aminolevulinic acid topical (Rx)

Brand and Other Names:Ameluz, Levulan Kerastick
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

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            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)

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                  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

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                  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
                  • Safety and efficacy not established on patients with inherited or acquired coagulation defects
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                  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.

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                  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
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                  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
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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Gleolan oral
                  -
                  30 mg/mL solution

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  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) 2021 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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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                  Additional Offers
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.