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Metvixia

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Metvixia

Metvixia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Metvixia (methyl aminolevulinate) Cream, 16.8% makes your skin more sensitive to light and is used in combination with red light therapy to treat a skin condition called actinic keratosis of the face and scalp. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include mild skin redness, warmth, burning, or swelling; puffy eyes; slight pain; or itching, peeling, scabs or crusting of treated skin.

Photodynamic therapy (PDT) for non-hyperkeratotic actinic keratoses with Metvixia Cream is a multi-stage process: Two treatment sessions one week apart should be administered. Not more than one gram (half tube) of Metvixia (methyl aminolevulinate cream) Cream should be applied per treatment session. Metvixia may interact with amiodarone, oral diabetes medications, diltiazem, furosemide, porfimer, quinidine, tacrolimus, verteporfin, ACE inhibitors, antibiotics, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), or sulfa drugs. Tell your doctor all medications and supplements you use. It is not known if Metvixia is harmful to a fetus. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Metvixia (methyl aminolevulinate) Cream, 16.8% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Metvixia in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have severe stinging, burning, redness, oozing, or swelling of treated skin areas, especially if you have these effects for longer than 3 weeks after treatment.

Less serious side effects may include:

  • mild skin redness, warmth, burning, or swelling;
  • puffy eyes;
  • slight pain; or
  • itching, peeling, scabs or crusting of treated skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Read the entire detailed patient monograph for Metvixia (Methyl Aminolevulinate Cream) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Metvixia FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Dermal Safety Studies

Studies in healthy volunteer subjects and subjects with actinic keratoses previously treated with Metvixia (methyl aminolevulinate cream) -PDT on at least 4 previous occasions have demonstrated that Metvixia (methyl aminolevulinate cream) Cream has the potential to cause irritancy and sensitization. A cumulative irritancy and sensitization (allergenicity) study of Metvixia (methyl aminolevulinate cream) Cream with a cross-sensitization challenge with aminolevulinic acid (ALA) was performed in 156 subjects. Metvixia (methyl aminolevulinate cream) Cream was applied 3 times each week for 3 weeks (total of 9 applications), to separate sites on the back of healthy volunteers. After each application, the area was covered by an aluminum Finn Chamber. After the 3-week continuous treatment period and a 2-week interval without further applications, subjects were challenged with Metvixia (methyl aminolevulinate cream) Cream, Metvixia (methyl aminolevulinate cream) vehicle, ALA, and ALA-vehicle creams for 48 hours. Assessment of skin reactions was performed 48, 72, and 96 h after start of the challenge cream application. Only 98 of the 156 subjects tested entered the challenge phase because of a high incidence of local irritancy evident as erythema. Of the 58 subjects who were challenged with Metvixia (methyl aminolevulinate cream) Cream, 30 (52 %) showed contact sensitization. Of the 98 subjects who were challenged with ALA, only 2 (2 %) showed equivocal reactions the remaining subjects having negative responses.

The potential for sensitization was also assessed by patch testing a total of 21 patients with actinic keratoses previously treated with Metvixia (methyl aminolevulinate cream) -PDT on at least 4 previous occasions. Metvixia (methyl aminolevulinate cream) Cream 16.8 % and vehicle cream were applied to different sites on the lower back for 48 hours. Three of the 21 patients (14%) showed contact sensitization associated with erythema scores ≥ 4 (strong erythema spreading outside the patch) and edema, vesiculation, papules and glazing.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 231 subjects, each with 4 - 10 actinic keratoses were enrolled in 2 double-blind, randomized, vehicle-controlled clinical trials. Subjects were randomized to receive Aktilite PDT with Metvixia (methyl aminolevulinate cream) Cream 16.8 % or Vehicle cream on 2 occasions 1 week apart. Cream was applied for approximately 3 hours under occlusion followed immediately by illumination using the Aktilite CL128 lamp, delivering red light at a dose of 37 J/cm².

Table 1 shows the incidence and severity of local (treatment site) adverse reactions in these two trials. The most frequent adverse reactions were associated with phototoxicity at the treatment site. Pain and burning sensation typically begin during illumination and generally 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.

In these two studies, out of 126 subjects treated with Metvixia (methyl aminolevulinate cream) Cream, six Metvixia (methyl aminolevulinate cream) Aktilite PDT subjects did not complete the full two treatment session regimen due to adverse reactions such as headache, pain, or burning. These subjects either stopped illumination early or did not have the second treatment. In addition, 12 Metvixia (methyl aminolevulinate cream) PDT subjects paused illumination due to pain, burning or stinging but did subsequently complete treatment.

Table 1: Incidence of Treatment Site Adverse Reactions in ≥ 1% of Subjects in Studies 1 and 2 (Safety Population)

  Metvixia & Aktilite PDT
n =126
Vehicle & Aktilite PDT
n =105
All Grades* Severe All Grades* Severe
Any Treatment Site Adverse Reaction 113 (90%) 28 (22%) 48 (46%) 0 (0%)
Skin burning/pain/discomfort 109 (86%) 25 (20%) 38 (36%) 0 (0%)
Erythema 80 (63%) 7 (6%) 11 (10%) 0 (0%)
Scabbing/crusting/blister/erosions 36 (29%) 2 (2%) 1 (1%) 0 (0%)
Pruritus 28 (22%) 0 (0%) 8 (8%) 0 (0%)
Skin or eyelid edema 23 (18%) 2 (2%) 1 (1%) 0 (0%)
Skin exfoliation 17 (14%) 4 (3%) 3 (3%) 0 (0%)
Skin warm 5 (4%) 0 (0%) 2 (2%) 0 (0%)
Application site discharge 3 (2%) 0 (0%) 0 (0%) 0 (0%)
Skin hemorrhage 2 (2%) 0 (0%) 0 (0%) 0 (0%)
Skin tightness 2 (2%) 0 (0%) 0 (0%) 0 (0%)
Skin hyperpigmentation 2 (2%) 0 (0%) 0 (0%) 0 (0%)
*Mild, Moderate, or Severe

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Metvixia (methyl aminolevulinate cream) Cream outside of the United States. Because these reactions are reported voluntary from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Reports of serious adverse reactions at or near the application site include pain, erythema, edema, pustules, scab, crusting, and hyperpigmentation. Allergic reactions reported include eczema, allergic contact dermatitis and urticaria. Most cases were localized to the treatment area; rarely erythema and swelling have been more extensive. At sites distant from the application site there have been reports of squamous cell carcinoma of the skin, as expected in this population. There have been occasional reports of eye disorders including edema, eyelid swelling, macular edema, vitreous detachment and keratitis.

Read the entire FDA prescribing information for Metvixia (Methyl Aminolevulinate Cream) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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