Innohep (Tinzaparin) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Innohep

Deep Vein Thrombosis (DVT) »

Introduction to deep vein thrombosis (DVT)

Arteries have thin muscles within their walls to be able to withstand the pressure of the heart pumping blood to the far reaches of the body. Veins don't have a significant muscle lining, and there is nothing pumping blood back to the heart except physiology. Blood returns to the heart because the body's large muscles squeeze the veins as they contract in their normal activity of moving the body. The normal activities of moving the body returns the blood back to the heart.

There are two types of veins in the leg; superficial veins and deep veins. Superficial veins lie just below the skin and are easily seen on the surface. Deep veins, as their name implies, are located deep within the muscles of the leg. Blood flows from the superficial veins into the deep venous system through small perforator veins. Superficial and perforator veins have one-way valves within them that allow blood to flow only in the direc...

Read the Deep Vein Thrombosis (DVT) article »

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Innohep User Reviews >>

Innohep

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Innohep®
(tinzaparin sodium) Injection

For Subcutaneous (SC) Use Only

WARNING

SPINAL/EPIDURAL HEMATOMAS

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

Use of indwelling epidural catheters
Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants.
A history of traumatic or repeated epidural or spinal punctures
A history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (see WARNINGS, Hemorrhage, and PRECAUTIONS: DRUG INTERACTIONS).

DRUG DESCRIPTION

INNOHEP® is a sterile solution, containing tinzaparin sodium, a low molecular weight heparin. It is available in a multiple dose 2 mL vial.

Each 2 mL vial contains 20,000 anti-Factor Xa IU (anti-Xa) of tinzaparin sodium per mL, for a total of 40,000 IU, and 3.1 mg/mL sodium metabisulfite as a stabilizer. The vial contains 10 mg/mL benzyl alcohol as a preservative. Sodium hydroxide may be added to achieve a pH range of 5.0 to 7.5.

Table 1 Composition of 20,000 anti-Xa IU/mL INNOHEP® (tinzaparin sodium injection)

Component	Quantity per mL
Tinzaparin sodium	20,000 anti-Xa IU
Benzyl alcohol, USP	10 mg
Sodium metabisulfite, USP	3.106 mg¹
Sodium hydroxide, USP	as necessary
Water for Injection, USP	q.s. to 1 mL
¹ Corresponding to 3.4 mg/mL sodium bisulfite

Tinzaparin sodium is the sodium salt of a low molecular weight heparin obtained by controlled enzymatic depolymerization of heparin from porcine intestinal mucosa using heparinase from Flavobacterium heparinum. The majority of the components have a 2-O-sulpho-4-enepyranosuronic acid structure at the non-reducing end and a 2-N,6-O-disulpho-D-glucosamine structure at the reducing end of the chain.

Potency is determined by means of a biological assay and interpreted by the first International Low Molecular Weight Heparin Standard as units of anti-factor Xa (anti-Xa) activity per milligram. The mean tinzaparin sodium anti-factor Xa activity is approximately 100 IU per milligram. The average molecular weight ranges between 5,500 and 7,500 daltons. The molecular weight distribution is:

< 2,000 Daltons < 10%
2,000 to 8,000 Daltons 60% to 72%
> 8,000 Daltons 22% to 36%

Structural Formula:

What are the possible side effects of tinzaparin (Innohep)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tinzaparin and call your doctor at once if you have any of these serious side effects:

unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop;
pale skin, weakness, easy bruising, purple or red pinpoint spots under your skin;
unexpected vaginal bleeding;
blood in your urine or stools, black or...

Read All Potential Side Effects and See Pictures of Innohep »