Tinzaparin Sodium: A Review of its Use in the Prevention and Treatment of Deep Vein Thrombosis and Pulmonary Embolism, and in the Prevention of Clotting in the Extracorporeal Circuit during Haemodialysis

Drugs

Volumn 70, Issue 10, 2010, Pages 1319-1347

  Hoy, Sheridan M ^a   Scott, Lesley J ^a   Plosker, Greg L ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Blood coagulation; Deep vein thrombosis; general; Haemodialysis; prevention; Pulmonary embolism; Tinzaparin sodium; treatment

Indexed keywords

ACENOCOUMAROL; ANTIVITAMIN K; BEMIPARIN; BLOOD CLOTTING FACTOR 10A; DALTEPARIN; ENOXAPARIN; FONDAPARINUX; HEPARIN; IODINE 125; NADROPARIN; PROTAMINE SULFATE; TINZAPARIN; TISSUE FACTOR PATHWAY INHIBITOR; WARFARIN; FIBRINOLYTIC AGENT; LOW MOLECULAR WEIGHT HEPARIN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLEEDING; BLOOD CLOTTING; CANCER PATIENT; CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG TOLERABILITY; EPISTAXIS; EXTRACORPOREAL CIRCULATION; FISTULA; FRACTURE; GENERAL SURGERY; HEART ATRIUM FIBRILLATION; HEMATOMA; HEMODIALYSIS; HEMOSTASIS; HIP ARTHROPLASTY; HUMAN; INJURY; KIDNEY FAILURE; LOW DRUG DOSE; LUNG EMBOLISM; MAINTENANCE THERAPY; NEOPLASM; ORTHOPEDIC SURGERY; OSTEOPOROSIS; PAIN; PARTIAL THROMBOPLASTIN TIME; REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; SKIN BRUISING; THROMBOCYTOPENIA; TOTAL KNEE REPLACEMENT; ULCER; VEIN THROMBOSIS; VENOUS THROMBOEMBOLISM; CLINICAL TRIAL (TOPIC); DRUG EFFECTS; PROCEDURES; PULMONARY EMBOLISM; RENAL REPLACEMENT THERAPY; VENOUS THROMBOSIS;

BLOOD COAGULATION; CLINICAL TRIALS AS TOPIC; FIBRINOLYTIC AGENTS; HEPARIN, LOW-MOLECULAR-WEIGHT; HUMANS; PULMONARY EMBOLISM; RENAL DIALYSIS; VENOUS THROMBOSIS;

EID: 77953829979     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11203710-000000000-00000     Document Type: Review

References (91)

