Dosing & Uses
Dosage Forms & Strengths
topical gel (Ameluz)
- 10%
topical solution (Levulan Kerastick)
- 20%
Actinic Keratosis
Ameluz: Used in combination with photodynamic therapy (PDT) using BF-RhodoLED lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp
Levulan Kerastick: Indicated for treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities with blue light illumination using the BLU-U Blue Light Photodynamic Therapy (PDT) Illuminator
See Administration
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (78)
- acitretin
acitretin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- adapalene
adapalene, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- afatinib
afatinib, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- alitretinoin topical
alitretinoin topical, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- aminolevulinic acid oral
aminolevulinic acid oral, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.
- amiodarone
amiodarone, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- bendroflumethiazide
bendroflumethiazide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- bexarotene
bexarotene, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- bicalutamide
bicalutamide, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- calcitriol topical
calcitriol topical, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- celecoxib
celecoxib, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- chlorothiazide
chlorothiazide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- chlorpromazine
chlorpromazine increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- chlorpropamide
chlorpropamide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- chlorthalidone
chlorthalidone increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- ciprofloxacin
ciprofloxacin increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- cobimetinib
cobimetinib, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- demeclocycline
demeclocycline increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- diclofenac
diclofenac, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- diclofenac topical
diclofenac topical, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- diflunisal
diflunisal, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- dong quai
dong quai, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- doxycycline
doxycycline increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- erythromycin base
erythromycin base increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- etodolac
etodolac, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- fenoprofen
fenoprofen, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- fluphenazine
fluphenazine increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- flurbiprofen
flurbiprofen, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- gemifloxacin
gemifloxacin increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- glimepiride
glimepiride increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- glipizide
glipizide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- glyburide
glyburide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- griseofulvin
griseofulvin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- hydrochlorothiazide
hydrochlorothiazide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- ibuprofen
ibuprofen, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- ibuprofen IV
ibuprofen IV, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- indapamide
indapamide, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- indomethacin
indomethacin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- isotretinoin
isotretinoin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- ketoprofen
ketoprofen, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- ketorolac
ketorolac, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- ketorolac intranasal
ketorolac intranasal, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- levofloxacin
levofloxacin increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- meclofenamate
meclofenamate, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- mefenamic acid
mefenamic acid, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- meloxicam
meloxicam, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- methyclothiazide
methyclothiazide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- methyl aminolevulinate
methyl aminolevulinate, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
aminolevulinic acid topical, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other. - metolazone
metolazone, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- minocycline
minocycline increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- moxifloxacin
moxifloxacin increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- nabumetone
nabumetone, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- naproxen
naproxen, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- ofloxacin
ofloxacin increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- oxaprozin
oxaprozin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- oxytetracycline
oxytetracycline, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- panitumumab
panitumumab, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- perphenazine
