Levulan® Kerastick®

(aminolevulinic acid HCl) for Topical Solution, 20%

Patient Education

Setting and managing patient expectations is an important part of the therapeutic process. To ensure patient acceptance and compliance with LEVULAN KERASTICK and BLU-U® PDT you must clearly communicate to them what they should expect before, during and after therapy. What follows is the step by step process including post treatment expectations.

Before treatment:

  • Provide patient with the patient insert and review potential side effects.
  • Be sure to ask if patients are taking any oral medications or using any topical prescription or non-prescription products on their face or scalp. LEVULAN KERASTICK and BLU-U PDT is contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK for Topical Solution.
  • On treatment days remind patients to bring a wide-brimmed hat or adequate sun-protective item to shield the treated lesions from sunlight or other forms of bright light.

During treatment:

  • Remind patients to not wash their face in between treatment steps.
  • Remind patients to avoid exposure of the treated lesions to sunlight and other forms of bright light for at least 40 hours. Examples include exam room examination lights, operating room lamps, tanning bed lights, and household lights at close range. Sunscreens will not protect against photosensitivity reactions caused by visible light during this time.
  • Inform patients that they may experience sensations of tingling, stinging (sometimes severe), prickling or burning of the treated AK lesions.
  • Patients and medical personnel must wear blue blocking protective eyewear.

After treatment:

  • Inform patients that they may apply moisturizers as needed.
  • Inform patients that following treatment, their treated AKs and to some degree the surrounding skin may redden.  Swelling, scaling, and itching may also occur.  However, these effects are temporary and should completely resolve by 4 weeks after treatment.

 

For additional information or support, please contact DUSA Medical Affairs at (877) 799-3872.

 

Important Safety Information

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for topical solution, 20%, plus blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratosis of the upper extremities.

Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400–450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK topical solution.

Application of LEVULAN KERASTICK topical solution should involve lesions on the face or scalp, or upper extremities. Multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously.

Do not apply to the eyes or to mucus membranes. Irritation may be experienced if LEVULAN KERASTICK topical solution is applied to eyes or mucous membranes. Treatment of upper extremities is approved after an incubation time of 3 hours under occlusion. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied by a qualified health professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.

Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material or a long-sleeved shirt and/or gloves to shade the treated actinic keratoses from sunlight or other bright light sources until at least 40 hours after the application of LEVULAN KERASTICK topical solution. Sunscreens will not protect against photosensitivity reactions caused by visible light. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.

It is possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with the LEVULAN KERASTICK topical solution.

During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear as specified in the BLU-U Blue Light Photodynamic Therapy Illuminator Operating Instructions.

The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness.

In clinical trials, severe stinging and/or burning was reported by at least 50% of face and scalp patients and 9% of upper extremity patients at some time during treatment. However, less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions.

Please refer to the full Prescribing Information for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%.

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