Protopic

Protopic is a prescription medicine used as second-line therapy for the treatment of moderate to severe eczema (itchy inflammation of the skin). Protopic belongs to a group of drugs called calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.

This medication comes in a topical ointment and is applied in a thin layer to the affected skin twice daily. 

Common side effects of Protopic include stinging, burning, or itching of the application site. 

Protopic is a prescription medicine used as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe eczema (itchy inflammation of the skin) for adults and children aged 2 years and older who do not have a weakened immune system. Protopic is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between.

Protopic is for use after other prescription medicines have not worked for you, or if your doctor recommends that other prescription medicines should not be used.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Astellas Pharma US, Inc.

Serious side effects have been reported with Protopic. See the "Protopic Precautions" section. 

• stinging, burning, and itching of the application site. These side effects are usually mild to moderate, are most common during the first few days of treatment, and usually go away as your skin heals.
• acne
• swollen or infected hair follicles
• headache
• increased sensitivity of the skin to hot or cold temperatures
• flu-like symptoms such as the common cold and stuffy nose, skin tingling, upset stomach, muscle pain, swollen glands (enlarged lymph nodes). Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you.
• skin infections including cold sores, chicken pox or shingles. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Protopic. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Drug interaction studies with Protopic have not been done but based on its limited absorption into the body it is unlikely to interact with medications taken by mouth. However, drug interactions cannot be ruled out and interactions may occur with the following medications:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone

This is not a complete list of Protopic drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Protopic including the following:

1. Increased risk of cancer. People who take Protopic have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).

2. Increased risk of infection. Protopic is a medicine that affects your immune system. Protopic can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving Protopic that can cause death. Call your doctor right away if you have symptoms of an infection such as:

• fever
• sweats or chills
• cough or flu-like symptoms
• muscle aches
• warm, red, or painful areas on your skin

Use Protopic for short periods, and if needed, treatment may be repeated with breaks in between.

While you are using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot. 

Do not take Protopic if you (or your child):

• are allergic to Protopic or any of the ingredients in Protopic
• have a weakened immune system
• are less than 2 years old

Grapefruit and grapefruit juice may interact with Protopic and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you take Protopic, tell your doctor if you:

• are allergic to Protopic
• have a skin disease called Netherton’s syndrome (a rare inherited condition)
• have any infection on your skin including chicken pox or herpes
• have been told you have a weakened immune system
• are pregnant, breastfeeding, or planning to become pregnant

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Call your doctor if :

• your symptoms get worse with Protopic.
• you get an infection on your skin.
• your symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.

Tell your doctor if you are pregnant or plan to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Protopic falls into category C. No well-controlled studies have been done in pregnant woman with topical Protopic. Protopic should be given to a pregnant woman only if clearly needed. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient of Protopic has been detected in human breast milk. Systemic absorption of tacrolimus following topical applications of Protopic is minimal. Because of the possibility for adverse reactions in nursing infants from Protopic, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. 

Use Protopic exactly as prescribed

• Use Protopic only on areas of your skin that have eczema
• Use Protopic for short periods, and if needed, treatment may be repeated with breaks in between.
• Stop Protopic when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor.
• Follow your doctor’s advice if symptoms of eczema return after treatment with Protopic.
• Do not use ultraviolet light therapy, sun lamps, or tanning beds during 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 protection from the sun you should use.
• Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal, loose fitting clothing.
• Avoid getting Protopic in the eyes or mouth. Do not swallow Protopic. If you do, call your doctor or contact an emergency medical center. 

How to apply Protopic:

• Wash your hands before applying Protopic.
• Apply a thin layer of Protopic twice daily to the areas of skin affected by eczema.
• Use the smallest amount of Protopic needed to control the signs and symptoms of eczema.
• If you are a caregiver applying Protopic to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying Protopic. This should remove any ointment left on the hands.
• Do not bathe, shower, or swim right after applying Protopic. This could wash off the ointment.
• You can use moisturizers with Protopic. Make sure you check with your doctor first about the products that are right for you. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If you use moisturizers, apply them after Protopic.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The dose you doctor recommends is based on the following:

• your age
• skin condition and sensitivity

The recommended use of Protopic for the treatment of eczema in adults and children 16 years of age and older is Protopic 0.03% or 0.1% applied in a thin layer to the affected skin twice daily. 

The recommended use of Protopic for the treatment of eczema in children aged 2-15 years old is Protopic 0.03%  applied in a thin layer to the affected skin twice daily. 

If you use too much Protopic or ingest any, call your doctor or go to the nearest hospital emergency room right away. 

Avoid getting Protopic in the eyes or mouth. Do not swallow Protopic. 

• Store Protopic at 59º F to 86ºF (15°C to 30º C).
• Do not leave Protopic in your car in cold or hot weather. Make sure the cap on the tube is tightly closed
• Keep Protopic and all medicines out of reach of children. 

BOX WARNING - MALIGNANCIES

• Increased risk of development of cancers (including skin and lymphoma). Limit Protopic to short-term and discontinuous use. Avoid use on cancerous or pre-cancerous skin conditions. Limit sun and ultraviolet light exposure and use appropriate sun protection. 
• Protopic is not indicated for use in children less than 2 years of age. Only 0.03% Protopic is indicated for use in children 2-15 years of age.