Nadroparin calcium

B01AB06

Antithrombotic agent, low molecular weight heparin

Antithrombinabhängig inhibits the coagulation factors Xa and to a lesser extent factor IIa (thrombin ).

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Nadroparin (trade name Fraxiparin ®, manufactured by GlaxoSmithKline) is a drug from the group of low molecular weight heparins, which is used for anticoagulation. On September 30, 2013 GlaxoSmithKline announced the sale of trademarks Fraxiparine and Arixtra for around 835 million euros to the South African pharmaceutical company Aspen Holdings known. Excluded from the global sales agreement are the rights in China, India and Pakistan. The regulatory approval is still pending.

Clinical information

Areas of application (indications )

Nadroparin is for the prevention of venous thrombosis by operations - including major orthopedic surgery (eg hip replacement ) - and used for the treatment of deep vein thrombosis. Furthermore, nadroparin is used for anticoagulation during hemodialysis ( hemodialysis and hemofiltration ) in the extracorporeal circuit.

Posology and method of administration

Nadroparin deep vein thrombosis is injected as calcium salt subcutaneously in the form of an injectable solution for prevention and treatment. The body weight- adjusted dosage and duration of treatment depend on the application area. Depending on up to 19,000 IU anti -Xa nadroparin calcium daily in one to two times daily for five days or more - as long as there is a risk of thrombosis - injected.

Werden.Gelegentlich Because of the risk of heparin-induced thrombocytopenia ( HIT) has the number of thrombocytes ( platelets) during treatment regularly checked, at the start of treatment, a mild, transient thrombocytopenia (type I) may occur with nadroparin. Since it generally does not lead to complications, treatment may be continued. The case of severe thrombocytopenia occurs ( type II ), however, the treatment must be stopped immediately with nadroparin, other heparins can not be used to reduce blood clotting then.

For anticoagulation during hemodialysis and hemofiltration, the dose for each patient must be individually adjusted.

Contraindications ( contraindications)

Nadroparin may, like other low molecular weight heparins are also not used in cases of hypersensitivity to the active substance, at Gerinnungsstöungen such as the presence of a reduced number of platelets ( thrombocytopenia) or a lack of clotting factors in bleeding about by ulcers or other organ changes and injuries, and in severe impairment of liver and kidney function. In newborns, especially premature infants, nadroparin may also not be used.

Side effects

The most common side effects are small bruising ( hematoma) at the injection site, bleeding complications, and an increase in potassium concentration and certain liver enzymes in the serum.

Operation

Low molecular weight heparins differed in the effect of standard heparin mainly in that they predominantly inhibit factor Xa in the coagulation cascade. Their half-life is longer than that of standard heparin. For nadroparin it amounts to about 3.5 hours after subcutaneous injection. Nadroparin inhibits to a lesser degree, the thrombin.

The potency of nadroparin is determined using the anti-factor Xa - determination and expressed in anti-Xa international units ( IU).

Efficacy / tolerability

The once- daily injection of 2,850 IU anti -Xa nadroparin prevented in general surgery in patients with moderate or high risk significantly more leg thrombosis and pulmonary embolism than the three times daily injection of standard heparin ( 5,000 IU ). The twice-daily regimen of body weight-adjusted nadroparin is at least as effective and safe as the continuous infusion of aPTT - controlled standard heparin and allows for outpatient treatment. Thrombocytopenia occur under nadroparin on significantly less than with standard heparin.

More information

Nadroparin obtained from heparin from porcine intestinal mucosa. The long-chain molecules by reaction with nitrous acid depolymerized ( = split ) and fractionated. The average molecular weight is 3600 to 5000, the degree of sulphation per disaccharide unit is about 2, the ratio of anti-factor Xa activity to anti-factor IIa activity is between 2.5 and 4