PIMECROLIMUS (Topical)

Some commonly used brand names are:

In the U.S.?

• Elidel

Category

• Immunomodulator

Description

Pimecrolimus (pim-e-KROW-li-mus) cream is used formild to moderate atopic dermatitis. This is a skin condition where there isitching, redness and inflammation, much like an allergic reaction. Pimecrolimushelps to suppress these symptoms which are a reaction caused by the body'simmune system. It can be used for short-term or long-term periodic treatment(not beyond one year). It is often used when other types of treatment areeither not working or when you cannot tolerate other types of treatment.

Pimecrolimus is available only with your doctor's prescription, in thefollowing dosage forms:

Topical
• Cream (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of using pimecrolimus cream must be weighed against the good itwill do. This is a decision you and your doctor will make. For pimecrolimuscream, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to pimecrolimus. Also tell your doctor and pharmacistif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Pimecrolimus cream has not been studied in pregnantwomen. However, studies in animals have shown that pimecrolimus taken orallycauses other problems in animals. Before taking this medicine, make sure yourdoctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether pimecrolimus appliedas a topical cream passes into the breast milk, and may cause unwanted effectsin nursing babies. It may be necessary for you to take another medicine orto stop breast-feeding during treatment. Be sure you have discussed the risksand benefits of the medicine with your doctor.

Children?This medicine is not known to cause different typesof side effects or problems in children over the age of two, than it doesin adults, although some side effects may occur more often than they do inadult patients. This medicine has not been tested and should not be used inchildren under 2 years of age.

Older adults?There is no specific information comparing theuse of pimecrolimus in the elderly with the use in other age groups. Pimecrolimusis not expected to cause different side effects or problems in older peoplethan it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of pimecrolimus cream. Make sure you tell yourdoctor if you have any other medical problems, especially:

• Eczema herpeticum (Kaposi's varicelliform eruption), or
• Herpes simplex virus infection or
• Varicella zoster virus infection (chicken pox or shingles)?Increasesthe risk of skin infections

• Erythroderma (exfoliative dermatitis [ED])?The safety of thismedicine is not known for patients who have this condition.

• Immunocompromised patients (weakened immune system)?The safetyof these patients using pimecrolimus cream has not been established.

• Lymphadenopathy or
• Mononucleosis, acute infectious?May cause enlargement of lymphnodes

• Netherton's syndrome?May cause too much of the pimecrolimuscream to be absorbed into the body

• Precancerous condition of the skin or
• Skin cancer?You should not use this medicine.

• Skin infections ?Safety of using pimecrolimus cream for someskin infections is unknown.

• Skin papilloma or
• Warts?May worsen condition

Proper Use of This Medicine

Dosing?Infections in the affected areas should be treated beforestarting treatment with pimecrolimus cream.

Apply a thin layer of pimecrolimus cream and rub it in well to cover theaffected areas.

Do not use this medicine in the eyes and do not swallow it.

Wash hands thoroughly after applying pimecrolimus cream, unless your handsare part of the area for treatment.

Use of this medicine may cause reactions at the site of application suchas a mild to moderate feeling of warmth and/or sensation of burning. You shouldcontact your doctor if this reaction is severe or persists for more than 1week.

While using pimecrolimus, if symptoms of your skin condition go away, consultyour doctor.

If after your doctor tells you to stop using pimecrolimus, your skin conditionreoccurs, consult your doctor.

Do not use any occlusive dressings (a dressing that seals the area thatis being treated such as a plastic exercise suit or plastic wraps used tostore foods).

Do not bathe, shower or swim right after applying this medicine. This couldwash off the cream.

The dose of pimecrolimus cream will be different for different patients. Follow your doctor's orders or the directions on the label.The following information includes only the average doses of pimecrolimus. If your dose is different, do not change it unlessyour doctor tells you to do so.

• For cream dosage form
  • For atopic dermatitis
    • Adults?Gently apply cream to skin that is clean and dry twotimes a day. Stop using when the signs and symptoms of eczema, such as itching,rash, and redness go away, as directed by your doctor.
    • Children over 2 years old?Gently apply cream to skin that isclean and dry two times a day. Stop using when the signs and symptoms of eczema,such as itching, rash, and redness go away, as directed by your doctor.
    • Children under 2 years of age?Use and dose must be determinedby your doctor.

Missed dose? If you miss a dose of this medicine, use itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Store at room temperature 77 ?F.
• Keep out of the reach of children.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits. Your doctor will want to make sure the pimecrolimuscream is working properly and to check for unwanted effects. If your conditionhas not improved after 6 weeks, your doctor will want to reexamine you.

Report any adverse reactions or side effects to your doctor or if yourskin condition seems to be getting worse.

Use this medicine only for the condition for which it was prescribed byyour doctor.

You should not use this medicine beyond a year.

Exposure to natural or artificial sunlight should be minimized or avoided.

• Stay out of direct sunlight, especially between the hours of 10:00a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF)of at least 15. Some people may require a product with a higher SPF number,especially if they have a fair complexion. If you have any questions aboutthis, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
• Do not use a sunlamp or tanning bed or booth.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctor as soon as possibleif any of the following side effects occur:

More common

Abdominal or stomach pain; body achesor pain; burning, itching, redness, skin rash, swelling,or soreness at site; change in hearing; chills; cold or flu-like symptoms; congestion, ear or nasal; cough producingmucus; diarrhea; difficultybreathing or shortness of breath; dryness or sorenessof throat; earache or pain in ear, ear drainage; fever; general feelingof discomfort or illness; headache; hoarseness; itching; joint pain; loss of appetite; loss of voice; muscle aches and pains; nausea; pain; redness; runny nose; shivering; sneezing; sore throat; sweating; swelling; tenderness; tender, swollen glands in neck; tightness in chest,wheezing; trouble in swallowing; trouble sleeping; unusual tiredness or weakness; voice changes; vomiting; warmth on skin

Less common

Blistering, crusting, irritation, itching, or reddening of skin; blurred vision or other change in vision; eye pain; fast heartbeat; hives; hives or welts, itching, rednessof skin; hoarseness; itching; itchy, raised, round, smooth, skin-colored bumpsfound on just one area of the body that are oozing, thick, white fluid; irritation; joint pain, stiffness orswelling; rash; rednessof eye; redness of skin; sensitivity of eye to light; shortness of breath; skin rash on face, scalp, or stomach; swelling of eyelids, face, lips, hands, or feet; tearing; tightness in chest; troubled breathing or swallowing; wheezing

Incidence not known

Black, tarry stools; change in size,shape or color of existing mole; cough; dizziness; itching, puffiness or swellingof the eyelids or around the eyes, face, lips or tongue; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs,feet, sex organs; mole that leaks fluid or bleeds; new mole; skin rash; small, red skin lesion, growth, or bump usually on face, ears,neck, hands or arms; sore that will not heal; swelling or puffiness of face; unusualtiredness or weakness; weight loss; yellow skin and eyes

Other side effects may occur that usually do not needmedical attention. These side effects may go away during treatment as yourbody adjusts to the medicine. Also, your health care professional may be ableto tell you about ways to prevent or reduce some of these side effects. Checkwith your health care professional if any of the following side effects continueor are bothersome or if you have any question about them:

More common

Less common

Incidence not known

Additional Information

Once a medicine has beenapproved for marketing for a certain use, experience may show that it is alsouseful for other medical problems. Although this use is not included in productlabeling, pimecrolimus is used in certain patients with the following medicalcondition:

• Atopic dermatitis in children less than 2 years of age