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| __NOTOC__
| | #REDIRECT [[Prasugrel#Warnings]] |
| {{Prasugrel}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings And Precautions==
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| ===General Risk of Bleeding===
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| [[thienopyridines]] , including Effient, increase the risk of bleeding. With the dosing regimens used in TRITON-TIMI 38, [[TIMI]] (Thrombolysis in Myocardial Infarction) Major (clinically overt bleeding associated with a fall in hemoglobin ≥5 g/dL, or intracranial hemorrhage) and TIMI Minor (overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL) bleeding events were more common on Effient than on [[clopidogrel]] [see Adverse Reactions (6.1)]. The bleeding risk is highest initially, as shown inFigure 1 (events through 450 days; inset shows events through 7 days). | |
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| 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 overt signs of bleeding.
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| Do not use Effient in patients with active bleeding, prior TIA or stroke [see Contraindications (4.1, 4.2)].
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| Other risk factors for bleeding are:
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| *Age ≥75 years. Because of the risk of bleeding (including fatal bleeding) and uncertain effectiveness in patients ≥75 years of age, use of Effient is generally not recommended in these patients, except in high-risk situations (patients with diabetes or history of [[myocardial infarction]]) where its effect appears to be greater and its use may be considered [see Adverse Reactions (6.1), Use in Specific Populations (8.5), Clinical Pharmacology (12.3), and Clinical Trials (14)].
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| *[[CABG]] or other surgical procedure [see Warnings and Precautions (5.2)].
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| *Body weight <60 kg. Consider a lower (5-mg) maintenance dose [see Dosage and Administration (2), Adverse Reactions (6.1), and Use in Specific Populations (8.6)].
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| *Propensity to bleed (e.g., recent [[trauma]], recent surgery, recent or recurrent [[gastrointestinal]] ([[GI]]) bleeding, active peptic ulcer disease, severe [[hepatic impairment]], or moderate to severe [[renal impairment]]) [see Adverse Reactions (6.1) and Use in Specific Populations (8.7, 8.8)].
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| *Medications that increase the risk of bleeding (e.g., oral anticoagulants, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs], and fibrinolytic agents). [[Aspirin]] and [[heparin]] were commonly used in TRITON-TIMI 38 [see Drug Interactions (7.1, 7.2. 7.3), and Clinical Studies (14)].
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| [[thienopyridines]] inhibit platelet aggregation for the lifetime of the platelet (7-10 days), so withholding a dose will not be useful in managing a bleeding event or the risk of bleeding associated with an invasive procedure. Because the half-life of prasugrel's active metabolite is short relative to the lifetime of the platelet, it may be possible to restore [[hemostasis]] by administering exogenous platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.
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| ===Coronary Artery Bypass Graft Surgery-Related Bleeding===
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| The risk of bleeding is increased in patients receiving Effient who undergo [[CABG]] . If possible, Effient should be discontinued at least 7 days prior to [[CABG]] .
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| Of the 437 patients who underwent [[CABG]] during TRITON-TIMI 38, the rates of [[CABG]] -related TIMI Major or Minor bleeding were 14.1% in the Effient group and 4.5% in the [[clopidogrel]] group [see Adverse Reactions (6.1)]. The higher risk for bleeding events in patients treated with Effient persisted up to 7 days from the most recent dose of study drug. For patients receiving a thienopyridine within 3 days prior to [[CABG]] , the frequencies of TIMI Major or Minor bleeding were 26.7% (12 of 45 patients) in the Effient group, compared with 5.0% (3 of 60 patients) in the [[clopidogrel]] group. For patients who received their last dose of thienopyridine within 4 to 7 days prior to [[CABG]] , the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 89 patients) in the [[clopidogrel]] group.
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| Do not start Effient in patients likely to undergo urgent [[CABG]] . [[CABG]] -related bleeding may be treated with transfusion of blood products, including packed red blood cells and platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.
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| ===Discontinuation of Effient===
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| Discontinue [[thienopyridines]] , including Effient, for active bleeding, elective surgery, stroke, or [[TIA]]. The optimal duration of [[thienopyridine]]therapy is unknown. In patients who are managed with [[PCI]] and stent placement, premature discontinuation of any antiplatelet medication, including [[thienopyridines]] , conveys an increased risk of stent thrombosis, myocardial infarction, and death. Patients who require premature discontinuation of a [[thienopyridine]] will be at increased risk for cardiac events. Lapses in therapy should be avoided, and if [[thienopyridines]] must be temporarily discontinued because of an adverse event(s), they should be restarted as soon as possible [see Contraindications (4.1, 4.2) and Warnings and Precautions (5.1)].
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| ===Thrombotic Thrombocytopenic Purpura===
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| [[Thrombotic thrombocytopenic purpura]] ([[TTP]]) has been reported with the use of Effient. [[TTP]] can occur after a brief exposure (<2 weeks). [[TTP]] is a serious condition that can be fatal and requires urgent treatment, including [[plasmapheresis]] (plasma exchange). [[TTP]] is characterized by thrombocytopenia, microangiopathic hemolytic [[anemia]] (schistocytes [fragment red blood cells] seen on peripheral smear), neurological findings, renal dysfunction, and fever [see Adverse Reactions (6.2)].
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| ===Hypersensitivity Including Angioedema===
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| Hypersensitivity including [[angioedema]] has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other [[thienopyridines]] [see Contraindications (4.3) and Adverse Reactions (6.2)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5fe9c118-c44b-48d7-a142-9668ae3df0c6 | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5fe9c118-c44b-48d7-a142-9668ae3df0c6 | publisher = | date = | accessdate = 6 February 2014 }}</ref>
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| </div>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Antiplatelet drugs]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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