Enoxaparin: Difference between revisions
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Revision as of 14:18, 21 May 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Black Box Warning
WARNING: SPINAL/EPIDURAL HEMATOMA
See full prescribing information for complete Boxed Warning.
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:
|
Overview
Enoxaparin is a low molecular weight heparin that is FDA approved for the {{{indicationType}}} of acute deep vein thrombosis, acute ST-segment elevation myocardial infarction and prophylaxis of deep vein thrombosis, ischemic complications of unstable angina, and non-Q-Wave myocardial infarction. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, nausea, anemia, bleeding, thrombocytopenia, increased liver function test, and fever.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Abdominal Surgery
- Dosing information
- Initial dosage(2 hours prior to surgery): 40 mg i.H qd
- Duration of administration: 7 to 10 days ; max: 12 days .
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Patients with solid tumor and low bleeding risk
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Class II
- Strength of Evidence: Level B
- Dosing Information
- Not applicable
Vitamin K Antagonists
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Outpatient Cancer Patients
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level B
- Dosing Information
- Not applicable
Thoracic Surgery
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level B
- Dosing Information
- Not applicable
Spinal Surgery
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Major Trauma
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Management of HIT
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 1
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Management of Acute HIT or Subacute HIT
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Management in Patients with a Past History of HIT
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Atrial Fibrillation Undergoing Cardioversion(≥ 48 h)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 1
- Strength of Evidence: Level B
- Dosing Information
- Not applicable
Atrial Fibrillation Undergoing Cardioversion(< 48 h)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Endocarditis
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
Mechanical Prosthetic Heart Valves
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing Information
- Not applicable
VTE Prevention in Hemorrhagic Stroke
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level B
- Dosing Information
- Not applicable
Adjunctive Antithrombotic Therapy to Support Reperfusion With Fibrinolytic Therapy
- Class of Recommendation: Grade Ib
- Strength of Evidence: Level A
- Dosing Information
- If age < 75 ys: 30 mg IV bolus followed by 1 mg/kg S.C bid
- If age > 75 ys: 0.75 mg/kg S.C bid( max 75 mg for the first 2 doses)
- Regardless of age, if CrCl < 30 ml/min: 1 mg/kg S.C qd
- Duration: For the index hospitalization, up to 8 days until revasculazation
Adjunctive Antithrombotic Therapy to Support PCI After Fibrinolytic Therapy
- Class of Recommendation: Grade I
- Strength of Evidence: Level B
- Dosing information
- No additional drug if last dose was within 8 h
- '0.3 mg/kg IV bolus if that dose was 8-12 h earlier
'
Non–Guideline-Supported Use
There is limited information about the non–guideline-supported off-label use.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information about the FDA-labeled indications and dosage information for children.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Homozygous Protein C Deficiency(Neonate)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Class I
- Strength of Evidence: Level C
- Dosing Information
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Cerebral Sinovenous Thrombosis(Neonate)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Class I
- Strength of Evidence: Level C
- Dosing Information
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Acute Ischemic Stroke(secondary to non-Moyamoya vasculopathy)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Class I
- Strength of Evidence: Level C
- Dosing Information(Used as a initial treatment for at least 3 months)
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Ventricular Assist Device (VAD) Placement
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing information
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Hemodialysis
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- Dosing information
- For children less than 2 months:
- Initial dosage: 1.5 mg/kg i.M bid or qd for 4 -6 hours
- Achived anti-factor Xa level: 0.35-0.7 units/ml
- Following treatment:
- For children over 2 months: 1 mg/kg i.M bid
- Initial dosage: 1.5 mg/kg i.M bid or qd for 4 -6 hours
- Achived anti-factor Xa level: 0.35-0.7 units/ml
Renal Vein Thrombosis(Neonate)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Femoral Artery Thrombosis(Neonate)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Venous Thromboembolism(Children)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 1
- Strength of Evidence: Level B
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Central Venous Access Device(Children)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Cancer(Children)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Femoral Artery Thrombosis(Children)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Cerebral Sinovenous Thrombosis(Children)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 1
- Strength of Evidence: Level B
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Acute Ischemic Stroke(Children)
- Developed by: American College of Chest Physicians (ACCP)
- Class of Recommendation: Grade 2
- Strength of Evidence: Level C
- For children less than 2 months: 1.5 mg/kg i.M bid
- For children over 2 months: 1 mg/kg i.M bid
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- There is limited information about Off-Label Non–Guideline-Supported Use of Enoxaparin in pediatric patients.
