Levulan Kerastick

Aminolevulinic acid hydrochloride · Kit

Prescription (Rx)

Uses

The LEVULAN KERASTICK for topical solution 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, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities. ( 1 )

Dosage and administration

2 DOSAGE AND ADMINISTRATION LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider.( 2.1 ) Apply the drug product to the target lesions. ( 2.1 ) Illuminate with blue light using the BLU-U ® Blue Light Photodynamic Therapy Illuminator after the incubation time of( 2.2 ): 14 to 18 hours for scalp or face 3 hours for upper extremities, with occlusion LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks ( 2.1 ) For topical use only. ( 2.1) See full prescribing information for complete dosage and administration instruction. ( 2 ) See BLU-U user manual for detailed lamp safety and operating instructions. ( 2.2 ) 2.1 Preparation and Administration Overview After mixing, the LEVULAN KERASTICK topical solution 20% is intended for direct application to individual lesions diagnosed as actinic keratoses and not to perilesional skin. This product is not intended for application by patients or unqualified medical personnel. Application should involve lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple treatment regions should not be treated simultaneously. The recommended treatment frequency is: one application of the LEVULAN KERASTICK topical solution and one dose of illumination per treatment region per 8-week treatment session. Each individual LEVULAN KERASTICK applicator should be used for only one patient. LEVULAN KERASTICK photodynamic therapy for actinic keratoses is a two-stage process involving application of the LEVULAN KERASTICK topical solution to the target lesions and then illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator after 3 hours for upper extremity lesions or after 14-18 hours for face or scalp lesions. TABLE 1 Schedule for LEVULAN KERASTICK Photodynamic Therapy 1 The incubation time is 14-18 hours for actinic keratosis lesions on the face or scalp. 2 The incubation time is 3 hours for actinic keratosis lesions on the upper extremities. LEVULAN KERASTICK topical solution application Time window 1 for Blue Light Illumination for face or scalp Time window 2 for Blue Light Illumination for upper extremities 6 am 8 pm to Midnight 9 am 7 am 9 pm to 1 am 10 am 8 am 10 pm to 2 am 11 am 9 am 11 pm to 3 am 12 Noon 10 am Midnight to 4 am 1 pm 11 am 1 am to 5 am 2 pm 12 pm 2 am to 6 am 3 pm 1 pm 3 am to 7 am 4 pm 2 pm 4 am to 8 am 5 pm 3 pm 5 am to 9 am 6 pm 4 pm 6 am to 10 am 7 pm 5 pm 7 am to 11 am 8 pm 6 pm 8 am to Noon 9 pm 7 pm 9 am to 1 pm 10 pm 8 pm 10 am to 2 pm 11 pm 9 pm 11 am to 3 pm 12 Midnight 10 pm Noon to 4 pm 1 am If for any reason the patient cannot be given BLU-U Blue Light Photodynamic Therapy Illuminator treatment during the prescribed time after applying LEVULAN KERASTICK topical solution, he or she may nonetheless experience sensations of stinging and/or burning if the photosensitized actinic keratoses are exposed to sunlight or prolonged or intense light at that time. Advise the patient to wear appropriate protective apparel (e.g., wide-brimmed hat, long sleeve shirt, 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. Advise the patient to reduce light exposure if the sensations of stinging and/or burning are experienced. LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved 8 weeks after the initial treatment. 2.2 Dosage and Administration Instructions Step A - Treatment of Actinic Keratoses with LEVULAN KERASTICK Topical Solution Preparation of Lesions Actinic keratoses targeted for treatment should be clean and dry prior to application of LEVULAN KERASTICK Topical Solution. Preparation of LEVULAN KERASTICK topical solution The LEVULAN KERASTICK applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains aminolevulinic acid HCl as a dry solid. LEVULAN KERASTICK topical solution is prepared by crushing the glass ampoules and mixing the contents together. The LEVULAN KERASTICK topical solution can be prepared either manually, or using the optional KERASTICK KRUSHER™. These methods are illustrated below. Figure 1: Manual Preparation: Hold the LEVULAN KERASTICK applicator with cap point up. Crush the bottom ampule containing the solution vehicle by applying finger pressure to Position A on the cardboard sleeve. Crush the top ampule containing the ALA HCl powder by applying finger pressure to Position B on the cardboard sleeve. To ensure both ampules are crushed continue crushing the applicator downward, applying finger pressure to Position A. Shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle. Figure 2: Optional KERASTICK KRUSHER Preparation: Open the KERASTICK KRUSHER and properly position one LEVULAN KERASTICK applicator into the KRUSHER making sure to orient the LEVULAN KERASTICK label “A” with the KRUSHER “A”. Firmly seat the LEVULAN KERASTICK applicator against the closed end of the KRUSHER (cap should be at open end). Once positioned properly, close and firmly press the top and bottom handles together until the top and bottom handles touch one another along their length. A distinct crushing sound is made during this process. Ensure KRUSHER handles meet. Remove the LEVULAN KERASTICK applicator from the KRUSHER and shake the LEVULAN KERASTICK applicator gently for at least 30 seconds to completely dissolve the drug powder in the solution vehicle. The LEVULAN KERASTICK topical solution must be used within two (2) hours of activation. If the solution is not completely applied within 2 hours of the activation, discard the applicator.

