Normiflo

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved May 1997

Specific Treatments:

Deep venous thrombosis

Therapeutic Areas

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General Information

Normiflo (andeparin sodium,)a low molecular weight heparin cleared for use in prevention of deep venous thrombosis (DVT), differs from others in its class by allowing the orthopedic surgeon to determine dosing based on a patient’s weight. The new dosing method eliminates the need for daily dosage adjustments and routine coagulation laboratory monitoring. Venous thromboembolic disease includes DVT, the formation of blood clots following surgery and its complications such as pulmonary embolism, which can be sudden and fatal.

Clinical Results

In one study, dosing regimens of Normiflo were compared to warfarin for preventing DVT in patients electing knee replacement surgery, a procedure that puts patients at high risk of developing the condition. Normiflo was found to be more effective than warfarin in preventing venous thromboembolism. Investigators concluded that ardeparin sodium was significantly more effective than warfarin and had a comparable safety profile. In another study, results showed that dosing based on body weight produced constant plasma antiXa levels. No routine coagulation monitoring is required during thromboprophylaxes with Normiflo. However, monitoring of complete blood counts, including platelet counts, urinalysis, and occult blood in stools, is recommended.

Side Effects

Normiflo should not be used in patients with active major bleeding, hypersensitivity to the drug, or thombocytopenia associate with a positive in vitro test for antiplatelet antibodies in the presence of Normiflo. Patients with a known hypersensitivity to ardeparin sodium or to pork products should not be treated with Normiflo. Bleeding can occur at virtually any site. If problematic bleeding occurs, Normiflo should be discontinued. Patients should be observed closely for bleeding if Normiflo is administered during or immediately following diagnostic lumbar puncture, epidural anesthesia, or spinal anesthesia.

Additional Information

Venous thromboembolic disease is considered to be responsible for more than 400,000 hospitalizations and up to 200,000 deaths in the U.S. alone. In the absence of prophylaxis with any agent or device, DVT is estimated to occur in 40% or 70% of patients following major orthopedic procedures with death resulting in 1% of knee replacement patients.