Dosage Form: injection
FULL PRESCRIBING INFORMATION
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- Use of indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
- A history of traumatic or repeated epidural or spinal punctures
- A history of spinal deformity or spinal surgery
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7)].
Indications and Usage for Enoxaparin Sodium Injection
Prophylaxis of Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
- in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies 14.1].
- in patients undergoing hip replacement surgery, during and following hospitalization.
- in patients undergoing knee replacement surgery.
- in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
Treatment of Acute Deep Vein Thrombosis
Enoxaparin Sodium Injection is indicated for:
- the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
- the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Enoxaparin Sodium Injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
Treatment of Acute ST-Segment Elevation Myocardial Infarction
Enoxaparin Sodium Injection, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).
Enoxaparin Sodium Injection Dosage and Administration
All patients should be evaluated for a bleeding disorder before administration of Enoxaparin Sodium Injection, unless the medication is needed urgently. Since coagulation parameters are unsuitable for monitoring Enoxaparin Sodium Injection activity, routine monitoring of coagulation parameters is not required [see Warnings and Precautions (5.9)].
For subcutaneous use, Enoxaparin Sodium Injection should not be mixed with other injections or infusions.
For intravenous use (i.e., for treatment of acute STEMI), Enoxaparin Sodium Injection can be mixed with normal saline solution (0.9%) or 5% dextrose in water.
Enoxaparin Sodium Injection is not intended for intramuscular administration.
Adult Dosage
Abdominal Surgery: In patients undergoing abdominal surgery who are at risk for thromboembolic complications, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection with the initial dose given 2 hours prior to surgery. The usual duration of administration is 7 to 10 days; up to 12 days administration has been administered in clinical trials.
Hip or Knee Replacement Surgery: In patients undergoing hip or knee replacement surgery, the recommended dose of Enoxaparin Sodium Injection is 30 mg every 12 hours administered by SC injection. Provided that hemostasis has been established, the initial dose should be given 12 to 24 hours after surgery. For hip replacement surgery, a dose of 40 mg once a day SC, given initially 12 (±3) hours prior to surgery, may be considered. Following the initial phase of thromboprophylaxis in hip replacement surgery patients, it is recommended that continued prophylaxis with Enoxaparin Sodium Injection 40 mg once a day be administered by SC injection for 3 weeks. The usual duration of administration is 7 to 10 days; up to 14 days administration has been administered in clinical trials.
Medical Patients During Acute Illness: In medical patients at risk for thromboembolic complications due to severely restricted mobility during acute illness, the recommended dose of Enoxaparin Sodium Injection is 40 mg once a day administered by SC injection. The usual duration of administration is 6 to 11 days; up to 14 days of Enoxaparin Sodium Injection has been administered in the controlled clinical trial.
Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism: In outpatient treatment, patients with acute deep vein thrombosis without pulmonary embolism who can be treated at home, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC. In inpatient (hospital) treatment, patients with acute deep vein thrombosis with pulmonary embolism or patients with acute deep vein thrombosis without pulmonary embolism (who are not candidates for outpatient treatment), the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg every 12 hours administered SC or 1.5 mg/kg once a day administered SC at the same time every day. In both outpatient and inpatient (hospital) treatments, warfarin sodium therapy should be initiated when appropriate (usually within 72 hours of Enoxaparin Sodium Injection). Enoxaparin Sodium Injection should be continued for a minimum of 5 days and until a therapeutic oral anticoagulant effect has been achieved (International Normalization Ratio 2.0 to 3.0). The average duration of administration is 7 days; up to 17 days of Enoxaparin Sodium Injection administration has been administered in controlled clinical trials.
Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is 1 mg/kg administered SC every 12 hours in conjunction with oral aspirin therapy (100 to 325 mg once daily). Treatment with Enoxaparin Sodium Injection should be prescribed for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 to 8 days; up to 12.5 days of Enoxaparin Sodium Injection has been administered in clinical trials. [See Warnings and Precautions (5.2) and Clinical Studies (14.5)].