Dosage forms and strengths

For topical solution: 354 mg of aminolevulinic acid hydrochloride as a powder in a plastic applicator device. Upon mixture, LEVULAN KERASTICK is a topical solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight. After mixture, topical solution contains 20% aminolevulinic acid hydrochloride (ALA HCl) by weight in a plastic applicator device. ( 3 )

Contraindications

The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with: Cutaneous photosensitivity at wavelengths of 400-450 nm [see Warnings and Precautions (5.2) ] Porphyria or known allergies to porphyrins [see Warnings and Precautions (5.2) ] Known sensitivity to any of the components of the LEVULAN KERASTICK. Cutaneous photosensitivity at wavelengths of 400-450 nm. ( 4 ) Porphyria or known allergies to porphyrins. ( 4 ) Sensitivity to any of the components of the LEVULAN KERASTICK. ( 4 )

Warnings and precautions

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. ( 5.1 ) Avoid exposure of the photosensitive actinic keratoses to sunlight or bright indoor light prior to blue light treatment. Protect treated lesions from sunlight exposure. Sunscreens will not protect the patient against photosensitivity reactions. ( 5.2 ) The LEVULAN KERASTICK for topical solution should be used by a qualified health professional. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion. ( 5.2 ) Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours. ( 5.3 ) 5.1 Transient Amnestic Episodes 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. 5.2 Photosensitivity 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. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin. Application of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization. Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy. Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions. If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, the patient should call the doctor. The patient should also continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced. 5.3 Irritation The LEVULAN KERASTICK topical solution contains alcohol and is intended for topical use only. Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours. 5.4 Coagulation Defects The LEVULAN KERASTICK for topical solution has not been tested on patients with inherited or acquired coagulation defects.

