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brand brilinta 90 mg tablet

In stock Manufacturer ASTRAZENECA 00186077760
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Uses

Acute Coronary Syndrome

Ticagrelor is used in combination with aspirin to reduce the risk of thrombotic cardiovascular events (e.g., cardiovascular death, myocardial infarction [MI]) in patients with an acute coronary syndrome (unstable angina, non-ST-segment-elevation MI [ NSTEMI], or ST-segment-elevation MI [ STEMI]) who are to be managed medically or with an invasive strategy (percutaneous coronary intervention [PCI] with or without coronary artery stent placement, coronary artery bypass grafting [CABG]). In a large, randomized study (The Study of Platelet Inhibition and Patient Outcomes [PLATO]) in patients with an acute coronary syndrome (ACS), ticagrelor was more effective than clopidogrel in reducing the rate of the composite end point of cardiovascular death, MI, or stroke without increasing the risk of major bleeding over that observed with clopidogrel. The benefits of ticagrelor over clopidogrel consisted principally of reductions in cardiovascular death and MI; there was no difference in the rate of stroke. Ticagrelor also was associated with a reduction in the rate of stent thrombosis in those undergoing PCI and a reduction in death from any cause. In this and other clinical studies, ticagrelor was given in conjunction with aspirin therapy.

Dual-drug antiplatelet therapy with a P2Y12-receptor antagonist (e.g., clopidogrel, prasugrel, ticagrelor) and aspirin is part of the current standard of care in patients with ACS. The American College of Cardiology Foundation (ACCF), the American Heart Association (AHA), the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Chest Physicians (ACCP), and other experts recommend antiplatelet therapy with a P2Y12-receptor antagonist and aspirin for treatment and secondary prevention of ACS. These experts generally recommend ticagrelor or clopidogrel as the P2Y12-receptor antagonist in patients with ACS who are treated medically without stenting; because prasugrel has been studied principally in patients undergoing planned PCI, recommendations for the use of this drug are restricted to that population. In patients with ACS who are being managed medically, therapy with a P2Y12 receptor antagonist should be continued for up to 12 months, while aspirin should be continued indefinitely. In patients undergoing PCI with stent placement (bare-metal or drug-eluting), a loading dose of ticagrelor, clopidogrel, or prasugrel is recommended, followed by maintenance therapy with one of these agents for at least 12 months (unless the risk of bleeding outweighs the anticipated net benefit of therapy); aspirin also should be continued indefinitely in such patients.

The relative role of ticagrelor versus other P2Y12-receptor antagonists in the management of ACS remains to be fully established. While current ACCF/AHA guidelines make no recommendations regarding the P2Y12-receptor antagonist of choice, ACCP suggests the use of ticagrelor over clopidogrel in patients with ACS (who are or are not undergoing PCI). The European Society of Cardiology (ESC) generally recommends ticagrelor or prasugrel over clopidogrel in patients with non-ST-segment elevation ACS; according to ESC, clopidogrel should be considered an alternative in such patients unable to receive ticagrelor or prasugrel therapy. Other clinicians state that because of its reversibility and faster offset of action, ticagrelor may be preferred over the irreversible P2Y12-receptor antagonists (clopidogrel, prasugrel) in patients with ACS who are being managed with an early invasive strategy (e.g., those in whom coronary anatomy has not been determined and who are likely to undergo CABG); switching from clopidogrel or prasugrel to ticagrelor therapy 5-7 days prior to CABG is considered reasonable in such patients. Ticagrelor also may be a reasonable alternative in patients who are nonresponsive to clopidogrel based on studies demonstrating that ticagrelor not only inhibits platelet aggregation in clopidogrel nonresponders, but also produces greater inhibition of platelet aggregation than clopidogrel in patients who remain responsive to clopidogrel. When selecting an appropriate antiplatelet regimen for the management of patients with ACS, clinicians should consider individual risks of ischemia and bleeding as well as the specific characteristics (e.g., adverse effects, drug interaction potential) of the drugs.

