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| __NOTOC__
| | #REDIRECT [[Ticagrelor#Warnings]] |
| {{Ticagrelor}}
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| {{CMG}}; {{AE}} {{JH}}
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| ==Warnings and Precautions==
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| ===General Risk of Bleeding===
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| 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 [[Ticagrelor adverse reactions|Adverse Reactions]]]''.
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| 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]).
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| When possible, discontinue BRILINTA five days prior to surgery. Suspect bleeding in any patient who is [[hypotension|hypotensive]] and has recently undergone [[coronary angiography]], [[PCI]], [[CABG]], or other surgical procedures, even if the patient does not have any signs of bleeding.
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| If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events ''[see [[Ticagrelor warnings and precautions|Warnings and Precautions]] and [[Ticagrelor adverse reactions|Adverse Reactions]]]''.
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| ===Concomitant Aspirin Maintenance Dose===
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| 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 [[Ticagrelor dosage and administration|Dosage and Administration]] and [[Ticagrelor clinical studies|Clinical Studies]]]''.
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| ===Moderate Hepatic Impairment===
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| 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.
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| ===Dyspnea===
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| 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.
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| 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.
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| ===Discontinuation of BRILINTA===
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| 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.
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| ===Strong Inhibitors of Cytochrome CYP3A===
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| Ticagrelor is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
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| ===Cytochrome CYP3A Potent Inducers===
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| Avoid use with potent [[CYP3A]] inducers, such as [[rifampin]], [[dexamethasone]], [[phenytoin]], [[carbamazepine]], and [[phenobarbital]] ''[see [[Ticagrelor drug interactions|Drug Interactions]] and [[Ticagrelor clinical pharmacology|Clinical Pharmacology]]]''. <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = BRILINTA (TICAGRELOR) TABLET [ASTRAZENECA LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8 | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| [[Category:ADP receptor inhibitors]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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