Acitretin

Soriatane[R] (acitretin), a systemic medication for severe psoriasis, has received approval for an enhanced product labeling.

The major changes to the label include:

-Information regarding reducing phototherapy dose in patients concurrently using Soriatane

-Clarification of dosing schedule. The recommended initial dose has been changed to 25 mg to 50 mg per day, rather than 25 mg or 50 mg. The availability of 10 mg and 25 mg capsules gives prescribers the ability to adjust the dose up or down in small increments.

-Inclusion of efficacy results from clinical trials in which Soriatane was shown to be effective in five major types of psoriasis--plaque, guttate, palmoplantar, erythrodermic, and pustular, as well as for maintenance therapy.

-Enhanced pregnancy warnings, similar to those for isotretinoin. The updated label strengthens warnings about birth defects and requires two negative pregnancy tests before the start of therapy. Female patients must use two effective forms of birth control simultaneously and sign an informed consent agreement acknowledging that they are aware that they must not be pregnant when they start taking Soriatane, or get pregnant during therapy or for three years after stopping treatment.

Soriatane is manufactured and distributed by Roche.

COPYRIGHT 2003 Journal of Drugs in Dermatology
COPYRIGHT 2003 Gale Group