INNOHEP® (tinzaparin) 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® (tinzaparin) were established in hospitalized patients.

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

Adult Dosage

The recommended dose of INNOHEP® (tinzaparin) 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® (tinzaparin) initiation). Pregnancy has little or no influence on the pharmacokinetics of INNOHEP® (tinzaparin) and no dosing adjustment is needed for pregnancy.

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

Table 8 provides INNOHEP® (tinzaparin) doses for the treatment of DVT with or without PE. It is necessary to calculate the appropriate INNOHEP® (tinzaparin) 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® (tinzaparin) vials.

Table 8 : INNOHEP® (tinzaparin) Weight-based Dosing for Treatment of Deep Vein Thrombosis With or Without Symptomatic Pulmonary Embolism

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

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

Administration

INNOHEP® (tinzaparin) 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® (tinzaparin) 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® (tinzaparin) 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® (tinzaparin) is available in a multiple dose 2 mL vial in the following packages:

Box of 1 - 2 mL vial (20,000 anti-Xa IU per mL) NDC 50222-342-08

Box of 10 - 2 mL vials (20,000 anti-Xa IU per mL) NDC 50222-342-53

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 by: LEO Pharmaceutical Products, DK-2750 Ballerup, Denmark. Distributed by: LEO Pharma Inc., 1 Sylvan Way, Parsippany, NJ 07054. 1-877-494-4536. Revised: May 2010.

Last reviewed on RxList: 11/8/2010
This monograph has been modified to include the generic and brand name in many instances.