Metrex formulation of Kaletra available on named patient access in UK

In October 2005 the FDA approved a new formulation of Kaletra (Meltrex). Until European approval, expected in Summer 2006, a named-patient programme can provide this formulation to patients who have a medical need for earlier access. These reasons could include adherence (reduced pill count), tolerability (reduced GI intolerance) or a need for non-refrigerated medication.

Doctors wishing to request named-patient access for the new formulation for their patients should call the Medical Information Department at Abbott 01628 773355.

Comment

The existing formulation of Kaletra will be phased out. During this process, particular care will need to be taken given the difference in doses. Currently standard dose Kaletra is dosed as 3 pills, twice a day. The new formulation requires two pills, twice-daily. Each film-coated new formulation tablet contains 200mg lopinavir and 50mg ritonavir.

Drugs interactions with NNRTIs with the new formulation, require different recommendations for treatment-naive (no adjustment) and treatment-experienced patients (consider increasing dose to 3 tables, twice-daily).

The Melt-Extruded (meltrex) Kaletra uses a new formulation of ritonavir that does not require refrigeration. So far Abbott have provided no indication or interest in making the non-refrigerated formulation of ritonavir available for use as a boosting agent for other protease inhibitors.