|
|
| (One intermediate revision by one other user not shown) |
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Desirudin#Adverse Reactions]] |
| {{Desirudin}}
| |
| {{CMG}}; {{AE}} {{SS}}
| |
| | |
| ==Adverse Reactions==
| |
| | |
| In the Phase II and III clinical studies, desirudin was administered to 2159 patients undergoing elective[[ hip replacement surgery]] to determine the safety and efficacy of Iprivask in preventing VTE in this population. Below is the safety profile of the Iprivask 15 mg (q12h) regimen from these 5 multicenter clinical trials.
| |
| | |
| ===Hemorrhagic Events===
| |
| | |
| The following rates of hemorrhagic events have been reported during clinical trials.
| |
| | |
| {|
| |
| |-
| |
| |[[File:Desirudin03.jpg|thumb|800px]]
| |
| |-
| |
| |}
| |
| | |
| <sup>a</sup> Includes hematomas which occurred at an incidence of 6% in the Iprivask and enoxaparin treatment groups and 5% in the heparin treatment group.
| |
| <sup>b</sup> Bleeding complications were considered serious if perioperative transfusion requirements exceeded 5 units of whole blood or packed red cells, or if total transfusion requirements up to postoperative Day 6 inclusive exceeded 7 units of whole blood or packed red cells, or total blood loss up to postoperative Day 6 inclusive exceeded 3500 mL.
| |
| <sub>c</sub> Bleeding complications were considered major if the hemorrhage was: (1) overt and it produced a fall in hemoglobin of ≥2g/dL or if it lead to a transfusion of 2 or more units of whole or packed cells outside the perioperative period (the time from start of surgery until up to 12 hours after); (2) Retroperitoneal, intracranial, intraocular, intraspinal, or occurred in a major prosthetic joint.
| |
| | |
| ===Non-hemorrhagic Events===
| |
| | |
| Non-hemorrhagic adverse events occurring at ≥2% incidence in patients treated with Iprivask 15 mg (q 12h) during elective[[ hip replacement surgery]] and considered to be remotely, possibly, or probably related to desirudin are provided below. ==
| |
| | |
| {|
| |
| |-
| |
| |[[File:Desirudin04.jpg|thumb|800px]]
| |
| |-
| |
| |}
| |
| | |
| <div>
| |
| <sup>a</sup> Represents events reported while on treatment, excluding unrelated adverse events
| |
| <sup>b</sup> All hemorrhages that occurred are included in ADVERSE REACTIONS, Hemorrhagic Events.
| |
| | |
| '''Related Adverse Events with a Frequency of <2% and >0.2% (in decreasing order of frequency)''': thrombosis, hypotension, leg edema, fever, decreased hemoglobin, hematuria, dizziness, epistaxis, vomiting, impaired healing, cerebrovascular disorder, leg pain, hematemesis.
| |
| | |
| '''Allergic Reactions'''. In clinical studies, allergic events were reported <2% overall and in 2% of patients who were administered 15 mg desirudin. (See PRECAUTIONS, General,Antibodies/ Re-exposure).
| |
| | |
| ===Post Marketing===
| |
| | |
| In addition to adverse events reported from clinical trials the following adverse events have been identified during post approval use of Iprivask. These events were reported voluntarily from a population of unknown size and the frequency of occurrence cannot be determined precisely: rare reports of major hemorrhages, some of which were fatal, and anaphylactic/anaphylactoid reactions.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = IPRIVASK (DESIRUDIN) KIT [MARATHON PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d768eca6-b25d-4aec-905f-b6a89e89ff29 | publisher = | date = | accessdate = 3 February 2014 }}</ref>
| |
| </div>
| |
| | |
| ==References==
| |
| | |
| {{Reflist|2}}
| |
| | |
| {{Antithrombotics}}
| |
| | |
| [[Category:Direct thrombin (II) inhibitors]]
| |
| [[Category:Anticoagulants]]
| |
| [[Category:Cardiovascular Drugs]]
| |
| {{WikiDoc Help Menu}}
| |
| {{WikiDoc Sources}}
| |