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Protopic (tacrolimus)

Reviewed by: HU Medical Review Board | Last reviewed: September 2023 | Last updated: September 2023

Protopic® (tacrolimus) is a topical treatment that may be recommended for people with plaque psoriasis. Protopic usually comes in an ointment and is available in 2 different strengths.1

The US Food and Drug Administration (FDA) has only approved Protopic for treating eczema (atopic dermatis) in people over the age of 2. But in some cases, doctors will recommend that people with plaque psoriasis try treatment with Protopic. This is called off-label use. An off-label drug is one that has not been approved by the FDA)to treat a certain condition. This also means the FDA has not yet determined the drug is safe and effective when used the way you are taking it.2,3

Off-label use of Protopic is usually recommended if a person has tried treatment with other types of topical drugs for psoriasis but these other medicines have not worked well enough or caused unwanted side effects. Protopic is usually prescribed to be used only for a short, limited amount of time.3

Protopic is most commonly recommended for treating psoriasis in certain sensitive areas, such as the skin on the face, around the genitals, and within skin folds and creases.3

What are the ingredients in Protopic?

The active ingredient in Protopic is tacrolimus.1

How does Protopic work?

Psoriasis is an autoimmune condition that causes special cells called T-cells to activate and trigger inflammation. This inflammation causes too many new skin cells to be produced, which in turn causes skin cells to build up and form plaques.4

Protopic works by preventing the T-cells from activating, which reduces inflammation, skin redness, and itching. It may also help stop plaques from forming.1

What are the possible side effects?

The most common side effects of Protopic include stinging, burning, or itching at the skin application site.1

Protopic has a boxed warning, the strictest warning from the FDA. It has this warning because people who use it have a slightly increased risk of certain types of cancers (such as lymphoma and skin tumors). Scientists recommend avoiding long, continuous use of the drug.1

These are not all the possible side effects of Protopic. Talk to your doctor about what to expect when taking Protopic. You also should call your doctor if you have any changes that concern you when taking Protopic.

Other things to know

Before starting treatment with Protopic, tell your doctor if you have:1

  • A skin disease called Netherton’s syndrome (a rare inherited condition)
  • Any infection on your skin, including chickenpox or herpes
  • Been told you have a weakened immune system

There is not enough data to know if Protopic is safe to use while pregnant or breastfeeding. Before starting treatment with Protopic, tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. They can help you decide if Protopic is right for you.1

Do not bathe, shower, or swim right after applying Protopic. This may wash off the cream.1

Do not use sun lamps, tanning beds, or phototherapy during treatment with Protopic.1

Limit time in the sun during treatment with Protopic, even if the medicine is not on your skin. If you need to be outdoors after applying Protopic, wear protective clothing. Ask your doctor what other types of sun protection you should use.1

Before beginning treatment for plaque psoriasis, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Protopic.

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