The current indication for ticagrelor is based principally on an international, randomized, double-blind study (PLATO) in more than 18,000 patients hospitalized for ACS. The study compared efficacy and safety of ticagrelor versus clopidogrel in reducing the rate of death from vascular causes, nonfatal MI (excluding silent MI), or nonfatal stroke in these patients. Because the study was designed to evaluate patients at hospital presentation or diagnosis (''upstream''), patients with various types of ACS were enrolled, including those with NSTEMI in whom conservative or invasive management was planned and those with STEMI undergoing primary PCI. Approximately 50% of patients were pretreated with clopidogrel prior to randomization; PCI was performed in about 64% of the patients and approximately 10% underwent CABG. Within 24 hours of symptom onset and before PCI, patients received either ticagrelor (180-mg loading dose followed by 90 mg twice daily) or clopidogrel (300-mg loading dose followed by 75 mg daily) in addition to aspirin and other standard therapy; treatment was continued for at least 6 months up to a maximum of 12 months. Those undergoing PCI received an additional loading dose of study drug at the time of PCI (90 mg of ticagrelor if more than 24 hours had passed since the initial loading dose or 300 mg of clopidogrel at the investigator's discretion). Aspirin was administered to all patients in the study at a recommended loading dose of 160-500 mg and daily maintenance dosage of 75-100 mg; higher maintenance dosages (e.g., 325 mg daily for 6 months following stent placement) were permitted based on clinician judgment.

In the PLATO study, ticagrelor substantially reduced the rate of the primary composite end point of cardiovascular death, nonfatal MI, or nonfatal stroke compared with clopidogrel. The primary outcome occurred in 9.8% of patients receiving ticagrelor compared with 11.7% of those receiving clopidogrel, a relative risk reduction of 16%. The difference in treatment effect was apparent by 30 days and maintained throughout the 12-month study period. The benefit associated with ticagrelor was based on a reduction in the incidence of cardiovascular death and MI, but not stroke. Although the overall rate of stroke was similar between the treatment groups, hemorrhagic strokes were more frequent in patients receiving ticagrelor. Among patients who received a coronary artery stent during the study, the rate of stent thrombosis was substantially lower with ticagrelor than with clopidogrel regardless of the type of stent (bare-metal or drug-eluting) implanted. In addition, death from any cause was reduced with ticagrelor (1.4% absolute reduction, 22% relative reduction). Some experts state, however, that additional study is needed to confirm this mortality benefit since all-cause mortality was not evaluated as a primary outcome in the PLATO study. The overall rate of major bleeding was similar for patients who received ticagrelor or clopidogrel; however, ticagrelor was associated with a higher incidence of non-CABG related major bleeding, including fatal intracranial bleeding.

In the PLATO study, clinical outcomes with ticagrelor generally were consistent across subgroups of patients with ACS regardless of whether a conservative or invasive management strategy was employed and regardless of the type of antiplatelet therapy received prior to the index ACS event. However, the benefits of ticagrelor appeared to be reduced in patients enrolled in North America compared with those enrolled in other regions. Results of additional statistical analyses of a variety of baseline and procedural differences between the US and non-US regions identified aspirin maintenance dosage as a possible factor accounting for this regional discrepancy. These analyses showed that ticagrelor was associated with a more favorable response than clopidogrel in patients receiving low (100 mg or less daily) maintenance dosages of aspirin. This was seen in both US and non-US patients; however, substantially more (about 54%) US patients were treated with aspirin dosages exceeding 300 mg daily, whereas patients in other countries rarely (only about 2% of patients) received such high aspirin dosages. Because of inherent limitations of subgroup analyses and the possibility that the effect of aspirin dosage on ticagrelor outcome could be due to chance, these findings should be interpreted with caution. Nevertheless, the manufacturer states that aspirin dosage should be limited to 75-100 mg daily in patients receiving ticagrelor; higher dosages do not have an established benefit in the management of ACS and may be associated with reduced efficacy of ticagrelor.

Dosage and Administration

Administration

Ticagrelor is administered orally without regard to meals. If a dose is missed, the next dose should be taken at the regularly scheduled time; the dose should not be doubled unless directed by the prescribing clinician.

Prescribing and Dispensing Precautions

Prescribing and dispensing errors have been reported because of similarities in the spelling and pronunciation of Brilinta (the trade name for ticagrelor) and Brintellix (the former trade name for vortioxetine hydrobromide, an antidepressant agent). To avoid such errors, the manufacturer of Brintellix changed the trade name for vortioxetine hydrobromide from Brintellix to Trintellix, which became commercially available in June 2016.(See Prescribing and Dispensing Precautions under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

Dosage

Acute Coronary Syndrome

For the reduction of thrombotic cardiovascular events in patients with an acute coronary syndrome (ACS), an initial ticagrelor loading dose of 180 mg is recommended, followed by a maintenance dosage of 90 mg twice daily. Aspirin should be administered concomitantly, with an initial loading dose (usually 325 mg) followed by a maintenance dosage of 75-100 mg daily.(See Adjunctive Aspirin Therapy under Dosage: Acute Coronary Syndrome, in Dosage and Administration.)

