Zyclara

Zyclara is a prescription medication used to treat warts around the genital and anal areas and actinic keratosis (flaking and discoloration of the skin from sun exposure). Zyclara belongs to a group of drugs called immune response modifiers, which stimulate the body's immune response to treat warts. The exact way Zyclara works to treat other conditions is unknown.

This medication comes in the form of a cream to be applied to the affected area once daily, just before your bedtime.

The dose schedule will differ and depend on what Zyclara is being used for. 

Common side effects include redness, swelling, sores, blisters and other changes to the area where Zyclara cream is applied. 

Zyclara cream is a prescription medicine used to treat:

• external genital and perianal warts in people 12 years and older. Imiquimod cream is not a cure for genital warts.
• actinic keratosis in adults with normal immune systems. 

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

• Medicis Pharmaceutical Corp.

The most common side effects with Zyclara are skin reactions where it is applied (treatment area) including:

• 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

This is not a complete list of Zyclara side effects. Ask your doctor or pharmacist for more information.

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

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

No Zyclara drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Be sure to tell your doctor if you are receiving other treatments for genital or anal warts or actinic keratoses. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

Some side effects can be serious. If you experience any of these symptoms, call your doctor right away:

• skin breakdown or sores that may have drainage, especially during the first week of treatment
• flu-like symptoms such as nausea, fever, chills, tiredness, and muscle weakness or pain

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.

Zyclara may cause changes in your skin color. These changes may not go away after you finish treatment with Zyclara. Tell your doctor if you notice any changes in your skin color.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zyclara cream there are no specific foods that you must exclude from your diet when receiving Zyclara cream.

Before receiving Zyclara tell your doctor about all of your medical conditions including 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 doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

This medication falls into category C. It is not known if Zyclara will harm your unborn baby. There are no adequate and well-controlled studies in pregnant women. Zyclara Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.

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

It is not known if Zyclara is excreted in breast milk or if it will harm your baby. Because many drugs are excreted in human milk, caution should be exercised when Zyclara Cream is administered to nursing women.

Use ZyclaraCream 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.
• 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.

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.

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.

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
• 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.

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.

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.

Apply Zyclara cream exactly as prescribed. Follow the directions on your prescription label carefully.

For external genital and perianal warts, the recommended dose schedule is apply once daily to the external genital/perianal warts until total clearance or up to 8 weeks.  

For actinic keratosis, the recommended dose schedule is apply once daily to the skin of the affected area (either the entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. 

Leave the cream on the affected area or areas for the time your doctor recommends. The length of time that Zyclara cream is left on the skin is not the same for the different skin conditions that Zyclara cream is used to treat. Do not bathe or get the treated area wet before the right time has passed. Do not leave Zyclara cream on your skin longer than prescribed.

If you apply too much Zyclara, or if someone swallows Zyclara cream, call your local poison control center right away or seek emergency medical attention. 

• Store Zyclara Cream at room temperature, 59°F to 86°F (15°C to 30°C).
• Store Zyclara Cream pumps upright.
• Do not freeze.