Lovenox (Enoxaparin Sodium) - Summary

LOVENOX SUMMARY

Lovenox Injection is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin.

• Lovenox Injection is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism:
  
  • in patients undergoing abdominal surgery who are at risk for thromboembolic complications;
  • 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.
• Lovenox Injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
• Lovenox 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.

NEWS HIGHLIGHTS

Media Articles Related to Lovenox (Enoxaparin)

Deep Vein Thrombosis (DVT)
Source: MedicineNet Antiphospholipid Syndrome Specialty [2008.04.30]
Title: Deep Vein Thrombosis (DVT)
Category: Diseases and Conditions
Created: 2/15/2000 10:55:00 PM
Last Editorial Review: 4/30/2008

ThromboGenics And BioInvent Complete Patient Recruitment Of Phase II DVT Prophylaxis Study With Anti-Factor VIII (TB-402)
Source: Bones / Orthopaedics News From Medical News Today [2009.10.29]
ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have completed recruitment of their Phase II trial of TB-402 ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The results of this study, which has recruited 315 patients, are anticipated in the second quarter of 2010.

Blood Clot Risk Higher In Apple-Shaped Men And Pear-Shaped Women, Danish Study
Source: Cardiovascular / Cardiology News From Medical News Today [2009.10.29]
New research from Denmark suggests that where middle-aged men and women carry excess body fat affects their risk of developing blood clots like deep vein thrombosis (DVT) , with apple-shaped men who carry excess fat mainly around the waist and pear-shaped women who carry excess fat mainly around the hips having the highest risk.

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Published Studies Related to Lovenox (Enoxaparin)

Apixaban or enoxaparin for thromboprophylaxis after knee replacement. [2009.08.06]
BACKGROUND: The optimal strategy for thromboprophylaxis after major joint replacement has not been established. Low-molecular-weight heparins such as enoxaparin predominantly target factor Xa but to some extent also inhibit thrombin. Apixaban, a specific factor Xa inhibitor, may provide effective thromboprophylaxis with a low risk of bleeding and improved ease of use... CONCLUSIONS: As compared with enoxaparin for efficacy of thromboprophylaxis after knee replacement, apixaban did not meet the prespecified statistical criteria for noninferiority, but its use was associated with lower rates of clinically relevant bleeding and it had a similar adverse-event profile. (ClinicalTrials.gov number, NCT00371683.) 2009 Massachusetts Medical Society

Adding intravenous unfractionated heparin to standard enoxaparin causes excessive anticoagulation not detected by activated clotting time: results of the STACK-on to ENOXaparin (STACKENOX) study. [2009.08]
BACKGROUND: The STACKENOX study assessed the cumulative anticoagulation effect of administering stack-on intravenous unfractionated heparin (UFH) to subjects already receiving enoxaparin... CONCLUSIONS: The administration of stack-on UFH to subjects already receiving recommended enoxaparin dosing may result in over-anticoagulation, and should be avoided. Activated clotting time assessment did not detect the over-anticoagulation resulting from co-administration of enoxaparin and UFH.

Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial. [2009.07.28]
OBJECTIVES: This study sought to evaluate the relative safety and efficacy of fondaparinux and enoxaparin in patients with acute coronary syndromes (ACS) treated with glycoprotein (GP) IIb/IIIa inhibitors or thienopyridines. BACKGROUND: The OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial showed that fondaparinux reduced major bleeding by 50% compared with enoxaparin while preserving similar efficacy. Whether this benefit is consistent in the presence or absence of concurrent antiplatelet therapy with clopidogrel and GP IIb/IIIa inhibitors is unknown... CONCLUSIONS: In patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding and improves net clinical outcome compared with enoxaparin.

Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. [2009.05.16]
BACKGROUND: Prophylaxis for venous thromboembolism is recommended for at least 10 days after total knee arthroplasty; oral regimens could enable shorter hospital stays. We aimed to test the efficacy and safety of oral rivaroxaban for the prevention of venous thromboembolism after total knee arthroplasty... INTERPRETATION: Oral rivaroxaban 10 mg once daily for 10-14 days was significantly superior to subcutaneous enoxaparin 30 mg given every 12 h for the prevention of venous thromboembolism after total knee arthroplasty. FUNDING: Bayer Schering Pharma AG, Johnson & Johnson Pharmaceutical Research & Development.

