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methyl aminolevulinate (Rx)Brand and Other Names:Metvixia

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream

  • 16.8%
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Actinic Keratosis

Indicated in conjunction with photodynamic therapy for treatment of minimally to moderately thick actinic keratoses of the face or scalp

Apply product only by a qualified physician, NOT patient or unqualified healthcare personnel

Metvixia

  • Apply on skin with spatula about 1 mm thick to lesion and surrounding 5 mm of normal skin, not to exceed >1 g per session
  • Cover area with occlusive non-absorbent dressing for 3 hr
  • Treatment area not to exceed 80 x 180 mm
  • Within 4 hr of application, remove dressing, rinse off cream, and perform red light (57-670 nm) photodynamic therapy (total light dose 75 J/cm²)
  • Repeat once after 7 days; assess response 3 months after the last treatment session

Not recommended

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Interactions

Interaction Checker

methyl aminolevulinate and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10% (with Aktilite PDT illum)

            Skin burning/pain/discomfort (86%)

            Erythema (63%)

            Scabbing/crusting/blisters (29%)

            Pruritus (22%)

            Skin or eyelid edema (18%)

            Skin exfoliation (14%)

            1-10%

            Skin warm (4%)

            Application site discharge (2%)

            Skin hemorhage (2%)

            Skin hyperpigmentation (2%)

            Skin tightness (2%)

            Postmarketing Reports

            Allergic reactions: Eczema, allergic contact dermatitis, and urticaria localized to treatment area; rarely erythema and swelling have been more extensive

            Hypersensitivity: Angioedema, facial edema, and application site infections

            Malignancies: Squamous cell carcinoma of the skin, as expected in this population

            Eye disorders: Macular edema, vitreous detachment, and keratitis

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            Warnings

            Contraindications

            Cutaneous photosensitivity

            Sensitivity to porphyrin or other components (contains peanut and almond oil)

            Cautions

            Use within 2 hr of activation

            Avoid light exposure between solution application and light treatment (wear hat, etc)

            Should not be applied in or around the eyes or to mucous membranes

            Avoid exposure to outdoor or bright light during time between drug application and light treatment, and for 2 days afterwards

            Photosensitized skin may produce a stinging or burning sensation and become erythematous similarly to actinic keratoses; to ensure drug is only applied to actinic keratoses and not perilesional skin aminolevulinic acid should be applied by qualified professional

            Therapy never tested in patients with inherited or acquired coagulation disorders

            Therapy not tested for carcinogenic risk

            Cream has demonstrated high rate of contact sensitization

            Effects on therapy on fertility unknown

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: unknown whether distributed in milk; use caution

            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

            Precursor of photoactive porphyrins, which accumulate in the skin lesions where the product has been applied and are subsequently illuminated with red light of narrow spectrum using a light dose of 37 J/cm² delivered by the Aktilite CL128 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

            Pharmacokinetics

            Peak fluorescence: 3 hr (methyl aminolevulinate)

            Half-life: 30 ± 10 hr (lesions)

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            Images

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            Formulary

            FormularyPatient Discounts

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            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.
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