Methyl aminolevulinate topical

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stinging, burning, redness, oozing, or swelling of treated skin areas (especially if these effects get worse or last longer than 3 weeks).

Common side effects may include:

• skin redness, warmth, burning, stinging, or swelling;
• blisters, skin ulcers; or
• peeling or crusting of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Tell your caregivers right away if any of this medicine gets into your eyes, mouth, or nose.

Avoid touching the treated skin areas after methyl aminolevulinate cream has been applied to them. Special gloves must be worn by the healthcare provider while applying this medication, and you should not allow your own fingers to come into contact with the cream on your skin.

For at least 48 hours after your treatment, avoid exposing treated skin to sunlight, sunlamps, tanning beds, or other bright lights. Sunscreen is not effective enough to protect treated skin from harm caused by bright light during this time. Wear protective clothing whenever you are outdoors.

Even if you do not receive the light therapy portion of your treatment, you must still protect your skin from light for 48 hours after the cream was applied.

Usual Adult Dose for Keratosis:

Non-hyperkeratotic, nonpigmented actinic keratoses of the face and scalp in immunocompetent patients: Apply directly on lesion(s), up to a total of 1 gram (half tube) per each treatment session. Two sessions one week apart should be administered. Cream application should be followed by photoactivation with Aktilite CL 128 lamp red light illumination.

Prior to cream application, a small dermal curette should be used to remove scales and crusts and to roughen the surface of the lesion(s). An approximately 1 mm-thick layer of cream should be applied with a spatula to each lesion and the surrounding 5 mm of normal skin. The application area should then be covered with an occlusive, nonabsorbent dressing for 3 hours (2.5 to 4 hours). Multiple lesions may be treated during the same session, up to an area of 80 X 180 mm (the area of illumination).

Following removal of the occlusive dressing, clean the area with saline and gauze before beginning Aktilite red light treatment. The light dose to be used is 37 J/cm2, and the lamp should be placed 50 to 80 mm (2 to 3.2 inches) from the skin. The required illumination time (7 to 10 minutes) is calculated automatically. Both the patient and operator should wear appropriate eye protection during illumination and avoid staring into the beam. The illumination stops automatically.

If Aktilite red light treatment is interrupted or stopped for any reason, it may be restarted. If the patient cannot have the red light treatment during the prescribed period after application, the cream should be rinsed off and the patient should protect the exposed area from sunlight and prolonged or intense light for at least 48 hours.

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.