Treatment of Acute ST-Segment Elevation Myocardial Infarction:
In patients with acute ST-segment elevation myocardial infarction, the recommended dose of Enoxaparin Sodium Injection is a single IV bolus of 30 mg plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC every 12 hours (maximum 100 mg for the first two doses only, followed by 1 mg/kg dosing for the remaining doses). Dosage adjustments are recommended in patients ≥75 years of age [see Dosage and Administration (2.3)]. All patients should receive aspirin as soon as they are identified as having STEMI and maintained with 75 to 325 mg once daily unless contraindicated.
When administered in conjunction with a thrombolytic (fibrin-specific or non-fibrin specific), Enoxaparin Sodium Injection should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. In the pivotal clinical study, the Enoxaparin Sodium Injection treatment duration was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is not known, but it is likely to be longer than 8 days.
For patients managed with percutaneous coronary intervention (PCI): If the last Enoxaparin Sodium Injection SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last Enoxaparin Sodium Injection SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3 mg/kg of Enoxaparin Sodium Injection should be administered [see Warnings and Precautions (5.2)].
Renal Impairment
Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30–50 mL/min) and mild (creatinine clearance 50–80 mL/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding.
The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
| Dosage Regimens for Patients with Severe Renal Impairment (creatinine clearance <30 mL/minute) | |
|---|---|
| Indication | Dosage Regimen |
| Prophylaxis in abdominal surgery | 30 mg administered SC once daily |
| Prophylaxis in hip or knee replacement surgery | 30 mg administered SC once daily |
| Prophylaxis in medical patients during acute illness | 30 mg administered SC once daily |
| Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium | 1 mg/kg administered SC once daily |
| Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium | 1 mg/kg administered SC once daily |
| Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin | 1 mg/kg administered SC once daily |
| Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin | 30 mg single IV bolus plus a 1 mg/kg SC dose followed by 1 mg/kg administered SC once daily |
| Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin | 1 mg/kg administered SC once daily (no initial bolus) |
Geriatric Patients with Acute ST-Segment Elevation Myocardial Infarction
For treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg/kg SC every 12 hours (maximum 75 mg for the first two doses only, followed by 0.75 mg/kg dosing for the remaining doses) [see Use in Specific Populations (8.5) and Clinical Phamacology (12.3)].
No dose adjustment is necessary for other indications in geriatric patients unless kidney function is impaired [see Dosage and Administration (2.2)].
Administration
Enoxaparin Sodium Injection is a clear, colorless to pale yellow sterile solution, and as with other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration.
Enoxaparin Sodium Injection must not be administered by intramuscular injection.
Enoxaparin Sodium Injection is intended for use under the guidance of a physician.
For subcutaneous administration, patients may self-inject only if their physicians determine that it is appropriate and with medical follow-up, as necessary. Proper training in subcutaneous injection technique (with or without the assistance of an injection device) should be provided.
Subcutaneous Injection Technique: Patients should be lying down and Enoxaparin Sodium Injection administered by deep SC injection. To avoid the loss of drug when using the 30 and 40 mg prefilled syringes, do not expel the air bubble from the syringe before the injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.
Enoxaparin Sodium Injection prefilled syringes and graduated prefilled syringes are for single, one-time use only and are available with a system that shields the needle after injection.
Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister. Do not remove by pulling on the plunger as this may damage the syringe.
- Remove needle cover by pulling straight off of needle (see Figure 1). If adjusting the dose is required, the adjustment must be done prior to injecting the prescribed dose into the patient.
- See Administration: Subcutaneous Injection Technique for a description of the Standard Protocol for administration.
- Depress the plunger while grasping the finger flange until the entire dose has been given. The Passive needle guard will NOT activate unless the ENTIRE dose has been given.
- Remove needle from patient, then let go of the plunger and allow syringe to move up until the entire needle is guarded.
- Dispose of syringe/needle guard assembly in approved sharps container.
NOTE:
- The safety system can only be activated once the syringe has been emptied.
- Activation of the safety system must be done only after removing the needle from the patient's skin.
- Do not replace the needle shield after injection.
- The safety system should not be sterilized.
Activation of the safety system may cause minimal splatter of fluid. For optimal safety activate the system while orienting it downwards away from yourself and others.