The manufacturer makes no specific recommendations regarding duration of ticagrelor therapy; however, the drug was administered for up to 12 months in the PLATO study. In general, long-term antiplatelet therapy is recommended in patients with coronary artery stents to prevent ischemic events. The American Heart Association (AHA), American College of Cardiology Foundation (ACCF), and other experts recommend continuation of dual-drug antiplatelet therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor) for at least 12 months following placement of a bare-metal or drug-eluting stent.

Switching Therapy from Clopidogrel to Ticagrelor

Patients may be transitioned directly from clopidogrel to ticagrelor therapy without interruption in antiplatelet effects. In clinical trials, patients who were switched from clopidogrel to ticagrelor received an initial loading dose of ticagrelor regardless of whether a previous loading dose of clopidogrel was given. Therefore, the manufacturer states that patients who have already received a loading dose of clopidogrel may subsequently receive ticagrelor at the recommended dosage (initial loading dose of 180 mg, followed by 90 mg twice daily).

Adjunctive Aspirin Therapy

Adjunctive antithrombotic therapy with aspirin is recommended in all patients with ACS, including those undergoing percutaneous coronary intervention (PCI). Aspirin should be administered as soon as possible after hospital presentation and continued indefinitely in those who are able to tolerate it. For additional information on use of aspirin as adjunctive antithrombotic therapy in the management of ACS, and also .

The optimal maintenance dosage of aspirin in patients with ACS has not been established; recommendations vary from 75-162 mg daily in current clinical practice guidelines. However, since aspirin dosages exceeding 100 mg daily have been associated with reduced effectiveness of ticagrelor, the manufacturer recommends that ticagrelor be administered with aspirin maintenance dosages of 75-100 mg daily. (See Uses: Acute Coronary Syndrome and also see Reduced Efficacy with Higher Aspirin Dosages under Warnings/Precautions: Warnings, in Cautions.)

Discontinuance in Patients Undergoing Invasive Procedures

Antiplatelet agents generally should be discontinued prior to surgery or other invasive procedures to minimize the risk of perioperative bleeding. Whenever feasible, ticagrelor should be discontinued at least 5 days prior to any surgery (e.g., coronary artery bypass grafting [CABG]) and resumed as soon as possible. If urgent CABG is required, ACCF and AHA state that ticagrelor should be discontinued at least 24 hours before the procedure. In the PLATO study, ticagrelor was discontinued 24-72 hours prior to CABG surgery and was associated with bleeding rates comparable to those observed with clopidogrel being withheld for 5 days.

The American College of Chest Physicians (ACCP) states that the decision to interrupt antiplatelet therapy prior to surgery or other invasive procedures should be individualized based on assessment of the patient's risks of thromboembolism and perioperative bleeding. The possible increased risk of stent thrombosis also should be considered when making decisions regarding the perioperative management of patients with coronary artery stents.(See Discontinuance of Therapy under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

Special Populations

No dosage adjustments are necessary in patients with renal impairment or mild hepatic impairment (Child-Pugh class A).(See Hepatic Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Dosage adjustments based on body weight, ethnicity, gender, age, or smoking status are not required.

Cautions

Contraindications

History of intracranial hemorrhage.

Active pathologic bleeding (e.g., peptic ulcer, intracranial hemorrhage).

Severe hepatic impairment.

Warnings/Precautions

Warnings

Bleeding

Like other antiplatelet agents, ticagrelor increases the risk of bleeding, which may be serious and sometimes fatal. When all major and minor bleeding events are considered, the overall risk of bleeding is somewhat greater with ticagrelor than with clopidogrel. The increased risk principally involves major bleeding events not related to coronary artery bypass grafting (CABG). In the PLATO study, total (major and minor) non-CABG-related bleeding occurred in 8.7% of patients who received ticagrelor compared with 7% of those who received clopidogrel. In addition, there was a small but statistically significant increase in the rate of fatal intracranial bleeding with ticagrelor versus clopidogrel; fatal bleeding of other types was not increased. Many of the bleeding events occurred early, at the time of coronary angiography, percutaneous coronary intervention (PCI), CABG, or other procedures, but the risk persisted throughout therapy.

