What to Know About Protopic (Tacrolimus)

In 2000, the U.S. Food and Drug Administration (FDA) approved Protopic (tacrolimus) for the treatment of atopic dermatitis (eczema). Protopic is an ointment and a member of a class of drugs known as topical calcineurin inhibitors.

It’s not completely clear how Protopic improves the symptoms of people with eczema. However, it is known to have certain effects on the immune system, such as decreasing signaling molecules that promote inflammation.

Uses

In the U.S., topical Protopic is FDA-approved for the short-term treatment of people with moderate to severe atopic dermatitis (commonly known as eczema). Tacrolimus is the generic name of the drug.

It might be used for six weeks or less to help tame down disease exacerbations known as disease flares. Eczema is the only medical condition for which Protopic is approved.

Specifically, it’s recommended when a person hasn’t had enough of a response to initial treatments with steroid creams. It can also be helpful if you’ve been using steroid cream for a while and your skin is irritated or displaying effects from steroids. It’s also an approved option for people who can’t use steroid creams for some reason. It is often a good option for use in sensitive areas of the body that a steroid cream might irritate.

Protopic might also help you use steroid creams less frequently. Healthcare providers may also prescribe it to be used continuously, over longer periods of time. This is another approved use of the drug in people who have frequent disease exacerbations. In some circumstances, this might help prevent disease flares.

Off-Label Uses for Other Conditions

Clinicians also sometimes prescribe Protopic for other skin conditions. Data from some clinical studies suggest the drug may be helpful, even though Protopic isn’t FDA approved for these conditions. Some of these include:

• Allergic contact dermatitis
• Lichen planus
• Psoriasis
• Vitiligo
• Seborrheic dermatitis

It’s important not to confuse topical creams like Protopic with drugs taken orally. When given as an oral drug, tacrolimus is sometimes given for other medical conditions, like in people who have received an organ transplant. However, though it contains the same active ingredient, such formulations (e.g., Prograf) do not have the same characteristics in terms of potential side effects, risks, and benefits. 

Before Taking

Before prescribing Protopic, your healthcare professional will perform a medical exam and talk to you about your medical history. If you have moderate to severe eczema and you don’t have a medical condition that might make it dangerous to take Protopic, it might be a good option.

Protopic is usually prescribed after you’ve already been prescribed topical steroid creams but find they haven’t adequately controlled your symptoms.

Precautions and Contraindications

People with a known allergy to Protopic should not use it.

People who are immunosuppressed also should not use Protopic. This might apply to people taking certain medications or to people with certain genetic or acquired medical conditions.

This drug can cross over into the placenta and be excreted in breast milk. Some data from animal studies suggest that Protopic may not be safe to take during pregnancy or while breastfeeding.

If you are considering becoming pregnant or breastfeeding while using Protopic, you should discuss the risks and benefits with your healthcare provider. The drug should only be used if the benefits in your case are considered greater than the risks.

Some people with kidney problems might not be able to take Protopic safely. Discuss the pros and cons with your healthcare provider.

You also may not be able to use Protopic if you currently have an active skin infection.

Other Topical Treatments for Eczema

Before deciding to start taking Protopic, you’ll want to consider other options with your healthcare provider. Depending on your preferences and your medical situation, you might find a better choice.

Other Calcineurin Inhibitors

Elidel (pimecrolimus) is another FDA approved drug in the same class as Protopic, another calcineurin inhibitor. It is similar to Protopic in terms of its effectiveness and potential side effects.

Steroid Creams

Steroid creams, such as betamethasone, are often used instead of calcineurin inhibitors. They can also be used at the same time.

Phosphodiesterase 4 Inhibitor Drug

In 2016, the FDA approved another topical treatment for eczema. Eucrisa (crisaborole) is a drug that works in a different way than these other options. It appears to be an effective, low-risk treatment that is approved for people with mild to moderate eczema.

Dosages

Protopic ointment is available in two strengths: 0.03% and the more concentrated 0.1% version. The lower dose is FDA approved for individuals 2 years and older, and the more concentrated version is only approved for people age 16 and older.

(Please note that all listed dosages are provided according to the drug manufacturer. Check your prescription to make sure that you are taking the right dose for you.)

Off-Label Dosage

Though technically these dosages are only approved for these age groups, the American Academy of Dermatology states that the 0.03% concentration can be safely used in younger children when given appropriately, and some clinicians prescribe the drug-off label for this group. Many clinicians also prescribe the stronger concentration to people less than 16 years of age, finding it to be more effective.

How to Take and Store

Often, clinicians prescribe Protopic to be applied twice daily for a few weeks, but ask if this is the case for you. Your dosing pattern may differ.

Here are a few things to remember while using Protopic:

• Store Protopic at room temperature.
• Wash your hands before and after applying.
• Apply a thin layer to the affected area.
• Do not shower or swim after applying.
• If using a moisturizer, put it on after you put on Protopic.
• Avoid tanning, sunlamps, or ultraviolet light therapy while using it.
• Limit sun exposure when using.
• Follow your clinician's instructions about when to stop using Protopic. You may need to stop when your symptoms go away.

Side Effects

Common

The most common side effects of Protopic occur where the ointment is applied. You might experience stinging, burning, redness, or itching in this area. These mild to moderate issues happen most frequently within the first few days of treatment. They will usually go away as your skin heals.

Less commonly, Protopic may cause other non-severe side effects, like acne, headache, or a stuffy nose. You may also notice that your face becomes flushed when you drink alcohol. You can find the full list of potential side effects on your package insert.

Severe

Some side effects are more severe.

For other serious symptoms, you should seek prompt care of a clinician. Some of these might include:

• Signs of a skin infection (redness, swelling, oozing)
• Swollen glands
• Signs of an infected hair follicle (redness, crusting)
• Severe stinging or burning where you apply the medication

Warnings and Interactions

Black Box Warning

In 2006, the Food and Drug Administration updated the product labeling for Protopic ointment (and for the other drug in its class, Elidel). In it, a new warning appeared, stating that the long-term safety of Protopic (and other calcineurin inhibitors) had not been clearly demonstrated. The label explained to patients that, rarely, people taking these drugs had developed skin cancer or lymphoma. The warning added that people shouldn’t use Protopic for an extended period of time.

This warning appears on package labels of Protopic today. However, this is a somewhat controversial area. Some of these data suggesting these risks were gathered from studies in animals. Data gathered since then suggest that the risks of Protopic were overstated. Some clinicians and researchers argue that the warning is unnecessarily strong and has decreased prescribing of a very helpful drug. Protopic doesn’t carry some of the same risks as steroid creams, and it has been proposed that, properly used, it helps people use steroid creams less often.

In the years since this warning first appeared, analyses have not demonstrated an increased risk of either skin cancer or lymphoma. Low to mid potency therapies of drugs like Protopic and Elidel appear to be safe when given in response to eczema flares. Less information is available about the potential safety of Protopic and other drugs in this class when given in mid to high doses continuously.

Potential Interactions

Because of the way it is absorbed, Protopic is unlikely to cause interactions with drugs that you take by mouth. However, it might theoretically be possible that Protopic would decrease their effectiveness. Some drugs that might be affected by this include:

• Antifungals, like ketoconazole
• Calcium channel blockers (like Norvasc)
• Histamine blockers, like cimetidine

As always, be sure to discuss your full list of medications and over-the-counter products (including herbal supplements) with your clinician.