Zyclara
Generic Name: imiquimod
Date of Approval: March 25, 2010
Company: Graceway Pharmaceuticals, LLC
Treatment for: Actinic Keratosis
FDA Approves Zyclara Cream
The United States Food and Drug Administration (FDA) has approved Zyclara (imiquimod) for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new treatment can be used on large areas of skin, including the full face or balding scalp on a convenient, 6-week dosing cycle.
Zyclara Patient Information
IMPORTANT: For use on the skin only (topical). Do not use Zyclara Cream in or on your eyes, nostrils, mouth or vagina.
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 is a prescription medicine for use on the face or balding scalp only (a topical medicine) to treat actinic keratosis (AK).
Actinic keratosis is caused by too much sun exposure.
It is not known if Zyclara Cream is safe and effective:
in people who do not have a normal immune system.
in the treatment of patients with xeroderma pigmentosum.
in the treatment of superficial basal cell carcinoma.
in the treatment of external genital warts.
It is not known if Zyclara Cream is safe and effective in children younger than 18 years old.
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
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.
How should I use Zyclara Cream?
Do not get Zyclara Cream in or near your eyes
Do not get Zyclara Cream in or on your nostrils, lips, or vagina.
Use this medicine exactly as your healthcare provider tells you to use it. 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 this cream to other areas.
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.
Talk to your healthcare provider if you think medicine is not working for you.
Applying Zyclara Cream:
Zyclara Cream should be applied just before your bedtime.
Do not use more cream than you need to cover the treatment area.
Do not use more than two packets of Zyclara Cream on the treatment area.
Wash the area where the cream will be applied with mild soap and water.
Allow the area to dry.
Wash your hands.
Open a packet of Zyclara Cream and apply a thin layer to the affected area on the scalp or face to be treated. You may need to use more than one packet.
Rub the cream into your skin until you can not see the Zyclara Cream.
After you apply Zyclara Cream, wash your hands with mild soap and water.
Leave the cream on the treated area for the amount of time your healthcare provider tells you (usually about 8 hours). Do not take a bath or get the treated area wet during this time.
After the right amount of time has passed, wash the treated area with mild soap and water.
If you forget to apply Zyclara Cream, just apply the next dose of cream at your regular time.
If you get Zyclara Cream in your mouth or in your eyes rinse well with water right away.
What should I avoid while using Zyclara Cream?
Do not cover the treated area with bandages or other closed dressings.
Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with this medicine. Use sunscreen and wear protective clothing if you go outside during daylight.
Zyclara side effects
Zyclara Cream may cause serious side effects, including:
Local Skin Reactions: skin redness, scabbing or crusting, flaking, scaling or dryness, swelling, sores or blisters, draining (weeping)
Flu-like symptoms: tiredness, nausea, vomiting, fever, chills, muscle pain, joint pain
The most common side effects of Zyclara Cream include:
headache
loss of appetite
itching at application site
dizziness
tiredness
cold sores
nausea
pain
skin irritation
chest pain
pain at the treatment area
diarrhea
fever
swelling of lymph nodes
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. or to Graceway Pharmaceuticals, LLC at 1-800-328-0255.
How do I store Zyclara Cream?
Store Zyclara Cream at 59°F to 86°F (15°C to 30°C).
Do not freeze.
Keep this medicine 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.
For more information call 1-800-328-0255.
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.
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