About LEVULAN

Trust in LEVULAN KERASTICK to protect your patients

 

LEVULAN KERASTICK + BLU-U has been approved to treat minimally to moderately thick actinic keratoses (AKs) of the face or scalp since 1999.2 This was expanded upon in 2018 to include the treatment of AKs on the upper extremities.6 It is a dual-mechanism photodynamic therapy (PDT) treatment that utilizes aminolevulinic acid (ALA), a porphyrin precursor found in LEVULAN KERASTICK and the BLU-U light source, which is used to activate the topical solution.2

  • LEVULAN KERASTICK is able to penetrate to the root of the AK lesions and successfully incite cell death when activated by BLU-U.2-4,7,8

LEVULAN KERASTICK + BLU-U is an effective solution that offers you the convenience and control of an in-office treatment for your patients who may be noncompliant with topical treatments.2,9

Why PDT?

PDT utilizes light in conjunction with a photosensitizing agent to produce singlet oxygen within the epidermis that results in subsequent cell death.5,10 Due to this, PDT treatments like LEVULAN KERASTICK + BLU-U can offer patients10:

  • The ability to treat multiple AK lesions over a larger area and penetrate down to the root of AK4,11
  • Minimal risk of scarring, because there were no accounts of scars reported in clinical trials5

Approximately 1 in 10 AK lesions will turn into skin cancer.12

 

The importance of treating AK early and aggressively

 

AKs are the most common epithelial precancerous lesions. While AK lesions are often thought of as surface lesions, many actually protrude beneath the surface of the skin up to 1.86 mm in depth.7,8

If these cells below the surface are not removed during treatment, they can progress into squamous cell carcinoma (SCC) or basal cell carcinoma (BCC). To prevent this, only treatments that can reach this depth should be administered.7,8

Many treatments for AK, like cryotherapy, only focus on the lesions that appear on the surface of the skin and often miss precancerous cells that exist beneath the surface.13

Treating with LEVULAN KERASTICK + BLU-U

Treatment takes place in a two-step process

Step One2

LEVULAN KERASTICK topical solution, 20%, is applied directly to target AK lesions of the face, scalp, or upper extremities by dabbing with applicator tip until all lesions are uniformly wet. If treating the upper extremities, cover the treated area in occlusive dressing. Treatment area commences incubation after application.

Incubation times

Face or scalp: 14-18 hours
Upper extremities: 3 hours with occlusive dressing

Step Two2

Following necessary incubation period, the patient returns for a 16-minute, 40-second BLU-U Blue Light Photodynamic Illumination.

The lighting head of the BLU-U device can be rotated in order to cover the appropriate areas by adjusting the knobs on both sides of the unit.2

Step-by-step administration of LEVULAN KERASTICK + BLU-U

Watch these videos below to learn how to set your patients up for a successful treatment with LEVULAN KERASTICK + BLU-U.

Preparing LEVULAN KERASTICK for use

Watch this video to learn how to properly distribute the active ingredients in LEVULAN KERASTICK.

Applying LEVULAN KERASTICK

Watch this video to learn how to use LEVULAN KERASTICK + BLU-U in combination to clear lesions.

Positioning BLU-U for effective treatment

Watch this video to learn how to effectively position and treat your patients with BLU-U.

Ready to add BLU-U to your practice? Request to be contacted by a LEVULAN Team Member.

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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%.

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%.

References:
  1. Symphony Health. Actinic Keratosis Total Patient Share. June 2018.
  2. LEVULAN KERASTICK full Prescribing Information, April 2018.
  3. Nestor MS, Gold MH, Kauvar AN, et al. The use of photodynamic therapy in dermatology: results of a consensus conference. J Drugs Dermatol. 2006:5(2):140-154.
  4. MacCormack MA. Photodynamic therapy. Adv Dermatol. 2006;22:219-258.
  5. Data on file, Sun Pharma.
  6. Department of health and human services. FDA approval letter. March 2018.
  7. Pyne JH, Myint E, Barr EM, Clark SP, Hou R. Basal cell carcinoma: variation in invasion depth by subtype, sex, and anatomic site in 4,565 cases. Dermatol Pract Concept. 2018;8(4):314-319.
  8. Criscione VD, Weinstock MA, Naylor MF, Luque C, Eide MJ, Bingham SF; Department of Veteran Affairs Topical Tretinoin Chemoprevention Trial Group. Actinic keratoses: natural history and risk of malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial. Cancer. 2009;115(11):2523-2530.
  9. Shergill B, Zokaie S, Carr AJ. Non-adherence to topical treatments for actinic keratosis. Patient Prefer Adherence. 2014;17(8):35-41.
  10. Patel G, Armstrong AW, Eisen DB. Efficacy of photodynamic therapy vs other interventions in randomized clinical trials for the treatment of actinic keratoses: a systemic review and meta-analysis. JAMA Dermatol. 2014;150(12):1281-1288.
  11. Taub AF. Photodynamic therapy in dermatology: history and horizons. J Drugs Dermatol. 2004;3(suppl 1):S8-S25.
  12. Fuchs A, Marmur E. The kinetics of skin cancer: progression of actinic keratosis to squamous cell carcinoma. Dermatol Surg. 2007;33(9):1009-1101.
  13. Dirschka T, Gupta G, Micali G, et al. Real-world approach to actinic keratosis management: practical treatment algorithm for office-based dermatology. J Dermatolog Treat. 2017;28(5):431-442.
  14. Model 4170 System Specifications. BLU-U® Optical Specifications Document. Wilmington, MA: DUSA Pharmaceuticals, 2006.
  15. AMELUZ® Prescribing Information. Wakefield, MA: BioFrontera Pharma GmbH, 2016.