Although major CABG-related bleeding occurred at a very high rate in the PLATO study, such bleeding rates were similar with ticagrelor or clopidogrel therapy. In addition, there was no difference in major bleeding between the treatment groups when antiplatelet therapy was discontinued 5 days or less prior to CABG surgery, suggesting that the pharmacokinetic advantages of ticagrelor (i.e., faster offset of action, reversibility) do not translate into a lower risk of bleeding in patients undergoing CABG.

Ticagrelor should not be used in patients who are actively bleeding or who have a history of intracranial hemorrhage.(See Cautions: Contraindications.) The drug also should not be initiated in patients who are likely to undergo urgent CABG. Risk factors for bleeding generally include advanced age, history of bleeding disorders, performance of percutaneous invasive procedures, and concurrent use of drugs that increase risk of bleeding (e.g., anticoagulants, thrombolytic agents, high dosages of aspirin, long-term use of nonsteroidal anti-inflammatory agents [NSAIAs]). Whenever possible, ticagrelor should be discontinued at least 5 days prior to surgery or other invasive procedures. Bleeding should be suspected in any patient receiving ticagrelor who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or any other invasive procedure, even if no overt manifestations of bleeding are present. If possible, bleeding should be managed without discontinuing ticagrelor since premature discontinuance of such therapy may be associated with an increased risk of subsequent cardiovascular events.(See Discontinuance of Therapy under Warnings/Precautions: Other Warnings and Precautions, in Cautions.)

Reduced Efficacy with Higher Aspirin Dosages

A reduced response to ticagrelor was observed in patients receiving aspirin maintenance dosages exceeding 100 mg daily in the PLATO study.(See Uses: Acute Coronary Syndrome.) After the initial loading dose, ticagrelor should be used in conjunction with an aspirin maintenance dosage of 75-100 mg daily; the manufacturer states that higher maintenance dosages should be avoided.(See Adjunctive Aspirin Therapy under Dosage: Acute Coronary Syndrome, in Dosage and Administration.)

Other Warnings and Precautions

Dyspnea

In clinical studies, dyspnea was reported more frequently with ticagrelor than with clopidogrel (13.8 versus 7.8% of patients, respectively, in the PLATO study). In most cases, dyspnea was mild to moderate in severity and resolved without further intervention. Although the mechanism of this adverse effect is unknown, it is thought to be an adenosine-mediated response. Ticagrelor does not appear to have adverse effects on cardiac or pulmonary function. Pulmonary function testing in a subset of patients from the PLATO study revealed no substantial difference in forced expiratory volume in 1 second (FEV1) in those who received ticagrelor versus those who received clopidogrel.

Patients who develop any new, prolonged, or worsening dyspnea during ticagrelor therapy should be evaluated to rule out any associated underlying conditions. If dyspnea appears to be related to ticagrelor, the manufacturer states that no specific treatment is required and the drug may be continued without interruption.

Discontinuance of Therapy

In general, treatment with ticagrelor should not be discontinued prematurely because this increases the risk of cardiovascular events. Premature discontinuance of antiplatelet therapy (e.g., P2Y12 adenosine diphosphate [ADP]-receptor antagonists, aspirin) in patients with coronary artery stents has been associated with an increased risk of ischemic cardiovascular events (e.g., stent thrombosis, myocardial infarction [MI], death). If temporary discontinuance of ticagrelor is necessary such as prior to elective surgery or for management of bleeding, the drug should be restarted as soon as possible.

Patients should be advised to never stop taking ticagrelor without first consulting the prescribing clinician, even if instructed by another clinician (e.g., dentist) to stop such therapy. Prior to scheduling an invasive procedure, patients should inform clinicians (including dentists) that they are currently taking ticagrelor and clinicians performing the invasive procedure should consult with the prescribing clinician before discontinuing such therapy.

Cardiovascular Effects

Bradyarrhythmias, including ventricular pauses, have occurred in patients receiving ticagrelor. In the PLATO study, Holter monitor-detected ventricular pauses of at least 3 seconds were reported more frequently during the first week of therapy in patients receiving ticagrelor than in those receiving clopidogrel (5.8 versus 3.6%, respectively). There was no difference in the overall risk of clinically important bradycardic effects (e.g., syncope, need for pacemaker insertion) between the treatment groups. Ventricular pauses were mostly asymptomatic and attributed to sinoatrial nodal suppression.

