performing some Aminolevulinic Acid Hydrochloride Class: Skin and Mucous Membrane Agents, Miscellaneous ATC Class: L01XD04 VA Class: DE350 Chemical Name: 5-Aminolevulinic acid hydrochloride Molecular Formula: C 5 H 9 N O 3 HCl CAS Number: 5451-09-2 Brands: Levulan Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Introduction Photosensitizer; hydrochloride salt of 5-aminolevulinic acid, an endogenous precursor of protoporphyrin IX. 1 2 Slideshow Hitting the Beach? Soak Up These Top Sun Safety Tips Uses for Aminolevulinic Acid Hydrochloride Nonhyperkeratotic Actinic Keratoses of Face or Scalp Treatment of minimally to moderately thick (nonhyperkeratotic) actinic keratoses of the face or scalp, in conjunction with blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator (BLU-U ). a Aminolevulinic Acid Hydrochloride Dosage and Administration General Topical solution should be applied only by qualified medical personnel. a Apply topically to individual actinic keratosis lesions on either scalp or face, but not both simultaneously. a Do not apply in or around eyes or mucous membranes or to perilesional skin. a Administration Topical Administration Preparation of the Applicator With the applicator cap pointing up, sequentially break the 2 glass ampuls within the plastic applicator by applying finger pressure to appropriate position on the bottom ampul (vehicle solution), then the top ampul (powdered drug). a With applicator cap pointed away from face, shake applicator gently for at least 3 minutes to completely dissolve the drug in the vehicle. a Do not press on end cap while shaking. a Topical Application Apply topically; use within 2 hours because of the instability of the activated product. a If application of the solution is not completed within 2 hours of activation, discard applicator and use a new one. 1 a Clean and dry lesions prior to application of solution. a Gently dab target lesions directly with wet applicator tip, uniformly wetting lesion surface, including the edges, without excess running or dripping. a Allow application to dry and then reapply one time in the same manner. a 7 Illumination of Treated Lesions 14 18 hours after application, gently rinse target lesions with water, pat dry, and photoactivate with blue light illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator. a Patients and medical personnel should use blue light-blocking protective eyewear during BLU-U illumination. a Solution is not intended for use with any device other than the BLU-U Blue Light Photodynamic Illuminator. a Dosage Adults Actinic Keratoses Topical Apply solution to lesions as directed (See Topical Application under Dosage and Administration); allow to dry and reapply once. a 7 14 18 hours later, expose affected areas to BLU-U illumination for 1000 seconds [16 minutes, 40 seconds]. a After 8 weeks, apply solution a second time to lesions that have not completely resolved. a Cautions for Aminolevulinic Acid Hydrochloride Contraindications Known cutaneous photosensitivity at wavelengths of 400 450 nm. a Known porphyria or known allergies to porphyrins. a Known sensitivity to aminolevulinic acid or any ingredient in the formulation. a Warnings/Precautions Warnings Topical Application Only Solution contains alcohol; for topical use only. a Do not apply in or around the eyes or to mucous membranes. a May cause excessive irritation if applied under occlusion. a General Precautions Application by Health Professional Only qualified medical personnel should apply solution; application to perilesional area of face or scalp may result in photosensitivity. a Photosensitivity Reactions Sites will be photosensitive after topical application of solution; stinging and/or burning sensation, erythema, and/or edema of lesions may occur with exposure to bright light. a Avoid exposure of treated sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, lights at close proximity) prior to blue light photoactivation. a Protect treated lesions from sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and keep lesions dry. a Sunscreens will not protect against photosensitivity reactions caused by visible light. a Reduce exposure to light if stinging and/or burning occurs. a Dermatologic Reactions Following photoactivation with blue light, reddening, swelling, and scaling of treated actinic keratoses and surrounding skin may occur. a Lesion changes usually resolve completely within 4 weeks after treatment. a Delay in Receiving Blue Light Treatment Patients should contact clinician if they cannot return for blue light treatment 14 18 hours after application of solution. a Patients should continue to avoid exposure of photosensitized lesions to sunlight or prolonged or intense light for 40 hours after solution application. a Specific Populations Pregnancy Category C. a Lactation Not known whether aminolevulinic acid is distributed into milk; use caution. a Common Adverse Effects Transient local stinging and/or burning, itching, erythema, edema, scaling/crusting, a itching, 1 hypopigmentation/hyperpigmentaion, a erosion, a skin disorder (unspecified), a wheal/flare, a vesiculation. a a Interactions for Aminolevulinic Acid Hydrochloride No formal drug interaction studies performed. a No drug-specific interactions noted during controlled clinical trials. a Other Known Photosensitizing Agents Potential pharmacologic interaction (increased photosensitivity reaction) with other known photosensitizing agents (e.g., griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, tetracyclines). a Aminolevulinic Acid Hydrochloride Pharmacokinetics Absorption Bioavailability 50-60% after a 128-mg oral dose of aminolevulinic acid hydrochloride (equivalent to 100 mg of aminolevulinic acid). a Distribution Time to Peak Fluorescence Peak fluorescence intensity for protoporphyrin IX (metabolite of aminolevulinic acid) reached at approximately 11 or 12 hours in actinic keratoses or perilesional skin, respectively. a Elimination Half-life 0.83 or 0.7 hours with a 128-mg aminolevulinic acid hydrochloride IV or oral dose, respectively. a Mean fluorescence half-life of 30 or 28 hours in lesions or perilesional skin, respectively. a Stability Storage Topical Solution 20 25 C; excursions permitted to 15 30 C. a Discard reconstituted solution 2 hours after mixing. a Actions Metabolism of aminolevulinic acid is first step in synthesis of heme, 2 which is formed when iron (under action of ferrochelatase) is incorporated into protoporphyrin IX. 2 Synthesis of endogenous aminolevulinic acid (ALA) tightly controlled by feedback inhibition of ALA synthetase, presumably by intracellular heme levels. a 2 Following topical application of aminolevulinic acid, it is converted into protoporphyrin IX (a photosensitizer), which accumulates in skin due to limited capacity of ferrochelatase to convert protoporphyrin IX into heme. a 2 6 When exposed to light of appropriate wavelength and energy, accumulated protoporphyrin IX produces a photodynamic reaction. a 3 5 6 Tissue-specific phototoxic effects result from generation of cytotoxic singlet oxygen atoms, which form superoxide and hydroxyl radicals. 1 2 3 4 5 6 Advice to Patients Aminolevulinic acid hydrochloride topical solution is not meant for application by patient. a Only qualified health professionals should apply drug. a Importance of advising patient to keep lesions dry and out of bright light following application of the topical solution. a Importance of informing patient of possible transient stinging and/or burning at treated lesion sites if exposed to bright light following topical solution application; a patient should reduce exposure to light if this occurs. a Importance of patient wearing light-protective clothing, such as a wide-brimmed hat or similar head covering of light-opaque material, before going into sunlight following topical solution application. a Importance of informing patient that sunscreens will not protect against photosensitivity reactions caused by visible light. a Importance of patient limiting exposure to bright indoor light following topical solution application. a Importance of informing patient that transient tingling, stinging, prickling, and/or burning may occur at target lesion sites during period of blue light photoactivation. a Importance of patient informing clinicians of existing or contemplated therapy, including prescription and OTC drugs. a Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. a Importance of informing patients of other important precautionary information. (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Aminolevulinic Acid Hydrochloride Routes Dosage Forms Strengths Brand Names Manufacturer Topical For solution 354 mg (for preparation of a 20% solution) Levulan Kerastick (1.5 mL alcohol 48% v/v and isopropyl alcohol diluent) DUSA AHFS DI Essentials. Copyright 2017, Selected Revisions August 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. DUSA Pharmaceuticals, Inc. Levulan (aminolevulinic acid hydrochloride) topical solution prescribing information. Wilmington, MA; 1999 Dec. 2. Peng Q, Warloe T, Berg K et al. 5-Aminolevulinic acid-based photodynamic therapy. Cancer. 1997; 79:2282-2308. [PubMed 9191516] 3. Stender IM, Wulf HC. Photodynamic therapy with 5-aminolevulinic acid in the treatment of actinic cheilitis. Br J Dermatol . 1996; 135:454-6. [PubMed 8949443] 4. Jeffes EW, McCullough JL, Weinstein GD et al. Photodynamic therapy of actinic keratosis with topical 5-aminolevulinic acid. Arch Dermatol . 1997; 133:727-32. [PubMed 9197826] 5. Fritsch C, Goerz G, Ruzicka T. Photodynamic therapy in dermatology. Arch Dermatol . 1998; 134:207-14. [PubMed 9487213] 6. Fritsch C, Lang K, Neuse W et al. Photodynamic diagnosis and therapy in dermatology. Skin Pharmacol Appl Skin Physiol . 1998; 11:358-73. [PubMed 10343206] 7. Manufacturer s comments (personal observations). a. DUSA Pharmaceuticals, Inc. Levulan (aminolevulinic acid hydrochloride) topical solution prescribing information. Wilmington, MA; revision F. Undated. Next Interactions Print this page Add to My Med List More about aminolevulinic acid topical Side Effects During Pregnancy Dosage Information Drug Interactions En Español 0 Reviews Add your own review/rating Drug class: topical photochemotherapeutics Consumer resources Aminolevulinic acid ... +3 more Professional resources Other brands: Ameluz , Levulan Kerastick Related treatment guides Actinic Keratosis Keratosis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Topical photochemotherapeutics Related Drugs Keratosis diclofenac topical , fluorouracil topical , Efudex , Santyl , imiquimod topical , Aldara , Collagenase Santyl , Carac , Picato , Solaraze , Fluoroplex , Zyclara , More... 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