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{{Short description|Pharmaceutical drug}}
{{Use dmy dates|date=July 2015}}
{{Drugbox
{{Drugbox
| Verifiedfields = changed
| Verifiedfields = changed
| Watchedfields = changed
| verifiedrevid = 409349221
| verifiedrevid = 409349221
| IUPAC_name =
| IUPAC_name =
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<!--Clinical data-->
<!--Clinical data-->
| tradename =Innohep
| tradename =innohep(R)
| Drugs.com = {{drugs.com|monograph|tinzaparin_sodium}}
| Drugs.com = {{drugs.com|monograph|tinzaparin_sodium}}
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
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<!--Pharmacokinetic data-->
<!--Pharmacokinetic data-->
| bioavailability = 90% for Anti-Xa activity, 67% for Anti-IIa activity)<ref>Cheer S.M. et al. Drugs 2004; 64 (13): 1479–1502''</ref>
| bioavailability = 90% for Anti-Xa activity, 67% for Anti-IIa activity)<ref>Cheer S.M. et al. Drugs 2004; 64 (13): 1479–1502</ref>
| protein_bound =
| protein_bound =
| metabolism = primarily by liver by desulfation and/or depolymerization
| metabolism = minor metabolisation in liver by desulfation and/or depolymerization; excretion via kidneys in almost unchanged form
| elimination_half-life = 200 min. for Anti-Xa activity, 257. min for Anti-IIa activity <ref>Pedersen P.C. et al. Thromb Res 1991; 61 (5-6): 477-487''</ref>
| elimination_half-life = 200 min. for Anti-Xa activity, 257. min for Anti-IIa activity <ref>Pedersen P.C. et al. Thromb Res 1991; 61 (5-6): 477-487</ref>
| excretion =
| excretion =


<!--Identifiers-->
<!--Identifiers-->
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number_Ref = {{cascite|changed|CAS}}
| CAS_number = 9005-49-6
| CAS_number = 9041-08-1
| CAS_supplemental = <br>[9041-08-1] (sodium salt)
| CAS_supplemental = (sodium salt)
| ATC_prefix = B01
| ATC_prefix = B01
| ATC_suffix = AB10
| ATC_suffix = AB10
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| UNII = 3S182ET3UA
| UNII = 3S182ET3UA
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D07510
| KEGG = D06398
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = 1201414
| ChEMBL = 1201414
| ChemSpiderID = none


<!--Chemical data-->
<!--Chemical data-->
| chemical_formula =
| chemical_formula =
| molecular_weight = 6500 (average)<ref>''European Pharmacopoeia, 6th Edition, 2008''</ref>
| molecular_weight = 6500
| molecular_weight_comment = g/mol (average)<ref>''European Pharmacopoeia, 6th Edition, 2008''</ref>
}}
}}


'''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 [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) for once daily treatment and prophylaxis of [[deep vein thrombosis]] and [[pulmonary embolism]].<ref>Hull et al. NEJM 1992;326,15:975-982''</ref> '''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.<ref>{{cite journal | author=Nagge J, Crowther M, Hirsch J | title=Is Impaired Renal Function a Contraindication to the Use of Low-Molecular-Weight Heparin? | journal=Arch Intern Med.| year=2002 | pages=2605–2609 | volume=162 | doi=10.1001/archinte.162.22.2605 | pmid=12456233}}</ref>
'''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 [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) for once daily treatment and prophylaxis of [[deep vein thrombosis]] (DVT) and [[pulmonary embolism]] (PE).<ref>Hull et al. NEJM 1992;326,15:975-982</ref>


It can be given [[Subcutaneous injection|subcutaneous]]ly by [[syringe]], or [[intravenously]].<ref>Farmaceutiska Specialiteter i Sverige - the Swedish official drug catalog. [http://www.fass.se Fass.se] > Innohep</ref>
It can be given [[Subcutaneous injection|subcutaneous]]ly by [[syringe]], or [[intravenously]].<ref>Farmaceutiska Specialiteter i Sverige - the Swedish official drug catalog. [http://www.fass.se Fass.se] {{Webarchive|url=https://web.archive.org/web/20110121152748/http://fass.se/ |date=21 January 2011 }} > Innohep</ref>
It was manufactured by Leo pharmaceutical company, who withdrew the product from the US in 2011 due to low sales and a contamination issue.<ref>http://www.ashp.org/DrugShortages/NotAvailable/Bulletin.aspx?id=749</ref>
It was manufactured by Leo pharmaceutical company, who withdrew the product from the US in 2011 due to low sales and a contamination issue.<ref>{{Cite web | url=http://www.ashp.org/menu/DrugShortages/DrugsNoLongerAvailable/Bulletin.aspx?id=749 | title=Drug Shortages List | access-date=4 October 2016 | archive-date=5 October 2016 | archive-url=https://web.archive.org/web/20161005122329/http://www.ashp.org/menu/DrugShortages/DrugsNoLongerAvailable/Bulletin.aspx?id=749 | url-status=dead }}</ref>