Patients with a baseline increased risk of bradycardia (e.g., those with sick sinus syndrome, second- or third-degree AV block, syncope due to bradycardia without a pacemaker) were excluded from the PLATO study; therefore, some clinicians recommend that ticagrelor be used with caution in such patients.

Prescribing and Dispensing Precautions

Because of similarities in the spelling and pronunciation of Brilinta (the trade name for ticagrelor) and Brintellix (the former trade name for vortioxetine hydrobromide, an antidepressant agent), prescribing and dispensing errors have been reported to FDA for these drugs. As of June 2015, FDA had received 50 medication error reports describing trade name confusion with Brilinta and Brintellix. In most cases, Brintellix was mistaken for Brilinta. The wrong drug was actually dispensed in 12 of the reported cases of name confusion; however, none of the reports indicated that a patient ingested the wrong drug. To avoid future prescribing and dispensing errors, FDA approved a change in the trade name for vortioxetine in May 2016; the manufacturer of Brintellix (vortioxetine hydrobromide) changed the trade name to Trintellix, which became commercially available under this trade name in June 2016. To reduce the risk of medication errors (e.g., during the transition period to the new name), FDA recommends that clinicians include both the trade (brand) and generic (nonproprietary) names of the drug and the indication for use as well as the correct dosage and directions for use in each prescription. In addition, patients should be advised to check their prescriptions to ensure that the correct drug was dispensed and to carefully read the medication guide provided with their prescriptions.

Specific Populations

Pregnancy

Category C.

Lactation

Ticagrelor is distributed into milk in rats; it is not known whether the drug or its metabolites are distributed into human milk. Because of the potential for serious adverse effects in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Pediatric Use

Safety and efficacy have not been established in patients younger than 18 years of age.

Geriatric Use

Of the total number of patients enrolled in the PLATO trial, 43% were 65 years of age or older and 15% were 75 years of age or older. No overall differences in efficacy or safety, including the risk of bleeding, were observed between geriatric and younger patients; however, increased sensitivity in some older individuals cannot be ruled out.

Age does not appear to substantially affect the pharmacokinetics of ticagrelor.

Hepatic Impairment

Ticagrelor has not been systematically evaluated in patients with moderate or severe hepatic impairment. Because the drug is metabolized by the liver, there is a potential for increased exposure and risk of bleeding in patients with impaired hepatic function. Ticagrelor is contraindicated in patients with severe hepatic impairment; use of the drug in those with moderate hepatic impairment should be considered carefully after weighing the risks and benefits of treatment.

Ticagrelor may be used in patients with mild hepatic impairment without the need for dosage adjustments. In a pharmacokinetic/pharmacodynamic study, systemic exposure to ticagrelor was slightly higher in individuals with mild (Child-Pugh class A) hepatic impairment compared with those with normal hepatic function; however, no clinically important effects of such impairment were observed.

Renal Impairment

No substantial differences in pharmacokinetics or clinical efficacy of ticagrelor have been observed in patients with renal impairment versus those with normal renal function.

Approximately 25% of patients enrolled in the PLATO study had chronic kidney disease (creatinine clearance less than 60 mL/minute); dosage reductions based on renal function were not required to prevent major bleeding. Data are lacking on the use of ticagrelor in patients undergoing dialysis.

Common Adverse Effects

Adverse effects reported in 3% or more of patients receiving ticagrelor in clinical studies include bleeding, dyspnea, headache, cough, dizziness, nausea, atrial fibrillation, hypertension, noncardiac chest pain, diarrhea, back pain, hypotension, fatigue, and chest pain.

Drug Interactions

Drugs Affecting Hemostasis

Risk of bleeding may be increased when ticagrelor is used concomitantly with drugs that affect hemostasis (e.g., anticoagulants, thrombolytics, high doses of aspirin, chronic nonsteroidal anti-inflammatory agents [NSAIAs]).(See Bleeding under Warnings/Precautions: Warnings, in Cautions.)

Efficacy of ticagrelor may be affected by aspirin maintenance dosage.(See Drug Interactions: Aspirin.)

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Ticagrelor is metabolized principally by the cytochrome P-450 (CYP) 3A4 isoenzyme, and to a lesser extent by CYP3A5. In vitro studies indicate that ticagrelor and its major active metabolite are weak inhibitors of CYP3A4/5 and potential activators of CYP3A5. Ticagrelor does not appear to inhibit CYP 1A2, 2C19, or 2E1.

