Protopic

OB/GYN News, Jan 15, 2001 by Elizabeth Mechcatie

(tacrolimus ointment 0.1%, 0.03%, Fujisawa Healthcare)

A topical formulation of an immunosuppressant drug for treating moderate to severe atopic dermatitis patients aged 2 years and older for whom the use of alternative, conventional therapies is considered inadvisable because of potential risks, and for those who do not have adequate responses to or are intolerant of alternative, conventional therapies. The first nonsteroidal topical immunomodulator approved.

* Dosage: For short-term and intermittent, long-term therapy Both concentrations approved for adults.

* Special Considerations: In studies, local irritation and skin burning were more common among people using Protopic; these symptoms lasted for a short period, occurred early in treatment, and rarely led to discontinuation. During treatment, patients should avoid unprotected exposure to sunlight, sun lamps, tanning beds, and UVA or UVB light treatments. Long-term safety issues that are not resolved are the uncertainty over whether treatment with a topical immunosuppressant drug increases the risk of lymphoma and non-melanoma skin cancers, known risks of systemic immunosuppresslon.

Women who are pregnant or plan to become pregnant should check with their physicians before using Protopic, which should be avoided during breast-feeding, the Food and Drug Administration said in a statement announcing the approval.

* Comment: Approval was based on three 12-week studies of people with moderate to severe atopic dermatitis. Studies compared treatment with twice-daily applications of 0.03% or 0.1% tacrolimus in more than 1,000 children and adults and 328 patients who received a vehicle alone. In the three studies combined, 38% of those on the 0.1% formulation and 30% of those on the 0,3% formulation had improvement greater than 90% vs. 7% of those on the vehicle. Improvement of 50% or more was seen in 75% of those using the 0.1% concentration and 66% of those using the 0.03% concentration vs. 22% with vehicle. Improvements were usually seen within a week of starting treatment.

Protopic is expected to be available in the first quarter of this year, according to Fujisawa, which will be conducting post-marketing trials to evaluate the drug's long-term safety and efficacy and different dosing regimens.