Eczema Facts

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

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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.

16 replies on “Protopic – Is a Non-Steroid Cream Better for your Child?”

Please help my Opthalmologist has prescribed protopic 0.03 to apply on my son,s eyes at night.He is 5yrs,suffers and has eczema which is subsiding but his eyes remains red and itchy especially at night for a long time it safe to apply protopic inside the eyes because that’s what the Dr said and the Pharmacist disagree.

Hi Thembi, I’ve never come across Protopic being on the eyes or prescribed by Opthalmologist. It is meant for the skin.
In fact, a common side effect of using it on skin is stinging.. I can’t imagine how it will end up being on the eyes if it is stinging for skin.
Should stop using Protopic on the eyes, take care!

I don’t know if this is the case for your child but it might be worth it to check for pink eye. I imagine an eye doctor would know but…

Three years ago I got a terrible eczema rash around my eyes/corners of my eyes. My doctors including my general doc, dermatologist, and ob (I was pregnant at the time) prescribed a variety of creams/ointments. Nothing worked. I suffered with this rash for almost 8 months and couldn’t even sleep some nights. Then I had my baby, and I hoped the rash might let up but it did not. When my newborn was 2 months old, he got pink eye and his pediatrician prescribed antibiotic eye drops. I gave my newborn the prescribed dosage for the proper amount of time and his pink eye resolved. About a month later, I noticed the bottle of leftover antibiotic drops in our medicine cabinet. I was so very very desperate that I decided to used the rest of it in my eyes. Well, that cleared everything up!! I couldn’t believe it, 3 doctors and countless appointments, and they missed the fact I had pink eye!

Thanks Anna for your sharing! Yes, I had personal experience of wrong diagnosis for pink eye as well. Really need to see an experienced eye doctor – seen two eye doctors at the emergency department and got the diagnosis wrong, and I went back to my usual eye doctor who is very senior and he got it right. Luckily, it was remedied in time without permanent damage to my cornea, since then, I only see back my own senior eye doctor. Thanks again for sharing, totally agree, but be careful though cos antibiotic eyedrop can’t really be ‘shared’ but so glad it worked for you the last round 🙂

I’ve very recently been prescribed this for facial eczema (last Saturday). I used to use hydrocortisone 1% in which did the job however as soon as I stopped using it the eczema came back. I was very concerned about the side effects of steriods like most people (thinning of skin- especially on eyelids).

I’ve use Protopic once and I can’t believe the results even after one application. Amazing – It almost seems too good to be true. Concerned about the side effects though. I just think surely the dermatologist wouldn’t have prescribed it if the cancer risk was a known fact? I’m just a little bit worried after looking online. But then again aren’t there possible side effects with everything we use?

I use protopic on my eczema (Seborrheic Dermatitis) which is located on my face. I believe at this point I’ve been using it 4-5 times per week for about a year and a half. I’m kind of concerned at this point. I have some questions if you’d be so kind.

1.) Is there any withdrawal once you stop using this cream? I stopped using the steroid creams after a few weeks ’cause I didn’t want to damage my skin, but are there negative reactions when you discontinue use of protopic? They say it doesn’t thin the skin, but I’m not so sure on that based on my own experience.

2.) Also how does this cream suppress your immune system? If you’re putting on a very thin layer right on the eczema surely that can’t seep very far into your body? I’m not sure I really understand. Also, as far as I’m aware, eczema can be cured via improving your immune system with diet and other lifestyle changes so why would you use an immune system suppressant medication? So confused here…. Feedback appreciated.

Hi, thanks for dropping by my blog. As far as I know, there’s no thinning of skin as it works differently from steroids. The side effect is likely to be from suppressing the immune system thus more susceptible to infection – the idea is to suppress the immune system from over-reacting to foreign matter. Separate concept from strengthening the overall immune system.
How did the Protopic work for you so far?
Take care!

I’m glad they don’t seem to think the cancer risk is significant, but I do have a tiny bit of worry over the length of time my daughter used Protopic. Our dermatologist prescribed it and we refilled many times. We haven’t used it in a year and a half, but I must say we used it fairly regularly for a couple of years before that. It was only used on the precise spots that were affected, which were not widespread, thankfully, but I do not that this will not cause her any issues down the road. I will also wonder if it had anything to do with the illnesses she had back then.

Hi Selena! So far the long-term use that I’ve read seems to suggest 2 years.. and I know the immune suppressing part makes me think that it may be making the child more vulnerable to catching colds, flu. My daughter doesn’t use TCI, but my take is if TCI works so that there will not be a worsening of eczema which warrant oral corticosteroids (which will be even more immune suppressing!) then its pros should outweigh the cons. 🙂

Comment on Eczema Support Group event during panel Q&A, in response to a mom’s question on Protopic on why it isn’t recommended before steroid
1. Very expensive
2. Stinging sensation commonly felt and not all patients can endure that
3. More for maintenance then for treating when eczema flares

A point was mentioned that in a convention in Seoul, there seems to be no collective evidence of increased cancer due to use of protopic.

My take is no one really knows why the immune system gone haywire in the sense it attacks the skin when there’s nothing worth attacking, just like arthritis is attacking the joints when it’s not supposed to attack. Some may call this ‘haywire’ overactive and thus, there’re immunity suppressing treatments.. Of course, it’s not a root treatment, as in it is not treating why, but trying to reduce the effects of, the skin being attacked.

I had to reply because this is completely inaccurate. There is no evidence to show that eczema is triggered by a weak immune system. You probably mean a weakened skin barrier, it’s not the same thing. Eczema has an autoimmune component to it, which is why drugs that suppress immunity improves eczema. Please stop spreading misinformation.

Your sharing will help others!