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Other indications

Fragmin® is a low molecular weight heparin with a number of indications which include the extended treatment of Cancer Associated Thrombosis in solid tumour patients

Renally Impaired Patients

Renal impairment is common in hospitalised patients^1,2

As can be seen in the pie chart above, a quarter of medical inpatients have some degree of renal impairment (Stage ≥3).^1,2

VTE treatment with UFH is associated with higher mortality rates than LMWH in patients with renal impairment^3*

In one study, compared with LMWH, initial VTE treatment with UFH in patients with severe renal impairment (CrCl <30 ml/min) resulted in:³

significantly higher mortality
higher rates of fatal PE

*P<0.05 vs. LMWH

VTE risk in renally impaired patients^4–6

While patients with VTE who have renal insufficiency are at higher risk of both fatal bleeding and fatal pulmonary embolism (PE)⁴, an analysis of this group found the risk of fatal PE far exceeded the risk of fatal bleeding.⁵

A post hoc analysis of the CLOT study found high-dose, extended treatment with Fragmin^® significantly reduced the risk of recurrent VTE in cancer patients with renal impairment. Compared with VKA, Fragmin^® significantly reduced risk of recurrent VTE in patients with cancer and renal impairment (p=0.01) while exhibiting a comparable safety profile.⁶

Advantages of LMWH vs UFH

The advantages of VTE treatment with LMWH compared with UFH in renal impairment^7–11

More predictable anticoagulant response^7,8
Better bioavailability at low doses^7,8
Dose-independent clearance mechanism⁷
Longer half-life^7,8
Lower incidence of bleeding complications⁸
Lower incidence of heparin-induced thrombocytopenia (HIT)^8,9
Decreased tendency to produce osteopenia on prolonged administration¹⁰
Ease of administration^8,11
No daily anticoagulation monitoring in the majority of patients⁸
Outpatient use⁸

LMWHs are not clinically interchangeable¹¹

LMWH = low-molecular-weight heparin; PE= pulmonary embolism; UFH = unfractioned heparin; VKA = vitamin K antagonists; VTE = venous thromboembolism;

References

1. Schmid P et al. Swiss Med Wkly 2007;137:514.
2. Schmid P et al. Swiss Med Wkly 2009;139:438–452.
3. Trujillo-Santos J et al. Am J Med 2013;126:425–434.
4. Schmid P et al. Swiss Med Wkly 2009;139:438–452.
5. Monreal M et al. Am J Med 2006;119:1073–1079.
6. Woodruff S et al. J Thromb Thrombolysis 2016;42:494–504.
7. Weitz JI. N Eng J Med 1997;337:688–698.
8. Quader MA et al. J Am Coll Surg 1998;187:641–658.
9. Warkentin TE et al. N Eng J Med 1995;332:1330–1335.
10. Pineo GF and Hull RD. Eur J Med Res 2004;9:215–224.
11. Fragmin SmPC [Surgical Thromboprophylaxis (2,500 IU and 5,000 IU syringes)]. Available at: https://www.medicines.org.uk/emc/product/4246 and https://www.medicines.org.uk/emc/product/4247

*Including, but not limited to: congestive cardiac failure (NYHA class III or IV), acute respiratory failure or acute infection, who also have a predisposing risk factor for VTE such as age over 75 years, obesity, cancer or previous history of VTE.~
†In patients with chronic renal insufficiency or acute renal failure.

Fragmin^® Prescribing Information

PP-FRA-GBR-0174. June 2019