Zyclara Cream

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.

How does Zyclara Cream work?

While exactly how ZYCLARA Cream works is unknown, it is thought that ZYCLARA Cream works (or cooperates) with your own immune system to control the abnormal cells associated with actinic keratoses.

When to apply Zyclara Cream

ZYCLARA Cream should be applied once a day just before bedtime. Your healthcare provider will tell you where to use it, how often, and how long to apply it.

Treating with Zyclara Cream

During the first two weeks of treatment, you may have a mild response or you may experience some level of increased redness, and an increase in the number of AK’s. This is to be expected and is a normal part of how ZYCLARA treatment works, revealing not only the lesions you can see, but the lesions you could not see before starting treatment. Stronger reactions may occur; contact your physician if they become troublesome.

At the end of the 2-week treatment period, there is a 2-week rest period, at which time the actinic keratoses may begin to clear.

After 2 weeks of rest, the process repeats itself for 2 additional weeks of treatment with ZYCLARA Cream. During this time, you may again notice increased redness and lesions, but the reaction is typically not as intense as during the first 2 weeks of treatment. Keep in mind, this is expected and it is important to remain on your medication.

After the final 2 weeks of treatment, you should have fewer lesions than you had at the beginning of your treatment.

Skin reaction

ZYCLARA® Cream may cause serious side effects, including:

Skin drainage (weeping) or breakdown of the outer layer of the skin (erosion). You may need to stop using ZYCLARA until the skin is healed. You should not use ZYCLARA until the skin has healed from any other treatments. ZYCLARA Cream may also cause flu-like symptoms. Tell your healthcare provider if you have tiredness, nausea, vomiting, fever, chills,muscle pain, or joint pain.

Zyclara Cream side effects

The most common side effects of ZYCLARA Cream include:

  • Local skin reactions, including skin redness, scabbing, crusting, flaking, scaling, dryness, and swelling
  • Headache
  • Itching at the treatment area(s)
  • 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 the FDA at 1-800-FDA-1088. You may also report side effects to Valeant Dermatology at 1-800-328-0255.

Before Treatment

5 to 20 AK lesions are visible

After 2-week Treatment Period

Additional AK lesions are revealed and treated

After 2 weeks off treatment

Patients see a reduction in AK lesions

After 2-week Treatment Period

Additional AK lesions are revealed and treated

8 weeks Post-Treatment

AK lesions are completely or partially cleared at the end of the trial

Mild Response

Partial Clearance*1-4: Before treatment, patient had a baseline of 18 AK lesions. After treatment, patient had 2 lesions.

Moderate Response

Complete Clearance*1-4: Before treatment, patient had a baseline of 12 AK lesions. After treatment, patient had 0 lesions.

Strong Response

Photos have not been retouched. Individual results may vary.

*Complete Clearance; 100% clearance of AK lesions; Partial Clearance: ≥75% clearance of AK lesions

How to apply Zyclara® Cream

How should I use the ZYCLARA Cream pump?

  • Remove the cap
  • For the first time only, you will need to press the top of the pump all of the way down repeatedly until the cream appears
  • After you see the cream come out of the top of the pump, the pump is now ready to use
  • When dispensing the cream, tilt the pump and press firmly all the way down to dispense the cream onto your hand or fingertip
  • Apply ZYCLARA Cream to the affected area

How should I apply ZYCLARA Cream?

  • Wash the area where the cream will be applied with soap and water
  • Allow the area to dry
  • Wash your hands
  • Apply a thin layer of ZYCLARA only to the affected area(s)
  • Rub the cream in all the way to the affected area(s)
  • Leave the cream on the affected area(s) and do not get the treated area(s) 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(s) with soap and water

When using ZYCLARA Cream:

  • 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

What should I avoid while using ZYCLARA Cream?

  • Do not cover the treated area(s) with bandages or other closed dressings
  • 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

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INDICATION

IMPORTANT SAFETY INFORMATION

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.


Please click here for Prescribing Information, including Patient Information.