IMPORTANT SAFETY INFORMATION

WARNING: The safety of using Protopic, and drugs like it, for a long period of time is not known.

Please see additional Important Safety Information below

What is Protopic?

Protopic is a prescription ointment used on the skin to treat moderate to severe eczema. Protopic is a member of the TCI class of medications. Protopic is a second-line treatment, which means it is used when other prescription medications have not worked or if a doctor recommends that other prescriptions not be used.

Protopic is indicated for adults and children older than 2 years of age who do not have a weakened immune system. Protopic Ointment is used only on skin with moderate to severe eczema for short periods of time. If needed, treatment may be repeated with breaks in between. You should not use Protopic if you are allergic to tacrolimus or any other ingredients contained in the product.

Protopic Dosing

Protopic is available in two strengths, 0.1% and 0.03%. Either strength may be used for adults and children 16 years and older. Only Protopic 0.03% can be used on children between 2 years and 16 years. Protopic should not be used on children younger than 2 years old.2

Ask your doctor today if Protopic is right for you or your child.

Related links:

Benefits of Protopic

Quick Facts

Significant Improvement*

In clinical studies, over 5 times as many adults had at least 90% improvement in their moderate to severe eczema when treated with Protopic than when treated with unmedicated ointment at 12 weeks.6 (37% Protopic vs 7% unmedicated ointment)

90% of patients showed some improvement within 1 week†7

90% of adult eczema sufferers experienced some improvement within 1 week during a clinical trial. At week 1 of treatment, 54% of patients had marked or excellent improvement and 36% had moderate to slight improvement in their moderate to severe eczema. Eczema signs and symptoms continued to improve throughout the 12-month study.7

Do you know...

What treatments are used for eczema?

  • Moisturizers
  • Steroclasss
  • TCIs
  • Daily planning
  • All of the above

Correct Answer

All of the above

Effective treatment for eczema requires a treatment plan that may include everything listed. From a daily plan of moisturizing to medications, the severity of your eczema will determine how your doctor treats your eczema.

Do you know...

What are ways to treat eczema?

  • Moisturizers
  • Steroclasss
  • TCIs
  • Daily planning
  • All of the above

Correct Answer

All of the above

Effective treatment for eczema requires a treatment plan that may include everything listed. From a daily plan of moisturizing to medications, the severity of your eczema will determine how your doctor treats your eczema.

Do you know...

Is eczema contagious?

  • Yes
  • No

Correct Answer

No

While many eczema sufferers avoclass physical contact with people, the condition is not contagious.

Do you know...

Which of these should be avoclassed when your eczema flares?

  • Cotton
  • Warm water
  • Lotion
  • Harsh soaps

Correct Answer

Harsh soaps

When a flare occurs, removing any potential triggers is crucial. And, often, flowers may be one of those allergens that can cause your eczema to become worse.

Do you know...

Many eczema sufferers also suffer from hay fever and asthma.

  • True
  • False

Correct Answer

True

All three conditions (hay fever, asthma, and eczema) are ATOPIC diseases, which are essentially allergic reactions. It is common for a person suffering from eczema to also show signs of these conditions as well. If a parent has a history of atopic diseases, there's a 60% chance his or her child will also have one of the diseases.16,17

Do you know...

Do certain foods cause eczema?

  • Yes
  • No

Correct Answer

No

While it can trigger a flare, food does not cause eczema. About 1/3 of eczema sufferers experience episodes, or flares, after eating particular foods. For sufferers, some of the most common triggers include dairy, eggs, soy, peanuts, and fish.16


*Response rate from two 12-week, randomized, double-blind, comparative pivotal studies with a total of 632 patients aged 15 to 79 years. Efficacy was evaluated on the basis of the physician's global evaluation of clinical response at the end of treatment.

  Adapted from Hanifin JM et al.6

†Investigator's global assessment of clinical improvement in adult patients treated with Protopic Ointment 0.1%. Results from a
long-term, open-label safety study of 316 adult patients with moderate to severe eczema.

Protopic Ointment is a prescription ointment used to treat moderate to severe eczema. Protopic is for use after other prescription medicines have not worked or when a doctor recommends that other prescription medicines should not be used. Protopic should be used for short periods, and, if needed, treatment may be repeated with breaks in between. Protopic is available in two strengths. Adults may use either Protopic Ointment 0.1% or 0.03%. Children 2 to 15 years of age should only use Protopic Ointment 0.03%. Protopic should not be used on children younger than 2 years of age.

Important Safety Information

WARNING: The safety of using Protopic, and drugs like it, for a long period of time is not known. A very small number of people who have used Protopic have had cancer (for example, skin or lymphoma). However, a link with Protopic has not been shown. Patients should avoid using Protopic continuously for a long time and apply Protopic only to areas with eczema. If the eczema does not improve within 6 weeks, patients should talk to their doctor.

Protopic should not be used by patients who are allergic to any of its ingredients. The most common side effects with the use of Protopic are stinging, burning, or itching.

Patients should avoid natural or artificial sunlight (sun lamps or tanning beds). Patients should not use Protopic if they have a skin infection on the area of skin to be treated. The skin being treated should not be covered with bandages, dressings, or wraps.

