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Metvixia (methyl aminolevulinate cream) Cream in combination with Aktilite CL128 lamp red light illumination is indicated for treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratoses of the face and scalp in immunocompetent patients. This photodynamic therapy should be used in conjunction with appropriate lesion preparation in the physician's office when other therapies are considered medically less appropriate [See DOSAGE AND ADMINISTRATION].
The safety and efficacy have not been established for the treatment of cutaneous malignancies or for skin lesions other than non-hyperkeratotic face and scalp actinic keratoses using PDT with Metvixia (methyl aminolevulinate cream) Cream. The safety and efficacy of Metvixia (methyl aminolevulinate cream) Cream have not been established in patients with immunosuppression, porphyria or pigmented actinic keratoses.
DOSAGE AND ADMINISTRATION
Photodynamic therapy (PDT) for non-hyperkeratotic actinic keratoses with Metvixia (methyl aminolevulinate cream) 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 (methyl aminolevulinate cream) 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 (methyl aminolevulinate cream) 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.
Use of Metvixia (methyl aminolevulinate cream) Cream without subsequent red light illumination is not recommended.
This product is to be used only by physicians in the physician's office. Metvixia (methyl aminolevulinate cream) Cream is not for ophthalmic, oral, or intravaginal use. Physicians should be knowledgeable about photodynamic therapy and familiar with the Aktilite Operators Manual prior to use of Metvixia (methyl aminolevulinate cream) Cream.
One Metvixia (methyl aminolevulinate cream) -PDT session consists of:
- Lesion preparation [See DOSAGE AND ADMINISTRATION]
- Application of Metvixia (methyl aminolevulinate cream) Cream [See DOSAGE AND ADMINISTRATION]
- Application of occlusive dressing [See DOSAGE AND ADMINISTRATION]
- Occlusion for 3 hours [See DOSAGE AND ADMINISTRATION]
- Removal of excess cream with saline [See DOSAGE AND ADMINISTRATION]
- Positioning Aktilite CL128 lamp [See DOSAGE AND ADMINISTRATION]
- Illumination with red light (Aktilite CL128 lamp) [See DOSAGE AND ADMINISTRATION]
Before applying Metvixia (methyl aminolevulinate cream) 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 (methyl aminolevulinate cream) Cream
Using a spatula, apply a layer of Metvixia (methyl aminolevulinate cream) Cream about 1 mm thick to the lesion and the surrounding 5 mm of normal skin. Do not apply more thanone gram (half tube) of Metvixia (methyl aminolevulinate cream) 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 (methyl aminolevulinate cream) 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 (methyl aminolevulinate cream) 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 to3.2 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
Dosage Forms And Strengths
16.8% cream in 2 g tubes
Storage And Handling
Metvixia (methyl aminolevulinate cream) Cream, 16.8%, is available as the following:
2 gram aluminum tube, box of 1 (NDC 63069-401-01)
Keep out of reach of children
For topical use only by physicians in the physician's office. Dispense only to physicians and only to be applied by a physician.
Physicians should wear nitrile gloves when applying and removing Metvixia (methyl aminolevulinate cream) Cream.
Vinyl and latex gloves do not provide adequate protection when using this product.
Store/Transport refrigerated, 2-8°C (36-46°F).
Use contents within one week after opening.
Should not be used after 24 hours out of refrigerator.
Issued June, 2008. Metvixia (methyl aminolevulinate cream) Cream is a trade name of PhotocureASA., Photocure ASA, Hoffsveien 48, NO-0377 Oslo, Norway. Manufacturer: Penn Pharmaceutical Services Ltd., Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, UK. FDA revision date: 06/26/08
Last reviewed on RxList: 8/4/2008
This monograph has been modified to include the generic and brand name in many instances.
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