Aminolevulinic Acid Gel

What is this medication?

AMINOLEVULINIC ACID (a MEE noe LEV ue LIN ik AS id) is used with light therapy to treat rough, scaly spots on the skin caused by sun exposure. It works by killing the irregular cells in the lesion.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Ameluz

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorders
• Porphyria
• Skin conditions or disease
• An unusual or allergic reaction to aminolevulinic acid, soybeans, porphyrins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for external use only. There are 2 steps in the use of this medication. First, it is applied to the affected areas of skin in a hospital or clinic. The second step happens about 3 hours after the medication has been applied. In the second step, the treated area is exposed to a special red light for about 10 minutes. The treatment may be repeated in 3 months.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss a scheduled appointment. The timing of the application of the medication determines when the light treatment may be given. If you miss a scheduled appointment, contact your care team as soon as possible. If you are not exposed to the red light, continue to avoid exposure to sunlight or prolonged bright light for at least 2 days.

What may interact with this medication?

This medication will make you sensitive to the sun. This effect may be increased by other medications that also cause sensitivity to the sun such as:

• Certain diuretics, such as chlorothiazide, hydrochlorothiazide, indapamide, metolazone
• Certain medications for diabetes, such as glipizide or glyburide
• Certain medications for infection, such as fluoroquinolones, griseofulvin, sulfonamides, or tetracyclines
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• St. John's wort
• Vitamin A and vitamin A-like medications and creams
• Vitamin E

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not get this medication in your eyes. If you do, rinse out with plenty of cool tap water.

This medication can make you more sensitive to the sun or bright indoor light. Avoid exposing skin to sunlight and prolonged or intense lights for 48 hours. If you cannot avoid being in the sun, wear a wide-brimmed hat or other head cover and protective clothing. Sunscreens will NOT protect against these reactions. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Burning, itching, crusting, or peeling of treated skin
• ConfusionSide effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
• Chills
• Headache
• Mild skin irritation, redness, or dryness
• Sensitivity to light

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.