What Is Protopic® (tacrolimus)?

Protopic® is a prescription topical medication used to treat moderate to severe atopic dermatitis 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 atopic dermatitis or those who cannot use other treatments.2

What are the ingredients in Protopic?

The active ingredient in Protopic is tacrolimus.2

How does Protopic work?

Topical calcineurin inhibitors like Protopic, block calcineurin, a naturally produced chemical that activates T-cells. T-cells are a type of white blood cell involved in the immune system response. In atopic dermatitis, 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 atopic dermatitis 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 atopic dermatitis are at risk for infections in the areas of skin compromised by flares. 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, he United States Food and Drug Administration has issued a black box warning that rare cases of cancer (skin cancer and lymphoma) have been reported in patients using topical calcineurin inhibitors including Protopic.1,2

These are not all the possible side effects of Protopic. Patients should talk to their doctor about what to expect with treatment with Protopic.

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

Protopic strength and potency

The more potent strength Protopic, tacrolimus 0.1%, is only indicated in individuals 16 and older. The tacrolimus 0.03% ointment can be used in individuals aged 2 years and older.2

UV light and sun exposure

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

Pregnancy

There aren't studies that distinguish the safety of topical use of Protopic 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

Other considerations

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

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

For additional information on Protopic, read the full prescribing information.

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Written by Emily Downward | Reviewed February 2022