Levulan Kerastick: Uses, Side Effects and Dosage

What is Levulan Kerastick used for?

Levulan Kerastick is used in combination with blue light (Photodynamic Therapy) for multiple actinic keratoses (AKs) of the face and scalp. AKs are rough, scaly patches on skin that develop from prolonged sun exposure.

It is not known if Levulan Kerastick is safe and effective in children younger than 18 years of age.

How does Levulan Kerastick work?

When Levulan Kerastick is applied to the skin, it accumulates in the abnormal cells (lesion cells). Cells that have accumulated Levulan become sensitive to light. This light sensitivity means that lesion cells containing Levulan Kerastick are destroyed when they are exposed to light.

What are the ingredients in Levulan Kerastick?

Medicinal ingredients: aminolevulinic acid hydrochloride

Non-medicinal ingredients: alcohol (ethanol content = 48% v/v), laureth-4, isopropyl alcohol, polyethylene glycol and water.

Levulan Kerastick comes in the following dosage form:

Powder for Topical Solution: 20% w/v

Do not receive Levulan Kerastick treatment if you:

• are allergic to aminolevulinic acid or any of the other ingredients in this drug or the container
• are allergic to porphyrins (parts of what form red blood cells pigments)
• have porphyria (type of inherited or acquired disorder involved in making red blood pigment)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Levulan Kerastick. Talk about any health conditions or problems you may have, including if you:

• are pregnant, think you are pregnant, or plan to become pregnant. It is not known if Levulan Kerastick can harm your unborn baby.

• are breast feeding or plan to breastfeed. It is not known if Levulan Kerastick passes into your breast milk. Talk to your healthcare professional about the best way to feed your baby during Levulan Kerastick treatment.

Other warnings you should know about:

Sensitivity to light (photosensitivity)

• Levulan Kerastick treatment can cause the treated areas of your skin to become sensitive to light (photosensitive). Exposure to light during this time may cause you to feel a burning or stinging sensation. It may also cause your treated areas to become red or swollen.
• After Levulan Kerastick is applied to your skin you should avoid sunlight or bright indoor light for at least 40 hours. Sources of light can include, but are not limited to: examination lights, operating room lights, tanning beds, or lights that are close to you.
• You should wear appropriate protective apparel such as a wide-brimmed hat, long sleeve shirt, and gloves to protect your treated skin from sunlight and other bright light. Sunscreen will not protect the treated areas of your skin against sensitivity to light.

Driving and using machinery

Levulan Kerastick treatment may affect your ability to drive and use machinery. Before you drive or do tasks that require special attention, wait until you know how you respond to Levulan Kerastick.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Levulan Kerastick:

• phototoxic drugs (that make your skin more sensitive to the sun) such as:

  • antifungals (such as Griseofulvin)
  • thiazide diuretics
  • diabetes drugs (such as sulfonylureas)
  • antipsychotic drugs (such as phenothiazines)
  • certain antibiotics (e.g. sulfonamides and tetracyclines)

How will I receive Levulan Kerastick treatment?

Levulan Kerastick will be given to you by a healthcare professional in a healthcare setting.

Prior to light therapy, the affected areas of your skin (AKs) will be rinsed with tap water. You will be given goggles to wear as eye protection during the light therapy. The light is of low intensity and will not heat the skin. The light treatment lasts for approximately 17 minutes.

Treatment will be given to you in two stages:

1. 1. On day 1, your healthcare professional will apply Levulan Kerastick to the affected areas of your skin. Make sure to keep the treated area dry and out of direct bright light.
2. 2.

   On day 2 (14 to 18 hours after application of Levulan Kerastick), you will return to your doctor’s office to receive light therapy. You may feel tingling, stinging, prickling or burning of the treated areas. These feelings should go away at the end of light therapy.

   Schedule for Levulan Kerastick Photodynamic Therapy

Usual dose:

Your healthcare professional will prepare and apply the right amount of Levulan Kerastick to your skin.

You will receive one treatment session with Levulan Kerastick (over 2 days). If the affected areas of your skin have not resolved after 8 or more weeks, your healthcare professional may decide another treatment session is needed.

Overdose:

There is no information on overdose of blue light following Levulan Kerastick application.

Missed Dose:

If for any reason you cannot return to your doctor for light treatment after Levulan Kerastick application (14 to 18 hours, as prescribed), you should:

• continue to avoid exposure to sunlight or excessively bright light of the areas to which Levulan Kerastick was applied for at least 40 hours; and
• contact your doctor right away.

What are possible side effects from using Levulan Kerastick?

These are not all the possible side effects you may have when taking Levulan Kerastick. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Sensitivity to light (photosensitivity)

• Skin reactions, such as:

  • redness, swelling, scaling, crusting, oozing, pustules, welts, scabbing, itching, erosion, changes in skin color, bleeding, tenderness, dryness and warm sensation.
• Headache
• Eye irritation

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Your healthcare professional will store this medication for you at 15 to 30^oC.

If you want more information about Levulan Kerastick:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html or by calling 1-800-668 5236.

Imported and Distributed By:

Clarion Medical Technologies Inc.

125 Fleming Drive

Cambridge, ON

N1T 2B8

Last Revised: January 20, 2025