Side effects

The following adverse reactions are discussed in greater detail in the other sections of the labeling: Transient Amnestic Episodes [see Warnings and Precautions (5.1) ] Increased Photosensitivity [see Warnings and Precautions (5.2) ] Irritation [see Warnings and Precautions (5.3) ] Coagulation defects [see Warnings and Precautions (5.4) ] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Dermatology at 877-533-3872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK photodynamic therapy. Photodynamic Therapy Response: The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK photodynamic therapy (PDT) was observed in all clinical trials for actinic keratoses treatment. Stinging and/or burning subsided between 1 minute and 24 hours after the BLU-U Blue Light Photodynamic Therapy Illuminator was turned off, and appeared qualitatively similar to that perceived by patients with erythropoietic protoporphyria upon exposure to sunlight. There was no clear drug dose or light dose dependent change in the incidence or severity of stinging and/or burning. Local skin reactions at the application site were observed in 99% of subjects treated with LEVULAN KERASTICK topical solution and BLU-U Blue Light Photodynamic Therapy Illuminator. The most common local adverse reactions (incidence ≥ 10%) were application site stinging/burning, erythema, edema, scaling/crusting, hypo/hyperpigmentation, itching, erosion, oozing/vesiculation/crusting, dryness. In the trials for face and scalp lesions, severe stinging and/or burning at one or more lesions during light treatment was reported by at least 50% of subjects. Severe stinging and/or burning also occurred during light treatment in 9% of subjects receiving treatment for upper extremity lesions. The majority of subjects reported that all lesions treated exhibited at least slight stinging and/or burning. In trials of the face and scalp, the sensation of stinging/burning appeared to reach a plateau at 6 minutes into the treatment. 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. In trials for the face or scalp lesions, 99% of the active treatment group and 79% of the vehicle group experienced erythema shortly after treatment. In the trial for the upper extremity lesions, 99% of LEVULAN KERASTICK topical solution treatment group and 52% of the vehicle group experienced erythema on visit Days 2-3. Approximately 35% of LEVULAN KERASTICK topical solution group had edema, while edema occurred in < 1% of the vehicle group. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy for face or scalp. Edema resolved by 4 weeks and erythema resolved to baseline by 8 weeks for upper extremities. The application of LEVULAN KERASTICK topical solution to perilesional skin resulted in stinging, burning, erythema and edema similar to treated actinic keratoses [see Warnings and Precautions (5.2) ] . Other Localized Cutaneous Adverse Experiences: Table 2 depicts the incidence and severity of cutaneous adverse events in trials for the face and scalp. TABLE 2 Post-PDT Cutaneous Adverse Events – ALA-018/ALA-019 For the Face and Scalp FACE SCALP LEVULAN KERASTICK Topical Solution + PDT (n=139) Vehicle + PDT (n=41) LEVULAN KERASTICK Topical Solution + PDT (n=42) Vehicle + PDT (n=21) Degree of Severity Mild/ Moderate Severe Mild/ Moderate Severe Mild/ Moderate Severe Mild/ Moderate Severe Scaling/Crusting 71% 1% 12% 0% 64% 2% 19% 0% Pain 1% 0% 0% 0% 0% 0% 0% 0% Tenderness 1% 0% 0% 0% 2% 0% 0% 0% Itching 25% 1% 7% 0% 14% 7% 19% 0% Edema 1% 0% 0% 0% 0% 0% 0% 0% Ulceration 4% 0% 0% 0% 2% 0% 0% 0% Bleeding/Hemorrhage 4% 0% 0% 0% 2% 0% 0% 0% Hypo/hyper-pigmentation 22% 20% 36% 33% Vesiculation 4% 0% 0% 0% 5% 0% 0% 0% Pustules 4% 0% 0% 0% 0% 0% 0% 0% Oozing 1% 0% 0% 0% 0% 0% 0% 0% Dysesthesia 2% 0% 0% 0% 0% 0% 0% 0% Scabbing 2% 1% 0% 0% 0% 0% 0% 0% Erosion 14% 1% 0% 0% 2% 0% 0% 0% Excoriation 1% 0% 0% 0% 0% 0% 0% 0% Wheal/Flare 7% 1% 0% 0% 2% 0% 0% 0% Skin disorder NOS 5% 0% 0% 0% 12% 0% 5% 0% Table 3 depicts the incidence of other cutaneous adverse events in Phase 3 studies for the upper extremities. TABLE 3 Percentage of Subjects with Cutaneous Adverse Reactions by the Most Severe Grade Reported Post-Baseline – CP0108 For Upper Extremities LEVULAN KERASTICK Topical Solution + PDT (N=135) Vehicle + PDT (N=134) Degree of Severity Minimal/ Mild Moderate/ Severe Total Minimal/ Mild Moderate/ Severe Total Edema 51% 4% 56% 7% 1% 8% Erythema 35% 65% 100% 63% 12% 75% Hyper-pigmentation 64% 9% 73% 57% 10% 66% Hypo-pigmentation 46% 4% 50% 50% 5% 55% Oozing/Vesiculation/ Crusting 36% 5% 41% 8% 2% 10% Scaling and Dryness 65% 22% 87% 58% 7% 64% Stinging/Burning 23% 73% 96% 23% 0% 23% In the trial for upper extremity lesions, itching and scabbing occurred in 8% and 4%, respectively, of the subjects in the LEVULAN KERASTICK photodynamic therapy group. No subjects in the vehicle group reported itching or scabbing.

