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warnings and cautions
5 WARNINGS AND PRECAUTIONS METVIXIA Cream is intended for topical use in the physician’s office by physicians only. The recurrence rate of treated lesions is unknown. (5.1) Patients should be cautioned to wear protective clothing after exposure to METVIXIA. (5.2) METVIXIA Cream has demonstrated a high rate of contact sensitization (allergenicity). (5.3) Patients and providers should wear protective eyewear before operating the Aktilite lamp. (5.4) 5.1 General METVIXIA Cream is intended for topical use in the physician’s office by physicians. METVIXIA Cream has not been studied for more than one course which consists of two treatment sessions one week apart. Clinical studies did not follow patients beyond 3 months, and the recurrence rate of treated lesions is unknown. 5.2 Photosensitivity During the time period between the application of METVIXIA Cream and exposure to Aktilite red light illumination, the treatment site will become photosensitive. If for any reason the patient cannot have the Aktilite red light treatment after application of METVIXIA Cream, the cream should be rinsed off, and the patient should protect the treated area from sunlight, prolonged or intense light for two days. Prolonged exposure for greater than 4 hours to METVIXIA Cream should be avoided. After METVIXIA Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Before exposure to sunlight, patients should, therefore, protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of METVIXIA Cream and Aktilite red light treatment. After illumination of METVIXIA Cream, the area treated should be kept covered and away from light for at least 48 hours. Because of the potential for skin to become photosensitized, the METVIXIA Cream should be used by a trained physician to apply drug only to non-hyperkeratotic actinic keratoses and perilesional skin within 5 mm of the lesion. Redness, swelling, burning, and stinging are expected as a result of therapy; however, if these symptoms increase in severity and persist longer than 3 weeks, the patient should contact their doctor. 5.3 Hypersensitivity METVIXIA Cream has demonstrated a high rate of contact sensitization (allergenicity) [ See Adverse Reactions (6.2) ]. Care should be taken by the physician applying METVIXIA Cream to avoid inadvertent skin contact. Nitrile gloves should be worn when applying and removing the cream. Vinyl and latex gloves do not provide adequate protection when using this product. METVIXIA Cream is formulated with peanut oil and refined almond oil. METVIXIA Cream has not been tested in patients who are allergic to peanuts. 5.4 Aktilite Lamp Before operating the Aktilite CL128 lamp, personnel should refer to the Operators Manual for specific warnings, cautions and instructions. Care should be exercised when positioning and operating the lamp. During the red light illumination period, the patient, operator and other persons present should wear protective goggles that sufficiently screen out the appropriate spectrum of red light. The protective goggles or eye shields provided for the patient are dark or of metal to block visible light. The green professional protective glasses provided for the operator screen out the relevant spectrum of red light and the room will still appear bright for the operator to see. Do not stare into the beam. For lamp assembly, maintenance, service and technical data the personnel should refer to the Operators Manual.
6 ADVERSE REACTIONS Most common related adverse reactions (incidence greater than 10% and greater than placebo) are erythema; pain, burning and discomfort; pruritus; scabbing, crusting and erosions; edema and exfoliation of the skin. (6) To report SUSPECTED ADVERSE REACTIONS, contact: Galderma Laboratories, L.P. at 1-866-735-4137, or FDA at 1-800-FDA-1088 or go to www.fda.gov/medwatch. 6.1 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/cm 2 . 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 trials, 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 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 6.2 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. 6.3 Postmarketing Experience The following adverse reactions have been identified during post approval use of METVIXIA Cream. 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. 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 macular edema, vitreous detachment and keratitis. There have been reports of angioedema, facial edema and application site infections.