Usual Adult Dose for Keratosis

Application is a multi-step process:

• Before applying this drug, 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 to facilitate access of the cream and light to all parts of the lesion.
• Using a spatula, apply a layer of cream about 1 mm thick to the lesion and the surrounding 5 mm of normal skin. Do not apply more than 1 gram of cream per treatment session.
• After application, cover the area 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 a diameter of 55 mm.
• Wait for 3 hours (at least 2.5 hours, but no more than 4 hours).
• After application, patients should avoid exposure of the area(s) to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds) 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.
• Patients should protect treated area(s) 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 cream outside the treatment site to the eyes or surrounding skin.
• Protect the treated site should from extreme cold.
• Remove the occlusive dressing and clean the area with saline and gauze.
• Illumination of the Treated Lesion: Ensure that the correct light dose is administered. Light intensity at the lesion surface should not be higher than 200 mW/cm2.
• The CureLight BroadBand Model CureLight 01 lamp is approved for the use in Metvixia -PDT. The lamp should be carefully calibrated so that dosing is accurate and immediately thereafter the lesion should be exposed to red light with a continuous spectrum of 570 to 670 nm and a total light dose of 75 J/cm2.
• If red light treatment is interrupted or stopped, it may be restarted. If the patient 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 2 days. Metvixia Cream is not intended for use with any device other than the approved lamp: CureLight BroadBand Model CureLight 01.

Comments:

• Use of this drug without subsequent red light illumination is not recommended.
• No more than 1 gram (half a tube) of product should be used for each of the 2 weekly treatment sessions.
• Multiple lesions may be treated during the same treatment session using a total of 1 gram of cream.
• Lesion response should be assessed 3 months after the last treatment session.
• This product is not intended for application by patients or unqualified medical personnel.
• Only nitrile gloves should be worn by the healthcare provider in order to avoid skin contact with the cream.
• Patient and operator should adhere to safety instructions and Universal Precautions provided with the lamp. The patient and operator should wear protective goggles during illumination.
• Patients should be advised that transient stinging and/or burning at the target lesion sites may occur during the period of light exposure.
• To avoid direct contact between lamp parts and patient skin, always use disposable protective plastic sleeves on the positioning device and on the light measuring probe.

Use: This drug in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of nonhyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) when other therapies are unacceptable or less appropriate.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Hypersensitivity to porphyrins
• Hypersensitivity to peanut or almond oil
• Cutaneous photosensitivity

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:

• Store refrigerated at 2C to 8C (36F to 46F).
• Use contents within one week after opening.
• Do not use this drug after 24 hours out of refrigerator.

General:

• Use of this drug without red light illumination is not recommended.
• This drug is not indicated for ophthalmic, oral, or intravaginal use.
• This drug has demonstrated a high rate of contact sensitization.
• Healthcare providers should take caution to avoid inadvertent skin contact, and wear Nitrile (not vinyl or latex) gloves for protection when applying and removing the cream.

Patient advice:

• This drug is only used in medical offices by healthcare providers trained to use it.
• Tell your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.
• Tell your healthcare provider if you are allergic to nuts or peanuts, have or had skin cancer or other skin growths on your body, have bleeding problems, and about all the medicines you take.
• Avoid exposure to sunlight or bright indoor light during the 3 hours that this drug is on your skin.
• Wear a protective hat and clothing if you need to be outside in the sun.
• Avoid exposure to cold temperatures during the 3 hours that this drug is on your skin. Wear warm clothing and keep your treated skin site covered if you are in cold temperatures.
• You may experience side effects such as burning feeling, redness, pain, stinging, swelling, crusting, peeling, blisters, bleeding, itching, ulcers, or infection.