Rotigotine patches: lifting of prescribing restrictions
- Medicines and Healthcare products Regulatory Agency
- 1 August 2009
- Therapeutic area:
Cold-chain storage and distribution system now been fully implemented by manufacturer.
Article date: August 2009
In July 2008, restrictions were placed on prescribing of the rotigotine transdermal patch (Neupro▼). These restrictions limited prescribing to 1 month’s supply and also asked that no new patients were initiated.
These restrictions arose because of reports of the development of crystals in some patches due to storage conditions. A cold-chain storage and distribution system has now been fully implemented by the manufacturer—all stocks of rotigotine patches are refrigerated from manufacturer to patient. No significant crystallisation should occur under these storage conditions. As a result, the restrictions on prescribing have now been lifted.
Advice for healthcare professionals:
- rotigotine patches can once again be prescribed in line with the approved indications of idiopathic Parkinson’s disease or restless legs syndrome
- prescriptions are no longer limited to 1 month’s supply
- patients should store their patches in the refrigerator; patches must not be stored in the freezer; there is no need to bring the patch to room temperature before application
Article citation: Drug Safety Update Aug 2009, vol 3 issue 1: 9a.
Published: 1 August 2009
Therapeutic area: Neurology