Thenox Special Precautions

General precaution: Periodic complete blood cell counts, including platelet counts and stool occult blood tests are recommended during use of enoxaparin.
Routine monitoring of anti-Xa levels is not required but has been utilized in patients with obesity, and/or renal insufficiency. Anti-Xa level monitoring is recommended in pregnant women receiving enoxaparin for the prevention of thromboembolism with mechanical heart valves or receiving therapeutic dose of enoxaparin.
Specific populations: Low body weight: Increased exposure to enoxaparin has been observed in patients with low body weight (less than 45 kg in women or less than 57 kg in men); which may lead to a higher risk of bleeding. Therefore, such patients should be carefully monitored for signs and symptoms of bleeding.
Obese Patients: Obese patients are at higher risk for thromboembolism. Safety and efficacy of thromboprophylactic dosages of enoxaparin in patients with a body mass index (BMI) greater than 30 kg/m² have not been established and there is no consensus on how dosage should be adjusted in such patients. These patients should be closely monitored for signs and symptoms of thromboembolism.
Traceability: Enoxaparin is a biological product similar to other biological products. It is recommended for healthcare professionals record the trade name and batch number of the administered product in patients file to improve the product traceability.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINE: Enoxaparin has no or negligible influence on the ability to drive and use machines.
Renal impairment: Using enoxaparin with caution in patients with renal impairment since elimination of the drug may be delayed. Patients with renal impairment should be carefully monitored for signs and symptoms of bleeding. In addition, anti-Xa levels may be used to monitor the anticoagulant effect of enoxaparin in patients with substantial renal impairment.
Hepatic impairment: Enoxaparin has not been studied in patients with hepatic impairment. Caution should be used in these patients.
Use in Children: Safety and efficacy not established in children younger than 18 years of age.
Use in the Elderly: No substantial differences in efficacy relative to younger adults. In elderly patients, a high incidence of bleeding complications has been observed following administration of enoxaparin sodium at a dosage of 1.5 mg/kg once daily or 1 mg/kg every 12 hours, and the risk of bleeding complications increases with age.