UCB Pharma Ltd
208 Bath Road
10th June 2008
Do not initiate any new patients on Neupro ® (rotigotine transdermal patch)
Neupro® to be stored in refrigerator
Earlier this year, we wrote to inform you of an issue related to the manufacture of Neupro®
(rotigotine transdermal patch) which resulted in a recall of certain affected batches of the product
across Europe. Neupro® is indicated for the treatment of the signs and symptoms of early-stage and
advanced-stage idiopathic Parkinson’s disease and the licence holder is Schwarz Pharma, a company
of the UCB Group.
It is important to emphasise that this manufacturing issue is not one involving product
contamination or toxicity. The manufacture of Neupro® can result in an alternative crystalline
structure of the active ingredient (rotigotine), visible as a snowflake-like pattern and not released
from the patch.
Although in most instances this snowflake-like pattern has no relevance, there is a theoretical
possibility that clinical efficacy may be reduced. To date, we have not seen a change in the
pattern of clinically relevant adverse events, including lack of efficacy, which could be attributed to
crystal formation. Nevertheless, you should be particularly attentive to any signs suggesting a lack
of efficacy. Refrigerated storage of Neupro® patches seems to reduce the development of crystals.
We are working to implement a full cold-chain distribution system throughout Europe over the next
In agreement with the European Medicines Agency (EMEA), we will be systematically supplying
refrigerated Neupro® to replace remaining products still in the distribution chain.
To this effect, from the end of July 2008 for an interim period the market will only be supplied with
the 2 and 4 mg/24 h patches.
In order to prioritise supply for existing patients, please limit each prescription to one month's
supply and please do not initiate any new patients on Neupro®.
We ask that you inform your patients that Neupro® patches currently available and already
with them can still be used. It is important that patients do not stop taking their existing
medication, even if they notice snowflake patterns on their patch, without first speaking
to you. They have to store their Neupro® supply in a refrigerator. There is no need to
transport Neupro® patches in special containers and they must not be stored in a freezer
compartment. Because of refrigeration, patients should take extra care to apply the patch
appropriately. There is no need to have it reach room temperature, though this will increase patient
comfort. It is recommended to apply and maintain gentle pressure with the palm of the hand on the
patch for at least one minute for proper adhesion.
In any case, patients must not abruptly discontinue therapy, even if they notice a
snowflake-like pattern. Abrupt withdrawal of dopamine agonists has been associated with a
syndrome resembling neuroleptic malignant syndrome or akinetic crisis.
If you have any questions, please contact UCB Medical Information: Tel: 01753 534655, Fax: 01753
536632, E-Mail: email@example.com. If your enquiry is in relation to Neupro
supply please contact UCB Customer Service: Tel: 0800 9233131
UCB is working hard on different pathways to ensure Neupro® supply to all patients. Meanwhile, we
thank you for your understanding and assistance.
Dr Gill Nelson
Medical Director UK and Ireland