Tinzaparin sodium

Tinzaparin is an antithrombotic drug in the heparin group. It is a low molecular weight heparin (LMWH) marketed as Innohep worldwide. It has been approved by the U.S. Food and Drug Administration (FDA) for once daily treatment and prophylaxis of deep vein thrombosis and pulmonary embolism.[1] Tinzaparin sodium is the only low molecular weight heparin shown to be safe in pregnancy and in critically ill people with renal failure at both treatment and prophylaxis dose levels.[2]

It can be given subcutaneously by syringe, or intravenously.[3] It is manufactured by Leo pharmaceutical company.

F.D.A approved indications

In the United States, tinzaparin is FDA approved for the following indications:

  • 1-Prophylaxis of DVT in medically ill and elderly patient.
  • 2-Total hip & knee replacement,
  • 3-Extended hip-replacement,
  • 4-Abdominal surgery.
  • 5-Treatment of DVT with or without PE.
  • 6-prophylaxis and treatment of DVT in pregnant women.
  • 7-as an assistant in the process of In Vitro Fertilization (IVF).

Indications approved in the UK and Australia

Tinzaparin is approved for the following

  • 1-The prophylaxis of thromboembolism disorders of venous origin, in particular those that may be associated with orthopaedic surgery.
  • 2-The prophylaxis of venous thromboembolism (VTE) in medical patients bedridden due to acute illness.
  • 3-prophylaxis and treatment of DVT in pregnant women.
  • 4-The treatment of venous thromboembolism disease (VTED) presenting with deep vein thrombosis (DVT), pulmonary embolism (PE) or both.
  • 5-The treatment of unstable angina (UA) and non-Q-wave myocardial infarction (NQMI), administered concurrently with aspirin.
  • 6-The prevention of thrombus formation in the extracorporeal circulation during haemodialysis.
  • 7-The prevention of thrombus formation during episodes of lone Atrial Fibrillation, administered concurrently with aspirin (in the absence of long term anticoagulation treatment with warfarin.

Use in elderly

In July 2008, the company revised the prescribing information to restrict the use of tinzaparin in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggests that the increased risk of mortality is not limited only to patients 90 years of age or older.

According to the study Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both.

(note the previous version of this article made a crucial error by removing the not from the sentence ...the increased risk of mortality is not limited only to patients 90 years of age... This revision corrects this and gives more detail of the advice..

Also see the Health Canada website. http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/innohep_hpc-cps-eng.php

Use in pregnancy

No LMWH, except tinzaparin, is licensed for use in gestational hypercoagulability.[4] Still, tinzaparin is often the LMWH of choice in pregnant women.[4]

Side effects

Bleeding in overdose. There is occasionally bruising at the site of injection.

Monitoring

Tinzaparin does NOT affect the international normalized ratio (INR), prothrombin time (PT) Anti-factor Xa levels can be measured, and are often used to monitor tinzaparin

Reversal agent

Protamine sulfate will reverse Tinzaparin by 85% per package insert.

References

  • 8- (22)ESHRE April-2011 volume 33 pages 12–13-14
  • 9- e-medicine 2011
  • 10- RCOG March-2010 (Royal college for Obestetric and Gynecology)
  • 11- DVT.org/cardiologist
  • 12- ^ Hull, New England Journal of Medicine, 2010 volume 22 page 19

External links

  • Medical Subject Headings (MeSH)
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