Zyclara: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ZYCLARA is the brand name for imiquimod cream, 2.5% and 3.75%. It is used to treat actinic keratosis (AK) of the face or balding scalp in adults with normal immune systems.

What it does:

ZYCLARA is an immune response modifier. ZYCLARA is a medicine that works by stimulating your body’s own immune response.

When it should not be used:

Do not use ZYCLARA if you are allergic to imiquimod, or other medications that contain imiquimod (e.g. ALDARA, VYLOMA), or any of the other ingredients in ZYCLARA.

What the medicinal ingredient is:

Imiquimod.

What the important nonmedicinal ingredients are:

Isostearic Acid, Cetyl Alcohol, Stearyl Alcohol, White Petrolatum, Polysorbate 60, Sorbitan Monostearate, Glycerin, Xanthan Gum, Purified Water, Benzyl Alcohol, Methylparaben, and Propylparaben.

What dosage forms it comes in:

ZYCLARA contains 25.0 mg imiquimod cream per gram (2.5%) or 37.5 mg imiquimod per gram (3.75%) and is supplied in pumps which contain 7.5 g of the cream and deliver 235 mg of the cream per actuation.

WARNINGS AND PRECAUTIONS

• ZYCLARA should not be used in patients under 18 years of age
• Avoid exposure to sunlight, sunlamp or tanning-bed during the treatment with ZYCLARA. Wear protective clothing and hat if you go outside during daylight
• ZYCLARA may cause severe skin reactions

• ZYCLARA may also cause flu-like symptoms before or during local skin reactions

  BEFORE you use ZYCLARA talk to your doctor or pharmacist if:

  • you have or had other skin cancers or other growths on your body
  • you are immunocompromised (have weak immune system)
  • you have or have had any other treatment for your actinic keratosis, such as freezing or surgery

  • you are pregnant or planning to become pregnant

  • you are breastfeeding or planning to breastfeed

ZYCLARA treatment is not recommended on areas larger than either the face or balding scalp.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about all the medicines you take or have taken, including prescription and non-prescription medicines, vitamins and herbal supplements. It is not known if ZYCLARA and other medicines can affect each other.

PROPER USE OF THIS MEDICATION

Use ZYCLARA exactly as prescribed by your doctor. Do not use ZYCLARA until your doctor has shown you the right way to use it.

Usual adult dose:

Apply ZYCLARA to the affected area(s) once a day just before bedtime.

Maximum daily dose is 500 mg (2 full actuations of the pump).

ZYCLARA should not be applied to areas larger than either the face or balding scalp.

The treatment consists of two 2-week treatment cycles, each cycle is separated by two weeks without treatment.

How to apply ZYCLARA pumps:

• Wash the area to be treated with mild soap and water. Allow the area to dry
• Wash your hands
• Before using the pump for the first time only, remove the cap and prime the pump by pressing the top of the pump all the way down (one or more times as needed) until the product appears. Discard this portion of the product
• Apply a thin layer of ZYCLARA ONLY to the affected area(s) to be treated. Do not use more than two full pump actuations for each daily application
• Rub the cream in all the way to the affected area(s). Avoid the cream in or around your eyes, lips and nostrils. If ZYCLARA accidentally gets in your mouth, your eyes, and nostrils rinse well with water right away
• Do not cover the treated area(s)
• After applying ZYCLARA, wash your hands well with soap and water
• Leave the cream on the affected area(s) for about 8 hours or as instructed by your doctor. Do not bathe or get the treated area(s) wet during the treatment period
• After the treatment period, wash the treated area(s) with mild soap and water
• When you have completed all of your doses as instructed, safely throw the pump away so that children and pets cannot get it.

Avoid exposure to sunlight, sunlamp or tanning-bed during the treatment with ZYCLARA.

Overdose:

In case of drug overdose, contact your doctor, or a poison control centre, or go to the emergency room of the hospital near you.

Missed Dose:

If you miss a dose of ZYCLARA, wait until the next night to apply it. Do not make up the missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Possible side effects in the treatment area observed in studies of ZYCLARA include:

Actinic keratoses that were not seen before may appear during treatment.

Very common: redness, scabbing or crusting, flaking or dry skin, swelling, small open sores, drainage; itching, irritation, pain.

Uncommon: abnormal sensation, scarring.

Very rare: bleeding.

The side effects may go outside of the area where ZYCLARA was applied.

During treatment and until the skin has healed, your skin in the treatment area is likely to appear noticeably different from normal skin. If your skin breaks down, if sores develop during the first week of treatment, or if you get any skin reactions that affect your daily activities or do not go away, stop ZYCLARA right away and call your healthcare provider.

Sometimes, ZYCLARA must be stopped for a while to allow your skin to heal.

Other possible side effects observed in studies of ZYCLARA include:

Common: headache, tiredness, nausea, fever, loss of appetite, dizziness, herpes outbreak, pain, diarrhea, swollen lymph nodes, joint aches, skin irritation, difficulty sleeping.

Uncommon: chills, influenza-like symptoms, muscle aches, lack of energy, and itching.

Very rare: lip cracking, low blood counts.

If flu-like symptoms (fatigue, fever, muscle and joint pain, chills) develop after beginning treatment with ZYCLARA, contact your healthcare provider.

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

HOW TO STORE IT

Store ZYCLARA between 15-25° C. Do not freeze.

Safely throw away ZYCLARA that is out of date or that you do not need.

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

Reporting Side Effects

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be requested by contacting the sponsor, Bausch Health, Canada Inc., at: 1-800-361-4261.

Bausch Health, Canada Inc.,

Laval, Quebec, H7L 4A8

Last revised: October 29, 2020