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]
- Known hypersensitivity to heparin or pork products
- Known hypersensitivity to benzyl alcohol (which is in only the multi-dose formulation of Lovenox)
Warnings
WARNING: SPINAL/EPIDURAL HEMATOMA
See full prescribing information for complete Boxed Warning.
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:
|
Cases of epidural or spinal hemorrhage and subsequent hematomas have been reported with the use of Lovenox and epidural or spinal anesthesia/analgesia or spinal puncture procedures, 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 and Drug Interaction].
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]
- *Increased Risk of Hemorrhage [see Warnings and Precautions (5.1)]
- *Thrombocytopenia [see Warnings and Precautions (5.5)]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical 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 thrombosisfollowing abdominal surgery in patients at risk for thromboembolic complications, 1,368 for prophylaxis of deep vein thrombosisfollowing hip or knee replacement surgery, 711 for prophylaxis of deep vein thrombosisin 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 thrombosiswith or without pulmonary embolism. Enoxaparin sodium doses in the clinical trials for prophylaxis of deep vein thrombosisfollowing 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 Lovenox treatment has been low.
The following rates of major bleeding events have been reported during clinical trials with Lovenox [see Tables 2 to 7].
![](/images/f/f9/ENOXAPARINO8.jpg)
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 Lovenox patients versus 1.8% of the placebo patients.
![](/images/b/ba/ENOXAPARINO9.jpg)
![](/images/5/56/ENOXAPARIN10.jpg)
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 Lovenox. 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 Lovenox should be interpreted with caution.
Local Reactions
Mild local irritation, pain, hematoma, ecchymosis, and erythema may follow SC injection of Lovenox.
Adverse Reactions in Patients Receiving Lovenox for Prophylaxis or Treatment of DVT, PE
Other adverse reactions that were thought to be possibly or probably related to treatment with Lovenox, 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 Lovenox group, are provided below [see Tables 8 to 11].
![](/images/9/96/ENOXAPARIN11.jpg)
![](/images/9/94/ENOXAPARIN12.jpg)
Adverse Events in Lovenox-Treated Patients with unstable angina or Non-Q-Wave myocardial infarction
Non-hemorrhagic clinical events reported to be related to Lovenox therapy occurred at an incidence of ≤1%.
Non-major hemorrhagic events, primarily injection site ecchymoses and hematomas, were more frequently reported in patients treated with SC Lovenox than in patients treated with IV heparin.
Serious adverse events with Lovenox or heparin in a clinical trial in patients with unstable angina or non-Q-wave myocardial infarction that occurred at a rate of at least 0.5% in the Lovenox group are provided below [see Table 12].
![](/images/e/e2/ENOXAPARIN13.jpg)
Adverse Reactions in Lovenox-Treated Patients with Acute ST-Segment Elevation myocardial infarction
In a clinical trial in patients with acute ST-segment elevation myocardial infarction, the only adverse reaction that occurred at a rate of at least 0.5% in the Lovenox group was thrombocytopenia (1.5%).
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Lovenox. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been reports of epidural or spinal hematoma formation with concurrent use of Lovenox and spinal/epidural anesthesia or spinal puncture. The majority of patients had a post-operative indwelling epidural catheter placed for analgesia or received additional drugs affecting hemostasis such as NSAIDs. Many of the epidural or spinal hematomas caused neurologic injury, including long-term or permanent paralysis.
Local reactions at the injection site (e.g. nodules, inflammation, oozing), systemic allergic reactions (e.g. pruritus, urticaria, anaphylactic/anaphylactoid reactions including shock), vesiculobullous rash, rare cases of hypersensitivity cutaneous vasculitis, purpura, skin necrosis (occurring at either the injection site or distant from the injection site), thrombocytosis, and thrombocytopenia with thrombosis [see Warnings and Precautions (5.5)] have been reported.
Cases of hyperkalemia have been reported. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia (e.g., renal dysfunction, concomitant potassium-sparing drugs, administration of potassium, hematoma in body tissues). Very rare cases of hyperlipidemia have also been reported, with one case of hyperlipidemia, with marked hypertriglyceridemia, reported in a diabetic pregnant woman; causality has not been determined.
Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported.
Osteoporosis has also been reported following long-term therapy.
