Danaparoid Explained

Danaparoid sodium (Orgaran) is an anticoagulant[1] with an antithrombotic action due to inhibition of thrombin generation (TGI) by two mechanisms: indirect inactivation of Factor Xa via AT and direct inhibition of thrombin activation of Factor IX (an important feedback loop for thrombin generation). It also possesses a minor anti-thrombin activity, mediated equally via AT and Heparin Co-factor II producing a ratio of anti-Xa:IIa activity >22. [Meuleman DG. Haemostasis 1992;22:58-65 and Ofosu FA Haemostasis 1992;22:66-72]

Danaparoid is a low molecular weight heparinoid devoid of heparin. It consists of a mixture of heparan sulfate, dermatan sulfate, and chondroitin sulfate.[2] It is chemically distinct from heparin, has different protein-binding properties because of its low degree of sulphation and low surface charge density and thus has little cross-reactivity in heparin-intolerant patients.

The TGI activity, considered by Fernandes et al. [Thromb Haemostas 1987;57/3:286-93] to provide an index of antithrombotic potential, of danaparoid has a half-life of 6.7 hours.

Uses

It is used to prevent deep venous clots, particularly in situations with a high risk of clot formation, such as after hip surgery.

It is also used as a heparin substitute in heparin-induced thrombocytopenia[3] [4] (HIT) which may otherwise cause paradoxical thrombosis. Danaparoid is used for thrombosis prophylaxis and treatment in heparin-induced thrombocytopenia patients. Although pre-treatment serological cross-reactivity with heparin-induced antibodies can occur in 5.2% of the patients it bears no systematic relationship with clinical cross-reactivity, 3.2% in the same study of 1478 patients with acute HIT [Magnani & Gallus Thromb Haemost 2006;95:967-81] (ESRA).

It is also approved for the treatment of DIC in Japan and although not approved for the following it has shown efficacy and safety in 406 case reports of paediatric use [Bidlingmaier et al. Acta Haematologica 2006;115:237-247], pregnancy [see Magnani HN. Thromb Res 2010;125:297-302] 197 cases & 81 additional uses to protect cesarian section, patients in renal failure requiring intermittent [Magnani HN. Thromb Res 2010;125:e171-e176] or continuous (CVVRT) [Magnani HN & Wester JPJ. Open access Scientific Reports 2012;1/9:423-9] renal replacement therapy and in patients with hepatic disorders associated with cirrhosis such as portal vein thrombosis [Fujiyama et al. BMC Gatsroenterol 2017;17:112-20] and the sinusoidal obstruction syndrome [Kato et al. Pediatr Transplant 2017;e13099] and thrombotic micro-angiopathy [Machida et al. Bone Marrow Transplant 2016;1-3 Doi:10.1038/bmt.2016.270] that occur after haemopoietic stem-cell transplantation in patients with haematogenous and solid malignancies.

It has also been used in Kasabach–Merritt syndrome in 3 cases.[5]

Discontinuation

On August 14, 2002, this drug was withdrawn by Organon International.[6] from the US market, due to a shortage in drug substance. The manufacturer has continued providing the medication in all other locales where it is approved for marketing.[7]

The drug is now owned and distributed by Aspen Pharma.

Administration

IV and SC

Side effects

Notes and References

  1. Hagiwara S, Iwasaka H, Hidaka S, Hishiyama S, Noguchi T . Danaparoid sodium inhibits systemic inflammation and prevents endotoxin-induced acute lung injury in rats . Crit Care . 12 . 2 . R43 . 2008 . 18380908 . 2447588 . 10.1186/cc6851 . free .
  2. de Pont AC, Hofstra JJ, Pik DR, Meijers JC, Schultz MJ . Pharmacokinetics and pharmacodynamics of danaparoid during continuous venovenous hemofiltration: a pilot study . Crit Care . 11 . 5 . R102 . 2007 . 17854496 . 10.1186/cc6119 . 2556745 . free .
  3. Schindewolf M, Magnani HN, Lindhoff-Last E . [Danaparoid in pregnancy in cases of heparin intolerance - use in 59 cases] ]. de . Hamostaseologie . 27 . 2 . 89–97 . May 2007 . 17479171 .
  4. Magnani HN, Gallus A . Heparin-induced thrombocytopenia (HIT). A report of 1,478 clinical outcomes of patients treated with danaparoid (Orgaran) from 1982 to mid-2004 . Thromb. Haemost. . 95 . 6 . 967–81 . June 2006 . 16732376 . 10.1160/TH05-07-0489 .
  5. Ontachi Y, Asakura H, Omote M, Yoshida T, Matsui O, Nakao S . Kasabach-Merritt syndrome associated with giant liver hemangioma: the effect of combined therapy with danaparoid sodium and tranexamic acid . Haematologica . 90 Suppl . ECR29 . November 2005 . 16266920 .
  6. Web site: Danaparoid (Subcutaneous Route) - MayoClinic.com . 2007-08-23 .
  7. "Heparin Induced Thrombocytopenia" Uptodate www.uptodate.com retrieved on 2/6/2009