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Zyclara

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Zyclara

PATIENT INFORMATION

ZYCLARA
[zi-clar-a]
(imiquimod) Cream

Important: For use on the skin only (topical). Do not use ZYCLARA Cream in or on your eyes, mouth, anus or vagina or inside your nose.

Read the Patient Information that comes with ZYCLARA Cream before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. If you do not understand the information, or have any questions about ZYCLARA Cream, talk with your healthcare provider or pharmacist.

What is ZYCLARA Cream?

ZYCLARA Cream, 2.5% and 3.75% are prescription medicines for skin use only (topical) to treat actinic keratosis on the face or balding scalp in adults with a normal immune system.

ZYCLARA Cream, 3.75% is a prescription medicine for use on the skin only (topical) to treat external genital and perianal warts in people 12 years and older.

It is not known if ZYCLARA Cream is safe and effective in the treatment of:

  • human papilloma virus (HPV) disease of the urethra, the inside of the vagina (intra-vaginal), cervix, rectum, or inside of the anus (intra-anal)
  • actinic keratosis, when treated with more than one 2-cycle treatment course in the same affected area
  • people who have a weakened immune system
  • xeroderma pigmentosum
  • superficial basal cell carcinoma

It is not known if ZYCLARA Cream is safe and effective for the treatment of actinic keratosis in children less than 18 years of age.

It is not known if ZYCLARA Cream is safe and effective in children less than 12 years of age for external genital and perianal warts.

What should I tell my healthcare provider before using ZYCLARA Cream?

Before you use ZYCLARA Cream, tell your healthcare provider if you:

  • have problems with your immune system
  • are being treated or have been treated for actinic keratosis with other medicines or surgery. You should not use ZYCLARA Cream until you have healed from other treatments
  • have other skin problems or sunburn
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if ZYCLARA Cream can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
  • are breast-feeding or plan to breast-feed. It is not known if ZYCLARA Cream passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use ZYCLARA Cream

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

Especially tell your healthcare provider if you have had other treatments for actinic keratosis or genital or perianal warts. ZYCLARA Cream should not be used until your skin has healed from other treatments.

How should I use ZYCLARA Cream?

Use ZYCLARA Cream exactly as your healthcare provider tells you to use it. ZYCLARA Cream is for skin use only.

  • Your healthcare provider will tell you where to apply ZYCLARA Cream and how often and for how long to apply it for your condition. Do not apply ZYCLARA Cream to other areas.
  • Do not use more ZYCLARA Cream than you need to cover the treatment area. Using too much ZYCLARA Cream, or using it too often, or for too long can increase your chances for having a severe skin reaction or other side effects.
  • ZYCLARA Cream should be applied once a day just before your bedtime.
  • Talk to your healthcare provider if you think ZYCLARA Cream is not working for you.

Applying ZYCLARA Cream:

  • Wash the area where the cream will be applied with mild soap and water.
  • Allow the area to dry.
  • Wash your hands.
  • Place the amount of cream to be used in your palm.
  • Apply a thin layer of ZYCLARA Cream only to the affected area or areas to be treated. Do not use more ZYCLARA Cream than is needed to cover the treatment area.
  • Rub the cream in all the way to the affected area or areas.
  • After you apply ZYCLARA Cream, wash your hands well.
  • Leave the cream on the affected area or areas for the time prescribed by your healthcare provider. Do not bathe or get the treated area wet before the prescribed time has passed.
  • Do not leave ZYCLARA Cream on your skin longer than prescribed.
  • After about 8 hours, wash the treated area or areas with mild soap and water.
  • If you forget to apply ZYCLARA Cream, just apply the next dose of ZYCLARA Cream at your regular time.

How do I use ZYCLARA Cream packets?

  • Open a packet of ZYCLARA Cream just before use.
  • Apply ZYCLARA Cream as described above.
  • After applying the ZYCLARA Cream, safely throw away the opened packet so that children and pets can not get it.
  • The opened packet should be thrown away even if all the ZYCLARA Cream was not completely used.

