Tinzaparin sodium: Difference between revisions
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==Use in elderly== |
==Use in elderly== |
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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 suggest that the increased risk of mortality is limited only to patients 90 years of age or older. Therefore, it is the best LMWH to be used in elderly patient less than 90 years old |
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 suggest that the increased risk of mortality is limited only to patients 90 years of age or older. Therefore, it is the best LMWH to be used in elderly patient less than 90 years old |
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On December 31, 2008, Celgene, the manufacturer of tinzaparin sodium injection (Innohep) issued a Dear Healthcare Professional Letter in regard to an increased risk for death in renal-impaired elderly patients receiving tinzaparin vs unfractionated heparin. The letter advises of a change in labeling to apply the warning to all renal-impaired elderly, not just those older than 90 years of age, as reported on December 2. |
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Findings from a controlled clinical study suggest that compared with unfractionated heparin, tinzaparin may increase the risk for death when used to treat elderly patients with renal insufficiency. When treating renal-impaired elderly patients for deep vein thrombosis with or without pulmonary embolism, clinicians should consider alternatives to tinzaparin. |
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The change in labeling was prompted by information received by the FDA about the Innohep in Renal Insufficiency Study (IRIS), a multicenter European study that was terminated in February, 2008 by the study's Data Safety Monitoring Committee. The interim finding leading to termination was that patients who received the drug, a low-molecular-weight heparin, had an increase in all-cause mortality. |
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The objective of IRIS was to assess the safety of tinzaparin compared with unfractionated heparin (UFH) in treating deep vein thromboses and/or pulmonary emboli (PE) in patients with impaired renal function who were older than 70 years. |
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At study termination, 350 patients had completed 90 days follow-up, and there were 23 deaths in the tinzaparin group (23 [13%] of 176 patients ) and 9 deaths in the UFH group (9 [5%] of 174 patients). Although the causes of death did not follow a clear pattern, they did not appear to be related to either overdosing causing bleeding or underdosing causing thrombosis. The data reported in the FDA's December 2 statement were deemed insufficient to exclude the possibility of another deep vein thrombosis or PE — or both — in patients who received tinzaparin. |
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==Use in pregnancy== |
==Use in pregnancy== |
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Revision as of 12:27, 31 December 2011
 | |
| Clinical data | |
|---|---|
| AHFS/Drugs.com | Monograph |
| Routes of administration | subcutaneous (once daily) |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | 90% for Anti-Xa activity, 67% for Anti-IIa activity)[2] |
| Metabolism | primarily by liver by desulfation and/or depolymerization |
| Elimination half-life | 200 min. for Anti-Xa activity, 257. min for Anti-IIa activity [3] |
| Identifiers | |
| CAS Number |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| ECHA InfoCard | 100.110.590 |
| Chemical and physical data | |
| Molar mass | 6500 (average)[4] |
  (what is this?) (verify) | |
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.[5] 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.[6]
It can be given subcutaneously by syringe, or intravenously.[7] it is manufactured by Leo pharmacutical 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 suggest that the increased risk of mortality is limited only to patients 90 years of age or older. Therefore, it is the best LMWH to be used in elderly patient less than 90 years old
On December 31, 2008, Celgene, the manufacturer of tinzaparin sodium injection (Innohep) issued a Dear Healthcare Professional Letter in regard to an increased risk for death in renal-impaired elderly patients receiving tinzaparin vs unfractionated heparin. The letter advises of a change in labeling to apply the warning to all renal-impaired elderly, not just those older than 90 years of age, as reported on December 2.
Findings from a controlled clinical study suggest that compared with unfractionated heparin, tinzaparin may increase the risk for death when used to treat elderly patients with renal insufficiency. When treating renal-impaired elderly patients for deep vein thrombosis with or without pulmonary embolism, clinicians should consider alternatives to tinzaparin.
The change in labeling was prompted by information received by the FDA about the Innohep in Renal Insufficiency Study (IRIS), a multicenter European study that was terminated in February, 2008 by the study's Data Safety Monitoring Committee. The interim finding leading to termination was that patients who received the drug, a low-molecular-weight heparin, had an increase in all-cause mortality.
The objective of IRIS was to assess the safety of tinzaparin compared with unfractionated heparin (UFH) in treating deep vein thromboses and/or pulmonary emboli (PE) in patients with impaired renal function who were older than 70 years.
At study termination, 350 patients had completed 90 days follow-up, and there were 23 deaths in the tinzaparin group (23 [13%] of 176 patients ) and 9 deaths in the UFH group (9 [5%] of 174 patients). Although the causes of death did not follow a clear pattern, they did not appear to be related to either overdosing causing bleeding or underdosing causing thrombosis. The data reported in the FDA's December 2 statement were deemed insufficient to exclude the possibility of another deep vein thrombosis or PE — or both — in patients who received tinzaparin.
Use in pregnancy
No LMWH, except tinzaparin, is licensed for use in gestational hypercoagulability.[8] Still, tinzaparin is often the LMWH of choice in pregnant women.[8]
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)[citation needed] 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
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
- ^ Cheer S.M. et al. Drugs 2004; 64 (13): 1479–1502
- ^ Pedersen P.C. et al. Thromb Res 1991; 61 (5-6): 477-487
- ^ European Pharmacopoeia, 6th Edition, 2008
- ^ Hull et al. NEJM 1992;326,15:975-982
- ^ Nagge J, Crowther M, Hirsch J (2002). "Is Impaired Renal Function a Contraindication to the Use of Low-Molecular-Weight Heparin?". Arch Intern Med. 162: 2605–2609. doi:10.1001/archinte.162.22.2605. PMID 12456233.
{{cite journal}}: CS1 maint: multiple names: authors list (link) - ^ Farmaceutiska Specialiteter i Sverige - the Swedish official drug catalog. Fass.se > Innohep
- ^ a b [1] Therapeutic anticoagulation in pregnancy. Norfolk and Norwich University Hospital (NHS Trust). Reference number CA3017. 9th June 2006 [review June 2009]
- 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
- tinzaparin at the U.S. National Library of Medicine Medical Subject Headings (MeSH)
- Sprigg N, Gray LJ, Bath PM; et al. (2007). "Early recovery and functional outcome are related with causal stroke subtype: data from the tinzaparin in acute ischemic stroke trial". Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 16 (4): 180–4. doi:10.1016/j.jstrokecerebrovasdis.2007.02.003. PMID 17689415.
{{cite journal}}: Explicit use of et al. in:|author=(help)CS1 maint: multiple names: authors list (link)
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