Drug interactions

There have been no formal studies of the interaction of LEVULAN KERASTICK topical solution with any other drugs, and no drug-specific interactions were noted during any of the controlled clinical trials. It is, however, 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 LEVULAN KERASTICK topical solution [see Warnings and Precautions (5.2) ] . 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. ( 7 )

Use in specific populations

8.1 Pregnancy Risk Summary Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid. LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown [see Clinical Pharmacology (12.3) ]. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of LEVULAN KERASTICK topical solution in either human or animal milk, the effects on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEVULAN KERASTICK topical solution and any potential adverse effects on the breastfeeding child from LEVULAN KERASTICK topical solution or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness in pediatric patients below the age of 18 have not been established. Actinic keratosis is not a disease generally seen in the pediatric population. 8.5 Geriatric Use Of the 512 subjects in Phase 3 clinical trials of LEVULAN KERASTICK topical solution, 63% (321/512) were 65 years old and over, while 24% (123/512) were 75 years old and over. No overall differences in safety or substantial differences in effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Pregnancy

8.1 Pregnancy Risk Summary Limited available data with LEVULAN KERASTICK topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Animal developmental toxicology studies were not conducted with aminolevulinic acid. LEVULAN KERASTICK solution has low systemic absorption following topical administration, and the risk of maternal use resulting in fetal exposure to the drug is unknown [see Clinical Pharmacology (12.3) ]. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Pediatric use

8.4 Pediatric Use The safety and effectiveness in pediatric patients below the age of 18 have not been established. Actinic keratosis is not a disease generally seen in the pediatric population.

Geriatric use

8.5 Geriatric Use Of the 512 subjects in Phase 3 clinical trials of LEVULAN KERASTICK topical solution, 63% (321/512) were 65 years old and over, while 24% (123/512) were 75 years old and over. No overall differences in safety or substantial differences in effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Overdosage

10.1 LEVULAN KERASTICK Topical Solution Overdose In the event that the drug is ingested, monitoring and supportive care are recommended. The patient should be advised to avoid incidental exposure to intense light sources for at least 40 hours after ingestion. The consequences of exceeding the recommended topical dosage are unknown. 10.2 BLU-U Light Overdose There is no information on overdose of blue light from the BLU-U Blue Light Photodynamic Therapy Illuminator following LEVULAN KERASTICK topical solution application.

Description

(aminolevulinic acid HCl) for topical solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone. ALA HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil. The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride (MW = 167.59). The structural formula is represented below: The LEVULAN KERASTICK for topical solution applicator is a two-component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of aminolevulinic acid HCl as a dry solid. The applicator tube is enclosed in a protective cardboard sleeve and cap. The 20% topical solution is prepared just prior to the time of use by breaking the ampules and mixing the contents by shaking the LEVULAN KERASTICK applicator. “LEVULAN KERASTICK for topical solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK topical solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK” refers to the applicator only. Levulan-04

Mechanism of action

12.1 Mechanism of Action Following the application of LEVULAN KERASTICK topical solution, photosensitization occurs through the metabolic conversion of aminolevulinic acid to protoporphyrin IX (PpIX), a photosensitizer, which accumulates in the skin. When exposed to light of appropriate wavelength and energy, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent upon the simultaneous presence of oxygen. The absorption of light results in an excited state of porphyrin molecules, and subsequent spin transfer from photoreactive porphyrins to molecular oxygen generates singlet oxygen, which can further react to form superoxide and hydroxyl radicals. LEVULAN KERASTICK Photodynamic Therapy of actinic keratoses is the combination of photosensitization by application of the LEVULAN KERASTICK topical solution to the lesions and subsequent illumination with BLU-U Blue Light Photodynamic Therapy Illuminator.

