D-Aminolevulinic acid

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D-Aminolevulinic acid
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

D-Aminolevulinic acid is a dermatological agent that is FDA approved for the treatment of minimally to moderately thick actinic keratoses of the face or scalp. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • The LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy (PDT) Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.

Dosage

LEVULAN KERASTICK for 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 either scalp or face lesions, but not both simultaneously. The recommended treatment frequency is: one application of the LEVULAN KERASTICK Topical Solution and one dose of illumination per treatment site per 8-week treatment session. Each individual LEVULAN KERASTICK for Topical Solution should be used for only one patient. Photodynamic therapy for actinic keratoses with LEVULAN KERASTICK for Topical Solution is a two stage process involving a) application of the product to the target lesions with LEVULAN KERASTICK Topical Solution, followed 14 to 18 hours later by b) illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator. The second visit, for illumination, must take place in the 14-18 hour window following application. Patients in clinical trials usually received application in the late afternoon, with illumination the following morning.

Treated lesions that have not completely resolved after 8 weeks may be treated a second time with LEVULAN KERASTICK for Topical Solution Photodynamic Therapy.

Step A - LEVULAN KERASTICK for Topical Solution Application: Actinic keratoses

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

LEVULAN KERASTICK can be prepared either manually, or using the optional Kerastick Krusher. These methods are illustrated below.

Application of solution

Following solution admixture, remove the cap from the LEVULAN KERASTICK Topical Solution. The dry applicator tip should be dabbed on a gauze pad until uniformly wet with solution. Apply the solution directly to the target lesions by dabbing gently with the wet applicator tip. Enough solution should be applied to uniformly wet the lesion surface, including the edges without excess running or dripping. The effect of LEVULAN KERASTICK Topical Solution on ocular tissues is unknown. LEVULAN KERASTICK Topical Solution should not be applied to the periorbital area or allowed to contact ocular or mucosal surfaces. Once the initial application has dried, apply again in the same manner. The LEVULAN KERASTICK Topical Solution must be used immediately following preparation (dissolution) due to the instability of the activated product. If the solution application is not completed within 2 hours of activation, the applicator should be discarded and a new LEVULAN KERASTICK for Topical Solution used.

Photosensitization of the treated lesions will take place over the next 14-18 hours. The actinic keratoses should not be washed during this time. The patient should be advised to wear a wide-brimmed hat or other protective apparel to shade the treated actinic keratoses from sunlight or other bright light sources until BLU-U treatment. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

If for any reason the patient cannot be given BLU-U treatment during the prescribed time after LEVULAN KERASTICK Topical Solution application, 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. The patient should be advised to wear a wide-brimmed hat or other protective apparel 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. The patient should be advised to reduce light exposure if the sensations of stinging and/or burning are experienced.

Step B - Administration of BLU-U Treatment 14 to 18 hours after application

LEVULAN KERASTICK for Topical Solution is not intended for use with any device other than the BLU-U Blue Light Photodynamic Therapy Illuminator. Use of LEVULAN KERASTICK Topical Solution without subsequent BLU-U illumination is not recommended.

At the visit for light illumination, the actinic keratoses to be treated should be gently rinsed with water and patted dry. Photoactivation of actinic keratoses treated with LEVULAN KERASTICK Topical Solution is accomplished with BLU-U illumination from the BLU-U Blue Light Photodynamic Therapy Illuminator. A 1000 second (16 minutes 40 seconds) exposure is required to provide a 10 J/cm2 light dose. During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U Operating Instructions. Please refer to the BLU-U Operating Instructions for further information on conducting the light treatment. Patients should be advised that transient stinging and/or burning at the target lesion sites occurs during the period of light exposure.

If blue light treatment with the BLU-U Blue Light Photodynamic Therapy Illuminator is interrupted or stopped for any reason, it should not be restarted and the patient should be advised to protect the treated lesions from exposure to sunlight or prolonged or intense light for at least 40 hours after application of the LEVULAN KERASTICK Topical Solution.

For patients with facial lesions:

The BLU-U Blue Light Photodynamic Therapy Illuminator is positioned so that the base is slightly above the patient’s shoulder, parallel to the patient’s face. The BLU-U is positioned around the patient’s head so the entire surface area to be treated lies between 2” and 4” from the BLU-U surface: The patient’s nose should be no closer than 2” from the surface; The patient’s forehead and cheeks should be no further than 4” from the surface; The sides of the patient’s face and the patient’s ears should be no closer than 2” from the BLU-U surface. A Chin Rest, available from DUSA Pharmaceuticals, Inc., may be used to provide support for the patient’s head during treatment.

For patients with scalp lesions:

The knobs on either side of the BLU-U are loosened and the BLU-U is rotated to a horizontal position. The BLU-U is positioned around the patient’s head so the entire surface area to be treated lies between 2” and 4” from the BLU-U surface: The patient’s scalp should be no closer than 2” from the surface; The patient’s scalp should be no further than 4” from the surface; The sides of the patient’s face and the patient’s ears should be no closer than 2” from the BLU-U surface. A Chin Rest, available from DUSA Pharmaceuticals, Inc., may be used to provide support for the patient’s head during treatment.

DOSAGE FORMS AND STRENGTHS

Solution containing 20% aminolevulinic acid hydrochloride (ALA HCl) by weight in a plastic applicator device.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of D-Aminolevulinic acid in adult patients.

Non–Guideline-Supported Use

  • Basal cell carcinoma of skin[1]
  • Squamous cell carcinoma[2]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of D-Aminolevulinic acid in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of D-Aminolevulinic acid in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of D-Aminolevulinic acid in pediatric patients.