Drug Interactions
Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of Lovenox therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If co-administration is essential, conduct close clinical and laboratory monitoring
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
All pregnancies have a background risk of birth defect, loss, or other adverse outcome regardless of drug exposure. The fetal risk summary below describes the potential of Lovenox to increase the risk of developmental abnormalities above the background risk.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Enoxaparin in women who are pregnant.
Labor and Delivery
Lovenox does not cross the placenta, and is not expected to result in fetal exposure to the drug. Human data from a retrospective cohort study, which included 693 live births, suggest that Lovenox does not increase the risk of major developmental abnormalities. Based on animal data, enoxaparin is not predicted to increase the risk of major developmental abnormalities
Nursing Mothers
It is not known whether Lovenox is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Lovenox, a decision should be made whether to discontinue nursing or discontinue Lovenox, taking into account the importance of Lovenox to the mother and the known benefits of nursing.
Pediatric Use
Safety and effectiveness of Lovenox in pediatric patients have not been established.
Geriatic Use
Prevention of Deep Vein Thrombosis in Hip, Knee and Abdominal Surgery; Treatment of Deep Vein Thrombosis, Prevention of Ischemic Complications of Unstable Angina and Non-Q-wave Myocardial Infarction
Over 2800 patients, 65 years and older, have received Lovenox in pivotal clinical trials. The efficacy of Lovenox in the geriatric (≥65 years) was similar to that seen in younger patients (<65 years). The incidence of bleeding complications was similar between geriatric and younger patients when 30 mg every 12 hours or 40 mg once a day doses of Lovenox were employed. The incidence of bleeding complications was higher in geriatric patients as compared to younger patients when Lovenox was administered at doses of 1.5 mg/kg once a day or 1 mg/kg every 12 hours. The risk of Lovenox-associated bleeding increased with age. Serious adverse events increased with age for patients receiving Lovenox. Other clinical experience (including postmarketing surveillance and literature reports) has not revealed additional differences in the safety of Lovenox between geriatric and younger patients. Careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. Lovenox should be used with care in geriatric patients who may show delayed elimination of enoxaparin. Monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered [see Warnings and Precautions and Clinical Pharmacology].
Treatment of Acute ST-Segment Elevation Myocardial Infarction
In the clinical study for treatment of acute ST-segment elevation myocardial infarction, there was no evidence of difference in efficacy between patients ≥75 years of age (n = 1241) and patients less than 75 years of age (n=9015). Patients ≥75 years of age did not receive a 30 mg IV bolus prior to the normal dosage regimen and had their SC dose adjusted to 0.75 mg/kg every 12 hours [see Dosage and Administration]. The incidence of bleeding complications was higher in patients ≥65 years of age as compared to younger patients (<65 years).
Gender
There is no FDA guidance on the use of Enoxaparin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Enoxaparin with respect to specific racial populations.
Renal Impairment
In patients with renal impairment, there is an increase in exposure of enoxaparin sodium. All such patients should be observed carefully for signs and symptoms of bleeding. Because exposure of enoxaparin sodium is significantly increased in patients with severe renal impairment (creatinine clearance <30 mL/min), a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges. No dosage adjustment is recommended in patients with moderate (creatinine clearance 30–50 mL/min) and mild (creatinine clearance 50–80 mL/min) renal impairment [see Dosage and Administration and Clinical Pharmacology (12.3)]. In patients with renal failure, treatment with enoxaparin has been associated with the development of hyperkalemia [see Adverse Reactions].
Hepatic Impairment
The impact of hepatic impairment on enoxaparin's exposure and antithrombotic effect has not been investigated. Caution should be exercised when administering enoxaparin to patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Enoxaparin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Enoxaparin in patients who are immunocompromised.
Low-Weight Patients
An increase in exposure of enoxaparin sodium with prophylactic dosages (non-weight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg). All such patients should be observed carefully for signs and symptoms of bleeding [see Clinical Pharmacology].
Administration and Monitoring
Administration
Lovenox 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.
The use of a tuberculin syringe or equivalent is recommended when using Lovenox multiple-dose vials to assure withdrawal of the appropriate volume of drug.
Lovenox must not be administered by intramuscular injection. Lovenox 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 Lovenox 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.
Lovenox 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.