How supplied

16.1 How Supplied The LEVULAN KERASTICK for topical solution, 20%, is supplied in packs of 6 applicators. Each LEVULAN KERASTICK applicator is for single use and consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains 354 mg of aminolevulinic acid HCl. The applicator is covered with a protective cardboard sleeve and cap. 16.2 Product Package - NDC Number Carton of 6 LEVULAN KERASTICK for topical solution, 20% applicators 67308-101-06 16.3 Storage Store between 20° - 25 °C (68° - 77 °F); excursions permitted to 15°- 30 °C (59° - 86 °F) [See USP Controlled Room Temperature]. The LEVULAN KERASTICK topical solution should be used immediately following preparation (dissolution). Solution application must be completed within 2 hours of preparation. An applicator that has been prepared must be discarded 2 hours after mixing (dissolving) and a new LEVULAN KERASTICK applicator used, if needed.

Patient information

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Transient Amnestic Episodes Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.1) ]. Photosensitivity Transient episodes of amnesia have been reported with LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Advise patients and their families or caregivers to contact their healthcare provider if memory impairment, confusion, or disorientation is observed [see Warnings and Precautions (5.2) ]. Advise patients that after LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and that they 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. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions [see Warnings and Precautions (5.2) ]. Advise patients to protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Advise patients sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin [see Warnings and Precautions (5.2) ]. If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, advise patients to call the doctor. Advise patient to continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced [see Warnings and Precautions (5.2) ]. Advise patients to avoid certain medications that may enhance the phototoxic reaction to PDT [see Drug Interactions (7) ] . Common Adverse Reactions Inform patients that treatment with LEVULAN KERASTICK topical solution plus BLU-U Blue Light Photodynamic Therapy Illuminator may result in sensitivity to light, skin irritation and local skin reactions including erythema, edema, stinging/burning, scaling, crusting, oozing, vesiculation, wheal, scabbing, pustules, ulceration, itching, erosion, hypo/hyperpigmentation, bleeding, tenderness, dysesthesia, and dryness. LEVULAN, KERASTICK, KERASTICK KRUSHER, BLU-U, and DUSA are registered trademarks of DUSA Pharmaceuticals, Inc., a Sun Pharma company © 2020 Sun Pharmaceutical Industries, Inc. All rights reserved. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA, 01821 LAB-0530AW, Revision: F Sun Pharmaceutical Industries, Inc. Princeton, NJ 1-877-533-3872 Levulan-09

Label text from the FDA structured product label by Sun Pharmaceutical Industries, Inc (revised Sep 12, 2024). Long sections are shortened; the complete label is on DailyMed.

Levulan Kerastick NDC products (1)

NDCStrength & formLabelerType
67308-101
Kit		Sun Pharmaceutical Industries, IncNDA

Frequently asked questions

What is Levulan Kerastick used for?

The LEVULAN KERASTICK for topical solution 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, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy…

What are the side effects of Levulan Kerastick?

The following adverse reactions are discussed in greater detail in the other sections of the labeling: Transient Amnestic Episodes [see Warnings and Precautions (5.1) ] Increased Photosensitivity [see Warnings and Precautions (5.2) ] Irritation [see Warnings and Precautions (5.3) ] Coagulation defects [see Warnings and Precautions (5.4) ] The most common local adverse reactions (incidence ≥ 10%)… See the full label for the complete list.

Who makes Levulan Kerastick?

Levulan Kerastick is listed by 1 labeler in the FDA NDC directory, including Sun Pharmaceutical Industries, Inc.