Version May 2024
Actinic keratosis:
Metvix c-PDT: Thin or nonhyperkeratotic and nonpigmented actinic keratosis on face or scalp: Topical: Apply up to a maximum of 2 g for all lesions combined per treatment session, occlude treated lesions for 3 hours, followed by red light illumination. Assess patient after 3 months and if needed may administer one additional treatment session. Use without subsequent red light illumination is not recommended.
Metvix DL-PDT: Thin or nonhyperkeratotic and nonpigmented actinic keratosis on face or scalp: Topical: Apply up to a maximum of 2 g for all lesions combined per treatment session, followed by daylight exposure (no occlusion is recommended). Assess patient after 3 months and if needed may administer one additional treatment session. Use without subsequent daylight exposure is not recommended.
Basal cell carcinoma (superficial): Metvix c-PDT: Topical: Apply up to a maximum of 2 g for all lesions combined per treatment session, occlude treated lesions for 3 hours, followed by red light illumination. Repeat treatment session after 7 days. Following second treatment session, assess patient after 3 months and if needed may administer up to 2 additional treatment sessions (separated by 7 days). Use without subsequent red light illumination is not recommended.
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Dermatologic: Burning sensation of skin (≤86%; severe: ≤20%), crusted skin (including scabbing: ≤29%; severe: ≤2%), erythema of skin (63%; severe 6%), exfoliation of skin (14%; severe: 3%), pruritus (22%), skin blister (≤29%; severe: ≤2%), skin edema (≤18%; severe: ≤2%), skin erosion (≤29%; severe: ≤2%), skin pain (including discomfort: ≤86%; severe: ≤20%), skin photosensitivity (9% to 22%)
Ophthalmic: Eyelid edema (≤18%; severe: ≤2%)
1% to 10%:
Dermatologic: Dermal hemorrhage (2%), hyperpigmentation (1% to 2%), milia (2%), skin tightness (2%)
Infection: Infection (application site: 1%)
Local: Application-site discharge (2%), localized warm feeling (skin: 4%)
Nervous system: Headache (1% to 2%), pain (1%)
Frequency not defined:
Dermatologic: Diaphoresis
Gastrointestinal: Nausea
Hematologic & oncologic: Bruise, purpuric disease
Nervous system: Chills, dizziness, fatigue
Ophthalmic: Eye irritation, eye pain, increased lacrimation
Postmarketing:
Cardiovascular: Hypertension
Dermatologic: Allergic contact dermatitis, eczema (application site), pustular rash (application site), urticaria
Hypersensitivity: Angioedema, facial edema
Nervous system: Amnesia, confusion, disorientation
Hypersensitivity to methyl aminolevulinate or any component of the formulation, including peanut and almond oil; cutaneous photosensitivity/porphyria; morpheaform basal cell carcinoma.
Concerns related to adverse effects:
• Photosensitivity: Treatment sites will become photosensitive and should be protected from sunlight or bright indoor light (eg, examination lamps, operating room lamps, tanning beds, lights at close proximity) and protected from extreme cold with adequate clothing or by remaining indoors between application of cream and red light illumination and for 48 hours after treatment. Sunscreens will not protect against photosensitivity reactions caused by visible light.
• Sensitization: Burning, edema of lesions, erythema, and/or stinging may occur when treated areas are exposed to light. Contact sensitization, including allergic contact dermatitis, angioedema, or eczema may also occur.
Disease-related concerns:
• Amnesia: c-PDT with a lamp may cause transient global amnesia (rare); may be due to stress and pain associated with illumination with the lamp.
• Cardiovascular: Use with caution in patients with hypertension; pain during illumination may increase BP.
• Coagulation defects: Has not been tested on individuals with coagulation defects (acquired or inherited).
• Pigmented actinic keratosis: Has not been tested on patients with pigmented keratosis.
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: [Canadian Boxed Warning]: For external use only. Do not apply to eyes or mucous membranes; avoid contact with healthy skin. Should be applied by a qualified health professional. Has not been studied for >1 course of treatment (2 application sessions separated by 1 week). Assess lesion response 3 months after the last treatment session.
Not available in the United States.
Yes
Cream (Metvixia External)
16.8% (2 g): $189.48
Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Metvix: 16.8% (60 mL) [contains cetostearyl alcohol, edetate (edta) disodium, methylparaben, peanut oil, propylparaben]
Topical: For administration by health care professional only. Prepare lesions using a small dermal curette to remove scales and crusts and roughen the surface of the lesion. Wearing nitrile gloves (latex and vinyl gloves do not provide enough protection) and using a spatula, apply a layer of methyl aminolevulinate cream about 1 mm thick topically to prepared lesion(s) and the surrounding 5 to 10 mm of normal skin (field up to ~20 cm2). Multiple lesions may be treated during the same treatment session; do not exceed a treatment field area greater than the size of the light field of the lamp. Do not exceed a total of 2 g per treatment session.
When used in conjunction with c-PDTL: Occlude the site(s) with a nonabsorbent dressing for 3 hours (minimum 2.5 hours, maximum 4 hours), then remove. Remove excess cream with saline and illuminate with red light following lamp manufacturer's instructions. Following illumination of site, the treated area should be kept covered and away from bright indoor light and sunlight from 48 hours. If red light treatment is interrupted or stopped it may be restarted. However, if for any reason, red light illumination is not done, the cream should be removed within 3 hours (from time of initial application) and the area protected from sunlight or prolonged/intense light for 48 hours. Use in conjunction with Atkilite CL 128 lamp.
When used in conjunction with DL-PDT: Prior to preparing the lesions, sunscreen (≥ SPF 30), that does not include filters which may inhibit absorption of visible light (eg, titanium dioxide, zinc oxide, iron oxide), should be applied to all sun exposed areas including the treatment areas. Sunscreen should be dried and lesions prepped before applying methyl aminolevulinate. Occlusion of the treatment site(s) is not necessary. Patients should go outside immediately after therapy or within 30 minutes; remain in daylight for 2 continuous hours, then remove cream with soap and water.
Note: Not available in the United States.
Actinic keratosis: c-PDT to be used in conjunction with red light illumination or as daylight-photodynamic therapy (DL-PDT) for the treatment of thin or nonhyperkeratotic and nonpigmented actinic keratosis of the face and scalp.
Basal cell carcinoma, superficial: c-PDT to be used in conjunction with red light illumination for the treatment of biopsy-confirmed primary superficial basal cell carcinoma outside the H-zone of the face (eg, ears and nose) when other therapies are less appropriate.
Methyl aminolevulinate may be confused with aminolevulinic acid.
ALERT: Canadian Boxed Warning: Health Canada–approved labeling includes a boxed warning. See "Warnings/Precautions" section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted with methyl aminolevulinate cream.
It is not known if methyl aminolevulinate is excreted in breast milk. Because many drugs are secreted in human milk, caution should be exercised when administered to a breastfeeding mother. If methyl aminolevulinate cream is used in a breastfeeding mother, a decision should be made whether or not to stop breastfeeding.
BP in patients experiencing severe pain; signs of confusion or disorientation.
Methyl aminolevulinate (prodrug) is metabolically converted to photoactive porphyrins (PAPs), which accumulate in the skin lesions resulting in photosensitization. When exposed to light of appropriate wavelength and energy, the accumulated PAPs produce a photodynamic reaction, releasing oxygen singlets which result in local cytotoxicity.
Peak fluorescence intensity: 3 hours after application
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