perphenazine increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- pirfenidone
pirfenidone, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- piroxicam
piroxicam, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- porfimer
porfimer, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- prochlorperazine
prochlorperazine increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- St John's Wort
St John's Wort increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- sulfadiazine
sulfadiazine increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- sulfamethoxazole
sulfamethoxazole, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- sulfisoxazole
sulfisoxazole increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- sulindac
sulindac, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- tetracycline
tetracycline increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- thioridazine
thioridazine increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- tolazamide
tolazamide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- tolbutamide
tolbutamide increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- tolmetin
tolmetin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- tretinoin
tretinoin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- tretinoin topical
tretinoin topical, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- trifluoperazine
trifluoperazine increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
- vemurafenib
vemurafenib, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- verteporfin
verteporfin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- voriconazole
voriconazole, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
Monitor Closely (0)
Minor (0)
Adverse Effects
Adverse effects are for all grades unless otherwise specified
>10%
Ameluz
- Erythema (92%)
- Pain/burning (92%)
- Irritation (72%)
- Edema (35%)
- Pruritus (34%)
- Exfoliation (19%)
- Scab (19%)
- Induration (12%)
- Vesicles (12%)
Levulan Kerastick
-
Face
- Scaling/crusting (1-71%)
- Itching (1-25%)
- Hypo/hyperpigmentation (22%)
- Erosion (1-14%)
-
Scalp
- Scaling/crusting (2-64%)
- Hypo/hyperpigmentation (36%)
- Itching (7-14%)
- Skin disorder NOS (12%)
-
Upper extremities
- Erythema (100%)
- Stinging/burning (96%)
- Scaling and dryness (87%)
- Hyperpigmentation (73%)
- Edema (56%)
- Hypopigmentation (50%)
- Oozing/vesiculation/crusting (41%)
1-10%
Ameluz
- Paresthesia (9%)
- Hyperalgesia (5%)
- Discomfort (3%)
- Erosion (3%)
- Discharge (2%)
- Bleeding (1%)
- Pustules (1%)
Levulan Kerastick
-
Face
- Wheal/flare (1-7%)
- Skin disorder NOS (5%)
- Ulceration (4%)
- Bleeding/hemorrhage (4%)
- Vesiculation (4%)
- Pustules (4%)
- Dysesthesia (2%)
- Scabbing (1-2%)
- Excoriation (1%)
- Oozing (1%)
- Pain (1%)
- Tenderness (1%)
- Edema (1%)
-
Scalp
- Vesiculation (5%)
- Tenderness (2%)
- Ulceration (2%)
- Bleeding/hemorrhage (2%)
- Erosion (2%)
- Wheal/flare (2%)
Postmarketing Reports
Skin and subcutaneous tissue disorders: Erythema, swelling, application site inflammation, skin discoloration; increased photosensitivity, allergic dermatitis
Eye disorders: Eye irritation, diplopia, ocular hyperemia, photophobia, and blurred vision
Coagulation defects
Transient amnestic episodes
Dysaesthesia
Fatigue
Warnings
Contraindications
Hypersensitivity to porphyrins
Hypersensitivity to any gel components, which includes soybean phosphatidylcholine
Porphyria; drug may cause uncontrolled phototoxic effects
Known photodermatoses of varying pathology and frequency (eg, metabolic disorders [aminoaciduria], idiopathic or immunological disorders [polymorphic light reaction], genetic disorders [xeroderma pigmentosum], and diseases precipitated or aggravated by exposure to sun light [lupus erythematoides or pemphigus erythematoides])
Levulan Kerastick
- Cutaneous photosensitivity at wavelengths of 400-450 nm
Cautions
Ameluz
- Transient amnestic episodes reported during postmarketing use of topical gel in combination with photodynamic therapy
- BF-RhodoLED lamp may cause eye irritation, glare, or injury; protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period
- Has not been tested on patients with inherited or acquired coagulation disorders; special care should be taken to avoid bleeding during lesion preparation
- Eyelid edema and mucous membrane irritation reported; rinse eyes with water in case of accidental contact
- Several cases of hypersensitivity reported during postmarketing use prior to PDT illumination; if allergic reactions occur, clean the area of skin where product was applied and institute appropriate therapy; inform patients and their caregivers that therapy may cause hypersensitivity, potentially including severe courses (anaphylaxis)
Levulan Kerastick
- Topical solution contains alcohol and is intended for topical use only; irritation may occur if applied to eyes or mucus membranes; do not apply to eyes or to mucous membranes; excessive irritation may be experienced if this product is applied under occlusion >3 hr
- Treatment site will become photosensitive and patients should avoid exposure of 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; before exposure to sunlight, patients should protect treated lesions from sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves; because of potential for skin to become photosensitized, the 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
