Metvixia Side Effects

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

Side Effects of Metvixia - for the Consumer

Metvixia Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Metvixia Cream:

Burning; crusting; flushing; itching; pain; redness; scabbing; scaling; skin blisters; stinging; swelling; tenderness; tightness.

Seek medical attention right away if any of these SEVERE side effects occur when using Metvixia Cream:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding; change of skin color; oozing; pustules; severe or persistent burning, inflammation, irritation, pain, redness, or tenderness; swelling of the eyes or eyelids; ulceration; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Metvixia Side Effects - for the Professional

Metvixia

Dermal Safety Studies

Studies in healthy volunteer subjects and subjects with actinic keratoses previously treated with Metvixia-PDT on at least 4 previous occasions have demonstrated that Metvixia Cream has the potential to cause irritancy and sensitization. A cumulative irritancy and sensitization (allergenicity) study of Metvixia Cream with a cross-sensitization challenge with aminolevulinic acid (ALA) was performed in 156 subjects. Metvixia 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 aluminum Finn Chamber. After the 3-week continuous treatment period and a 2-week interval without further applications, subjects were challenged with Metvixia Cream, Metvixia 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 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-PDT on at least 4 previous occasions. Metvixia 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 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 Cream, six Metvixia 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 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
* Mild, Moderate, or Severe
Any Treatment Site Adverse Reaction	All Grades*	Severe	All Grades*	Severe
	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%)

Postmarking Experience

The following adverse reactions have been identified during post approval use of Metvixia 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.

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Side Effects by Body System - for Healthcare Professionals

Local

Local (treatment site) side effects reported in two clinical trials have included 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); skin warmth (4%); application site discharge (2%); skin hemorrhage (2%); skin tightness (2%); and skin hyperpigmentation (2%).

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.

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.

Hypersensitivity side effects reported in postmarketing use outside the U.S. have included eczema, allergic contact dermatitis, and 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.

Ocular

Ocular side effects reported in postmarketing use outside the U.S. have included edema, eyelid swelling, macular edema, vitreous detachment, and keratitis.

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