1.Remove the needle shield by pulling it straight off the syringe (see Figure A). If adjusting the dose is required, the dose adjustment must be done prior to injecting the prescribed dose to the patient. Figure A
Monitoring
- 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
- 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
- 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
- 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
- Whenever possible, agents which may enhance the risk of hemorrhage should be discontinued prior to initiation of enoxaparin sodium injection therapy. These agents include medications such as: anticoagulants, platelet inhibitors including acetylsalicylic acid, salicylates, NSAIDs (including ketorolac tromethamine), dipyridamole, or sulfinpyrazone. If co-administration is essential, conduct close clinical and laboratory monitoring
- Monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered
IV Compatibility
There is limited information regarding the compatibility of Enoxaparin and IV administrations.
Overdosage
Accidental overdosage following administration of Lovenox may lead to hemorrhagic complications. Injected Lovenox may be largely neutralized by the slow IV injection of protamine sulfate (1%
solution). The dose of protamine sulfate should be equal to the dose of Lovenox injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Lovenox, if enoxaparin sodium was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 1 mg of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required. The second infusion of 0.5 mg protamine sulfate per 1 mg of Lovenox may be administered if the aPTT measured 2 to 4 hours after the first infusion remains prolonged.
If at least 12 hours have elapsed since the last enoxaparin sodium injection, protamine administration may not be required; however, even with higher doses of protamine, the aPTT may remain more prolonged than following administration of heparin. In all cases, the anti-Factor Xa activity is never completely neutralized (maximum about 60%). Particular care should be taken to avoid overdosage with protamine sulfate. Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, it should be given only when resuscitation techniques and treatment of anaphylactic shock are readily available. For additional information consult the labeling of protamine sulfate injection products.
Pharmacology
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Enoxaparin
| |
Systematic (IUPAC) name | |
? | |
Identifiers | |
CAS number | |
ATC code | B01 |
PubChem | |
DrugBank | |
Chemical data | |
Formula | (C26H40N2O36S5)n |
Mol. mass | 4500 daltons (average) |
Pharmacokinetic data | |
Bioavailability | 92% |
Protein binding | 80% bound-albumin |
Metabolism | primarily by kidneys |
Half life | 4.5 hours |
Excretion | ? |
Therapeutic considerations | |
Licence data |
|
Pregnancy cat. |
B |
Legal status |
POM(UK) [[Prescription drug|Template:Unicode-only]](US) |
Routes | Subcutaneous (SC) Injection and intravenous (IV) per package insert |
Mechanism of Action
Enoxaparin is a low molecular weight heparin which has antithrombotic properties.
Structure
Lovenox is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains an 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is:
<2000 daltons ≤20%
2000 to 8000 daltons ≥68%
>8000 daltons ≤18%
STRUCTURAL FORMULA
![](/images/8/84/Enoxaparin_structure_01.jpg)
Lovenox 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.
Lovenox 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.
The Lovenox prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative
Pharmacodynamics
In humans, enoxaparin given at a dose of 1.5 mg/kg subcutaneously (SC) is characterized by a higher ratio of anti-Factor Xa to anti-Factor IIa activity (mean ± SD, 14.0 ± 3.1) (based on areas under anti-Factor activity versus time curves) compared to the ratios observed for heparin (mean±SD, 1.22 ± 0.13). Increases of up to 1.8 times the control values were seen in the thrombin time (TT) and the activated partial thromboplastin time (aPTT). Enoxaparin at a 1 mg/kg dose (100 mg/mL concentration), administered SC every 12 hours to patients in a large clinical trial resulted in aPTT values of 45 seconds or less in the majority of patients (n = 1607). A 30 mg IV bolus immediately followed by a 1 mg/kg SC administration resulted in aPTT post-injection values of 50 seconds. The average aPTT prolongation value on Day 1 was about 16% higher than on Day 4.
Pharmacokinetics
There is limited information regarding Enoxaparin Pharmacokinetics in the drug label.
Nonclinical Toxicology
- Carcinogenesis, Mutagenesis, Impairment of Fertility
- No long-term studies in animals have been performed to evaluate the carcinogenic potential of enoxaparin. Enoxaparin was not mutagenic in in vitro tests, including the Ames test, mouse lymphoma cell forward mutation test, and human lymphocyte chromosomal aberration test, and the in vivo rat bone marrow chromosomal aberration test. Enoxaparin was found to have no effect on fertility or reproductive performance of male and female rats at SC doses up to 20 mg/kg/day or 141 mg/m2/day. The maximum human dose in clinical trials was 2.0 mg/kg/day or 78 mg/m2/day (for an average body weight of 70 kg, height of 170 cm, and body surface area of 1.8 m2).
