TM Owner Sun Pharmaceutical Industries, Inc.
Levulan Kerastick 20% Topical Solution
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Indications & Clinical Uses
- Levulan Kerastick 20% topical solution contains aminolevulinic acid hydrochloride and is used together with the BLU-U Blue Light Photodynamic Therapy Illuminator to treat minimally to moderately thick actinic keratoses of the face, scalp or upper extremities in adults.
- This is a clinic procedure, not a home treatment.
- A qualified healthcare professional crushes the two glass ampoules inside the applicator, mixes the 354 mg of powder with 1.5 mL of diluent and paints the solution onto individual lesions only, never onto the surrounding skin.
- The treated area is then left for 14 to 18 hours for face or scalp lesions, or 3 hours under occlusion for lesions on the upper extremities, before blue light illumination.
- Safety and effectiveness in children under 18 years have not been established.
- Levulan Kerastick is supplied as a carton of 6 single-use applicators.
Side Effects
- Almost everyone treated with Levulan Kerastick (aminolevulinic acid) feels stinging or burning at the treated spots during and shortly after blue light illumination; this usually eases within 24 hours.
- Local reactions occurring in 10% or more of people include redness, swelling, scaling and crusting, itching, skin erosion and lightening or darkening of the skin.
- These normally settle over about four weeks.
- The label carries no boxed warning.
- Transient amnestic episodes, meaning brief memory lapses, have been reported after marketing in people treated with the product and the BLU-U illuminator.
- Tell the clinic if pain during illumination becomes intolerable, because the light can be paused.
- Seek advice for spreading redness, blistering, oozing or other signs of infection, or if a treated lesion has not healed after several weeks.
Precautions & Warnings
- Levulan Kerastick must be applied only by a trained healthcare professional and only to the target lesions.
- It is not intended for application by patients or unqualified personnel, and not for the eyes, mucous membranes or perilesional skin.
- After application the treated sites stay photosensitive for 40 hours.
- During that time avoid sunlight and bright indoor light, including examination lamps, tanning beds and halogen lighting, and wear a wide-brimmed hat, long sleeves and gloves.
- Sunscreens will not protect against this reaction, because it is caused by visible light.
- Both the patient and clinic staff wear blue-blocking protective eyewear during illumination.
- Prepared solution must be used within two hours and any unused portion discarded.
- Take care in people with photosensitive skin conditions such as porphyria.
- Unopened applicators are stored at 20°C to 25°C, with excursions permitted between 15°C and 30°C.
Avoid Interactions
- The main interaction risk with Levulan Kerastick (aminolevulinic acid) is with other medicines that make the skin sensitive to light, because they can intensify the photosensitivity reaction.
- The label specifically names St John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines.
- Tell the clinic about all of these before treatment, and about every other medicine, herbal product and supplement you take, since that list is not exhaustive.
- No interaction that reduces the effectiveness of treatment is described.
- Topical products on the same area can interfere with even application, so the skin is cleaned and dried first, and no creams, sunscreens, moisturisers or cosmetics should be put on the treated lesions until the clinic says it is safe.
- The prepared solution is not mixed or diluted with anything else before application.
References
Frequently Asked Questions
Levulan Kerastick (aminolevulinic acid) 20% topical solution treats minimally to moderately thick actinic keratoses on the face, scalp or upper extremities in adults. It is used with the BLU-U blue light illuminator as photodynamic therapy. It has not been shown safe or effective in children under 18.
A trained healthcare professional applies Levulan Kerastick (aminolevulinic acid) directly onto each actinic keratosis in the clinic, never onto surrounding skin. Face and scalp lesions are left for 14 to 18 hours; upper-extremity lesions for 3 hours under occlusion. You then return for blue light illumination.
Stinging or burning during blue light illumination is almost universal with Levulan Kerastick (aminolevulinic acid) and usually settles within 24 hours. Redness, swelling, scaling, crusting, itching, skin erosion and changes in skin colour affect at least one in ten people and clear over about four weeks.
Avoid sunlight and bright indoor light on the treated areas for 40 hours after Levulan Kerastick (aminolevulinic acid) is applied. Sunscreen will not protect you, because the reaction is caused by visible light, so wear a wide-brimmed hat, long sleeves and gloves. Avoid other photosensitising medicines.
You wear blue-blocking goggles and sit in front of the BLU-U illuminator for 1,000 seconds, about 17 minutes, which delivers a 10 J/cm2 light dose. Stinging or burning peaks during this time and the light can be paused if it becomes severe. Clinic staff wear protective eyewear too.
Rarely. Transient amnestic episodes, meaning brief memory lapses, have been reported after marketing in people treated with Levulan Kerastick (aminolevulinic acid) and the BLU-U illuminator. Tell the clinic if you feel confused after treatment, and arrange for someone to accompany you home from the appointment.
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