Levulan® Kerastick®

(aminolevulinic acid HCl) for Topical Solution, 20%

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LEVULAN KERASTICK and BLU-U® Photodynamic Therapy (PDT):  A Unique Therapeutic Approach to Manage Actinic Keratoses

What is LEVULAN KERASTICK and BLU-U PDT?

LEVULAN KERASTICK and BLU-U PDT is an in-office therapy that provides high clearance with low downtime for appropriate actinic keratosis patients.*1

Who are appropriate AK patients?       

  • Patients with few minimally to moderately thick AKs of the face or scalp                                          
  • Patients with multiple minimally to moderately thick AKs of the face or scalp  
  • Patients with minimally to moderately thick AKs in sensitive areas on the face or scalp  

Why is patient adherence important?

Appropriate patient selection requires the evaluation of a range of factors, such as AK lesion characteristics, patient expectations, patient history and patient adherence. Patient adherence is closely linked to treatment outcome which makes patient selection very important in order to reduce risk of nonadherence.2,3

Among the patients at risk for nonadherence are those who:

  • Are elderly
  • Have asymptomatic disease
  • Have poor understanding of the condition
  • Lack belief in benefit of the treatment

Among the factors associated with nonadherence are:

  • Side effects or fear of side effects
  • Complexity of the drug regimen
  • Cost of treatment/poor health coverage

 Poor medication adherence is reaching crisis proportions in the US2

A 2009 survey by the Senior Citizens League found4

  • 42% of the elderly had either postponed filling their prescription or were reducing their dosage

Another survey found5

  • 3 of every 4 American consumers report not always taking their prescription medicine as directed
  • 49% said they had forgotten to take a prescribed medicine
  • 31% had not filled a prescription they were given
  • 24% had taken less than the recommended dose

Why choose LEVULAN KERASTICK and BLU-U PDT?

PDT is an effective therapy that will not only add value for your practice, but it may also be the right treatment choice for your new AK patients or those who are unwilling to repeat a prior topical treatment. In addition, an in-office therapy can impact patient adherence.   

  • PDT is initiated and completed in an in-office setting
  • Physician-controlled treatment is administered by a qualified healthcare professional**
  • No prescription for the patient to fill
  • No daily medication for the patient to remember
  • The 2-part, 2-office visit treatment is completed in less than 24 hours
  • Recovery begins when treatment ends

 

Make LEVULAN KERASTICK and BLU-U PDT your FIRST treatment choice for your appropriate AK patients.

* Patients treated with LEVULAN KERASTICK and BLU-U PDT should avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours.

** Please consult your local/state regulations.

LEVULAN KERASTICK Prescribing Information, DUSA Pharmaceuticals, Inc.

2 Enhancing Prescription Medicine Adherence: A National Action Plan. National Council on Patient Information and Education. August 2007.

3 Gupta G, et al. Adherence to topical dermatological therapy: lessons from oral drug treatment. BR J Dermatol. 209; 161:221-227.

4 http://seniorjournal.com//NEWS/Money/2009/20090722-SenCitSkippingMedicine.htm

5 Take as Directed: A Prescription Not Followed. Research conducted by The Polling Company™. National Community Pharmacists Association. December 15, 2006.

 

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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