- Animal Toxicology and/or Pharmacology
- A single SC dose of 46.4 mg/kg enoxaparin was lethal to rats. The symptoms of acute toxicity were ataxia, decreased motility, dyspnea, cyanosis, and coma.
- Reproductive and Developmental Toxicology
- Teratology studies have been conducted in pregnant rats and rabbits at SC doses of enoxaparin up to 30 mg/kg/day corresponding to 211 mg/m2/day and 410 mg/m2/day in rats and rabbits respectively. There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin.
Clinical Studies
Prophylaxis of Deep Vein Thrombosis Following Abdominal Surgery in Patients at Risk for Thromboembolic Complications
Abdominal surgery patients at risk include those who are over 40 years of age, obese, undergoing surgery under general anesthesia lasting longer than 30 minutes or who have additional risk factors such as malignancy or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE).
In a double-blind, parallel group study of patients undergoing elective cancer surgery of the gastrointestinal, urological, or gynecological tract, a total of 1116 patients were enrolled in the study, and 1115 patients were treated. Patients ranged in age from 32 to 97 years (mean age 67 years) with 52.7% men and 47.3% women. Patients were 98% Caucasian, 1.1% Black, 0.4% Asian and 0.4% others. Lovenox 40 mg SC, administered once a day, beginning 2 hours prior to surgery and continuing for a maximum of 12 days after surgery, was comparable to heparin 5000 U every 8 hours SC in reducing the risk of DVT. The efficacy data are provided below [see Table 14].
![](/images/2/20/ENOXAPARIN17.jpg)
In a second double-blind, parallel group study, Lovenox 40 mg SC once a day was compared to heparin 5000 U every 8 hours SC in patients undergoing colorectal surgery (one-third with cancer). A total of 1347 patients were randomized in the study and all patients were treated. Patients ranged in age from 18 to 92 years (mean age 50.1 years) with 54.2% men and 45.8% women. Treatment was initiated approximately 2 hours prior to surgery and continued for approximately 7 to 10 days after surgery. The efficacy data are provided below [see Table 15].
![](/images/9/9d/ENOXAPARIN18.jpg)
Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery
Lovenox has been shown to reduce the risk of post-operative deep vein thrombosis (DVT) following hip or knee replacement surgery.
In a double-blind study, Lovenox 30 mg every 12 hours SC was compared to placebo in patients with hip replacement. A total of 100 patients were randomized in the study and all patients were treated. Patients ranged in age from 41 to 84 years (mean age 67.1 years) with 45% men and 55% women. After hemostasis was established, treatment was initiated 12 to 24 hours after surgery and was continued for 10 to 14 days after surgery. The efficacy data are provided below [see Table 16].
![](/images/2/2b/ENOXAPARIN19.jpg)
A double-blind, multicenter study compared three dosing regimens of Lovenox in patients with hip replacement. A total of 572 patients were randomized in the study and 568 patients were treated. Patients ranged in age from 31 to 88 years (mean age 64.7 years) with 63% men and 37% women. Patients were 93% Caucasian, 6% Black, <1% Asian, and 1% others. Treatment was initiated within two days after surgery and was continued for 7 to 11 days after surgery. The efficacy data are provided below [see Table 17].
![](/images/d/d3/ENOXAPARIN20.jpg)
There was no significant difference between the 30 mg every 12 hours and 40 mg once a day regimens. In a double-blind study, Lovenox 30 mg every 12 hours SC was compared to placebo in patients undergoing knee replacement surgery. A total of 132 patients were randomized in the study and 131 patients were treated, of which 99 had total knee replacement and 32 had either unicompartmental knee replacement or tibial osteotomy. The 99 patients with total knee replacement ranged in age from 42 to 85 years (mean age 70.2 years) with 36.4% men and 63.6% women. After hemostasis was established, treatment was initiated 12 to 24 hours after surgery and was continued up to 15 days after surgery. The incidence of proximal and total DVT after surgery was significantly lower for Lovenox compared to placebo. The efficacy data are provided below [see Table 18].
