bleeding or for significant surgery), restart it as soon as possible. When possible, interrupt therapy with BRILINTA for five days prior to surgery that has a major risk of bleeding. Resume BRILINTA as soon as hemostasis is achieved.

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.

Maintenance doses of aspirin above 100 mg daily reduce the effectiveness of BRILINTA and should be avoided.

Patients at NIHSS >5 and patients receiving thrombolysis were excluded from THALES and use of BRILINTA in such patients is not recommended.

In clinical trials, about 14% of patients treated with BRILINTA developed dyspnea.

BRILINTA can cause ventricular pauses. Bradyarrhythmias including AV block have been reported in the postmarketing setting. Patients with a history of sick sinus syndrome, 2nd or 3rd degree AV block or bradycardia-related syncope not protected by a pacemaker were excluded from clinical studies and 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.

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. If central sleep apnea is suspected, consider further clinical assessment.

Gout occurred more commonly in patients on BRILINTA than in patients on aspirin alone.

BRILINTA is contraindicated in:

• patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population
• patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage

Do not administer BRILINTA with another oral P2Y12 platelet inhibitor.

Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse effects. Avoid simvastatin and lovastatin doses greater than 40 mg.

Strong CYP3A inhibitors substantially increase ticagrelor exposure and so increase the risk of dyspnea, bleeding, and other adverse events. Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin).

Strong CYP3A inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor. Avoid use with strong inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine and phenobarbital).

As with other oral P2Y12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of ticagrelor and its active metabolite presumably because of slowed gastric emptying. Consider the use of a parenteral anti-platelet agent in acute coronary syndrome patients requiring co-administration of morphine or other opioid agonists. 

BRILINTA inhibits the P-glycoprotein transporter; monitor digoxin levels with initiation of or change in BRILINTA therapy.

Drugs that inhibit platelet function including BRILINTA increase the risk of bleeding.

BRILINTA has been reported to cause false negative results in platelet functional tests (to include, but may not be limited to, the heparin-induced platelet aggregation (HIPA) assay) for patients with Heparin Induced Thrombocytopenia (HIT).

There are no adequate and well-controlled studies of BRILINTA use in pregnant women. In animal studies, ticagrelor caused structural abnormalities.

Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from BRILINTA, a decision should be made whether to discontinue nursing or to discontinue BRILINTA.

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• Adult dosage greater than 90 mg twice a day. GoToSource

• Use in patients under the age of 18. GoToSource

• Symptomatic atherosclerosis. GoToSource

• Peripheral artery disease. GoToSource

⚠️  Patients with CYP4F2 gene variation had higher antiplatelet effect of ticagrelor and had more frequent nonprocedural bleeding during ticagrelor therapy.

Dyspnea (difficulty breathing). GoToSource

Angioedema (swelling). GoToSource

Hypotension (low blood pressure), syncope (loss of consciousness) and ventricular pauses. GoToSource 

Bradycardia (slow heart rate), gynecomastia (enlarged male breast tissue), increased serum uric acid and creatinine levels. GoToSource 

Hematuria (blood in urine), intracranial hemorrhage including subdural or other hematoma (bleeding inside the skull), subcutaneous, ecchymosis, epistaxis (nosebleed), retroperitoneal hematoma or hemorrhage (bleeding in the muscle and tissues behind the abdominal wall cavity) and gastrointestinal and anal bleed. GoToSource

Lawsuits filed for bleeding, heart attacks and strokes.