Version May 2024
Note: Should only be applied by qualified medical personnel (not intended for application by patients).
Actinic keratosis: Topical:
Gel (Ameluz): Apply ~1 mm thick to actinic keratosis and to ~5 mm of surrounding skin; application area should not exceed 20 cm2 and a maximum of 2 g at one time. Cover with a light-blocking occlusive dressing and leave on for 3 hours. After 3 hours of occlusion, remove dressing, wipe off remaining gel, and follow with red light illumination. Lesions that have not completely resolved after 3 months following the initial treatment may be retreated.
Solution (Levulan Kerastick): Apply to actinic keratoses (not perilesional skin) followed by blue light illumination 3 hours (upper extremity lesions) or 14 to 18 hours (face or scalp lesions) later. Application/treatment may be repeated at a treatment region (once) after 8 weeks; multiple lesions can be treated within a treatment region but multiple treatment regions should not be treated simultaneously.
Actinic cheilitis (off-label use): Topical: Apply solution (20%) to lip lesion followed 2 to 3 hours later by photodynamic therapy. Application/treatment may be repeated as necessary once every 4 weeks or until complete clearing, for up to 3 treatment sessions (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Dermatologic: Application site scaling (≤87%; severe: ≤22%), burning sensation of skin (≤96%; severe: ≤73%), crusted skin (≤71%; severe: ≤5%, including scabbing), exfoliation of skin (19%), hyperpigmentation (≤73%; severe: 9%), hypopigmentation (≤50%; severe: 4%), local dryness of skin (≤87%; severe: ≤22%), localized vesiculation (≤41%; severe: ≤5%), skin erosion (2% to 14%; severe: 1%), stinging of the skin (≤96%; severe: ≤73%)
Local: Application site discharge (≤41%; severe: ≤5%, including oozing), application site edema (1% to 56%; severe: 4%), application site erythema (35% to 100%; severe: 65%), application site induration (12%), application site irritation (72%), application site pruritus (8% to 34%; severe: 1% to 7%), application site vesicles (12%), local pain (≤92%; severe: ≤30%)
1% to 10%:
Dermatologic: Dermal ulcer (2% to 4%), excoriation of skin (1%), pruritic rash (perilesional: <2%), pustules (1% to 4%), skin blister (<2%), skin pain (1%), skin tenderness (1% to 2%), urticaria (2% to 7%; severe: 1%)
Hematologic & oncologic: Local hemorrhage (1% to 4%), squamous cell carcinoma (2% to 10%), squamous cell carcinoma of skin (2% to 10%)
Nervous system: Chills, dysesthesia (2%), headache, hyperalgesia (6%), local discomfort (3%), paresthesia (application site: 9%)
Ophthalmic: Eyelid edema
Respiratory: Sinusitis (2% to <10%)
<1%:
Dermatologic: Pruritus, pustular rash
Hematologic: Petechia
Local: Local swelling
Nervous system: Feeling hot, nervousness, pain
Miscellaneous: Fever
Frequency not defined: Dermatologic: Skin photosensitivity
Postmarketing:
Dermatologic: Allergic dermatitis, skin discoloration (application site)
Hypersensitivity: Hypersensitivity reaction
Local: Local inflammation
Nervous system: Fatigue, temporary amnesia
Ophthalmic: Blurred vision, diplopia, eye irritation, ocular hyperemia, photophobia
Hypersensitivity to aminolevulinic acid or any component of the formulation; known allergy/hypersensitivity to porphyrins; known porphyria; hypersensitivity to soybean phosphatidylcholine (Ameluz); cutaneous photosensitivity at wavelengths of 400 to 450 nm (Levulan Kerastick); photodermatoses (Ameluz)
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity (including anaphylaxis) has been reported with application of gel (Ameluz) prior to photodynamic therapy (PDT). If hypersensitivity occurs, clean area of skin where gel was applied and institute appropriate therapy.
• Mucous membrane irritation: May cause irritation to mucous membranes; do not apply to mucous membranes; rinse with water if contact occurs.
• Ocular injury: Eyelid edema has been observed with topical aminolevulinic acid. Do not apply into eyes; rinse with water if eye contact occurs. Illumination light therapy may result in eye irritation, glare, or injury. During light treatment, patients, health care personnel, and any others present during illumination should wear appropriate eye protection. Avoid staring directly into the light source. Eye exposure to red light must be prevented.
• Photosensitivity: Treatment site will become photosensitive following topical application. Patients should be instructed to avoid exposure to sunlight, bright indoor lights, or tanning beds for 40 hours following application for blue light treatment or for 48 hours following application for red light treatment. Exposure may result in lesion burning, edema, erythema, and/or stinging. Sunscreen will not protect against visible light; head should be covered with light-opaque material or wide-brimmed hat. If unable to return for blue light treatment, continue to avoid sunlight/bright light exposure to treated lesions for at least 40 hours. If unable to perform red light illumination within 3 hours of gel application, protect lesion sites and surrounding skin from sunlight or prolonged intense light (eg, tanning beds, sun lamps) for 48 hours.
• Skin irritation: Excessive irritation may occur if solution (Levulan Kerastick) is applied under occlusion for >3 hours.
• Transient amnesia: Transient amnestic episodes have been reported with aminolevulinic acid in combination with PDT. Advise patients to report amnesia that occurs after treatment.
Disease-related concerns:
• Coagulation defects: Has not been tested in individuals with coagulation defects (acquired or inherited). Avoid bleeding during lesion preparation in patients with coagulation defects; bleeding must be controlled prior to application.