![](/images/3/32/ENOXAPARIN21.jpg)
Additionally, in an open-label, parallel group, randomized clinical study, Lovenox 30 mg every 12 hours SC in patients undergoing elective knee replacement surgery was compared to heparin 5000 U every 8 hours SC. A total of 453 patients were randomized in the study and all were treated. Patients ranged in age from 38 to 90 years (mean age 68.5 years) with 43.7% men and 56.3% women. Patients were 92.5% Caucasian, 5.3% Black, and 0.6% others. Treatment was initiated after surgery and continued up to 14 days. The incidence of deep vein thrombosis was significantly lower for Lovenox compared to heparin.
Extended Prophylaxis of Deep Vein Thrombosis Following Hip Replacement Surgery: In a study of extended prophylaxis for patients undergoing hip replacement surgery, patients were treated, while hospitalized, with Lovenox 40 mg SC, initiated up to 12 hours prior to surgery for the prophylaxis of post-operative DVT. At the end of the peri-operative period, all patients underwent bilateral venography. In a double-blind design, those patients with no venous thromboembolic disease were randomized to a post-discharge regimen of either Lovenox 40 mg (n = 90) once a day SC or to placebo (n = 89) for 3 weeks. A total of 179 patients were randomized in the double-blind phase of the study and all patients were treated. Patients ranged in age from 47 to 87 years (mean age 69.4 years) with 57% men and 43% women. In this population of patients, the incidence of DVT during extended prophylaxis was significantly lower for Lovenox compared to placebo. The efficacy data are provided below [see Table 19].
![](/images/c/c4/ENOXAPARIN22.jpg)
In a second study, patients undergoing hip replacement surgery were treated, while hospitalized, with Lovenox 40 mg SC, initiated up to 12 hours prior to surgery. All patients were examined for clinical signs and symptoms of venous thromboembolic (VTE) disease. In a double-blind design, patients without clinical signs and symptoms of VTE disease were randomized to a post-discharge regimen of either Lovenox 40 mg (n = 131) once a day SC or to placebo (n = 131) for 3 weeks. A total of 262 patients were randomized in the study double-blind phase and all patients were treated. Patients ranged in age from 44 to 87 years (mean age 68.5 years) with 43.1% men and 56.9% women. Similar to the first study the incidence of DVT during extended prophylaxis was significantly lower for Lovenox compared to placebo, with a statistically significant difference in both total DVT (Lovenox 21 [16%] versus placebo 45 [34%]; p = 0.001) and proximal DVT (Lovenox 8 [6%] versus placebo 28 [21%]; p = <0.001).
Prophylaxis of Deep Vein Thrombosis in Medical Patients with Severely Restricted Mobility During Acute Illness
In a double blind multicenter, parallel group study, Lovenox 20 mg or 40 mg once a day SC was compared to placebo in the prophylaxis of deep vein thrombosis (DVT) in medical patients with severely restricted mobility during acute illness (defined as walking distance of <10 meters for ≤3 days). This study included patients with heart failure (NYHA Class III or IV); acute respiratory failure or complicated chronic respiratory insufficiency (not requiring ventilatory support): acute infection (excluding septic shock); or acute rheumatic disorder [acute lumbar or sciatic pain, vertebral compression (due to osteoporosis or tumor), acute arthritic episodes of the lower extremities]. A total of 1102 patients were enrolled in the study, and 1073 patients were treated. Patients ranged in age from 40 to 97 years (mean age 73 years) with equal proportions of men and women. Treatment continued for a maximum of 14 days (median duration 7 days). When given at a dose of 40 mg once a day SC, Lovenox significantly reduced the incidence of DVT as compared to placebo. The efficacy data are provided below [see Table 20].
![](/images/0/02/ENOXAPARIN23.jpg)
At approximately 3 months following enrollment, the incidence of venous thromboembolism remained significantly lower in the Lovenox 40 mg treatment group versus the placebo treatment group.
Treatment of Deep Vein Thrombosis with or without Pulmonary Embolism
In a multicenter, parallel group study, 900 patients with acute lower extremity deep vein thrombosis (DVT) with or without pulmonary embolism (PE) were randomized to an inpatient (hospital) treatment of either (i) Lovenox 1.5 mg/kg once a day SC, (ii) Lovenox 1 mg/kg every 12 hours SC, or (iii) heparin IV bolus (5000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds). A total of 900 patients were randomized in the study and all patients were treated. Patients ranged in age from 18 to 92 years (mean age 60.7 years) with 54.7% men and 45.3% women. All patients also received warfarin sodium (dose adjusted according to PT to achieve an International Normalization Ratio [INR] of 2.0 to 3.0), commencing within 72 hours of initiation of Lovenox or standard heparin therapy, and continuing for 90 days. Lovenox or standard heparin therapy was administered for a minimum of 5 days and until the targeted warfarin sodium INR was achieved. Both Lovenox regimens were equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism (DVT and/or PE). The efficacy data are provided below [see Table 21].