1. Alexander JH, Singh KP. Inhibition of factor Xa: a potential target for the development of new anticoagulants. Am J Cardiovasc Drugs 2005; 5 (5): 279-290
2. Tincani E, Crowther MA, Turrini F, et al. Prevention and treatment of venous thromboembolism in the elderly patient. Clin Interv Aging 2007; 2 (2): 237-246
3. Nutescu EA, Shapiro NL, Feinstein H, et al. Tinzaparin: considerations for use in clinical practice. Ann Pharmaco-ther 2003 Dec; 37 (12): 1831-1840
4. Simonneau G, Sors H, Charbonnier B, et al. A comparison of low-molecular-weight heparin with unfractionated he-parin for acute pulmonary embolism. N Engl J Med 1997; 337 (10): 663-669
5. Clark NP. Low-molecular-weight heparin use in the obese, elderly, and in renal insufficiency. Thromb Res 2008; 123 Suppl. 1: S58-61
6. Hull RD, Pineo GF, Brant RF, et al. Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med 2006 Dec; 119 (12): 1062-1072
7. Lim W, Dentali F, Eikelboom JW, et al. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med 2006 May 2; 144 (9): 673-684
8. U.S. Pharmacopeia. 2009 USP dictionary of USAN and international drug names. Rockville (MD): U.S. Pharmacopeia, 2009
9. Nader HB, Walenga JM, Berkowitz SD, et al. Preclinical differentiation of low molecular weight heparins. Semin Thromb Hemost 1999; 25 Suppl. 3: 63-72
10. Linhardt RJ, Gunay NS. Production and chemical proces-sing of low molecular weight heparins. Semin Thromb Hemost 1999; 25 Suppl. 3: 5-16
11. Cheer SM, Dunn CJ, Foster R. Tinzaparin sodium: a review of its pharmacology and clinical use in the prophylaxis and treatment of thromboembolic disease. Drugs 2004; 64 (13): 1479-1502
12. Friedel HA, Balfour JA. Tinzaparin: a review of its phar-macology and clinical potential in the prevention and treatment of thromboembolic disorders. Drugs 1994; 48 (4): 638-660
13. Sweetman SC, editor. Martindale: the complete drug re-ference. 36th ed. London: Pharmaceutical Press, 2009
14. Kuczka K, Baum K, Picard-Willems B, et al. Long-term administration of LMWH: pharmacodynamic parameters under therapeutic or prophylactic regimen of enoxaparin or tinzaparin in neurological rehabilitation patients. Thrombosis Res 2009 Nov; 124 (5): 625-630
15. Bara L, Planes A, Samama M-M. Occurrence of thrombosis and haemorrhage, relationship with anti-Xa, anti-IIa activities, and D-dimer plasma levels in patients receiving a low molecular weight heparin, enoxaparin or tinzaparin, to prevent deep vein thrombosis after hip surgery. Br J Hae-matol 1999; 104: 230-240
16. Christidou FN, Frangia TK, Bamichas GI, et al. Compar-ison of two low-molecular weight heparins (LMWHs), tinzaparin and bemiparin, during hemodialysis. Int J Clin Pharmacol Ther 2005 Jul; 43 (7): 335-338
17. Sabry A, Taha M, Nada M, et al. Anticoagulation therapy during haemodialysis: a comparative study between two heparin regimens. Blood Coagul Fibrinolysis 2009 Jan; 20 (1): 57-62
18. Badawi L, Akeel N, Shaheen FAM, et al. Dose and lipid lowering effect of tinzaparin sodium: a single center experience. Saudi J Kidney Dis Transpl 2005 Apr-Jun; 16 (2): 161-165
19. Koutsikos D, Fourtounas C, Kapetanaki A, et al. A cross-over study of a new low molecular weight heparin (Logiparin®) in hemodialysis. Int J Artif Organs 1996; 19 (8): 467-471
20. Gouin-Thibault I, Pautas E, Depasse F, et al. Heparin-releasable TFPI is not depleted after repeated injections of tinzaparin at therapeutic dosages for up to 30 days. J Thromb Haemost 2003; 1: 2694-2695
21. Elisaf MS, Germanos NP, Bairaktari HT, et al. Effects of conventional vs. low-molecular-weight heparin on lipid profile in hemodialysis patients. Am J Nephrol 1997; 17: 153-157
22. Akiba T, Tachibana K, Ozawa K, et al. Long-term use of low molecular weight heparin ameliorates hyperlipide-mia in patients on hemodialysis. ASAIO J 1992; 38 (3): M326-30
23. Fossler MJ, Barrett JS, Hainer JW, et al. Pharmaco-dynamics of intravenous and subcutaneous tinzaparin and heparin in healthy volunteers. Am J Health Syst Pharm 2001 Sep 1; 58(17): 1614-1621
24. Matzsch T, Bergqvist D, Hedner U, et al. Effects of an en-zymatically depolymerized heparin as compared with conventional heparin in healthy volunteers. Thromb Haemost 1987; 57 (1): 97-101
