Administration of enoxaparin sodium to patients with severe renal impairment

Abstract

Methods having novel enoxaparin sodium dosing regimens for patients with severe renal impairment are disclosed. The methods may be used for one or more of preventing thrombotic episodes, treating thrombotic episodes, preventing postoperative venous thrombosis, controlling thrombosis and/or decreasing blood hypercoagulation and/or hemorrhaging risks, treating unstable angina, and treating non-Q-wave myocardial infarction in human patients with severe renal impairment. The methods of preventing thrombotic episodes, treating thrombotic episodes, preventing postoperative venous thrombosis, and controling thrombosis and/or decreasing blood hypercoagulation and/or hemorrhaging risks, comprise administering from more than 20 mg to less than 40 mg, from 25 mg to 35 mg, about 30 mg, or 30 mg of enoxaparin sodium to the patient once daily. The methods of treating unstable angina, and non-Q-wave myocardial infarction, comprise administering from more than 0.5 mg/kg body weight to less than 1.5 mg/kg body weight, or about 1 mg/kg body weight of enoxaparin sodium once daily. Articles of manufacture comprising enoxaparin sodium and instructions for the use of the enoxaprin sodium are also disclosed.

1 - 120 . (canceled)  
   
   
       121 . A method for the prevention of acute deep vein thrombosis with pulmonary embolism in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily.  
   
   
       122 . A method as recited in  claim 121  wherein the administration is continued for a minimum of 5 days.  
   
   
       123 . A method as recited in  claim 122  wherein the administration is continued for about 7 days.  
   
   
       124 . A method for the prevention of acute deep vein thrombosis without pulmonary embolism, in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily.  
   
   
       125 . A method as recited in  claim 124  wherein the administration is continued for a minimum of 5 days.  
   
   
       126 . A method as recited in  claim 125  wherein the administration is continued for about 7 days.  
   
   
       127 . A method for the prevention of acute deep vein thrombosis with pulmonary embolism in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily and concurrently administering warfarin sodium.  
   
   
       128 . A method as recited in  claim 127  wherein the administration of warfarin sodium is initiated within about 72 hours of the initiation of the administration of enoxaparin sodium.  
   
   
       129 . A method as recited in  claim 127  wherein the administration of enoxaparin sodium is continued for a minimum of 5 days.  
   
   
       130 . A method as recited in  claim 129  wherein the administration of enoxaparin sodium is continued for about 7 days.  
   
   
       131 . A method for the prevention of acute deep vein thrombosis without pulmonary embolism, in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily and concurrently administering warfarin sodium.  
   
   
       132 . A method as recited in  claim 131  wherein the administration of warfarin sodium is initiated within about 72 hours of the initiation of the administration of enoxaparin sodium.  
   
   
       133 . A method as recited in  claim 131  wherein the administration of enoxaparin sodium is continued for a minimum of 5 days.  
   
   
       134 . A method as recited in  claim 133  wherein the administration of enoxaparin sodium is continued for about 7 days.  
   
   
       135 . A method for the treatment of acute deep vein thrombosis with pulmonary embolism in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily.  
   
   
       136 . A method as recited in  claim 135  wherein the administration is continued for a minimum of 5 days.  
   
   
       137 . A method as recited in  claim 136  wherein the administration is continued for about 7 days.  
   
   
       138 . A method for the treatment of acute deep vein thrombosis without pulmonary embolism, in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily.  
   
   
       139 . A method as recited in  claim 138  wherein the administration is continued for a minimum of 5 days.  
   
   
       140 . A method as recited in  claim 139  wherein the administration is continued for about 7 days.  
   
   
       141 . A method for the treatment of acute deep vein thrombosis with pulmonary embolism in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily and concurrently administering warfarin sodium.  
   
   
       142 . A method as recited in  claim 141  wherein the administration of warfarin sodium is initiated within about 72 hours of the initiation of the administration of enoxaparin sodium.  
   
   
       143 . A method as recited in  claim 141  wherein the administration of enoxaparin sodium is continued for a minimum of 5 days.  
   
   
       144 . A method as recited in  claim 143  wherein the administration of enoxaparin sodium is continued for about 7 days.  
   
   
       145 . A method for the treatment of acute deep vein thrombosis without pulmonary embolism, in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily and concurrently administering warfarin sodium.  
   
   
       146 . A method as recited in  claim 145  wherein the administration of warfarin sodium is initiated within about 72 hours of the initiation of the administration of enoxaparin sodium.  
   
   
       147 . A method as recited in  claim 145  wherein the administration of enoxaparin sodium is continued for a minimum of 5 days.  
   
   
       148 . A method as recited in  claim 147  wherein the administration of enoxaparin sodium is continued for about 7 days.