Only your doctor can weigh the risks and benefits and decide if Protopic is right for you. Please see the Medication Guide and talk to your doctor if you have any questions.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read Patient Medication Guide and Prescribing Information including boxed warning.

Before & After

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Baseline
3 Weeks
12 Weeks

Caucasian female, 27

Individual results may vary. 27-year-old Caucasian female treated with Protopic (tacrolimus) Ointment 0.03% in a 12-week study. Physician assessment of patient disease severity at baseline according to Rajka/Langeland criteria: severe atopic dermatitis. Physician Global Evaluation at end of treatment: marked improvement.
From Hanifin JM et al. J Am Acad Dermatol. 2001;44:s28-s38.

Caucasian male, 2

Individual results may vary. 2-year-old Caucasian male treated with Protopic (tacrolimus) Ointment 0.03% in a 12-week study. Physician assessment of patient disease severity at baseline according to Rajka/Langeland criteria: severe atopic dermatitis. Physician global evaluation at end of treatment: marked improvement.
From Paller et al. J Am Acad Dermatol 2001:44:s47-s57.

Caucasian female, 6

Individual results may vary. 6-year-old Caucasian female treated with Protopic (tacrolimus) Ointment 0.03% in a 12-week study. Physician assessment of patient disease severity at baseline according to Rajka/Langeland criteria: severe atopic dermatitis. Physician global evaluation at end of treatment: marked improvement.
From Paller A et al. J Am Acad Dermatol. 2001;44:s47-s57.

African-American female, 3

Individual results may vary. 3-year-old African-American female treated with Protopic (tacrolimus) Ointment 0.03% in a 12-week study. Physician assessment of patient disease severity at baseline according to Rajka/Langeland criteria: severe atopic dermatitis. Physician global evaluation at end of treatment: excellent improvement.
From Paller A et al. J Am Acad Dermatol. 2001;44:s47-s57.

Safety Considerations

WARNING: The safety of using Protopic, and drugs like it, for a long period of time is not known. A very small number of people who have used Protopic have had cancer (for example, skin or lymphoma). However, a link with Protopic has not been shown. Patients should avoid using Protopic continuously for a long time and apply Protopic only to areas with eczema. If the eczema does not improve within 6 weeks, patients should talk to their doctor.

Protopic should not be used by patients who are allergic to any of its ingredients. The most common side effects with the use of Protopic are stinging, burning, or itching.

Patients should avoid natural or artificial sunlight (sun lamps or tanning beds). Patients should not use Protopic if they have a skin infection on the area of skin to be treated. The skin being treated should not be covered with bandages, dressings, or wraps. Only your doctor can weigh the risks and benefits and decide if Protopic is right for you.

Protopic should not be used on children younger than 2 years of age.

Please see Important Safety Information.

Please read Patient Medication Guide and Prescribing Information including boxed warning.

Symptom Assessment Form

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How the Symptom Assessment Form Works:

The Symptom Assessment form asks a number of questions to identify pertinent information about you or your child that may be suffering from eczema. Once the form is complete, you will receive a recap to print and take with you to your next doctor's appointment.

Who is affected by eczema?

Adult

Child (2-15)

Where is the skin affected?

  • Face
  • Scalp
  • Neck
  • Back
  • Arms
  • Hands
  • Legs
  • Knees
  • Elbows
  • Ankles

Describe the skin

  • Red
  • Itchy
  • Dry
  • Cracked
  • Oozing

What treatments have you tried?

  • Nothing yet
  • Natural Remedies
  • Moisturizers
  • Prescription Medications
  • Other

Has any one of these remedies had any effect?

  • Yes
  • No
  • If so, what kind of effect?

How frequent are flares?

  • Continuous
  • Frequent
  • Rare

Are there any noticeable triggers?

  • Yes
  • No
  • If yes, what are they?

What type of lifestyle?

How would you describe the child?

  • Active
  • Moderately Active
  • Not Active

Is there a family history of eczema?

  • Yes
  • No

Any food allergies?

  • Yes
  • No
  • If so, what?

You're done!

Now that you have completed the Symptom Assessment form, print out the results and take them to your next doctor appointment.

You will find a recap of the questions you have answered along with a list of questions to ask your doctor. Take this to your next appointment and do not be afraid to ask the questions.

Eczema Journal

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My Journal

Track your flare, create a daily regimen, and chart it all for your doctor. This Eczema Journal will empower you to help manage your care.

Trigger Tracker

Whenever a flare begins, track it! What did you eat? What did you touch? What did you use to help? Is your skin itchy? Red? Burning? Chart everything in your Eczema Journal.

Daily Schedule

Your day is filled with many challenges to managing your eczema. Moisturizing, bathing, and medication. Creating a daily schedule will allow you to plan ahead and help manage your condition.

Recap

Telling your doctor about your experience is important to good treatment from your doctor. The Eczema Journal enables you to do just that.

Savings Program

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Ask your doctor about the Protopic Savings Card and save up to $40 for your prescription.*

*Card can be used up to three times with a maximum savings of $120. You must present this card to the pharmacist along with your prescription to be eligible for savings. Restrictions may apply. Subject to eligibility. Card must be accompanied by a valid prescription for Protopic (tacrolimus) Ointment 0.03% or 0.1%. No substitutions.

Please read Patient Medication Guide and Prescribing Information including boxed warning.