Aminolevulinic acid Topical

Name: Aminolevulinic acid Topical

How should this medicine be used?

Aminolevulinic acid comes in a special applicator to be made into a solution and applied to the affected skin area by a doctor. You must return to the doctor 14 to 18 hours after aminolevulinic acid application to be treated by blue light PDT. For example, if you have aminolevulinic acid applied in the late afternoon, you will need to have the blue light treatment the next morning. You will be given special goggles to protect your eyes during blue light treatment.

Do not put a dressing or bandage on the area treated with aminolevulinic acid. Keep the treated area dry until you go back to the doctor for blue light treatment.

Your doctor will examine you 8 weeks after aminolevulinic acid and PDT treatment to decide whether you need retreatment of the same skin area.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

For topical use only; not for ophthalmic, oral, or intravaginal use. During light treatment, both patients and health care personnel should wear appropriate eye protection.

Gel: Carefully wipe all lesions with an ethanol or isopropanol-soaked cotton pad (to degrease skin) and remove any scaling or crusts prior to application. Gently roughen lesion surfaces (avoid bleeding). Using a gloved fingertip or a spatula, apply gel ~1 mm thick and include ~5 mm of surrounding skin. Application area should not exceed 20 cm2 and no more than 2 g should be used at one time. May be applied to healthy skin around the lesion(s). Avoid mucous membranes (eyes, nostrils, mouth or ears); maintain a distance of 1 cm from these areas; rinse thoroughly if accidental contact with these areas occurs. Allow gel to dry ~10 minutes before covering with a light-blocking occlusive dressing. After 3 hours, remove dressing and wipe off residual gel. Immediately after removing dressing and residual gel, illuminate the treatment area with red light source. Position lamp 5 to 8 cm from patient’s skin. Healthy untreated skin does not need protection during illumination.

If unable to perform red light illumination within 3 hours of gel application, rinse off gel with saline and water. Protect lesion sites and surrounding skin from sunlight or prolonged intense light (eg, tanning beds, sun lamps) for 2 days.

Solution: Clean and dry lesion prior to application. Dab lesion gently with wet applicator tip (apply enough to uniformly wet lesion without excess running or dripping). Only apply to affected skin. Do not apply to periorbital area, ocular tissue, or mucosal surfaces. Allow to dry, then reapply to same lesion. Apply to either scalp or facial lesions, but not to both simultaneously. Follow application with blue light exposure in 14 to 18 hours. Do not wash the application area during the time between application and photosensitization; after photosensitization, gently rinse actinic keratosis with water and pat dry. Stinging or burning may occur during blue light treatment. Following blue light treatment, the lesion will temporarily redden, swell and/or scale, which should resolve within 4 weeks after treatment.

If unable to perform the blue light treatment after topical application or if treatment with the blue light is interrupted or stopped, advise patient to avoid sunlight/bright light exposure to treated lesions (and wear a wide brimmed hat or other protective apparel) for at least 40 hours after application (burning/stinging sensation may still occur).

Drug Interactions

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination

Photosensitizing Agents: May enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Pregnancy Risk Factor C Pregnancy Considerations

Animal reproduction studies have not been conducted. Systemic absorption following topical application of the gel is negligible.

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