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 disorder
• Have had a skin reaction to ultraviolet (UV) radiation
• Porphyria
• An unusual or allergic reaction to aminolevulinic acid, soybeans, porphyrins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

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. Call your care team as soon as possible if you are unable to keep an appointment.

What may interact with this medication?

• Certain diuretics, such as chlorothiazide, hydrochlorothiazide, indapamide, metolazone
• Certain medications for diabetes, such as glipizide or glyburide
• Certain medications for infection, such as sulfamethoxazole or tetracyclines
• Phenothiazines, such as chlorpromazine, 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?

Your condition will be monitored carefully while you are receiving this medication.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning 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
• Confusion

Side 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.