25. Holst J, Lindblad B, Bergqvist D, et al. Protamine neutral-ization of intravenous and subcutaneous low-molecular-weight heparin (tinzaparin, Logiparin™): an experimental investigation in healthy volunteers. Blood Coagul Fibrinolysis 1994; 5 (5): 795-803
26. Mousa SA, Bozarth J, Barrett JS. Pharmacodynamic prop-erties of the low molecular weight heparin, tinzaparin: effect of molecular weight distribution on plasma tissue factor pathway inhibitor in healthy human subjects. J Clin Pharmacol 2003 Jul; 43 (7): 727-734
27. Depasse F, Gonzalez de Suso MJ, Lagoutte I, et al. Com-parative study of the pharmacokinetic profiles of two LMWHs-bemiparin (3500IU, anti-Xa) and tinzaparin (4500 IU, anti-Xa)-administered subcutaneously to healthy male volunteers. Thromb Res 2003 Jan 25; 109 (2-3): 109-117
28. Ellison J, Thomson AJ, Conkie JA, et al. Thromboprophy-laxis following caesarean section: a comparison of the antithrombotic properties of three low molecular weight heparins-dalteparin, enoxaparin and tinzaparin. Thromb Haemost 2001 Dec; 86 (6): 1374-1378
29. Yoneda M, Brosnan JF, Norris LA, et al. The effect of LMWH (tinzaparin) on coagulation and fibrinolytic activation in pregnant women at risk of thrombosis. Thromb Res 2006; 117 (3): 283-290
30. Crowther MA, Berry LR, Monagle PT, et al. Mechanisms responsible for the failure of protamine to inactivate low-molecular-weight heparin. Br J Haematol 2002; 116 (1): 178-186
31. SobelM, AdelmanB. Characterization of platelet binding of heparins and other glycosaminoglycans. Thromb Res 1988; 50 (6): 815-826
32. Young E, Wells P, Holloway S, et al. Ex-vivo and in-vitro evidence that low molecular weight heparins exhibit less binding to plasma proteins than unfraction ated heparin. Thromb Haemost 1994; 71 (3): 300-304
33. Padilla A, Gray E, Pepper DS, et al. Inhibition of thrombin generation by heparin and low molecular weight (LMW) heparins in the absence and presence of platelet factor 4 (PF4). Br J Haematol 1992 Oct; 82: 406-413
34. Gerotziafas GT, Petropoulou AD, Verdy E, et al. Effect of the anti-factor Xa and anti-factor IIa activities of low-molecular-weight heparins upon the phases of thrombin generation. J Thromb Haemost 2007 May; 5 (5): 955-962
35. Leo Laboratories Limited. Innohep 10,000 IU/ml and In-nohep syringe 10,000 IU/ml: summary of product characteristics [online]. Available from URL: http://emc.medicines.org.uk/[Accessed 2010 Apr 12]
36. Leo Laboratories Limited. Innohep 20,000 IU/ml and In-nohep syringe 20,000 IU/ml: summary of product characteristics [online]. Available from URL: http://emc.medcines.org.uk/[Accessed 2010 Apr 12]
37. Leo Pharmaceutical Products. Innohep®: tinzaparin sodium injection [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda-docs/ label/2009/020484s013lbl.pdf [Accessed 2010 Apr 12]
38. Weitz JI. Low-molecular-weight heparins [published erra-tum appears in N Engl J Med 1997 Nov 20; 337 (21): 1567]. N Engl J Med 1997 Sep 4; 337 (10): 688-698
39. Planes A, Samama MM, Lensing AWA, et al. Prevention of deep vein thrombosis after hip replacement: comparison between two low-molecular-weight heparins, tinzaparin and enoxaparin. Thromb Haemost 1999; 81: 22-25
40. Cambus J-P, Saivin S, Heilmann J-J, et al. The pharmaco-dynamics of tinzaparin in healthy volunteers. Br J Haematol 2002 Mar; 116 (3): 649-652
41. Barrett JS, Gibiansky E, Hull RD, et al. Population pharmacodynamics in patients receiving tinzaparin for the prevention and treatment of deep vein thrombosis. Int J Clin Pharmacol Ther 2001 Oct; 39 (10): 431-446
42. Johansen PB, Rasmussen SN, Østergaard PB. Pharmaco-kinetics of tinzaparin (Logiparin®) - a low molecular weight heparin-after single and repeated intravenous administration in rats. Thromb Res 1994 Aug 15; 75 (4): 453-464
43. Mahe I, Aghassarian M, Drouet L, et al. Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function: a comparative pharmacokinetic study. Thromb Haemost 2007 Apr; 97 (4): 581-586
44. Siguret V, Pautas E, Fevrier M, et al. Elderly patients treated with tinzaparin (Innohep®) administered once daily (175 anti-Xa IU/kg): anti-Xa and anti-IIa activities over 10 days. Thromb Haemost 2000 Nov; 84 (5): 800-804
45. Siguret V, Leizorovicz A, Pautas E, et al. No accumulation of peak anti-Xa activity of tinzaparin in elderly patients with moderate to severe renal impairment: a substudy of IRIS clinical trial [abstract no. 172]. Blood 2009; 114 (22): 77
