Dear Healthcare Professional Letter on recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding
16.12.2014
Eli Lilly Croatia d.o.o., in agreement with the agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding.
Summary
- In patients with UA/NSTEMI whose coronary angiography is carried out within 48 h after hospitalisation, the loading dose of Efient may be given only at the moment of percutaneous coronary intervention, in order to minimise the bleeding risk.
- In patients with acute coronary syndrome (UA/NSTEMI and STEMI) due to a bleeding risk, the lower 5 mg dose daily should be used in:
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- patients with body mass under 60 kg
- patients above 75 years and more. The use of Efient is generally not recommended in patients whose age is ≥75 years. If the prescriber after a careful benefit/risk review finally concludes that the use of this medicine is necessary in these patients, the lower dose indicated above is applied.
Further information to the recommended loading dose
The recommendation on the loading dose in patients with UA/NSTEMI whose coronary angiography is carried out within 48 hours after hospitalisation is based on the outcome of the recently completed ACCOAST clinical study in patients with NSTEMI that had to be subject to coronary angiography within 2 to 48 h after randomisation. In this study, subjects receiving the loading dose of prasugrel of 30 mg in average 4 h before coronary angiography and then the loading dose of 30 mg during the percutaneous coronary intervention, had an increased risk of bleeding non-related to the implantation of a coronary artery bypass graft (CABG) during the procedure and did have no additional benefits with regard to patients receiving a loading dose of 60 mg during the percutaneous coronary intervention.
Additional information on the lower recommended maintenance dose in patients with the body mass ˂60kg and age ≥75 years
The recommendation on the use of the maintenance dose of 5 mg in patients with body mass ˂60 kg and age of ≥75 years due to a bleeding risk is based on the further analysis of patient subgroups in TRITON_TIMI 38 trial. Details on this trial and recommendations resulting from it are indicated in the education material for healthcare professionals attached hereto.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