Intravenous (Bolus) Injection Technique
For intravenous injection, the multiple-dose vial should be used. Enoxaparin Sodium Injection should be administered through an intravenous line. Enoxaparin Sodium Injection should not be mixed or co-administered with other medications. To avoid the possible mixture of Enoxaparin Sodium Injection with other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of Enoxaparin Sodium Injection to clear the port of drug. Enoxaparin Sodium Injection may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Dosage Forms and Strengths
Enoxaparin Sodium Injection is available in two concentrations:
100 mg/mL concentration
| -Prefilled Syringes | 30 mg / 0.3 mL, 40 mg / 0.4 mL |
| -Graduated Prefilled Syringes | 60 mg / 0.6 mL, 80 mg / 0.8 mL, 100 mg / 1 mL |
150 mg/mL concentration
| -Graduated Prefilled Syringes | 120 mg / 0.8 mL, 150 mg / 1 mL |
Contraindications
- Active major bleeding
- Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium
- Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/ anaphylactoid reactions) [see Adverse Reactions (6.2)]
- Known hypersensitivity to heparin or pork products
Warnings and Precautions
Increased Risk of Hemorrhage
Cases of epidural or spinal hematomas have been reported with the associated use of Enoxaparin Sodium Injection and spinal/epidural anesthesia or spinal puncture resulting in long-term or permanent paralysis. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [see Boxed Warning, Adverse Reactions (6.2) and Drug Interactions (7)].
Enoxaparin Sodium Injection should be used with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors.
Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal.
Bleeding can occur at any site during therapy with Enoxaparin Sodium Injection. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site.
Percutaneous Coronary Revascularization Procedures
To minimize the risk of bleeding following the vascular instrumentation during the treatment of unstable angina, non-Q-wave myocardial infarction, and acute ST-segment elevation myocardial infarction, adhere precisely to the intervals recommended between Enoxaparin Sodium Injection doses. It is important to achieve hemostasis at the puncture site after PCI.
In case a closure device is used, the sheath can be removed immediately. If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC Enoxaparin Sodium Injection. If the treatment with enoxaparin sodium is to be continued, the next scheduled dose should be given no sooner than 6 to 8 hours after sheath removal. The site of the procedure should be observed for signs of bleeding or hematoma formation [see Dosage and Administration (2.1)].
Use of Enoxaparin Sodium Injection with Concomitant Medical Conditions
Enoxaparin Sodium Injection should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction and hemorrhage.
History of Heparin-Induced Thrombocytopenia
Enoxaparin Sodium Injection should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia.
Thrombocytopenia
Thrombocytopenia can occur with the administration of Enoxaparin Sodium Injection.
Moderate thrombocytopenia (platelet counts between 100,000/mm3 and 50,000/mm3) occurred at a rate of 1.3% in patients given Enoxaparin Sodium Injection, 1.2% in patients given heparin, and 0.7% in patients given placebo in clinical trials.
Platelet counts less than 50,000/mm3 occurred at a rate of 0.1% in patients given Enoxaparin Sodium Injection, in 0.2% of patients given heparin, and 0.4% of patients given placebo in the same trials.
Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, Enoxaparin Sodium Injection should be discontinued. Cases of heparin-induced thrombocytopenia with thrombosis have also been observed in clinical practice. Some of these cases were complicated by organ infarction, limb ischemia, or death [see Warnings and Precautions (5.4)].
Interchangeability with Other Heparins
Enoxaparin Sodium Injection cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. Each of these medicines has its own instructions for use.
Pregnant Women with Mechanical Prosthetic Heart Valves
The use of Enoxaparin Sodium Injection for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves has not been adequately studied. In a clinical study of pregnant women with mechanical prosthetic heart valves given enoxaparin (1 mg/kg twice daily) to reduce the risk of thromboembolism, 2 of 8 women developed clots resulting in blockage of the valve and leading to maternal and fetal death. Although a causal relationship has not been established these deaths may have been due to therapeutic failure or inadequate anticoagulation. No patients in the heparin/warfarin group (0 of 4 women) died. There also have been isolated postmarketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin for thromboprophylaxis. Women with mechanical prosthetic heart valves may be at higher risk for thromboembolism during pregnancy, and, when pregnant, have a higher rate of fetal loss from stillbirth, spontaneous abortion and premature delivery. Therefore, frequent monitoring of peak and trough anti-Factor Xa levels, and adjusting of dosage may be needed [see Use in Specific Populations (8.6)].
