Lovenox 80 mg/.8mL

enoxaparin sodium · INJECTION · Sanofi-Aventis U.S. LLC

No Recall History

Plain English

Lovenox is a injection containing enoxaparin sodium at 80 mg/.8mL, taken subcutaneous. Manufactured by Sanofi-Aventis U.S. LLC.

Key Facts

Brand Name: Lovenox
Generic Name: enoxaparin sodium
NDC Code (Product): 0075-8018
Manufacturer: Sanofi-Aventis U.S. LLC
Strength: 80 mg/.8mL
Dosage Form: INJECTION
Route: SUBCUTANEOUS
Marketing Status
Application #: NDA020164
Marketing Start: 03/29/1993

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use2,428 reports

dyspnoea2,397 reports

nausea2,382 reports

diarrhoea2,273 reports

anaemia2,208 reports

thrombocytopenia2,080 reports

pyrexia2,065 reports

fatigue1,991 reports

vomiting1,877 reports

pulmonary embolism1,798 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Lovenox is a low molecular weight heparin (LMWH) indicated for: • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness ( 1.1 ) • Inpatient treatment of acute DVT with or without pulmonary embolism ( 1.2 ) • Outpatient treatment of acute DVT without pulmonary embolism ( 1.2 ) • Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction (MI) ( 1.3 ) • Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) ( 1.4 ) 1.1 Prophylaxis of Deep Vein Thrombosis Lovenox ® 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 s…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION See full prescribing information for dosing and administration information. ( 2 ) 2.1 Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting Lovenox treatment, unless treatment is urgently needed. 2.2 Adult Dosage Abdominal Surgery The recommended dose of Lovenox is 40 mg by subcutaneous injection once a day (with the initial dose given 2 hours prior to surgery) in patients undergoing abdominal surgery who are at risk for thromboembolic complications. The usual duration of administration is 7 to 10 days [see Clinical Studies (14.1) ] . Hip or Knee Replacement Surgery The recommended dose of Lovenox is 30 mg every 12 hours administered by subcutaneous injection in patients undergoing hip or knee replacement surgery. Administer the initial dose 12 to 24 hours after surgery, provided that hemostasis has been established. The usual duration of administration is 7 to 10 days [see Clinical Studies (14.2) ] . A dose of Lovenox of 40 mg once a day subcutaneously may be considered for hip replacement surgery for up to 3 weeks. Administer the initial dose 12 (±3) hours prior to surgery. Medical Patients during Acute Illness The recom…

Contraindications

4 CONTRAINDICATIONS Lovenox is contraindicated in patients with: • Active major bleeding • History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies [see Warnings and Precautions (5.4) ] • Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria, anaphylactic/anaphylactoid reactions) [see Adverse Reactions (6.2) ] • Known hypersensitivity to heparin or pork products • Known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of Lovenox) [see Warnings and Precautions (5.8) ] • Active major bleeding ( 4 ) • History of heparin-induced thrombocytopenia (HIT) within the past 100 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 multiple-dose formulation only) ( 4 )

Drug Interactions

7 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 coadministration is essential, conduct close clinical and laboratory monitoring [see Warnings and Precautions (5.1) ] . Discontinue agents which may enhance hemorrhage risk prior to initiation of Lovenox or conduct close clinical and laboratory monitoring. ( 2.6 , 7 )

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are also discussed in other sections of the labeling: • Spinal/epidural hematomas [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) ] Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 Lovenox. These included 1,228 for prophylaxis of deep vein thrombosis following abdominal surgery in patients at risk for t…

Frequently Asked Questions

What is Lovenox used for?

Lovenox contains enoxaparin sodium. It is a injection taken subcutaneous. Consult your doctor for specific uses.

Is Lovenox a controlled substance?

Lovenox is not classified as a controlled substance by the DEA.

What is the generic name for Lovenox?

The generic name for Lovenox is enoxaparin sodium. There are 9 other brand versions of enoxaparin sodium.

What is the NDC code for Lovenox 80 mg/.8mL?

The NDC (National Drug Code) for Lovenox 80 mg/.8mL is 0075-8018, listed by Sanofi-Aventis U.S. LLC.

Product NDC

0075-8018

Package NDC

0075-8018-10

Other Lovenox Dosages

Other Enoxaparin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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