46. Pautas E, Gouin I, Bellot O, et al. Safety profile of tinza-parin administered once daily at a standard curative dose in two hundred very elderly patients. Drug Saf 2002; 25 (10): 725-733
47. Kuhle S, Massicotte P, Dinyari M, et al. Dose-finding and pharmacokinetics of therapeutic doses of tinzaparin in pediatric patients with thromboembolic events. Thromb Haemost 2005 Dec; 94 (6): 1164-1171
48. Hainer JW, Barrett JS, Assaid CA, et al. Dosing in heavy-weight/obese patients with the LMWH, tinzaparin: a pharmacodynamic study. Thromb Haemost 2002 May; 87 (5): 817-823
49. Hull RD, Raskob GE, Pineo GF, et al. Subcutaneous low-molecular-weight heparin compared with continuous intravenous heparin in the treatment of proximal-vein thrombosis. N Engl J Med 1992 Apr 9; 326 (15): 975-982
50. Smith MP, Norris LA, Steer PJ, et al. Tinzaparin sodium for thrombosis treatment and prevention during pregnancy. Am J Obstet Gynecol 2004; 190 (2): 495-501
51. Parent F, Deruelle P, Jais X, et al. Treatment of venous thromboembolism during pregnancy with a once-daily regimen of LMWH [abstract no. PP-MO-376]. J Thromb Haemost 2009 Jul; 7 Suppl. 2: 445
52. Andersen AS, Berthelsen JG, Bergholt T. Venous thrombo-embolism in pregnancy: prophylaxis and treatment with low molecular weight heparin. Acta Obstet Gynecol Scand 2010; 89 (1): 15-21
53. Ni Ainle F, Wong A, Appleby N, et al. Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy. Blood Coagul Fibrinolysis 2008 Oct; 19 (7): 689-692
54. Hull R, Raskob G, Pineo G, et al. A comparison of sub-cutaneous low-molecular-weight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation. N Engl J Med 1993 Nov 4; 329 (19): 1370-1376
55. Lassen MR, Borris LC, Christiansen HM, et al. Prevention of thromboembolism in 190 hip arthroplasties: comparison of LMW heparin and placebo. Acta Orthop Scand 1991 Feb; 62 (1): 33-38
56. Leizorovicz A, Picolet H, Peyrieux JC, et al. Prevention of perioperative deep vein thrombosis in general surgery: a multicentre double blind study comparing two doses of Logiparin and standard heparin. Br J Surg 1991; 78 (4): 412-416
57. Bergqvist D, Flordal PA, Friberg B, et al. Thrombopro-phylaxis with a low molecular weight heparin (tinzaparin) in emergency abdominal surgery: a double-blind multi-center trial. Vasa 1996; 25 (2): 156-160
58. Jørgensen PS, Warming T, Hansen K, et al. Low molecular weight heparin (Innohep) as thromboprophylaxis in outpatients with a plaster cast: a venografic controlled study. Thromb Res 2002 Mar 15; 105 (6): 477-480
59. Lassen MR, Borris LC, Jensen HP, et al. Dose relation in the prevention of proximal vein thrombosis with a low molecular weight heparin (tinzaparin) in elective hip arthroplasty. Clin Appl Thromb Hemost 2000 Jan; 6 (1): 53-57
60. Lausen I, Jensen R, Jorgensen LN, et al. Incidence and prevention of deep venous thrombosis occurring late after general surgery: randomised controlled study of prolonged thromboprophylaxis. Eur J Surg 1998; 164 (9): 657-663
61. Green D, Lee MY, Lim AC, et al. Prevention of thrombo-embolism after spinal cord injury using low-molecular-weight heparin. Ann Intern Med 1990 Oct 15; 113: 571-574
62. Hauch O, Jørgensen LN, Kølle TR, et al. Low molecular weight heparin (Logiparin™) as thromboprophylaxis in elective abdominal surgery: a dose finding study. Acta Chir Scand Suppl 1988; 543: 90-95
63. Green D, Chen D, Chmiel JS, et al. Prevention of throm-boembolism in spinal cord injury: role of low molecular weight heparin. Arch Phys Med Rehabil 1994; 75: 290-292
64. Planes A. An equivalence study of two low-molecular-weight heparins in the prevention and treatment of deep-vein thrombosis after total hip replacement. Semin Thromb Hemost 2000; 26 Suppl. 1: 57-60
65. Wells PS, Anderson DR, Rodger MA, et al. A randomized trial comparing 2 low-molecular-weight heparins for the outpatient treatment of deep vein thrombosis and pulmonary embolism. Arch Intern Med 2005 Apr 11; 165 (7): 733-738
66. Hull RD, Raskob GE, Brant RF, et al. Low-molecular-weight heparin vs heparin in the treatment of patients with pulmonary embolism. Arch Intern Med 2000 Jan 24; 160 (2): 229-236
67. Hull RD, Pineo GF, Brant RF, et al. Self-managed long-term low-molecular-weight heparin therapy: the balance of benefits and harms. Am J Med 2007 Jan; 120 (1): 72-82
