Aminolevulinic acid causes skin cells to become more sensitive to certain types of light. Skin cells treated with aminolevulinic acid will die and slough off after being exposed to a special light treatment.

Aminolevulinic acid is used to treat actinic keratosis (warty overgrowths of skin) on the face and scalp. aminolevulinic acid is used together with a special light treatment, also called photodynamic therapy.

Aminolevulinic acid may also be used for purposes not listed in this medication guide.

Avoid exposure to sunlight or bright indoor light for up to 48 hours after aminolevulinic acid is applied to your skin or scalp.

A healthcare provider will apply aminolevulinic acid directly to your skin lesions to prepare you for light treatment.

Your face and scalp may need to be treated in separate sessions if you have actinic keratosis on both areas.

If you are treated with Ameluz gel:

• The treated skin will be covered with a dressing to block out light.

• After 3 hours, the dressing will be removed and light treatment will be applied to the lesions.

If you are treated with Levulan Kerastick solution:

• You must return to your doctor's office within 14 to 18 hours afterward to receive light treatment.

• Once the solution has been applied, keep the treated skin dry.

• Do not wash the skin while waiting for your light treatment.

The photodynamic light has a low intensity and will not heat your skin. However, you may feel tingling, stinging, prickling, or burning where aminolevulinic acid was applied. This discomfort is usually temporary.

For up to 48 hours, you will need to protect your skin from bright light. Sunscreen will not be effective enough to protect you while this medicine is on your skin or scalp. Avoid exposure to both sunlight and bright indoor light. Wear protective clothing and a wide-brimmed hat when you are outdoors. If you feel stinging or burning of the treated skin, reduce your exposure to light.

You may have some redness, swelling, and scaling of your lesions and the surrounding skin. These symptoms should go away completely within 4 weeks.

Call your doctor if you have severe skin discomfort, or if you have new or worsening skin problems.

If your actinic keratosis lesions do not clear up completely, you may need a second treatment. Levulan Kerastick and light treatment can be repeated after 8 weeks. Ameluz and light treatment can be repeated after 3 months.

Usual Adult Dose for Actinic Keratosis:

One application and one dose of illumination per treatment site per 8 week treatment session
Duration of therapy: Treated lesions that have not completely resolved after 8 weeks may be treated a second time.

Comments:
-Each individual aminolevulinic acid topical solution should be used for only one patient.
-Photodynamic therapy is a two stage process involving application of the product followed 14 to 18 hours later by illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator.

Use: Treatment of minimally to moderately thick actinic keratoses of the face or scalp

You should not be treated with aminolevulinic acid if you are allergic to it.

Tell your doctor if you have ever had:

• a soybean allergy; or

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Tell your doctor if you are pregnant or breast-feeding.

Call your doctor for instructions if you cannot return for your light treatment within the recommended 14 to 18 hours after Levulan Kerastick was applied. The timing of this medicine and light treatment is extremely important to the success of your treatment.

Since aminolevulinic acid is applied by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid exposure to sunlight or bright indoor light for up to 48 hours. Wear a hat and clothing that covers your skin. Even if you miss your light treatment appointment, continue avoiding bright light for up to 48 hours.

Avoid using other medications on the areas treated with aminolevulinic acid unless your doctor tells you to.

Get emergency medical help if you have 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 or burning that lasts longer than 4 weeks.

Common side effects of aminolevulinic acid may include:

• pain, burning, redness, or swelling of treated skin;

• itching, stinging, tingling, or prickly feeling;

• scaling or crusting of the skin;

• headache;

• chills; or

• puffy eyelids.

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.

Tell your doctor about all your other medicines. Some drugs can make you more sensitive to sunlight, especially:

• an antibiotic or sulfa drug;

• a diuretic or "water pill";

• medicine to treat nausea or vomiting;

• antipsychotic medication; or

• an oral diabetes medicine.

This list is not complete. Other drugs may affect aminolevulinic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.