Nadroparin has recently relisted on the Pharmaceutical Benefits Scheme (PBS) for the treatment of deep vein thrombosis (DVT), prophylaxis of DVT associated with surgery, and the prevention of clotting during haemodialysis.
Nadroparin is a low molecular weight heparin (LMWH) and offers some clinical benefits compared to unfractionated heparin. In comparison to other LMWHs, the Pharmaceutical Benefits Advisory Committee (PBAC) determined that nadroparin is likely to exhibit non-inferior efficacy to enoxaparin; manufacturer’s claims of superior safety were rejected on the grounds of insufficient evidence.
Nadroparin is unlikely to significantly alter antithrombotic prescribing practices. However, it does offer another clinical option. Clinical trials often exclude obese patients, leading to a paucity of data in this patient group. Although data for nadroparin is also limited, it has been studied in patients up to 252kg resulting in a proposed dosing algorithm that may simplify prescribing in this patient group. Another potential benefit relates to formulation differences. Nadroparin is formulated as the calcium salt which may result in a lower incidence of pain at the injection site. Enoxaparin and dalteparin utilise the sodium salt.
The proposed weighted therapeutic relativity is nadroparin 98.7 IU being equivalent to enoxaparin 1mg. However, as each LMWH possess a unique molecular weight profile, anti-factor Xa to anti-factor IIa ratio, and rate of plasma clearance, they are not considered clinically interchangeable.
- Diepstraten J, Janssen EJ, Hackeng CM, van Dongen EP, Wiezer RJ, van Ramshorst B, et al. Population pharmacodynamic model for low-molecular-weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint. Eur J Clin Pharmacol.2015; 71(1): 25-34.
- Eric P.A. van Dongen, René J. Wiezer, Bert van Ramshorst, Catherijne A.J. Knibbe Pharmaceutical Benefits Advisory Committee. Public Summary Document – July 2015 PBAC Meeting. Canberra: Australian Government Department of Health; 2015.
- Fraxiparine® (nadroparin calcium) Australian approved product information. St Leonards: Aspen Pharmacare Australia Pty Ltd. Approved November 2015.