View source for Brilinta tablet/warnings

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{{BlackBoxTemplate|blackBoxWarningTitle=WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS|blackBoxWarningBody=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 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.

B. 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.}}

===Warnings===

====General Risk of Bleeding====

Drugs that inhibit platelet function including BRILINTA increase the risk of bleeding. BRILINTA increased the overall risk of bleeding (Major + Minor) to a somewhat greater extent than did [[clopidogrel]]. The increase was seen for non-CABG-related bleeding, but not for CABG-related bleeding. Fatal and life-threatening bleeding rates were not increased ''(see [[Brilinta tablet/adverse reactions|Adverse Reactions]])''.

In general, 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 (e.g., [[anticoagulant]] and [[fibrinolytic]] therapy, higher doses of [[aspirin]], and chronic nonsteroidal anti-inflammatory drugs [[[NSAIDS]]]).

When possible, discontinue BRILINTA five days prior to surgery. Suspect bleeding in any patient who is hypotensive and has recently undergone coronary [[angiography]], [[PCI]], [[CABG]], or other surgical procedures, even if the patient does not have any signs of bleeding.

If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events [see Warnings and Precautions (5.5) and [[Brilinta tablet/adverse reactions|Adverse Reactions]]).

====Concomitant Aspirin Maintenance Dose====

In [[PLATO]], use of BRILINTA with maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Therefore, after the initial loading dose of aspirin (usually 325 mg), use BRILINTA with a maintenance dose of [[aspirin]] of 75-100 mg (see [[Brilinta tablet/adult indications and dosage|Adult indications and dosage]] and ([[Brilinta tablet/clinical studies|Clinical studies]])

====Moderate 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====

In [[PLATO]], [[dyspnea]] was reported in 14% of patients treated with BRILINTA and in 8% of patients taking [[clopidogrel]]. [[dyspnea]] was usually mild to moderate in intensity and often resolved during continued treatment, but occasionally required discontinuation (0.9% of patients taking BRILINTA versus 0.1% of patients taking clopidogrel). If a patient develops new, prolonged, or worsened [[dyspnea]] during treatment with BRILINTA, exclude underlying diseases that may require treatment. If [[dyspnea]] is determined to be related to BRILINTA, no specific treatment is required; continue BRILINTA without interruption. In the case of intolerable [[dyspnea]] requiring discontinuation of BRILINTA, consider prescribing another antiplatelet agent.

In a substudy, 199 patients from PLATO underwent pulmonary function testing irrespective of whether they reported [[dyspnea]]. There was no significant difference between treatment groups for FEV1. There was no indication of an adverse effect on pulmonary function assessed after one month or after at least 6 months of chronic treatment.

====Discontinuation of BRILINTA====

Avoid interruption of BRILINTA treatment. If BRILINTA must be temporarily discontinued (e.g., to treat bleeding or for elective surgery), restart it as soon as possible. Discontinuation of BRILINTA will increase the risk of [[myocardial infarction]], [[stent thrombosis]], and death.

====Strong Inhibitors of Cytochrome CYP3A====

Ticagrelor is metabolized by [[CYP3A]]4/5. Avoid use with strong [[CYP3A]] inhibitors, such as [[atazanavir]], [[clarithromycin]], [[indinavir]], [[itraconazole]], [[ketoconazole]], [[nefazodone]], [[nelfinavir]], [[ritonavir]], [[saquinavir]], [[telithromycin]] and [[voriconazole]] (see [[Brilinta tablet/drug interactions|Drug interactions]] and [[Brilinta tablet/pharmacology|pharmacology]]).

====Cytochrome CYP3A Potent Inducers====

Avoid use with potent [[CYP3A]] inducers, such as [[rifampin]], [[dexamethasone]], [[phenytoin]], [[carbamazepine]], and [[phenobarbital]] (see [[Brilinta tablet/drug interactions|Drug interactions]] and [[Brilinta tablet/pharmacology|pharmacology]]).

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