Enoxaparin Sodium Injection, USP

About Deep Vein Thrombosis (DVT)

What is Deep Vein Thrombosis (DVT)?

Deep vein thrombosis (DVT) is a medical condition that occurs when a blood clot forms in one of the deep veins and blocks blood flow. Deep vein blood clots typically form in your lower limb, thigh, or pelvis, but it can occur in other parts of the body, too. DVT can be very serious because blood clots in your veins may break loose, travel through your blood stream and lodge in your lungs leading to a pulmonary embolism (PE).

What Causes DVT?

DVT is most common in adults over age 60, but it can occur at any age. Risk factors include:

  • A pacemaker catheter that has been passed through the vein in the groin
  • Bed rest or sitting in one position for too long, such as plane travel
  • Family history of DVT blood clot
  • Fractures in the pelvis or legs
  • Giving birth within the last 6 months
  • Pregnancy
  • Obesity
  • Recent surgery (most commonly hip, knee, or female pelvic surgery)
  • Too many blood cells being made by the bone marrow, causing the blood to be thicker than normal (polycythemia vera)
  • Having an indwelling (long-term) catheter in a blood vessel
  • Blood is more likely to clot in someone who has certain problems or disorders, such as:
  • Certain types of cancer and its treatment:
  • Certain autoimmune disorders
  • Cigarette smoking
  • Birth control pills and hormone replacement therapy (this risk is even higher with smoking)
  • Sitting for long periods when traveling can increase the risk for DVT. This is most likely when you also have one or more of the risk factors listed above

What Are the Signs to indicate DVT?

Deep vein thrombosis (DVT) can occur without noticeable symptoms. Call your doctor immediately if you experience any of the following warning signs:

  • Changes in skin color (redness)
  • Leg pain
  • Leg swelling
  • Skin that feels warm to the touch

Possible Complications

Complications of DVT may include:

  • Fatal pulmonary embolism (blood clots in the thigh are more likely to break off and travel to the lungs than blood clots in the lower leg or other parts of the body)
  • Constant pain and swelling (post-phlebitic syndrome)
  • Varicose veins
  • Non-healing ulcers (less common)
  • Changes in skin color

When to Contact a Medical Professional

Call your provider if you have symptoms of DVT. Go to the emergency room or call 911 if you experience any of the following warning signs:

  • Chest pain
  • Coughing up blood
  • Difficulty breathing
  • Fainting
  • Loss of consciousness
  • Other severe symptoms

Important Safety Information

Enoxaparin Sodium Injection, USP 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
  • Inpatient treatment of acute DVT with or without pulmonary embolism
  • Outpatient treatment of acute DVT without pulmonary embolism
  • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI)
  • Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI).
  • Enoxaparin Sodium Injection, USP is contraindicated in patients with active major bleeding, history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies, hypersensitivity to enoxaparin sodium and hypersensitivity to heparin or pork products.
Warnings and Precautions:
  • Increased Risk of Hemorrhage
  • Increased Risk of Bleeding following Percutaneous Coronary Revascularization Procedures
  • Increased Risk of Bleeding in Patients with Concomitant Medical Conditions
  • Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis
  • Thrombocytopenia
  • Interchangeability with other Heparins
  • Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves

The 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. For additional information, please see full Prescribing Information including boxed warning.