How do I use ZYCLARA Cream pump:

  • Remove the cap
  • Before using the pump for the first time only, prime the pump by pressing the top of the pump all the way down repeatedly until the cream appears. The cream obtained from priming should be dispensed into a tissue and then discarded. The pump is now primed and is ready to use. You will not have to repeat this priming process during your treatment.
  • When dispensing the cream, slightly tilt the pump as shown

When dispensing the cream, slightly tilt the pump - Illustration

  • Firmly press the top of the pump all the way down to dispense the cream onto your hand or fingertip.
  • Apply ZYCLARA Cream as described above.

When using ZYCLARA Cream for actinic keratosis:

  • Do not get ZYCLARA Cream in or near your eyes, in or on your lips, or in your nose.
  • If you get ZYCLARA Cream in your mouth or in your eyes, rinse well with water right away.
  • For actinic keratosis, ZYCLARA Cream should be applied once daily to the skin of the affected area (either entire face or balding scalp) for two weeks, then stop using for two weeks, then applied once daily again for two weeks.
  • If you have been prescribed ZYCLARA Cream packets, do not use more than two packets for each daily application.
  • If you have been prescribed ZYCLARA Cream pump, do not use more than two actuations of the pump for each daily application.

When using ZYCLARA Cream for external genital warts:

  • Do not get ZYCLARA Cream in or on your anus or vagina.
  • Apply a thin layer of ZYCLARA Cream only to the affected area or areas to be treated. Do not use more ZYCLARA Cream than is needed to cover the treatment area.
  • Rub the cream into your skin until you can not see the ZYCLARA Cream.
  • ZYCLARA Cream is usually left on the skin for approximately 8 hours. Treatment should continue until the warts are completely gone or for up to 8 weeks.
  • Uncircumcised males treating warts under their penis foreskin must pull their foreskin back and clean before treatment and clean daily during treatment.
  • Female patients treating genital warts must be careful when applying ZYCLARA Cream around the vaginal opening. Do not put ZYCLARA Cream in your vagina.
  • If you have been prescribed ZYCLARA Cream packets, do not use more than one packet for each daily application.
  • If you have been prescribed ZYCLARA Cream pump, do not use more than one actuation of the pump for each daily application.

What should I avoid while using ZYCLARA Cream?

  • Do not cover the treated area with bandages or other closed dressings.
  • Cotton gauze dressings can be used. Cotton underwear can be worn after applying ZYCLARA Cream to the genital or perianal area.
  • Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with ZYCLARA Cream. Use sunscreen and wear protective clothing if you go outside during daylight.
  • Do not have sexual contact including genital, anal, or oral sex when ZYCLARA Cream is on your genital or perianal skin. ZYCLARA Cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy.

What are the possible side effects of ZYCLARA Cream?

ZYCLARA Cream may cause serious side effects, including:

  • Local Skin Reactions: Skin drainage (weeping) or breakdown of the outer layer of your skin (erosion). Swelling outside of the vagina (vulvar swelling) may happen in female patients. You should take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can cause pain or swelling, and may cause problems passing urine. Tell your healthcare provider if this happens.
  • Flu-like symptoms: Tell your healthcare provider if you have tiredness, nausea, vomiting, fever, chills, muscle pain, and joint pain.

The most common side effects of ZYCLARA Cream include:

  • local skin reactions including: skin redness, scabbing, crusting, flaking, scaling, dryness, swelling
  • headache
  • itching at the treatment area
  • tiredness
  • nausea
  • skin irritation
  • pain at the treatment area

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

These are not all the possible side effects of ZYCLARA Cream. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Medicis, The Dermatology Company at 1-800-328-0255.

How do I store ZYCLARA Cream?

  • Store ZYCLARA Cream at room temperature, 59°F to 86°F (15°C to 30°C).
  • Store ZYCLARA Cream pumps upright.
  • Do not freeze.
  • Safely throw away ZYCLARA Cream that is out of date, unused or partially used.

Keep ZYCLARA Cream and all medicines out of the reach of children.

General Information about ZYCLARA Cream:

Medicines are sometimes prescribed for purposes other than those listed in the patient information. Do not use ZYCLARA Cream for a condition for which it was not prescribed. Do not give ZYCLARA Cream to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about ZYCLARA Cream. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZYCLARA Cream that is written for the health professionals.

What are the ingredients in ZYCLARA Cream?

Active Ingredient: imiquimod

Inactive ingredients: isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.

This patient information leaflet has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/1/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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