Innohep

Innohep®
(tinzaparin sodium) Injection

For Subcutaneous (SC) Use Only

Innohep

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:

Innohep®
(tinzaparin sodium)  Structural Formula Illustration

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 a serious side effect such as:

  • unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;
  • easy bruising, purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • black or bloody...

Read All Potential Side Effects and See Pictures of Innohep »

What are the precautions when taking tinzaparin (Innohep)?

See also Warning section.

Before using tinzaparin, tell your doctor or pharmacist if you are allergic to it; or to heparin or pork products; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites, benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using tinzaparin, tell your doctor or pharmacist your medical history, especially of: a past blood-clotting problem because of heparin (heparin-induced thrombocytopenia), artificial heart valves, bleeding/blood problems (such as low platelet count, bleeding ulcer), a certain eye problem (diabetic retinopathy), high blood pressure, infections in the heart (bacterial endocarditis), kidney disease, liver disease,...

Read All Potential Precautions of Innohep »

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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