PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Refludan?
Refludan is a powder to be dissolved to obtain a solution for injection or infusion (drip into a vein). Contains the active ingredient lepirudin.
What is Refludan used for?
Refludan is used to prevent blood from clotting. It is used in adult patients with heparin-induced thrombocytopenia (HIT, a type of heparin allergy, which causes platelet deficiency in the blood or clots in blood vessels) and thromboembolic disease (abnormal production of blood clots) that requires parenteral antithrombotic therapy, generally heparin. The diagnosis must be confirmed by specific tests, such as the heparin-induced platelet activation test (HIPPA).
The medicine can only be obtained with a prescription.
How is Refludan used?
Treatment with Refludan should be started by a doctor who has experience in treating bleeding disorders.
The recommended dose is 0.4 mg / kg body weight with a single injection into a vein followed by a continuous infusion of 0.15 mg / kg per hour over a period of 2-10 days or longer if necessary. The dose should be reduced in patients with kidney problems.
How does Refludan work?
Refludan is an antithrombotic (a medicine that prevents the formation of blood clots). The active ingredient in Refludan, lepirudin, is almost identical to hirudin, the anticoagulant substance produced by leeches. Specifically, lepirudin blocks a substance called thrombin, which is essential to complete the blood coagulation process. By blocking thrombin, Refludan greatly reduces the risk of blood clot formation preventing damage that would result.
Lpirudin is produced by a method known as "recombinant DNA technology": it consists of a cell that has received a gene (DNA) that allows it to produce lepirudin.
How has Refludan been studied?
Refludan has been studied in two main studies involving 198 patients, 125 of whom had HIT and tormboembolic disease. The studies looked at the number of patients who had died, who had undergone amputation and had new thromboembolic complications (clot formation). The studies did not compare Refludan with any other treatment, so the results were evaluated with historical control (the expected results in patients not subjected to treatment based on previous studies).
What benefit has Refludan shown during the studies?
During the study period, 9% of patients died (11 of 125), 6% had amputations (7 of 125) and 10% had new thromboembolic complications (12 of 125).
In comparison with historical controls, the two studies combined showed a significant benefit of Refludan on the frequency of new thromboembolic complications and a tendency to increase survival.
What is the risk associated with Refludan?
As with other antithrombotics, the most common side effect of Refludan (seen in more than 1 patient in 10) is bleeding. Bleeding leading to death occurs in about 1 in 100 patients. For the full list of side effects reported with Refludan, see the Package Leaflet.
Refludan must not be used in people who may be hypersensitive (allergic) to lepirudin, other hirudin derivatives or any other component. It should not be given to pregnant or breastfeeding patients. Its use is not recommended in patients who bleed or are at risk of bleeding due to a recent biopsy, a stroke, an important operation, or because they are older than 65 years or for other factors. For the complete list of usage restrictions, see the package leaflet.
Some patients receiving Refludan for the second time may have an allergic shock; the doctor must be very careful when administering the medicine to the patient a second time.
Why has Refludan been approved?
As this is a very serious disease, for which there is no other effective treatment approved, the Committee for Medicinal Products for Human Use (CHMP) has decided that the benefits of Refludan outweigh its risks for treating patients affected by HIT and thromboembolic disease. The Committee therefore recommended that Refludan be given marketing authorization.
Other information on Refludan:
On 13 March 1997 the European Commission issued a marketing authorization for Refludan, valid throughout the European Union. The marketing authorization was renewed on 13 March 2002 and 13 March 2007. The marketing authorization holder is Celgene Europe Ltd.
The full EPAR for Refludan can be found here.
Last update of this summary: 04-2009.
