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

Treatment
With Protopic

Talk to your doctor about your symptoms. Your doctor can determine if you have eczema and prescribe the appropriate medication for you. Protopic is for second-line, non-continuous treatment of moderate to severe eczema and may be prescribed by your doctor for short-term use after other treatment options.

But what does "second-line" treatment mean? Well, very simply, it's a SECONDARY treatment option. Second-line treatment is used when either the first-line treatment did not work or it is not advisable for you to continue with that treatment. Talk to your doctor about whether Protopic is right for you.

Protopic should not be used on children younger than 2 years of age or on patients allergic to any of its ingredients.

What should I tell my doctor before using Protopic?

Before you start using Protopic, you and your doctor should talk about all of your medical conditions, including if you:

  • Have a skin disease called Netherton's syndrome (a rare inherited condition)
  • Have any infection on your skin, including chicken pox and herpes
  • Have been told you have a weakened immune system
  • Are pregnant, breast-feeding, or planning to become pregnant
  • Are allergic to Protopic or any of its ingredients (The active ingredient is tacrolimus)

Tell your doctor about all the medicines you take and skin products you use, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.

How to apply Protopic

Close
012F-041-5692 7/12

Be sure to contact your doctor immediately if:

  • Your symptoms get worse with Protopic Ointment
  • You get an infection on your skin
  • Your symptoms do not improve within 6 weeks. Sometimes other skin diseases can resemble eczema

Keep in mind that it is impossible to know in advance how well Protopic will work for any individual patient. However, because every patient is different, only your doctor can decide if Protopic is the right treatment for you.

Why Protopic?

There are a number of
reasons your doctor might prescribe a second-line treatment such as Protopic:

  • First-line therapy is not
    advisable for you
  • Taking you off your first-line therapy and moving you to something else
  • Deciding that your current
    eczema medicine is not
    working adequately
  • Your moderate to severe eczema is in a sensitive area, such as your face or neck

When Using Protopic...

  • Use Protopic Ointment exactly as prescribed
  • Use Protopic only on areas of skin that have eczema
  • Use Protopic for short periods. If needed, treatment may be repeated with breaks in between
  • Follow your doctor's advice if symptoms of eczema return after treatment with Protopic
  • Stop using Protopic when the signs and symptoms of eczema, such as itching, rash, and redness, go away or as directed by your doctor
  • Avoid getting Protopic in your eyes or mouth. Do not swallow Protopic. If you do, call your doctor

What should I avoid while using Protopic Ointment?

  • Do not use ultraviolet light therapy, sun lamps, or tanning beds during your treatment with Protopic
  • Limit sun exposure during treatment with Protopic even when the medicine is not on your skin. If you need to be outdoors after applying Protopic, wear loose-fitting clothing that protects the treated area from the sun. Ask your doctor what other types of sun protection you should use
  • Do not cover the skin being treated with bandages, dressings, or wraps. You can wear normal clothing
  • Avoid getting Protopic in the eyes or mouth. Do not swallow Protopic. If you do, call your doctor
  • Do not use Protopic for a condition for which it was not prescribed. Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide
  • Do not give Protopic to other people, even if they have the same symptoms you have. It may not be right for them

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

Close
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

Close

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

Close

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

Close

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.