Dear Healthcare Professional Letter on the introduction of new pre-filled pen Clearclick for medicinal product PegIntron powder and solvent for solution for injection in pre-filled pen (peginterferon alfa-2b)

20.02.2014

Merck Sharp & Dohme (MSD), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) has sent a letter to healthcare professionals on the introduction of new pre-filled pen Clearclick for medicinal product PegIntron powder and solvent for solution for injection in pre-filled pen (peginterferon alfa -2b).

Summary

As of the 27 february 2014, MSD will place the medicinal product PegIntron powder and solvent for solution for injection in pre-filled pen in the new pre-filled pen Clearclick.
This is an injection device that will replace the existing pre-filled pen device. Only the injection device will change. There will be no change to the drug product/diluent cartridge.
To ensure correct use of the new Clearclick pre-filled pen device, patients who are currently on treatment or who are about to start treatment with PegIntron need to be appropriately informed and trained.
It is expected that some stock of the current pre-filled pen device will continue to be available for approximately 3 months after initial introduction of the new Clearclick pre-filled pen device, although the exact time will depend on the amount of available stock on national markets and its expiration date.

Further recommendations

Patients who currently use PegIntron powder and solvent for solution for injection in pre-filled pen should be changed over to the new Clearclick pre-filled pen device.

In an effort to ensure that new and existing patients not only receive their prescription without interruption but also do not miss a dose, we ask that healthcare professionals inform patients of this transition and train the patients on the new Clearclick pre-filled pen device as soon as possible. Healthcare professionals should also refer patients to the Instructions for Use, which provides step-by-step instructions for patients on how to use the new Clearclick pre-filled pen device.

Here you may view the Dear Healthcare Professional Letter.

We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. 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 with their doctor or pharmacist about the continuation of their therapy.