What Is Protopic (tacrolimus)?

Topical calcineurin inhibitors are medications that are applied to the skin that are used in the treatment of atopic dermatitis (AD). Topical calcineurin inhibitors are usually prescribed as second-line treatment, which means they are used after primary treatment with other topical medications, like corticosteroids, has already been tried and has not sufficiently improved symptoms of AD.1

What is Protopic?

Protopic is a prescription topical medication used to treat moderate to severe AD in adults and children over the age of 2. Protopic ointment should only be used for short-term and non-continuous use in individuals who do not have compromised immune systems and who have already tried other topical treatments for their AD or those who cannot use other treatments.2 The active ingredient in Protopic is tacrolimus.2

How does Protopic work?

Topical calcineurin inhibitors like Protopic block calcineurin, a chemical naturally produced by the bacteria Streptomyces that activates T-cells. T-cells are a type of white blood cell involved in the immune system response. In AD, there is a dysfunction in the immune system causing excessive inflammation in the skin. Topical calcineurin inhibitors block cytokines (chemical messengers) that trigger the inflammatory response. Once absorbed into the skin, topical calcineurin inhibitors reduce symptoms of AD like redness and itchiness.1,2

What are the possible side effects of Protopic?

Common side effects experienced by patients using Protopic include skin burning or stinging when first applied. These side effects tend to lessen after several applications of the medication. People with acute or severe AD are at risk for infections in the areas of skin compromised by AD. Because of the immunosuppressant effects of Protopic, it is not recommended for use in people who have active skin infections.

Although no causal relationship has been established, rare cases of cancer (skin cancer and lymphoma) have been reported in patients using topical calcineurin inhibitors including Protopic.1,2

Things to know about Protopic

Topical calcineurin inhibitors like Protopic can be used on any area of the skin, and they are particularly useful in sensitive skin areas, such as the face and skin folds, which may be more susceptible to side effects from topical corticosteroids.1

The more potent strength Protopic, tacrolimus 0.1%, is only indicated in individuals older than 15 years. The tacrolimus 0.03% ointment can be used in individuals aged 2 years and older.2
People should not use ultraviolet (UV) light therapy, sun lamps, or tanning beds while using Protopic ointment. Sun exposure should be limited while using Protopic ointment, even when the medication is not on the skin. If sun exposure cannot be avoided, the skin should be protected with loose fitted clothing.2

The skin that is being treated with Protopic ointment should not be bandaged or wrapped.2
People using Protopic ointment should avoid getting it in the eyes or mouth.2

Pregnancy and Protopic

It is not known whether Protopic is safe to use during pregnancy. Women who are pregnant or plan to become pregnant should talk to their doctor about the risks and benefits of using Protopic.2
Protopic should not be used on skin with malignant or pre-malignant conditions or in patients with a skin barrier defect, such as Netherton’s syndrome, lamellar ichthyosis, generalized erythroderma, or cutaneous Graft versus Host Disease.2

Dosing

Protopic ointment comes in two strengths: 0.03% tacrolimus and 0.1% tacrolimus. A thin layer of ointment is applied to the areas of skin affected by AD twice daily. Use of Protopic should be discontinued when the signs and symptoms of AD resolve. If symptoms do not improve within 6 weeks, patients should be re-examined by their doctor.2

Proactive, intermittent application of topical calcineurin inhibitors like Protopic two to three times weekly on areas where AD recurs has been shown to be effective in reducing relapses.1
For additional information on Protopic, read the full prescribing information.

Emily Downward | June 2017
View References