Laboratory Tests
Periodic complete blood counts, including platelet count, and stool occult blood tests are recommended during the course of treatment with Enoxaparin Sodium Injection. When administered at recommended prophylaxis doses, routine coagulation tests such as Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) are relatively insensitive measures of Enoxaparin Sodium Injection activity and, therefore, unsuitable for monitoring. Anti-Factor Xa may be used to monitor the anticoagulant effect of Enoxaparin Sodium Injection in patients with significant renal impairment. If during Enoxaparin Sodium Injection therapy abnormal coagulation parameters or bleeding should occur, anti-Factor Xa levels may be used to monitor the anticoagulant effects of Enoxaparin Sodium Injection [see Clinical Pharmacology (12.3)].
Adverse Reactions
Clinical Trials Experience
The following serious adverse reactions are also discussed in other sections of the labeling:
- Spinal/epidural hematoma [see Boxed Warning and Warnings and Precautions (5.1)]
- Increased Risk of Hemorrhage [see Warnings and Precautions (5.1)]
- Thrombocytopenia [see Warnings and Precautions (5.5)]
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
During clinical development for the approved indications, 15,918 patients were exposed to enoxaparin sodium. These included 1,228 for prophylaxis of deep vein thrombosis following abdominal surgery in patients at risk for thromboembolic complications, 1,368 for prophylaxis of deep vein thrombosis following hip or knee replacement surgery, 711 for prophylaxis of deep vein thrombosis in medical patients with severely restricted mobility during acute illness, 1,578 for prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, 10,176 for treatment of acute ST-elevation myocardial infarction, and 857 for treatment of deep vein thrombosis with or without pulmonary embolism. Enoxaparin sodium doses in the clinical trials for prophylaxis of deep vein thrombosis following abdominal or hip or knee replacement surgery or in medical patients with severely restricted mobility during acute illness ranged from 40 mg SC once daily to 30 mg SC twice daily. In the clinical studies for prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction doses were 1 mg/kg every 12 hours and in the clinical studies for treatment of acute ST-segment elevation myocardial infarction enoxaparin sodium doses were a 30 mg IV bolus followed by 1 mg/kg every 12 hours SC.
Hemorrhage
The incidence of major hemorrhagic complications during Enoxaparin Sodium Injection treatment has been low.
The following rates of major bleeding events have been reported during clinical trials with Enoxaparin Sodium Injection [see Tables 2 to 7].
| Indications | Dosing Regimen | |
|---|---|---|
| Enoxaparin Sodium Inj. | Heparin | |
| 40 mg q.d. SC | 5000 U q8h SC | |
| ||
| Abdominal Surgery | n=555 | n=560 |
| 23 (4%) | 16 (3%) | |
| Colorectal Surgery | n=673 | n=674 |
| 28 (4%) | 21 (3%) | |
| Dosing Regimen | |||
|---|---|---|---|
| Indications | Enoxaparin Sodium Inj. 40 mg q.d. SC | Enoxaparin Sodium Inj. 30 mg q12h SC | Heparin 15,000 U/24h SC |
| NOTE: At no time point were the 40 mg once a day pre-operative and the 30 mg every 12 hours post-operative hip replacement surgery prophylactic regimens compared in clinical trials. Injection site hematomas during the extended prophylaxis period after hip replacement surgery occurred in 9% of the Enoxaparin Sodium Injection patients versus 1.8% of the placebo patients. | |||
| |||
| Hip Replacement Surgery without Extended Prophylaxis† | n = 786 31 (4%) | n = 541 32 (6%) | |
| Hip Replacement Surgery with Extended Prophylaxis | |||