Fondaparinux versus Enoxaparin in non-ST-elevation acute coronary syndromes: short-term cost and long-term cost-effectiveness using data from the Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators (OASIS-5) trial. [2009.05]
BACKGROUND: The study aimed to compare the short-term costs and long-term cost-effectiveness of 2 antithrombotics, fondaparinux and enoxaparin, for non-ST-elevation acute coronary syndrome in the United States... CONCLUSIONS: Fondaparinux is a more cost-effective antithrombotic agent than enoxaparin in non-ST-elevation acute coronary syndrome. This is true across the range of event risks seen in OASIS-5.

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Clinical Trials Related to Lovenox (Enoxaparin)

Safety Evaluation of Use Sodic Enoxaparin [Completed]
The purpose of this study was to evaluate safety, not inferiority clinical and pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when compared with Clexane product, produced by Laboratory Sanofi-Aventis in 60 patients with Chronic Renal Desease.

Once Daily Enoxaparin for Outpatient Treatment of Acute DVT and/or Pulmonary Embolism [Active, not recruiting]
To investigate the efficacy and safety of once daily enoxaparin as a "bridge" to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.

Study to Evaluate Weight-Based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT [Completed]
Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients. Consensus guidelines recommend using medications such as heparin or low-molecular-weight heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a fixed dose that is the same for everyone. The appropriate dose of medication in patients with severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in severely obese patients may not provide adequate protection against DVT. The purpose of this study is to evaluate a weight-based dose(0. 5 milligrams per kilogram of body weight) of the commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0. 5mg/kg once daily in severely obese patients will lead to predictable blood levels.

LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin [Completed]
To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3. 5 months. The secondary outcome is cost analysis comparing the two arms.

Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles [Recruiting]
Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the lung, colon, or pancreas and also have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness. Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.

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PATIENT REVIEWS / RATINGS / COMMENTS

Lovenox review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Blood thinning/ circulation during pregnancy
Dosage & duration:		30 mg/ml taken twice a day for the period of 9 months
Other conditions:		None
Other drugs taken:		Low dose aspirin
		Reported Results
Benefits:		Lovenox is given in subsequent pregnancies to women with recurrent miscarriage due to autoimmune issues. Prior to taking Lovenox, I had two second trimester losses and thanks to Lovenox I was able to carry my two daughters to term. It allowed my placenta to last the pregnancy without clotting and I was able to successfully have two children.
Side effects:		There are no major side effects. There is an increased risk of bleeding but I did not experience this. The only mild side effects was burning at the site of the injection when the medicine was going in, and some bruising at the site of the injection. Other than this I did not experience any sorts of side effects what so ever.
Comments:		I had to self administer the shots twice a day. Lovenox shots are primarily given on the belly. However, the area usually remains sensitive and for anyone taking the drug for a prolonged period of time like I was, eventually you will run out of spots in your abdominal area and have to move to the thigh (I had to move to the thigh area during my last month of pregnancy). Other than slight burning and bruising, there was no other issues. Initially I had a hard time giving myself the shot, and my husband had to do it, but once you get used to it, it's not really that bad and I was able to do it easily later on. I was supposed to start the shots prior to conception and continue them six weeks postpartum. My overall experience with Lovenox is very good and I am very happy that this drug was around to help me.

Lovenox review by 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Blood clot as a cause of early stage misscarriage
Dosage & duration:		40mg/0.4ml taken subcutaneous injection/on my own for the period of 60 days
Other conditions:		none
Other drugs taken:		baby asperin
		Reported Results
Benefits:		I had two early stage miscarriages, so I was tested by a reproductive specialist. She diagnosed that I have high blood clot factor. As soon as the third pregnancy was confirmed (5th week), I stated to take Lovenox once a day. After reaching 13th week and ultrasound confirmed the baby is growing well, I was allow to be off Lovenox. I am now in third trimester and my pregnancy went well.
Side effects:		There was no side effect, however I really hated giving injection to myself. I was so painfull. The injection spot became bruised, even though I iced it right away after injection. And the bruises did not heal for a week to two weeks. I picked different injection spot every day to avoid the bruised area, so my abdomen was purple for the 9 weeks.
Comments:		As memtioned above in treatment benefits, this drug was used to avoid recurrance of early stage miscarriage. The high blood clot factor originates from two reasons: for one my husband and I share two HLA, and two I have condition so called antiphospholipid syndrome. To reduce the factor I was directed to take baby asperin and Lovenox. Once I reached 13th week when the plecenta is well establised and growth of baby was well, my doctor decided Lovenox is no longer needed and baby asperin alone be fine onward.