- Temporary memory problems reported during treatment in combination with BLU-U Blue Light Photodynamic Therapy Illuminator; inform healthcare provider right away if problems with memory, confusion, or disorientation occur during treatment
- Safety and efficacy not established on patients with inherited or acquired coagulation defects
Pregnancy
Pregnancy
Ameluz: No available data
Levulan Kerastick: Limited available data with topical solution use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes
Lactation
Unknown if distributed in human breast milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Aminolevulinic acid is a precursor of photoactive porphyrins, which accumulate in the skin lesions where the product has been applied and are subsequently illuminated with a photodynamic lamp
When exposed to the light, the accumulated photoactive porphyrins produce a photodynamic reaction, resulting in a cytotoxic process dependent on the simultaneous presence of oxygen, which as a result generates a singlet oxygen; the singlet oxygen can then react to form superoxide and hydroxyl radicals
Absorption
Ameluz
- Plasma concentration: After occlusion for 3 hr, up to 2.5-fold increase of aminolevulinic acid plasma concentrations observed
- Peak plasma time: 3 hr
- Peak plasma concentration: 27.19 ng/mL
- AUC: 142.83 ng·hr/mL
Levulan Kerastick
- Peak plasma time: 2 hr
- Peak plasma concentration: 249.9 ng/mL
- AUC: 669.9 ng·hr/mL
Excretion
Levulan Kerastick
- Half-life: 5.7 hr
Administration
Topical Administration
Topical product should be only applied by physician or qualified medical personnel
For topical use only; not for ophthalmic, oral, or intravaginal use
Photodynamic therapy is a multistep process
Ameluz
- One session of photodynamic therapy should be administered for single lesions or an entire field affected by multiple lesions
- Evaluate 3 months after treatment
- Non- or partially responding lesions should be retreated in a second session
Step 1: Lesion preparation
- Before applying gel, carefully wipe all lesions with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin
- Thereafter, gently roughen all lesion surfaces; take care to avoid bleeding
Step 2: Gel application
- Using gloved protected fingertips or spatula, apply gel ~1 mm thick to lesion(s) and include ~5 mm of the surrounding skin; if multiple lesions, cover the entire area (not to exceed 20 cm² and no more than 2 g (ie, 1 tube) for a session
- The gel can be administered to healthy skin around the lesions, whereas application near the eyes, nostrils, mouth, ears or mucosa should be avoided (keep a distance of 1 cm)
- Avoid direct contact of gel with the eyes or mucous membrane; if accidentally exposed, rinse with water
Step 3: Occlude for 3 hours
- Allow gel to dry for ~10 minutes, before an occlusive light-tight dressing is placed over the treatment site
- Following 3 hr of incubation, the dressing should be removed and the remnant gel wiped off
Illumination with red light
- Immediately after cleaning the lesions, the entire treatment area will be illuminated with a red light source with a narrow spectrum around 635 nm that delivers a light dose of approximately 37 J/cm² within 10 minutes
- During illumination the lamp should be fixed at the distance from the skin surface that is indicated in the user manual
- Position the lamp head 5-8 cm from the skin’s surface; when an area of 8 x 18 cm is illuminated, the effective treatment area is 6 x16 cm
- Larger areas can be illuminated in several steps
- If for any reason, the lesions cannot be illuminated within 3 hr after application, rinse off the gel with saline and water
- For 2 days, protect the lesion sites and surrounding skin from sunlight or prolonged or intense light
Levulan Kerastick
- Prepare solution by crushing the bottom ampule (diluent) and then the top ampule (powder) of the stick to; shake gently for 30 sec
- 1 application per site per 8 week session
- Apply to affected area; allow to dry
- Do not apply solution to the periorbital area or allow it to contact ocular or mucosal surfaces
- For upper extremities: Occlude upper extremity with low density polyethylene plastic wrap and hold in place with an elastic net dressing
- Follow application with blue light (400-450 nm) photodynamic blue light treatment 14-18 hr later
- May treat a second time lesions that did not completely healed after 8 hr
- At light illumination visit before treatment, gently rinse treated area with water and patted dry
Storage
Ameluz
- Unopened gels: Store refrigerated between 2-8°C (36-46°F); excursions permitted to 15-30°C (59-86°F)
- Opened gels: Refrigerate at 2-8°C (36-46°F) if the tube is tightly closed for up to 12 wk
Levulan Kerastick
- Unused applicators: Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
- Prepared solutions: Must be used within 2 hr of dissolution
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Gleolan oral - | 30 mg/mL solution |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
aminolevulinic acid HCl topical
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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