INNOHEP is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of INNOHEP were established in hospitalized patients.

All patients should be evaluated for bleeding disorders before administration of INNOHEP. Since coagulation parameters are unsuitable for monitoring INNOHEP activity, routine monitoring of coagulation parameters is not required (see PRECAUTIONS, Laboratory Tests ).

Adult Dosage

The recommended dose of INNOHEP for the treatment of DVT with or without PE is 175 anti-Xa IU/kg of body weight, administered SC once daily for at least 6 days and until the patient is adequately anticoagulated with warfarin (INR at least 2.0 for two consecutive days). Warfarin sodium therapy should be initiated when appropriate (usually within 1-3 days of INNOHEP initiation).

As INNOHEP may theoretically affect the PT/INR, patients receiving both INNOHEP and warfarin should have blood for PT/INR determination drawn just prior to the next scheduled dose of INNOHEP.

Table 8 provides INNOHEP doses for the treatment of DVT with or without PE. It is necessary to calculate the appropriate INNOHEP dose for patient weights not displayed in Table 8.

An appropriately calibrated syringe should be used to assure withdrawal of the correct volume of drug from INNOHEP vials.

To calculate the volume (mL) of an INNOHEP 175 anti-Xa IU per kg subcutaneous dose for treatment of deep vein thrombosis:

Patient weight (kg) 0.00875 mL/kg = volume to be administered (mL) subcutaneously

Administration

INNOHEP is a clear, colorless to slightly yellow solution, and as with other parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

INNOHEP is administered by SC injection. It must not be administered by intramuscular or intravenous injection.

Subcutaneous Injection Technique:   Patients should be lying down (supine) or sitting and INNOHEP administered by deep SC injection. Administration should be alternated between the left and right anterolateral and left and right posterolateral abdominal wall. The injection site should be varied daily. The whole length of the needle should be introduced into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. To minimize bruising, do not rub the injection site after completion of the injection.

INNOHEP is available in a multiple dose 2 mL vial in the following packages:

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature].

Keep out of the reach of children.

Manufactured for:

DuPont Pharma

Wilmington, DE 19880 USA

By:

Leo Pharmaceutical Products

Ballerup, Denmark

Innohep® is a registered trademark of Leo Pharmaceutical Products.

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