Concomitant use of ticagrelor with potent CYP3A inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may result in substantially increased exposure to ticagrelor and possible increased risk of bleeding; such concomitant use should be avoided. Moderate CYP3A inhibitors (e.g., diltiazem) also may increase ticagrelor exposure, but to a lesser extent; therefore, these drugs may be used with ticagrelor without any dosage adjustments. Concomitant use of ticagrelor with potent inducers of CYP3A (e.g., carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin) may result in substantially reduced plasma concentrations and possible reduced efficacy of ticagrelor; such concomitant use should be avoided.

Ticagrelor may increase serum concentrations of drugs metabolized by CYP3A4 (e.g., lovastatin, simvastatin). In some cases, reduced dosages of the CYP3A4 substrate may be required.(See Drug Interactions: HMG-CoA Reductase Inhibitors [Statins].)

Drugs Affecting or Affected by P-glycoprotein Transport

Ticagrelor is a substrate and weak inhibitor of the P-glycoprotein transport system. Increased serum concentrations of P-glycoprotein substrates (e.g., digoxin) are possible when these drugs are used concomitantly with ticagrelor; appropriate laboratory and/or clinical monitoring is recommended.

Aspirin

When ticagrelor is used in conjunction with aspirin maintenance dosages exceeding 100 mg daily, efficacy of ticagrelor may be reduced.(See Reduced Efficacy with Higher Aspirin Dosages under Warnings/Precautions: Warnings, in Cautions)

Aspirin does not appear to substantially affect the pharmacokinetics of ticagrelor.

Desmopressin

Desmopressin does not appear to affect peak concentrations of or systemic exposure to ticagrelor; no dosage adjustment is necessary when these drugs are used concomitantly.

Digoxin

Concomitant administration of ticagrelor and digoxin did not substantially affect pharmacokinetics of digoxin; therefore, these drugs may be used concomitantly without dosage adjustments. However, because of the possibility of increased digoxin concentrations as a result of P-glycoprotein inhibition, serum digoxin concentrations should be monitored during initiation of and following any change in ticagrelor therapy.

HMG-CoA Reductase Inhibitors (Statins)

Concomitant administration of ticagrelor and simvastatin (a CYP3A4 substrate) resulted in substantially increased exposure to simvastatin and its active metabolite. If ticagrelor is used concomitantly with simvastatin or lovastatin, the manufacturer states that dosage of the statin should not exceed 40 mg daily.

Concomitant administration of ticagrelor and atorvastatin did not substantially affect the pharmacokinetics of atorvastatin; therefore, these drugs may be used concomitantly without dosage adjustments.

Ketoconazole

Concomitant use of ketoconazole 200 mg twice daily and ticagrelor substantially increased peak plasma concentrations of and systemic exposure to ticagrelor. Concomitant use of ticagrelor and ketoconazole should be avoided.

Oral Contraceptives

In healthy women receiving stable dosages of an oral contraceptive containing ethinyl estradiol and levonorgestrel, administration of ticagrelor (90 mg twice daily) increased peak plasma concentrations of and systemic exposure to the estrogen component, but did not alter the pharmacokinetics of levonorgestrel. Ticagrelor is not expected to affect contraceptive efficacy; therefore, no dosage adjustment is necessary when the drug is administered with levonorgestrel or ethinyl estradiol.

Proton-pump Inhibitors

Ticagrelor may be used concomitantly with proton-pump inhibitors. In a clinical study in patients with acute coronary syndrome (ACS), concomitant administration of ticagrelor with a proton-pump inhibitor did not affect the platelet response to ticagrelor.

Rifampin

Concomitant administration of ticagrelor and rifampin 600 mg once daily substantially decreased peak plasma concentrations of and systemic exposure to ticagrelor. Concomitant use of ticagrelor and rifampin should therefore be avoided.

Tolbutamide

Concomitant administration of ticagrelor and tolbutamide did not substantially affect pharmacokinetics of tolbutamide; therefore, the drugs may be used concomitantly without dosage adjustments.

Other Concomitant Therapy

Ticagrelor may be administered in conjunction with heparin, platelet glycoprotein (GP) IIb/IIIa-receptor inhibitors, β-adrenergic blocking agents, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II receptor antagonists.

Concomitant administration of ticagrelor with heparin or enoxaparin did not affect peak plasma concentrations of or systemic exposure to ticagrelor; therefore, no dosage adjustments are required when these drugs are used concomitantly.

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