Generic name: METHYL AMINOLEVULINATE HYDROCHLORIDE 168mg in 1g
Dosage form: cream
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This product is to be used only by physicians in the physician’s office.
METVIXIA Cream is not for ophthalmic, oral or intravaginal use.
Photodynamic therapy (PDT) for non-hyperkeratotic actinic keratoses with METVIXIA Cream is a multi-stage process as described below: Two treatment sessions one week apart should be administered. Not more than one gram (half tube) of METVIXIA Cream should be applied per treatment session. Multiple lesions may be treated during the same treatment session using a total of one gram of METVIXIA Cream. Lesion response should be assessed 3 months after the last treatment session. Nitrile gloves should be worn when applying and removing the cream.
The Aktilite CL128 lamp, which is equipped with light emitting diodes (LEDs), emits red light with a narrow spectrum at approximately 630 nm, and a half-width of approximately 20 nm. The light dose to be used is 37 J/cm2, and the lamp should be placed 50 to 80 mm from the skin. The area of skin that can be illuminated is 80 x 180 mm. Calibration by the operator is not needed, and the illumination time is calculated automatically. The LED panel window should be cleaned daily with a slightly moist clean cloth.
If Aktilite red light treatment is interrupted or stopped for any reason, it may be restarted. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off and the patient should protect the exposed area from sunlight, prolonged or intense light for at least 48 hours.
Physicians should be knowledgeable about photodynamic therapy and familiar with the Aktilite Operators Manual prior to use of METVIXIA Cream.
One METVIXIA-PDT session consists of:
- Lesion preparation [See Dosage and Administration (2.1)]
- Application of METVIXIA Cream [See Dosage and Administration (2.2)]
- Application of occlusive dressing [See Dosage and Administration (2.3)]
- Occlusion for 3 hours [See Dosage and Administration (2.4)]
- Removal of excess cream with saline [See Dosage and Administration (2.5)]
- Positioning Aktilite CL128 lamp [See Dosage and Administration (2.6)]
- Illumination with red light (Aktilite CL128 lamp) [See Dosage and Administration (2.7)]
- Before applying METVIXIA Cream, the surface of the lesions should be prepared with a small dermal curette to remove scales and crusts and roughen the surface of the lesion. This is to facilitate access of the cream and light to all parts of the lesion.
Figure 1A Lesion debriding
- Only nitrile gloves should be worn during this and subsequent steps and Universal Precautions should be taken. Vinyl and latex gloves do not provide adequate protection when using this product.
Figure 1B Lesion debriding
Application of METVIXIA Cream
- Using a spatula, apply a layer of METVIXIA Cream about 1 mm thick to the lesion and the surrounding 5 mm of normal skin. Do not apply more than one gram (half tube) of METVIXIA Cream per treatment session.
Figure 2: Cream application
Occlusive Dressing Cover
- The area where the cream has been applied should then be covered with an occlusive, non-absorbent dressing for 3 hours. Multiple lesions may be treated during the same treatment session. Each treatment field is limited to an area of 80 x 180 mm.
Figure 3: Occlusive dressing application
Occlusion for 3 hours
(at least 2.5 hours, but no more than 4 hours)
- After 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 Aktilite 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. Patients should protect treated areas 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. It has not been determined if perspiration can spread the METVIXIA Cream outside the treatment site to the eyes or surrounding skin. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of METVIXIA Cream and Aktilite PDT light treatment.
Removal of Excess Cream with Saline
- Following removal of the occlusive dressing, clean the area with saline and gauze. Wear nitrile gloves.
Figure 4: Cream removal
Positioning Aktilite CL128 Lamp
- See Aktilite CL128 Operators Manual for specific warnings, cautions and instructions. If necessary adjust the dose to 37 J/cm2 . Calibration by the operator is not required. Position the lamp over the area to be illuminated by the use of guide light. The distance between the LED panel and the lesion surface should be 50 to 80 mm (2 to 3.2 in). Do not stare into the beam. The patient and operator should wear appropriate eye protection during illumination. Patient protective goggles or eye shields are dark or of metal to block visible light.
Figure 5: Positioning Aktilite CL128
Illumination with Aktilite CL128 Lamp Red Light
- The required illumination time (7-10 minutes) is calculated automatically, and remaining time will be displayed at the control panel. The illumination stops automatically. The illumination may be paused and started again. Patients should be advised that transient pain, burning or stinging at the target lesion sites may occur during the period of light exposure.
Figure 6: Illumination
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