| Peri-operative Period‡ | n = 288 | ||
| 4 (2%) | |||
| Extended Prophylaxis Period§ | n = 221 0 (0%) | ||
| Knee Replacement Surgery without Extended Prophylaxis† | n = 294 3 (1%) | n = 225 3 (1%) | |
| Dosing Regimen | |||
|---|---|---|---|
| Indications | Enoxaparin Sodium Inj.† | Enoxaparin Sodium Inj.† | Placebo† |
| 20 mg q.d. SC | 40 mg q.d. SC | ||
| |||
| Medical Patients During Acute Illness | n = 351 1 (<1%) | n = 360 3 (<1%) | n = 362 2 (<1%) |
| Dosing Regimen† | |||
|---|---|---|---|
| Indication | Enoxaparin Sodium Inj. 1.5 mg/kg q.d. SC | Enoxaparin Sodium Inj. 1 mg/kg q12h SC | Heparin aPTT Adjusted IV Therapy |
| |||
| Treatment of DVT and PE | n = 298 5 (2%) | n = 559 9 (2%) | n = 554 9 (2%) |
| Dosing Regimen | ||
|---|---|---|
| Indication | Enoxaparin Sodium Inj.* 1 mg/kg q12h SC | Heparin* aPTT Adjusted IV Therapy |
| ||
| Unstable Angina and Non-Q-Wave MI †,‡ | n = 1578 17 (1%) | n = 1529 18 (1%) |
| Dosing Regimen | ||
|---|---|---|
| Indication | Enoxaparin Sodium Inj.* Initial 30 mg IV bolus followed by 1 mg/kg q12h SC | Heparin* aPTT Adjusted IV Therapy |
| ||
| Acute ST-Segment Elevation | n = 10176 | n = 10151 |
| Myocardial Infarction | n (%) | n (%) |
| -Major bleeding (including ICH)† | 211 (2.1) | 138 (1.4) |
| -Intracranial hemorrhages (ICH) | 84 (0.8) | 66 (0.7) |
Elevations of Serum Aminotransferases
Asymptomatic increases in aspartate (AST [SGOT]) and alanine (ALT [SGPT]) aminotransferase levels greater than three times the upper limit of normal of the laboratory reference range have been reported in up to 6.1% and 5.9% of patients, respectively, during treatment with Enoxaparin Sodium Injection. Similar significant increases in aminotransferase levels have also been observed in patients and healthy volunteers treated with heparin and other low molecular weight heparins. Such elevations are fully reversible and are rarely associated with increases in bilirubin.
Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease, and pulmonary emboli, elevations that might be caused by drugs like Enoxaparin Sodium Injection should be interpreted with caution.
Local Reactions
Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow SC injection of Enoxaparin Sodium Injection.
Adverse Reactions in Patients Receiving Enoxaparin Sodium Injection for Prophylaxis or Treatment of DVT, PE:
Other adverse reactions that were thought to be possibly or probably related to treatment with Enoxaparin Sodium Injection, heparin, or placebo in clinical trials with patients undergoing hip or knee replacement surgery, abdominal or colorectal surgery, or treatment for DVT and that occurred at a rate of at least 2% in the Enoxaparin Sodium Injection group, are provided below [see Tables 8 to 11].
| Dosing Regimen | ||||
|---|---|---|---|---|
| Enoxaparin Sodium Inj. 40 mg q.d. SC n = 1228 % | Heparin 5000 U q8h SC n = 1234 % | |||
| Adverse Reaction | Severe | Total | Severe | Total |
| Hemorrhage | <1 | 7 | <1 | 6 |
| Anemia | <1 | 3 | <1 | 3 |
| Ecchymosis | 0 | 3 | 0 | 3 |
| Dosing Regimen | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Enoxaparin Sodium Inj. 40 mg q.d. SC | Enoxaparin Sodium Inj. 30 mg q12h SC | Heparin 15,000 U/24h SC | Placebo q12h SC | |||||||
| Peri-operative Period | Extended Prophylaxis Period | |||||||||
| n = 288* % | n = 131† % | n = 1080 % | n = 766 % | n = 115 % | ||||||
| Adverse Reaction | Severe | Total | Severe | Total | Severe | Total | Severe | Total | Severe | Total |
| ||||||||||
| Fever | 0 | 8 | 0 | 0 | <1 | 5 | <1 | 4 | 0 | 3 |
| Hemorrhage | <1 | 13 | 0 | 5 | <1 | 4 | 1 | 4 | 0 | 3 |
| Nausea | <1 | 3 | <1 | 2 | ||||||
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