68. Hull RD, Pineo GF, Brant R, et al. Home therapy of venous thrombosis with long-term LMWH versus usual care: patient satisfaction and post-thrombotic syndrome. Am J Med 2009 Aug; 122 (8): 762-9.e3
69. Romera A, Cairols MA, Vila-Coll R, et al. A randomised open-label trial comparing long-term sub-cutaneous low-molecular-weight heparin compared with oral-anticoagulant therapy in the treatment of deep venous thrombosis. Eur J Vasc Endovasc Surg 2009 Mar; 37 (3): 349-356
70. Lapidus L, Borretzen J, Fahlen M, et al. Home treatment of deep vein thrombosis: an out-patient treatment model with once-daily injection of low-molecular-weight heparin (tin-zaparin) in 555 patients. Pathophysiol Haemost Thromb 2002 Mar; 32 (2): 59-66
71. Leizorovicz A, on behalf of the IRIS Group. Tinzaparin compared to unfraction ated heparin for initial treatment of deep vein thrombosis in very elderly patients with renal insufficiency: the IRIS trial [abstract no. 434]. Blood 2008 Nov 16; 112 (11): 166
72. Beijering RJR, ten Cate H, Stevens P, et al. Randomised long-term comparison of tinzaparin and dalteparin in haemodialysis. Clin Drug Investig 2003; 23 (2): 85-97
73. Simpson HKL, Baird J, Allison M, et al. Long-term use of the low molecular weight heparin tinzaparin in haemodialysis. Haemostasis 1996; 26: 90-97
74. Ryan KE, Lane DA, Flynn A, et al. Dose finding study of low molecular weight heparin, Innohep, in haemodialysis. Thromb Haemost 1991; 66 (3): 277-282
75. Bramham K, Varrier M, Asgari E, et al. Comparison of tinzaparin and unfractionated heparin as anticoagulation on haemodialysis: equal safety, efficacy and economical parity. Nephron Clin Pract 2008; 110 (2): c107-13
76. Egfjord M, Rosenlund L, Hedegaard B, et al. Dose titration study of tinzaparin, a low molecular weight heparin, in patients on chronic hemodialysis. Artif Organs 1998; 22 (8): 633-637
77. Lord H, Jean N, Dumont M, et al. Comparison between tinzaparin and standard heparin for chronic hemodialysis in a Canadian center. Am J Nephrol 2002; 22 (1): 58-66
78. Leo Pharma Inc. Product monograph PRinnohep® (tinza-parin sodium injection) anticoagulant/antithrombotic agent [online]. Available from URL: http://www.hc-sc.gc.ca [Accessed 2010 Mar 15]
79. Bates SM, Ginsberg JS. Clinical practice: treatment of deep-vein thrombosis. N Engl J Med 2004 Jul 15; 351 (3): 268-277
80. Torbicki A, Perrier A, Konstantinides S, et al. Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J 2008 Sep; 29 (18): 2276-2315
81. Krishnan JA, Segal JB, Streiff MB, et al. Treatment of ve-nous thromboembolism with low-molecular-weight heparin: a synthesis of the evidence published in systematic literature reviews. Respir Med 2004 May; 98 (5): 376-386
82. Segal JB, Streiff MB, Hofmann LV, et al. Management of venous thromboembolism: a systematic review for a practice guideline. Ann Intern Med 2007 Feb 6; 146 (3): 211-222
83. Myers J. Selecting an agent for prophylaxis of venous thromboembolism. Am J Health Syst Pharm 2006 Dec 15; 63 (24): 2448-2450
84. Messmore HL, Coyne E, Wehrmacher WH, et al. Studies comparing low molecular weight heparin with heparin for the treatment of thromboembolism: a literature review. Curr Pharm Des 2004; 10 (9): 1001-1010
85. Wolf H. Low-molecular-weight heparin. Med Clin North Am 1994 May; 78 (3): 733-743
86. Kearon C, Kahn SR, Agnelli G, et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008 Jun; 133 (6 Suppl.): 454S-545S (Pubitemid 351892971)
87. Geerts WH, Bergqvist D, Pineo GF, et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008 Jun; 133 (6 Suppl.): 381S-453S
88. Patel JP, Hunt BJ. Where do we go now with low molecular weight heparin use in obstetric care? J Thromb Haemost 2008 Sep; 6 (9): 1461-1467
89. Lykke JA, Grønlykke T, Langhoff-Roos J. Treatment of deep venous thrombosis in pregnant women. Acta Obstet Gynecol Scand 2008; 87 (11): 1248-1251
90. Bates SM, Greer IA, Pabinger I, et al. Venous thromboem-bolism, thrombophilia, antithrombotic therapy, and pregnancy: American CollegeofChest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008 Jun; 133 (6 Suppl.): 844S-86S
91. Spyropoulos AC, Merli G. Management of venous thrombo-embolism in the elderly. Drugs Aging 2006; 23 (8): 651-671