FOR U.S. RESIDENTS ONLY

About LOVENOX®

LOVENOX® (enoxaparin sodium injection) is a unique chemical entity in a class of antithrombotic agents known as low-molecular-weight heparins (LMWH). LOVENOX® was approved in the United States and Canada in 1993, and it has been available in Europe since 1987. LOVENOX® is the only low-molecular-weight heparin in the United States approved by the Food and Drug Administration in 7 approved indications for the prophylaxis and treatment of thromboembolic disease.

The #1 selling low-molecular-weight heparin in the world, the safety and efficacy of LOVENOX® has been demonstrated for more than 15 years treating over 100 million patients in 96 countries.

Important Safety Information

LOVENOX® Full Prescribing Information

Certain procedures, called "epidural/spinal anesthesia" and "spinal puncture," may be used as a normal part of hospitalization. Patients requiring these procedures while being treated with LOVENOX® (enoxaparin sodium injection) or other low-molecular-weight heparins are at risk of developing a blood clot in or around the spine. This condition may result in long-term or permanent paralysis.

LOVENOX® is not the same as "unfractionated heparin" or other drugs called "low-molecular-weight heparins." Therefore, these drugs cannot be used interchangeably with LOVENOX®.

LOVENOX® can alter the blood’s ability to clot. Patients treated with LOVENOX®, who also have conditions affecting the clotting system, must be carefully monitored by their physician. Adjusting the dose of LOVENOX® may be necessary for patients who have certain forms of kidney disease. All patients receiving LOVENOX®, as well as other anticoagulants, should be carefully monitored for bleeding by their physician. Bleeding can occur at any site with LOVENOX® use.

Platelet drops, known as "thrombocytopenia," can occur with LOVENOX® use. Cases of a related condition called "heparin-induced thrombocytopenia" have been observed in clinical practice. If you have had this condition, you must notify your healthcare professional. Your physician may perform blood tests to monitor for the occurrence of any drop in platelet count.

The use of LOVENOX® has not been adequately studied in pregnant women with artificial (mechanical) heart valves.

LOVENOX® should not be used in patients with an allergy or sensitivity reaction to the active ingredient called enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding.

Common side effects include mild local reactions or irritation at the site of injection, pain, bruising, and redness of skin.

For specific questions about your health, you should always consult your physician or a qualified healthcare professional who is responsible for your care.

Please see Full Prescribing Information including boxed WARNING, for additional important information.
Last Update: November 2002