Concurrent drug therapy issues:
• Photosensitizing agents: Concomitant use of other known photosensitizing agents may increase the degree of photosensitivity reaction.
Other warnings/precautions:
• Appropriate use: For external use only. Do not apply to eyes or mucous membranes. Application of solution (Levulan Kerastick) should involve lesions on the scalp, face, or upper extremities, although not simultaneously; avoid application to perilesional skin. Should be applied by a qualified health professional.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External, as hydrochloride:
Ameluz: 10% (2 g) [contains isopropyl alcohol, phosphatidylcholine, soy, polysorbate 80, propylene glycol, sodium benzoate]
Solution Reconstituted, External, as hydrochloride:
Levulan Kerastick: 20% (1 ea) [contains alcohol, usp, isopropyl alcohol, laureth, polyethylene glycol (macrogol)]
No
Gel (Ameluz External)
10% (per gram): $207.60
Solution (reconstituted) (Levulan Kerastick External)
20% (per each): $471.86
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, External, as hydrochloride:
Levulan Kerastick: 20% (1 ea) [contains alcohol, usp, isopropyl alcohol, laureth, polyethylene glycol (macrogol)]
For topical use only; not for ophthalmic, oral, or intravaginal use. During light treatment, both patients and health care personnel should wear appropriate eye protection.
Gel: Carefully wipe all lesions with an ethanol or isopropanol-soaked cotton pad (to degrease skin) and remove any scaling or crusts prior to application. Gently roughen lesion surfaces (avoid bleeding). Using a gloved fingertip or a spatula, apply gel ~1 mm thick and include ~5 mm of surrounding skin. Application area should not exceed 20 cm2 and no more than 2 g should be used at one time. May be applied to healthy skin around the lesion(s). Avoid mucous membranes (eyes, nostrils, mouth or ears); maintain a distance of 1 cm from these areas; rinse thoroughly if accidental contact with these areas occurs. Allow gel to dry ~10 minutes before covering with a light-blocking occlusive dressing. After 3 hours, remove dressing and wipe off residual gel. Immediately after removing dressing and residual gel, illuminate the treatment area with red light source. Position lamp 5 to 8 cm from patient's skin. Healthy untreated skin does not need protection during illumination.
After gel application, protect lesion sites and surrounding skin from sunlight or prolonged intense light (eg, tanning beds, sun lamps) for 2 days. If unable to perform red light illumination within 3 hours of gel application, rinse off gel with saline and water and protect lesion sites and surrounding skin from sunlight or prolonged intense light for 2 days.
Solution: Clean and dry lesion prior to application. Dab lesion gently with wet applicator tip (apply enough to uniformly wet lesion without excess running or dripping). Only apply to affected skin. Do not apply to periorbital area, ocular tissue, or mucosal surfaces. Allow to dry, then reapply to same lesion. Apply to either lesions on scalp, face, or upper extremities, but not to multiple regions simultaneously; lesions on the upper extremities should be occluded with low density polyethylene plastic wrap held in place with elastic net dressing until blue light therapy. Follow application with blue light exposure in 3 hours (upper extremity lesions) or in 14 to 18 hours (face or scalp lesions). Do not wash the application area during the time between application and during photosensitization; prior to blue light therapy, remove occlusive dressing (if applicable) and gently rinse actinic keratosis with water and pat dry. Stinging or burning may occur during blue light treatment. Following blue light treatment, the lesion will temporarily redden, swell and/or scale, which should resolve within 4 weeks after treatment.
After solution application, advise patient to avoid sunlight/bright light exposure to treated lesions (and wear a wide brimmed hat or other protective apparel) for at least 40 hours after application (burning/stinging sensation may still occur) even if blue light treatment is not performed, interrupted, or is stopped.
Actinic keratosis:
Gel (Ameluz): Lesion-directed and field-directed topical treatment of mild to moderate actinic keratosis of the face and scalp; to be used in conjunction with photodynamic therapy with narrowband red light illumination (using BF-RhodoLED or RhodoLED XL lamp).
Solution (Levulan Kerastick): Topical treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities; to be used in conjunction with photodynamic therapy with blue light illumination (using BLU-U blue light).
Actinic cheilitis; Basal cell skin cancer, superficial, low risk; Squamous cell skin cancer in situ, low risk (Bowen disease)
Aminolevulinic acid (topical) may be confused with aminolevulinic acid (systemic), methyl aminolevulinate
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Photosensitizing Agents: May enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Animal reproduction studies have not been conducted. Systemic absorption following topical application is negligible.
It is not known if aminolevulinic acid is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Systemic absorption following topical application is negligible.
Aminolevulinic acid is a metabolic precursor of the photosensitizer protoporphyrin IX (PpIX). Photosensitization following local/topical application of aminolevulinic acid occurs through the metabolic conversion to PpIX. When exposed to light of appropriate wavelength and energy, accumulated PpIX produces a photodynamic reaction resulting in local cytotoxicity. Precancerous and cancerous cells exhibit a higher rate of porphyrin induction compared to normal cells.
Peak fluorescence intensity of protoporphyrin IX (PpIX): Actinic keratosis: Solution: 11 hours ± 1 hour; Perilesional skin: 12 hours ± 1 hour
Half-life elimination: Mean fluorescence clearance half-life of PpIX for lesions: Solution: 30 ± 10 hours
Time to peak: Gel: 3 hours
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