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| | | #REDIRECT [[Tirofiban#Adverse Reactions]] |
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| __NOTOC__
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| {{Tirofiban}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| ===Clinical Trial Experience===
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| Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
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| In the PRISM (Platelet Receptor Inhibition for Ischemic Syndrome Management), PRISM-PLUS (Platelet Receptor Inhibition for Ischemic Syndrome Management — Patients Limited by Unstable Signs and Symptoms) and RESTORE (Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis) trials, 1946 patients received AGGRASTAT in combination with [[heparin]] and 2002 patients received AGGRASTAT alone for about 3 days. Forty-three percent of the population was >65 years of age and approximately 30% of patients were female. In clinical studies with the recommended regimen (25 mcg/kg bolus followed by a 0.15 mcg/kg/min maintenance infusion), AGGRASTAT was administered in combination with [[aspirin]], [[clopidogrel]] and [[heparin]] or [[bivalirudin]] to over 8000 patients for typically ≤24 hours. Approximately 30% of the population was >65 years of age and approximately 25% were female.
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| ====Bleeding====
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| PRISM-PLUS Regimen
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| The incidences of major and minor bleeding using the TIMI criteria in the PRISM-PLUS study are shown below.
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| |[[File:TIROFIBAN02.jpg|thumb|800px]]
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| The incidence rates of TIMI major bleeding in patients undergoing percutaneous procedures in PRISM-PLUS are shown below.
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| {|
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| |[[File:TIROFIBAN03.jpg|thumb|800px]]
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| The incidence rates of TIMI major bleeding in patients undergoing [[coronary artery bypass graft]] surgery ([[CABG]]) in PRISM-PLUS within one day of discontinuation of AGGRASTAT were 17% on AGGRASTAT plus [[heparin]] (N=29) and 35% on [[heparin]] alone (N=31).
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| ====Recommended (“High-Dose Bolus”) Regimen====
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| Rates of major bleeds (including any intracranial, intraocular or retroperitoneal [[hemorrhage]], clinically overt signs of [[hemorrhage]] associated with a drop in hemoglobin of >3 g/dL or any drop in hemoglobin by 4g/dL, bleeding requiring transfusion of >2U blood products, bleeding directly resulting in death within 7 days or hemodynamic compromise requiring intervention) were consistent with the rates observed in subjects administered the PRISM-PLUS regimen of AGGRASTAT. There was a trend toward greater bleeding in ST segment elevation myocardial infarction (STEMI) patients treated with [[fibrinolytics]] prior to administration of AGGRASTAT using the recommended regimen during rescue PCI.
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| ====Non-Bleeding====
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| The incidences of non-bleeding adverse events that occurred at an incidence of >1% and numerically higher than control, regardless of drug relationship, are shown below:
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| {|
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| |[[File:TIROFIBAN04.jpg|thumb|800px]]
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| ====Thrombocytopenia====
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| Patients treated with AGGRASTAT plus [[heparin]], were more likely to experience decreases in platelet counts than were those on [[heparin]] alone. These decreases were reversible upon discontinuation of AGGRASTAT. The percentage of patients with a decrease of platelets to <90,000/mm3 was 1.5%, compared with 0.6% in the patients who received [[heparin]] alone. The percentage of patients with a decrease of platelets to <50,000/mm3 was 0.3%, compared with 0.1% of the patients who received [[heparin]] alone.
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| ===Post-Marketing Experience===
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| The following additional adverse reactions have been identified during post-approval use of AGGRASTAT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure.
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| [[Hypersensitivity]]: Severe allergic reactions including [[anaphylactic reaction]]s have occurred during the first day of AGGRASTAT infusion, during initial treatment, and during readministration of AGGRASTAT. Some cases have been associated with severe [[thrombocytopenia]] (platelet counts <10,000/mm3). No information is available on the formation of antibodies to tirofiban.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f | publisher = | date = | accessdate = 6 February 2014 }}</ref>
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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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