Dear Health Care Professional Letter about the risk from stopper particles when preparing the medicinal product Taxotere (docetaxel) using inappropriate gauge needle


Sanofy-aventis Croatia d.o.o. has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to health care professionals about the risk of stopper particles when preparing the medicinal product Taxotere (docetaxel). The letter informs health care professionals about the usage of the appropriate gauge needle in order to avoid creating stopper particles.

When using 18 or 19-gauge needles at preparation of Taxotere Injection Concentrate, a risk of stopper coring may occur. Therefore, the aspiration of the appropriate docetaxel volume from the vial of Taxotere Injection Concentrate, a 21-gauge needle should be used. This needle size is recommended based upon reports received from the world according to which, in the syringe used for transferring the concentrate from the vial into an infusion bag or bottle, particles were discovered when preparing Taxotere Injection Concentrate by using a 19-gauge needle. Particles were discovered during a visual inspection of the syringe content prior injection of the medicine into the infusion. Therefore, Taxotere injection Concentrate should always be visually inspected prior administration for particulate matter or discoloration, whenever the solution and container permit.

Here you can find the text of the letter.

HALMED has not received any report of the adverse reaction to the medicinal product Taxotere that would relate to stopper coring. HALMED will continue to monitor the safe use of this medicinal product and promptly make publicly available any new information.

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.