![](/images/c/ce/ENOXAPARIN24.jpg)
Similarly, in a multicenter, open-label, parallel group study, patients with acute proximal DVT were randomized to Lovenox or heparin. Patients who could not receive outpatient therapy were excluded from entering the study. Outpatient exclusion criteria included the following: inability to receive outpatient heparin therapy because of associated co-morbid conditions or potential for non-compliance and inability to attend follow-up visits as an outpatient because of geographic inaccessibility. Eligible patients could be treated in the hospital, but ONLY Lovenox patients were permitted to go home on therapy (72%). A total of 501 patients were randomized in the study and all patients were treated. Patients ranged in age from 19 to 96 years (mean age 57.8 years) with 60.5% men and 39.5% women. Patients were randomized to either Lovenox 1 mg/kg every 12 hours SC or heparin IV bolus (5000 IU) followed by a continuous infusion administered to achieve an aPTT of 60 to 85 seconds (in-patient treatment). All patients also received warfarin sodium as described in the previous study. Lovenox or standard heparin therapy was administered for a minimum of 5 days. Lovenox was equivalent to standard heparin therapy in reducing the risk of recurrent venous thromboembolism. The efficacy data are provided below [see Table 22].
![](/images/1/10/ENOXAPARIN25.jpg)
Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction
In a multicenter, double-blind, parallel group study, patients who recently experienced unstable angina or non-Q-wave myocardial infarction were randomized to either Lovenox 1 mg/kg every 12 hours SC or heparin IV bolus (5000 U) followed by a continuous infusion (adjusted to achieve an aPTT of 55 to 85 seconds). A total of 3171 patients were enrolled in the study, and 3107 patients were treated. Patients ranged in age from 25–94 years (median age 64 years), with 33.4% of patients female and 66.6% male. Race was distributed as follows: 89.8% Caucasian, 4.8% Black, 2.0% Asian, and 3.5% other. All patients were also treated with aspirin 100 to 325 mg per day. Treatment was initiated within 24 hours of the event and continued until clinical stabilization, revascularization procedures, or hospital discharge, with a maximal duration of 8 days of therapy. The combined incidence of the triple endpoint of death, myocardial infarction, or recurrent angina was lower for Lovenox compared with heparin therapy at 14 days after initiation of treatment. The lower incidence of the triple endpoint was sustained up to 30 days after initiation of treatment. These results were observed in an analysis of both all-randomized and all-treated patients. The efficacy data are provided below [see Table 23].
![](/images/c/c9/ENOXAPARIN26.jpg)
The combined incidence of death or myocardial infarction at all time points was lower for Lovenox compared to standard heparin therapy, but did not achieve statistical significance. The efficacy data are provided below [see Table 24].
![](/images/d/da/ENOXAPARIN27.jpg)
In a survey one year following treatment, with information available for 92% of enrolled patients, the combined incidence of death, myocardial infarction, or recurrent angina remained lower for Lovenox versus heparin (32.0% vs 35.7%).
Urgent revascularization procedures were performed less frequently in the Lovenox group as compared to the heparin group, 6.3% compared to 8.2% at 30 days (p = 0.047).
Treatment of Acute ST-Segment Elevation Myocardial Infarction
In a multicenter, double-blind, double-dummy, parallel group study, patients with acute ST-segment elevation myocardial infarction (STEMI) who were to be hospitalized within 6 hours of onset and were eligible to receive fibrinolytic therapy were randomized in a 1:1 ratio to receive either Lovenox or unfractionated heparin.
