PRESCRIBING INFORMATION
FOR U.S. HEALTHCARE PROFESSIONALS ONLY

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About LEVULAN

In clinical studies of the face and scalp

LEVULAN® KERASTICK® +
BLU-U®—High clearance, low downtime

Proven Results

  • 72% of face or scalp patients were 100% clear at 12 weeks after 1 or 2 treatments3*
  • 66% of patients experienced 100% clearance of all AK lesions of the face or scalp 8 weeks after treatment3†
  • In studies, the majority of treated AK lesions of the face or scalp cleared at 3 months remained clear 12 months after treatment3‡

*78% of face patients and 50% of scalp patients were clear at 12 weeks after 1 or 2 treatments.3

†Results from two identically designed, Phase III studies. These were multicenter, blinded, active treatment-controlled, randomized, uneven parallel group, two-arm studies. A total of 243 patients were randomized at a 3 to 1 LEVULAN KERASTICK PDT to vehicle ratio. Patients returned for follow-up visits 24 hours after BLU-U light treatment and at Weeks 1, 4, and 8. Those patients who were not complete responders at Week 8 had retreatment of the persistent target lesions at Week 8. All patients returned at 12 weeks after the initial treatment.

‡Results from a Phase IV open-label multicenter study of patients with actinic keratoses (AKs) on the face or scalp. 28% of the 748 lesions were treated twice. Lesions were designated as cleared if the lesion had completely cleared and adherent scaling plaques were no longer evident on the surface of the treated skin when palpated. Of the 72 subjects with 100% of treated lesions cleared at Month 3, 53% had a recurrence by Month 12. Of the 624 treated lesions determined cleared at Month 3, 24% had recurred by Month 12, while 5% were lost to follow-up and their recurrence status is unknown.2,3

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.

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.

Trusted by dermatologists for over a decade, LEVULAN KERASTICK plus BLU-U has treated over 3 million patients.2

Why PDT?

For your patients who may be non-compliant on topical treatments, LEVULAN KERASTICK plus BLU-U offers you the convenience and control of an in-office treatment4

  • No scarring was reported in clinical trials2
  • In two Phase III clinical trials, at least 50% of patients experienced severe stinging and burning, however less than 3% of patients discontinued therapy due to stinging and/or burning3
  • The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting. itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling, and dryness3

Treating with LEVULAN KERASTICK + BLU-U

Treatment takes place in a two-step process

Step One

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 Two

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.

LEVULAN KERASTICK is the only PDT product FDA-approved for use on the upper extremities.3

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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. Data on file, Sun Pharma.
  3. LEVULAN KERASTICK full Prescribing Information, April 2018.
  4. Shergill B, Zokaie S, Carr AJ. Non-adherence to topical treatments for actinic keratosis. Patient Prefer Adherence. 2014;17(8):35-41.
  5. Taub AF. Photodynamic therapy in dermatology: history and horizons. J Drugs Dermatol. 2004;3(suppl 1):S8-S25.
  6. BLU-U Blue Light Photodynamic Therapy llluminator Model 4170 Operating manual.
  7. AMELUZ® Prescribing Information, BioFrontera Pharma GmbH. Wakefield, MA. 2016