Protopic – Is a Non-Steroid Cream Better for your Child?

This is a post that I wanted to write for some time because I’ve been reading parents’ differing views on whether Protopic has worked for their child. I did a quick internet search on forums, and 10 out of 14 parents said it worked, 3 mentioned it gave a stinging sensation and 1 believed it led to herpes virus. Of course, my limited browsing of forum posts is not a scientific study but it certainly has piqued my interest to find out more about Protopic (something I didn’t research earlier because a mom with eczema child is busy! and also Marcie doesn’t use nor has been prescribed Protopic).

So What’s Protopic and what does it do?

According to its website, Protopic is a topical calcineurin inhibitor (TCI) that is available upon prescription. Calcineurin activates the T-cells of the immune system, which when over-produced attacks the skin leading to inflammation (read more in this post). Protopic, whose drug name is tacrolimus, belongs to a class of drugs known as calcineurin inhibitors and works to decrease the effects of, or suppresses, the immune system. Tacrolimus is also known as FK-506 or fujimycin and typically prescribed to reduce the likelihood of new organs being rejected in a transplant operation. Tacrolimus was discovered in 1984 from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. Protopic is a product of Japanese pharmaceutical company, Astellas Pharma, and its ingredients are tacrolimus, mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.

Who can and How to use Protopic?

It is recommended for moderate to severe eczema and to be prescribed by doctors, who are to prescribe it only when topical corticosteroids are not effective. It is only to be used for short periods, generally not more than 6 weeks. It comes in two strengths, 0.1% and 0.03% but for children (at least 2 years of age), only the 0.03% is recommended. The application of Protopic ought to be thin and improvement (if any) is usually seen in two weeks.

Protopic is not to be used with wet wraps, lest there’s over-absorption into the body. Protopic should also not be used on eczema that is infected as there’s no study relating to its safety in infected eczema. Going outdoors in the sun and tanning beds are also to be avoided because of shorter time to tumor formation when applying Protopic, as disclosed on their website. Hands ought to be washed after applying Protopic. The long-term use of Protopic has not been studied and thus, its application as a maintenance topical treatment to prevent flare-ups need to be advised by doctors. It is also not recommended for nursing moms or moms who are trying to be pregnant.

Pros and Cons of Protopic

Various studies have been conducted on Protopic, and it appears to be more effective than low-potency steroid creams. The other advantages over steroid creams is that it doesn’t cause skin thinning and therefore can be used on parts of other where skin is generally thinner, such as the face, eyelids and neck. However, as it suppresses the immune system, there’s increased risk of viral infection, in particular from herpes/ eczema herpeticum/ chickenpox/ shingles virus. Skin burning and itching sensations are the most common side effects (usually in its initial use) of using Protopic. It is also possible to be allergic to tacrolimus or other ingredients in Protopic, such as mineral oil and paraffin. Furthermore, a number of cases of cancer of skin or of lymphocytes cells have been reported, resulting in FDA issuing a black box cancer warning (read more on webmd post). Protopic may also interact with certain medications, including some antibiotics such as azithromycin which is commonly prescribed to children. You can read the product leaflet here.

Update in Feb 2015 – 10 year follow-up study on children who use pimecrolimus showed no significant cancer risk.

MarcieMom’s Take?

Marcie hasn’t been prescribed Protopic but from various talks that I’ve attended, it appears that though calcineurin inhibitors are mentioned, it’s always fairly down in the list of treatment options. One thing I feel is clear is that I wouldn’t opt to use Protopic just because I’m worried about the side effects of steroids as a drug that works on the immune system would surely has its own sets of side effects.