LOVENOX® is indicated to help reduce the risk of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE). Read full important safety. /83/EC for Lovenox and associated names, in order to resolve divergences The PI was split as follows according to the indications the. Save money on your Lovenox® Injection prescription by switching to Teva’s FDA- approved generic version, Enoxaparin Sodium Injection, USP.

Author: Grosho Arashigor
Country: Finland
Language: English (Spanish)
Genre: Medical
Published (Last): 22 September 2005
Pages: 405
PDF File Size: 10.40 Mb
ePub File Size: 4.59 Mb
ISBN: 624-8-14871-513-9
Downloads: 98117
Price: Free* [*Free Regsitration Required]
Uploader: Zulkijar

Although a causal relationship has not been established these deaths may have been due to therapeutic failure or inadequate anticoagulation. 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 the pivotal clinical study, the Lovenox treatment duration was 8 days or until hospital discharge, whichever came first. The second infusion of 0.

There are no adequate and well-controlled studies in pregnant women. Periodic complete blood counts, including platelet count, and stool occult blood tests are recommended during the course of treatment with Lovenox. Lovenox once a day versus heparin For patients on enoxaparin, the PCI was to be performed on enoxaparin no switch using the regimen established in previous studies, i. There also have been isolated postmarketing reports of valve thrombosis in pregnant women with mechanical prosthetic heart valves while receiving enoxaparin for thromboprophylaxis.

Lovenox should be used with care in geriatric patients who may show delayed elimination of enoxaparin. A retrospective study reviewed the records of women who used enoxaparin during pregnancy. Lovenox and mg graduated prefilled syringes contain 15 mg enoxaparin sodium per 0.

Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non—Q-wave myocardial infarction, when concurrently administered with aspirin. It is important to achieve hemostasis at the puncture site after PCI. Activation of the safety system must be done only after removing the needle from the patient’s skin. The beneficial effect of enoxaparin on the primary endpoint 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.


Total follow-up was one year. Pharmacokinetic Interaction No pharmacokinetic interaction was observed between enoxaparin and thrombolytics when po concomitantly. Figure C Orient the needle away from you and others, and activate the safety system by firmly pushing the plunger rod.

Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. These results provide evidence that UFH was effective and that it would be better if used longer than 48 hours.

There is a trend in favor of enoxaparin during the first 48 hours, but most of the treatment difference is attributed to a lovenos increase in the event rate in the UFH group at 48 hours seen in Figure 2an effect that is more striking when comparing the event rates just prior to and just subsequent to actual times of discontinuation.

Consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [see Boxed Warning ]. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Urgent revascularization denotes episodes of recurrent myocardial ischemia without infarction leading to the clinical decision to perform coronary revascularization during the same hospitalization. Active major bleeding 4 History of heparin-induced thrombocytopenia HIT within the past days or in the presence of circulating antibodies 4 Hypersensitivity to enoxaparin sodium 4 Hypersensitivity to heparin or pork products 4 Hypersensitivity to benzyl alcohol for multidose formulation only 4.

A double-blind, multicenter study compared three dosing regimens of Lovenox in patients with hip replacement. In patients with a history of HIT, Lovenox should only be used if more than days have elapsed since the prior HIT episode and no circulating antibodies are present.

Teva’s generic of Lovenox® Injection: Enoxaparin Sodium Injection, USP

Clinical Considerations Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high risk pregnancy conditions. Lovenox is a low molecular weight heparin LMWH indicated for: 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.

A clinical study using enoxaparin in pregnant women with mechanical prosthetic heart valves has been conducted [see Warnings and Precautions 5. Do not exchange with heparin or other Pu 5. A total of patients were enrolled in the study, and patients were treated. Lovenox 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.



The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Patients ranged in age from 19 to 96 years mean age The rates of intracranial hemorrhage at 30 days were 0. The drug substance is the sodium salt.

In a single study, elimination rate appeared similar but AUC was two-fold higher than control population, after a single 0. While not adequately studied, pregnant women with mechanical prosthetic heart valves may be at even higher risk for thrombosis [see Warnings and Precautions 5.

Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism [see Warnings and Precautions 5.

A total of patients were randomized in the double-blind phase of the study and all patients were treated. Observe for thromboembolism 8.

Hip Replacement Surgery with Extended Prophylaxis. Lovejox Lovenox prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. An infusion of 0. To avoid the loss of drug when using the 30 and 40 lovehox prefilled syringes, do not expel the air bubble from ;i syringe before the injection.

Increases of up to 1. All patients were examined for clinical signs and symptoms of venous thromboembolic VTE disease. Significant anti-Factor Xa activity persists in plasma for about 12 hours following a 40 mg subcutaneous once a day dose. Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic disease and certain high risk pregnancy conditions. At the end of the peri-operative period, all patients underwent bilateral venography.

Serious adverse events increased with age for patients receiving Lovenox. Remove the prefilled syringe from the blister packaging by peeling at the arrow as directed on the blister.