Five Questions About Protopic (tacrolimus) Ointment

CHICAGO, Aug. 3 /PRNewswire/ -- Known medically as atopic dermatitis (AD), eczema is characterized by dry, itchy skin and rashes.(1) Scratching the affected area of skin may result in redness, swelling, scaling, cracking, weeping of clear fluid, and crusting of the skin.(2) Immuno-modulators called topical calcineurin (cal-SEE-nur-in) inhibitors (TCIs) can be effective treatments for patients with mild, moderate or severe eczema(3) who fail to respond adequately to first-line prescription treatments, such as topical corticosteroids, or when those treatments are not advisable. Applied to the affected area of skin, TCIs can reduce the signs and symptoms of eczema.

One of the TCIs currently on the market is called Protopic Ointment. Protopic is a prescription ointment used to treat moderate to severe eczema in adults or children two years of age or older who have a normal immune system. Protopic is for use after other prescription medicines have not worked or when a doctor recommends that other prescription medicines should not be used. Protopic should be used for short periods and, if needed, treatment may be repeated after breaks. Protopic can be a valuable part of an overall treatment strategy for managing moderate to severe AD, which also includes a proper skin care regimen and avoiding substances such as foods, detergents and fabrics that may trigger a flare.

How is Protopic used?
Protopic ointment is a prescription medicine used on the skin to treat moderate to severe eczema for short periods, and, if needed, may be repeated with breaks in between.(4) After first-line treatments, or when those treatments are not advisable, Protopic has been shown to be safe and effective in sensitive and/or difficult to treat areas when used as directed.

Is Protopic suitable for children?
Protopic is available in two concentrations: 0.1% and 0.03%. Either concentration can be used in adults, while only the 0.03% concentration is indicated for children between the ages of 2 and 15. Protopic should not be used in children under the age of 2.(5)

What clinical studies were conducted to support the approval of Protopic?
Three randomized, double-blinded, clinical studies using un-medicated ointment were conducted to support approval of Protopic and demonstrate its safety and effectiveness in treating adults and children with moderate to severe eczema.(7,8,9)

In the adult studies of 632 patients, a significantly greater number of patients achieved at least a 90% or better improvement of their eczema with either the 0.1% or 0.03% concentrations of Protopic, based on their physician's global assessment, at 12 weeks compared to those patients who were treated with an un-medicated ointment.(8)

Similarly, a study of 351 patients ages 2 to 15 showed that a significantly greater number of patients had at least 90% or more improvement with Protopic, based on physician global assessment, compared with an un-medicated ointment.(9) Only Protopic Ointment 0.03% is indicated for children aged 2 to 15 years.

These clinical trials also showed that both pediatric and adult eczema patients who used Protopic had an itch reduction 5 times greater than those who used an un-medicated ointment.(8,9)

What is the important safety information for Protopic?
Protopic should not be used by patients who are allergic to any of its ingredients. The most common side effects with the use of Protopic are sensation of skin burning or itching, flu-like symptoms and headaches. Patients using Protopic should avoid natural or artificial sunlight (sun lamps or tanning beds). Patients should not use Protopic if they have a skin infection on the area of skin to be treated. The skin being treated should not be covered with bandages, dressings, or wraps.

As with all prescription medications, patients should talk with their doctor about their medical history, other health conditions and any other prescription, over-the-counter or natural medicines they may be using. Patients also should tell their doctor if they have a skin disease called Netherton's syndrome, or skin infections such as chicken pox or herpes or if they've been told they have a weakened immune system, or are pregnant, breast feeding or planning to become pregnant.(11)

Important Information Patients Should Know About Protopic Ointment
The safety of using Protopic Ointment for a long period of time is not known. A very small number of people who have used Protopic Ointment have had cancer (for example, skin or lymphoma). However, a link with Protopic Ointment has not been shown. Because of this concern, patients should:

• Not use Protopic Ointment continuously for a long time
• Use Protopic Ointment only on areas of skin that have eczema
• Not use Protopic Ointment on a child under 2 years old(12)

If the eczema does not improve within six weeks, patients should contact their doctor.

Visit www.protopic.com for more information including full prescribing information.

References

1. Handout on Health: Atopic Dermatitis. National Institute of Arthritis and Muscoskeletal and Skin Diseases. NIH Publication No. 03-4272. Revised April 2003, page 3
2. Eczema/Atopic Dermatitis, American Academy of Dermatology web site. http//www.aad.org/public/publications/pamphlets/skin_eczema.html. Accessed October 21, 2008, page 1
3. Handout on Health: Atopic Dermatitis. National Institute of Arthritis and Muscoskeletal and Skin Diseases. NIH Publication No. 03-4272. Revised April 2003, page 3
4. Protopic(R) (tacrolimus) Ointment full Prescribing Information, Deerfield, Ill., Astellas Pharma US, Inc. 2006
5. Protopic(R) (tacrolimus) Ointment full Prescribing Information, Deerfield, Ill., Astellas Pharma US, Inc. 2006
6. Protopic Ointment full Prescribing Information, ibid.
7. Soter N, et al. J Am Acad Dermatol. 2001;44;S39-46.
8. Hanfin, J, et al. J Am Acad Dermatol. 2001;44:S28-S38.
9. Paller A, et al. J Am Acad Dermatol. 2001;44:S47-S57
10. Protopic Ointment full Prescribing Information, op. cit.
11. Protopic Ointment full Prescribing Information, op. cit.
12. Protopic Ointment full Prescribing Information, op. cit.