==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==
==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.
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.
According to the study Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with [[chronic kidney disease]]. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with chronic kidney disease and [[deep vein thrombosis]], [[pulmonary embolism]], 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==
==Use in pregnancy==
No LMWH, except tinzaparin, is licensed for use in [[gestational hypercoagulability]].<ref name=nhs>[http://www.nnuh.nhs.uk/viewdoc.asp?ID=265&t=TrustDoc] ''Therapeutic anticoagulation in pregnancy.'' Norfolk and Norwich University Hospital (NHS Trust). Reference number CA3017. 9th June 2006 [review June 2009]</ref> Still, tinzaparin is often the LMWH of choice in pregnant women.<ref name=nhs/>
No LMWH, except tinzaparin, is licensed for use in [[gestational hypercoagulability]].<ref name=nhs>{{cite web |url=http://www.nnuh.nhs.uk/viewdoc.asp?ID=265&t=TrustDoc |title=Archived copy |access-date=2010-05-15 |url-status=dead |archive-url=https://web.archive.org/web/20100612122902/http://www.nnuh.nhs.uk/viewdoc.asp?ID=265&t=TrustDoc |archive-date=12 June 2010 |df=dmy-all }} ''Therapeutic anticoagulation in pregnancy.'' Norfolk and Norwich University Hospital (NHS Trust). Reference number CA3017. 9 June 2006 [review June 2009]</ref> Still, tinzaparin is often the LMWH of choice in pregnant women.<ref name=nhs/>


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


==Monitoring==
==Monitoring==
Tinzaparin does NOT affect the international normalized ratio (INR), prothrombin time (PT){{Citation needed|date=September 2011}}
Tinzaparin does ''not'' affect the international normalized ratio (INR), prothrombin time (PT).{{Citation needed|date=September 2011}} Anti-factor Xa levels can be measured, and are often used to monitor tinzaparin.
Anti-factor Xa levels can be measured, and are often used to monitor tinzaparin


==Reversal agent==
==Reversal agent==
Protamine sulfate will reverse Tinzaparin by 85% per package insert.
[[Protamine sulfate]] will reverse tinzaparin by 85% per package insert.


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


==External links==
==External links==
* {{MeshName|tinzaparin}}
* {{MeshName|tinzaparin}}
* {{cite journal |author=Sprigg N, Gray LJ, Bath PM, ''et al.'' |title=Early recovery and functional outcome are related with causal stroke subtype: data from the tinzaparin in acute ischemic stroke trial |journal=Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association |volume=16 |issue=4 |pages=180–4 |year=2007 |pmid=17689415 |doi=10.1016/j.jstrokecerebrovasdis.2007.02.003}}
* {{cite journal |vauthors=Sprigg N, Gray LJ, Bath PM, etal |title=Early recovery and functional outcome are related with causal stroke subtype: data from the tinzaparin in acute ischemic stroke trial |journal=Journal of Stroke and Cerebrovascular Diseases |volume=16 |issue=4 |pages=180–4 |year=2007 |pmid=17689415 |doi=10.1016/j.jstrokecerebrovasdis.2007.02.003}}


{{Antithrombotics}}
{{Antithrombotics}}

Latest revision as of 18:26, 22 December 2024

Tinzaparin sodium
n = 1 to 25, R = H or SO3Na, R1 = H, SO3Na or COCH3, R2 = H and R3 = COONa or R2 = COONa and R3 = H
Clinical data
Trade namesinnohep(R)
AHFS/Drugs.comMonograph
Routes of
administration		subcutaneous (once daily)
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability90% for Anti-Xa activity, 67% for Anti-IIa activity)[2]
Metabolismminor metabolisation in liver by desulfation and/or depolymerization; excretion via kidneys in almost unchanged form
Elimination half-life200 min. for Anti-Xa activity, 257. min for Anti-IIa activity [3]
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.110.590 Edit this at Wikidata
Chemical and physical data
Molar mass6500 g/mol (average)[4]
 ☒NcheckY (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 (DVT) and pulmonary embolism (PE).[5]

It can be given subcutaneously by syringe, or intravenously.[6] It was manufactured by Leo pharmaceutical company, who withdrew the product from the US in 2011 due to low sales and a contamination issue.[7]

Use in elderly

[edit]

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 chronic kidney disease. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with chronic kidney disease and deep vein thrombosis, pulmonary embolism, or both.

Use in pregnancy

[edit]

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

[edit]

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

Monitoring

[edit]

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

[edit]

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

References

[edit]
  1. ^ "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 October 2023.
  2. ^ Cheer S.M. et al. Drugs 2004; 64 (13): 1479–1502
  3. ^ Pedersen P.C. et al. Thromb Res 1991; 61 (5-6): 477-487
  4. ^ European Pharmacopoeia, 6th Edition, 2008
  5. ^ Hull et al. NEJM 1992;326,15:975-982
  6. ^ Farmaceutiska Specialiteter i Sverige - the Swedish official drug catalog. Fass.se Archived 21 January 2011 at the Wayback Machine > Innohep
  7. ^ "Drug Shortages List". Archived from the original on 5 October 2016. Retrieved 4 October 2016.
  8. ^ a b "Archived copy". Archived from the original on 12 June 2010. Retrieved 15 May 2010.{{cite web}}: CS1 maint: archived copy as title (link) Therapeutic anticoagulation in pregnancy. Norfolk and Norwich University Hospital (NHS Trust). Reference number CA3017. 9 June 2006 [review June 2009]
  • (22)ESHRE April-2011 volume 33 pages 12–13-14
  • e-medicine 2011
  • RCOG March-2010 (Royal college for Obestetric and Gynecology)
  • DVT.org/cardiologist
  • Hull, New England Journal of Medicine, 2010 volume 22 page 19
[edit]
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