Study medication was initiated between 15 minutes before and 30 minutes after the initiation of fibrinolytic therapy. Unfractionated heparin was administered beginning with an IV bolus of 60 U/kg (maximum 4000 U) and followed with an infusion of 12 U/kg per hour (initial maximum 1000 U per hour) that was adjusted to maintain an aPTT of 1.5 to 2 times the control value. The IV infusion was to be given for at least 48 hours. The enoxaparin dosing strategy was adjusted according to the patient's age and renal function. For patients younger than 75 years of age, enoxaparin was given as a single 30 mg intravenous bolus plus a 1 mg/kg SC dose followed by an SC injection of 1 mg/kg every 12 hours. For patients at least 75 years of age, the IV bolus was not given and the SC dose was reduced to 0.75 mg/kg every 12 hours. For patients with severe renal insufficiency (estimated creatinine clearance of less than 30 mL per minute), the dose was to be modified to 1 mg/kg every 24 hours. The SC injections of enoxaparin were given until hospital discharge or for a maximum of eight days (whichever came first). The mean treatment duration for enoxaparin was 6.6 days. The mean treatment duration of unfractionated heparin was 54 hours.
When percutaneous coronary intervention was performed during study medication period, patients received antithrombotic support with blinded study drug. For patients on enoxaparin, the PCI was to be performed on enoxaparin (no switch) using the regimen established in previous studies, i.e. no additional dosing, if the last SC administration was less than 8 hours before balloon inflation, IV bolus of 0.3 mg/kg enoxaparin if the last SC administration was more than 8 hours before balloon inflation.
All patients were treated with aspirin for a minimum of 30 days. Eighty percent of patients received a fibrin-specific agent (19% tenecteplase, 5% reteplase and 55% alteplase) and 20% received streptokinase.
Among 20,479 patients in the ITT population, the mean age was 60 years, and 76% were male. Racial distribution was: 87% Caucasian, 9.8% Asian, 0.2% Black, and 2.8% other. Medical history included previous MI (13%), hypertension (44%), diabetes (15%) and angiographic evidence of CAD (5%). Concomitant medication included aspirin (95%), beta-blockers (86%), ACE inhibitors (78%), statins (70%) and clopidogrel (27%). The MI at entry was anterior in 43%, non-anterior in 56%, and both in 1%.
The primary efficacy end point was the composite of death from any cause or myocardial re-infarction in the first 30 days after randomization. Total follow-up was one year.
The rate of the primary efficacy end point (death or myocardial re-infarction) was 9.9% in the enoxaparin group, and 12.0% in the unfractionated heparin group, a 17% reduction in the relative risk, (P=0.000003) [see Table 25].
![](/images/d/db/ENOXAPARIN28.jpg)
The beneficial effect of enoxaparin on the primary end point was consistent across key subgroups including age, gender, infarct location, history of diabetes, history of prior myocardial infarction, fibrinolytic agent administered, and time to treatment with study drug (see Figure 1); however, it is necessary to interpret such subgroup analyses with caution.
![](/images/a/aa/ENOXAPARIN29.jpg)
The beneficial effect of enoxaparin on the primary end point observed during the first 30 days was maintained over a 12 month follow-up period (see Figure 2).
![](/images/d/df/ENOXAPARIN30.jpg)
There is a trend in favor of enoxaparin during the first 48 hours, but most of the treatment difference is attributed to a step increase in the event rate in the UFH group at 48 hours (seen inFigure 2), an effect that is more striking when comparing the event rates just prior to and just subsequent to actual times of discontinuation. These results provide evidence that UFH was effective and that it would be better if used longer than 48 hours. There is a similar increase in endpoint event rate when enoxaparin was discontinued, suggesting that it too was discontinued too soon in this study.
The rates of major hemorrhages (defined as requiring 5 or more units of blood for transfusion, or 15% drop in hematocrit or clinically overt bleeding, including intracranial hemorrhage) at 30 days were 2.1% in the enoxaparin group and 1.4% in the unfractionated heparin group. The rates of intracranial hemorrhage at 30 days were 0.8% in the enoxaparin group 0.7% in the unfractionated heparin group. The 30-day rate of the composite endpoint of death, myocardial re-infarction or ICH (a measure of net clinical benefit) was significantly lower in the enoxaparin group (10.1%) as compared to the heparin group (12.2%).
How Supplied
Lovenox is available in two concentrations [see Tables 26 and 27]:
![](/images/c/c8/Enoxaparin_how_supplied_01.jpg)
![](/images/5/59/Enoxaparin_how_supplied_02.jpg)
Storage
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Do not store the multiple-dose vials for more than 28 days after the first use.
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Patient Counseling Information
For patient information about enoxaparin from NLM, click here.
Precautions with Alcohol
Alcohol-Enoxaparin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Enoxaparin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Enoxaparin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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