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 ischemic complications of unstable angina 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 of  claim 121  wherein the administration is continued for a minimum of two days.  
   
   
       123 . A method of  claim 121  wherein the administration is continued for approximately 2-8 days.  
   
   
       124 . A method of  claim 121  wherein the administration is continued for approximately 2-12.5 days.  
   
   
       125 . A method for the treatment of ischemic complications of unstable angina in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily.  
   
   
       126 . A method of  claim 125  wherein the administration is continued for a minimum of two days.  
   
   
       127 . A method of  claim 125  wherein the administration is continued for approximately 2-8 days.  
   
   
       128 . A method of  claim 125  wherein the administration is continued for approximately 2-12.5 days.  
   
   
       129 . A method for the prevention of ischemic complications of non-Q-wave myocardial infarction in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily.  
   
   
       130 . A method of  claim 129  wherein the administration is continued for a minimum of two days.  
   
   
       131 . A method of  claim 129  wherein the administration is continued for approximately 2-8 days.  
   
   
       132 . A method of  claim 129  wherein the administration is continued for approximately 2-12.5 days.  
   
   
       133 . A method for the treatment of ischemic complications of non-Q-wave myocardial infarction in a human patient with severe renal impairment, comprising administering to said patient 1 mg/kg of enoxaparin sodium by subcutaneous injection once daily.  
   
   
       134 . A method of  claim 133  wherein the administration is continued for a minimum of two days.  
   
   
       135 . A method of  claim 133  wherein the administration is continued for approximately 2-8 days.  
   
   
       136 . A method of  claim 133  wherein the administration is continued for approximately 2-12.5 days.  
   
   
       137 . A method for the prevention of ischemic complications of unstable angina 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 aspirin.  
   
   
       138 . A method of  claim 137  wherein the administration of enoxaparin sodium is continued for a minimum of two days.  
   
   
       139 . A method of  claim 137  wherein the administration of enoxaparin sodium is continued for approximately 2-8 days.  
   
   
       140 . A method of  claim 137  wherein the administration of enoxaparin sodium is continued for approximately 2-12.5 days.  
   
   
       141 . A method of  claim 137  wherein approximately 100 to 325 mg of aspirin is administered daily.  
   
   
       142 . A method for the treatment of ischemic complications of unstable angina 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 aspirin.  
   
   
       143 . A method of  claim 142  wherein the administration of enoxaparin sodium is continued for a minimum of two days.  
   
   
       144 . A method of  claim 142  wherein the administration of enoxaparin sodium is continued for approximately 2-8 days.  
   
   
       145 . A method of  claim 142  wherein the administration of enoxaparin sodium is continued for approximately 2-12.5 days.  
   
   
       146 . A method of  claim 142  wherein approximately 100 to 325 mg of aspirin is administered daily.  
   
   
       147 . A method for the prevention of ischemic complications of non-Q-wave myocardial infarction 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 aspirin.  
   
   
       148 . A method of  claim 147  wherein the administration of enoxaparin sodium is continued for a minimum of two days.  
   
   
       149 . A method of  claim 147  wherein the administration of enoxaparin sodium is continued for approximately 2-8 days.  
   
   
       150 . A method of  claim 147  wherein the administration of enoxaparin sodium is continued for approximately 2-12.5 days.  
   
   
       151 . A method of  claim 147  wherein approximately 100 to 325 mg of aspirin is administered daily.  
   
   
       152 . A method for the treatment of ischemic complications of non-Q-wave myocardial infarction 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 aspirin.  
   
   
       153 . A method of  claim 152  wherein the administration of enoxaparin sodium is continued for a minimum of two days.  
   
   
       154 . A method of  claim 152  wherein the administration of enoxaparin sodium is continued for approximately 2-8 days.  
   
   
       155 . A method of  claim 152  wherein the administration of enoxaparin sodium is continued for approximately 2-12.5 days.  
   
   
       156 . A method of  claim 152  wherein approximately 100 to 325 mg of aspirin is administered daily.