In September 2011, Janssen had issued a communication about supply problems with pegylated liposomal doxorubicin (Caelyx 20mg and 50mg vials) due to production difficulties at their speciality contract drug manufacturer’s site. A regulatory inspection in November 2011 had identified additional issues relating to deficiencies in sterility assurance at Ben Venue Laboratories. Consequently the benefit/risk for Caelyx can only be considered positive for absolutely essential use, to meet the clinical needs of patients already part way through a treatment course. Following discussion with regulatory agencies, Janssen recommends that:

• Existing stocks should only be used to complete treatments that have been started.

• No new patients should be started on Caelyx until further notice.

In addition, the company is experiencing a further deterioration of the supply shortage of Caelyx because manufacture at the contract facility has been suspended on a voluntary basis until the issues can be resolved. Until then, Janssen is unable to provide a date of return of Caelyx to the market. Based on current UK levels, stocks will run out at the end of December 2011.

The company states that non-liposomal and non-pegylated forms of doxorubicin have not demonstrated bioequivalence to Caelyx, therefore they should only be used where the benefit outweighs the risk for individual patients. Furthermore, non-anthracycline alternatives may be considered if the benefits outweigh the risks.

For further information, contact Medical Information at Janssen on 01494 567444.