Metvixia topical

Name: Metvixia topical

What is the most important information I should know about methyl aminolevulinate?

You should not use this medicine if you are allergic to porphyrins, peanuts or almonds, or if your skin is especially sensitive to light.

Precautions

Consult your pharmacist.

Interactions

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

What happens if I miss a dose?

Because Metvixia cream is applied only when needed prior to red light therapy, you will not be on a dosing schedule.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

For Healthcare Professionals

Applies to methyl aminolevulinate topical: topical cream

Hypersensitivity

In a cumulative irritancy and sensitization study, methyl aminolevulinate cream was applied three times each week for 3 weeks to separate sites on the back of healthy volunteers. Following a 2-week interval without further applications, 30 out of 58 subjects (52%) who were rechallenged with the cream for 48 hours showed contact sensitization.

The potential for sensitization was also assessed by patch testing in a total of 21 patients with actinic keratoses previously treated with methyl aminolevulinate cream on at least four occasions. Methyl aminolevulinate cream and vehicle cream were applied to different sites on the lower back for 48 hours. Three patients (14%) showed contact sensitization associated with erythema scores of 4 or higher (strong erythema spreading outside the patch), edema, vesiculation, papules, and glazing.[Ref]

Postmarketing reports: Eczema, allergic contact dermatitis, urticaria, . Most cases were localized to the treatment area, but rarely, erythema and swelling have been more extensive. Contact sensitization has been demonstrated in dermal safety studies.[Ref]

Ocular

Very common (10% or more): Eyelid edema (18%)
Postmarketing reports: Edema, eyelid swelling, macular edema, vitreous detachment, keratitis[Ref]

Local

Very common (10% or more): Skin burning/pain/discomfort (86%; 20% severe), erythema (63%; 6% severe), scabbing/crusting/blister/erosions (29%; 2% severe), pruritus (22%), skin or eyelid edema (18%; 2% severe), skin exfoliation (14%; 3% severe)
Common (1% to 10%): Skin warmth (4%), application site discharge (2%), skin hemorrhage (2%), skin tightness (2%), and skin hyperpigmentation (2%)
Postmarketing reports: Angioedema[Ref]

Treatment site reactions occurred in 113 out of 126 (90%) patients treated with methyl aminolevulinate cream in two clinical trials. The most frequent adverse reactions were associated with phototoxicity at the treatment site. Pain and burning sensation typically begin during illumination and resolve completely within a few minutes or hours, but may last up to a few days. Erythema and other signs generally resolve within a few days to 3 weeks.[Ref]

Some side effects of Metvixia may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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