[Dear]
[Hello]
{{recipient.persontitle}} {{recipient.firstname}} {{recipient.lastname}},
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[It was great to see you today and, as always, I appreciate your time. I wanted to follow up on our discussion about the LEVULAN KERASTICK + BLU-U blue light patient-facing videos you were interested in displaying in your office.]
[Sorry I missed you today—but I have some exciting news that will benefit your practice. Now, you can educate your patients and caregivers on LEVULAN KERASTICK + BLU-U blue light by displaying our patient-facing videos in your waiting room.]
[I hope you’re doing well! I wanted to share some resources with you that will benefit your practice. Now, you can educate your patients and caregivers on LEVULAN KERASTICK + BLU-U blue light by displaying our patient-facing videos in your waiting room.]
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Without any extra effort or time, you can give your patients and caregivers more information about an in-office treatment option for minimally to moderately thick actinic keratoses (AKs) of the face, scalp, and upper extremities.1
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After downloading these videos, print versions of the full Prescribing Information will be delivered to your practice, and are to be displayed alongside the screens.
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If you would like to learn more about LEVULAN KERASTICK + BLU-U blue light, please do not hesitate to reach out and schedule a virtual or in-person meeting by contacting me at the phone number or email address provided below.
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Important Safety Information
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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.
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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.
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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.
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Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with the 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 their healthcare provider if the patient develops amnesia after treatment.
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Do not apply to the eyes or to mucous membranes. Irritation may be experienced if LEVULAN KERASTICK topical solution is applied to eyes or mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.
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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 healthcare professional to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion.
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Advise patients to wear a wide-brimmed hat or similar head covering of light-opaque material and/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.
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LEVULAN KERASTICK topical solution has not been tested on patients with inherited or acquired coagulation defects.
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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.
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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.
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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.
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Limited available data with LEVULAN KERASTICK topical solution use in pregnant or breastfeeding women are insufficient to inform a drug-associated risk in this population. The safety and effectiveness in pediatric patients below the age of 18 have not been established.
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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.
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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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Sincerely,
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{{sender.name}}
{{sender.phone}}
{{sender.email}}
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| Please refer to the full Prescribing Information for complete discussion of the risks associated with LEVULAN KERASTICK (aminolevulinic acid HCl) for topical solution, 20%. |
Reference:
- LEVULAN KERASTICK. Package insert. Sun Pharma; 2020.
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