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, porphyria or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK for Topical Solution.

Warnings

  • Photosensitivity

During the time period between the application of LEVULAN KERASTICK Topical Solution and exposure to activating light from the BLU-U Blue Light Photodynamic Therapy Illuminator, the treatment site will become photosensitive. After LEVULAN KERASTICK Topical Solution application, 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) during the period prior to blue light treatment. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Before exposure to sunlight, patients should, therefore, protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. 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 eye or surrounding skin.

Application of LEVULAN KERASTICK Topical Solution to perilesional areas of photodamaged skin of the face or scalp may result in photosensitization. Upon exposure to activating light from the BLU-U Blue Light Photodynamic Therapy Illuminator, 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 should be used by a qualified health professional to apply drug only to actinic keratoses and not perilesional skin.

If for any reason the patient cannot return for blue light treatment during the prescribed period after application of LEVULAN KERASTICK Topical Solution (14 to 18 hours), 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.

5.2 Irritation The LEVULAN KERASTICK Topical Solution contains alcohol and is intended for topical use only. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion.

5.3 Coagulation Defects The LEVULAN KERASTICK for Topical Solution has not been tested on patients with inherited or acquired coagulation defects

Adverse Reactions

Clinical Trials Experience

In Phase 3 studies, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK Topical Solution application followed by blue light exposure.

Photodynamic Therapy Response: The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK Topical Solution plus BLU-U treatment was observed in all clinical studies of LEVULAN KERASTICK for Topical Solution Photodynamic Therapy 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.

In two Phase 3 trials, the sensation of stinging and/or burning appeared to reach a plateau at 6 minutes into the treatment. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of the patients at some time during treatment. The majority of patients reported that all lesions treated exhibited at least slight stinging and/or burning. Less than 3% of patients discontinued light treatment due to stinging and/or burning.

In the Phase 3 trials, the most common changes in lesion appearance after LEVULAN KERASTICK for Topical Solution Photodynamic Therapy were erythema and edema. In 99% of active treatment patients, some or all lesions were erythematous shortly after treatment, while in 79% of vehicle treatment patients, some or all lesions were erythematous. In 35% of active treatment patients, some or all lesions were edematous, while no vehicle-treated patients had edematous lesions. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy. LEVULAN KERASTICK Topical Solution application to photodamaged perilesional skin resulted in photosensitization of photodamaged skin and in a photodynamic response (see WARNINGS AND PRECAUTIONS)).

Other Localized Cutaneous Adverse Experiences: TABLE 2 depicts the incidence and severity of cutaneous adverse events in Phase 3 studies, stratified by anatomic site treated.

Adverse Experiences Reported by Body System: In the Phase 3 studies, 7 patients experienced a serious adverse event. All were deemed remotely or not related to treatment. No clinically significant patterns of clinical laboratory changes were observed for standard serum chemical or hematologic parameters in any of the controlled clinical trials.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of D-Aminolevulinic acid in the drug label.

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 griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with LEVULAN KERASTICK for Topical Solution.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Animal reproduction studies have not been conducted with aminolevulinic acid (ALA HCl). It is also not known whether LEVULAN KERASTICK Topical Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. LEVULAN KERASTICK for Topical Solution should be given to a pregnant woman only if clearly needed.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of D-Aminolevulinic acid in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of D-Aminolevulinic acid during labor and delivery.

Nursing Mothers

  • The levels of ALA or its metabolites in the milk of subjects treated with LEVULAN KERASTICK for Topical Solution have not been measured. Because many drugs are excreted in human milk, caution should be exercised when LEVULAN KERASTICK for Topical Solution is administered to a nursing woman.

Pediatric Use

  • The safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatic Use

  • Of the 243 subjects in controlled clinical trials of LEVULAN KERASTICK for Topical Solution, 64% (156/243) were 65 years old and over, while 23% (55/243) were 75 years old and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Gender

There is no FDA guidance on the use of D-Aminolevulinic acid with respect to specific gender populations.

Race

There is no FDA guidance on the use of D-Aminolevulinic acid with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of D-Aminolevulinic acid in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of D-Aminolevulinic acid in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of D-Aminolevulinic acid in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of D-Aminolevulinic acid in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Topical

Monitoring

There is limited information regarding Monitoring of D-Aminolevulinic acid in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of D-Aminolevulinic acid in the drug label.

Overdosage

LEVULAN KERASTICK Topical Solution Overdose LEVULAN KERASTICK Topical Solution overdose has not been reported. In the unlikely 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.

Pharmacology

There is limited information regarding D-Aminolevulinic acid Pharmacology in the drug label.

Mechanism of Action

Structure

File:D-Aminolevulinic acid01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of D-Aminolevulinic acid in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of D-Aminolevulinic acid in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of D-Aminolevulinic acid in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of D-Aminolevulinic acid in the drug label.

How Supplied

Storage

There is limited information regarding D-Aminolevulinic acid Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of D-Aminolevulinic acid in the drug label.

Precautions with Alcohol

  • Alcohol-D-Aminolevulinic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Hürlimann AF, Hänggi G, Panizzon RG (1998). "Photodynamic therapy of superficial basal cell carcinomas using topical 5-aminolevulinic acid in a nanocolloid lotion". Dermatology. 197 (3): 248–54. PMID 9812030.
  2. ↑ Peng Q, Warloe T, Berg K, Moan J, Kongshaug M, Giercksky KE; et al. (1997). "5-Aminolevulinic acid-based photodynamic therapy. Clinical research and future challenges". Cancer. 79 (12): 2282–308. PMID 9191516.
  3. ↑ Empty citation (help)
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