Zyclara (imiquimod) is an immune response modifier. Zyclara cream is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.
Zyclara cream is also used to treat genital warts that appear on the outside of the body, but this medicine is not a cure for genital warts. Imiquimod may be used in adults and children who are at least 12 years.
Zyclara may also be used for purposes not listed in this medication guide.
Important information
Using too much Zyclara, or using it for too long can increase your risk of severe skin reactions. Follow your doctor"s instructions.
Do not use Zyclara cream on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using Zyclara.
Before using Zyclara cream, tell your doctor if you have a weak immune system, an autoimmune disorder, graft-versus-host disease, or if you have recently received a bone marrow transplant or cord blood transplant.
When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination. Avoid exposure to sunlight or tanning beds. Zyclara can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Zyclara is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with Zyclara. For best results, keep using the medicine for the entire length of time prescribed by your doctor.
Zyclara cream will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis.
If you are treating the genital or rectal area with Zyclara, avoid sexual activity while the medicine is on your skin. Zyclara can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm for birth control, these items could break if the rubber weakens and an unplanned pregnancy could result.
Before using Zyclara
To make sure you can safely take Zyclara, tell your doctor if you have any of these other conditions:
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sunburn or other skin problems;
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a weak immune system or autoimmune disorder;
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graft-versus-host disease;
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if you have recently been treated for actinic keratosis or genital warts with surgery or other medications; or
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if you have recently received a bone marrow transplant or cord blood transplant.
FDA pregnancy category C. It is not known whether Zyclara will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. If you are treating the genital or rectal area with Zyclara, avoid sexual activity while the medicine is on your skin. Zyclara can weaken the rubber that condoms or diaphragms are made out of. If you use a condom or diaphragm, these items could break if the rubber weakens, and an unplanned pregnancy could result. It is not known whether imiquimod passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 12 years old. Zyclara is for use in treating genital warts in patients who are at least 12 years old. All other uses of this medication are for adults over 18 only.
See also: Pregnancy and breastfeeding warnings (in more detail)
How should I apply Zyclara?
Use Zyclara exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.
Before applying Zyclara, wash your hands and wash the skin area to be treated. Allow the skin to dry for at least 10 minutes before applying the medicine. Always wash your hands after applying the medicine also. Do not use Zyclara on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using Zyclara.
Actinic keratosis:
Zyclara is applied once daily for 2 weeks followed by 2 weeks without treatment. Apply the cream to the treatment area in a thin layer, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.
Genital warts:
Apply Zyclara cream once daily for no longer than 8 weeks. Apply the cream from one Zyclara packet to the treatment area, and rub in the cream until it disappears. Do not cover the treated skin areas with any type of plastic bandaging, and avoid nylon underwear. You may wear cotton gauze or underwear over the treated area. Use the medicine before going to bed and leave it on for approximately 8 hours. Then wash off the medicine with water and a mild soap.
When treating genital warts under the foreskin of an uncircumcised penis, pull back the foreskin and wash it with mild soap and water before applying Zyclara cream. Clean this area daily during treatment. When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination.
Zyclara is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with Zyclara. For best results, keep using the medicine for the entire length of time prescribed by your doctor.
All conditions:
Your doctor will need to check your skin on a regular basis, especially if you have a more severe skin reaction to the medication. Do not miss any scheduled appointments.
Call your doctor if your skin condition does not improve or if it gets worse during treatment.
Do not use Zyclara to treat any skin condition that has not been checked by a doctor. Do not share this medication with anyone else, even if they have the same symptoms you have.
Each packet of Zyclara is for a single application only. Throw away the packet after one use, even if there is medicine left in it. If you treat more than one skin area at a time, ask your doctor how many packets to use.
Store Zyclara at room temperature away from moisture and heat. Do not freeze. Keep each packet unopened until you are ready to use it.
What happens if I miss a dose?
Skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.
What should I avoid?
Avoid getting this medication in your eyes, mouth, and nose, or on your lips. Do not place the cream in your rectum, vagina, or urethra. If it does get into any of these areas, rinse with water. Do not use Zyclara on sunburned, windburned, dry, chapped, irritated, or broken skin.
Avoid using other medications on the areas you treat with Zyclara unless your doctor tells you to.
Avoid exposure to sunlight or tanning beds. Zyclara can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Avoid having unprotected sex. Zyclara is not a cure for genital warts, and it will not protect against sexually transmitted diseases such as chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safe ways to prevent transmission during sex.
Zyclara side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Zyclara: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied.
Stop using Zyclara and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands. When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using Zyclara and call your doctor right away.
Less serious Zyclara side effects may include:
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mild skin irritation, itching, dryness, flaking, scabbing, crusting, redness, or hardening of the skin where the medicine was applied;
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changes in the color of treated skin;
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headache, dizziness, chest pain, back pain;
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cold sores, fever blisters;
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cold symptoms such as stuffy nose, sneezing, sore throat;
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nausea, diarrhea, loss of appetite; or
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vaginal itching or discharge.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Zyclara?
It is not likely that other drugs you take orally or inject will have an effect on topically applied Zyclara. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
