Aminolevulinic Acid Hydrochloride Topical solution

What is this medicine?

AMINOLEVULINIC ACID (a MEE noe LEV ue LIN ik AS id) is a light sensitizing drug that is used in photodynamic therapy (PDT). PDT is used to treat many types of skin conditions including actinic keratosis and certain types of skin cancer. PDT is a two-step process that requires application of a drug and then exposure to a certain type of light.

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

What should I tell my health care provider before I take this medicine?

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

• bleeding disorders

• conditions that make you sensitive to light or sunlight

• porphyria

• an unusual or allergic reaction to aminolevulinic acid, porphyrins, other medicines, foods (especially peanuts or almonds), dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

In the first step of photodynamic therapy (PDT), the medicine is applied by a trained health care professional to the affected areas of the skin. Fourteen to eighteen hours after application of the medicine, the treated area is exposed to a special blue light for about 17 minutes. The treatment may be repeated in 8 weeks.

Talk to your pediatrician regarding the use of this medicine 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 drug determines when the light treatment may be given. If you miss a scheduled appointment, contact your doctor or health care professional as soon as possible. If you are not exposed to the blue light, continue to avoid exposure to sunlight or prolonged bright light for at least 40 hours.

What may interact with this medicine?

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

• certain diuretics

• griseofulvin

• medicines including sulfa or tetracycline antibiotics

• medicines for depression, anxiety, or psychotic disturbances

• vitamin A and vitamin A-like medicines 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 medicine?

This medicine will cause your skin to be very sensitive light in the areas where it is applied. You must avoid exposing treated areas to sunlight and bright indoor lights (unshaded light bulbs at close range) during the treatment period. Use a wide-brimmed hat or other protective clothing. Sunscreen will NOT work to protect your skin. If you begin to experience stinging and/or burning, decrease your exposure to light.

During the second step of therapy, you will be exposed to a blue light for about 17 minutes. This light will not heat the skin. You will receive goggles to protect your eyes. During exposure to the blue light you may experience stinging, burning, tingling, or prick-like feelings at the treated sites.

After treatment with the blue light, the treated areas and sometimes the surrounding skin will get red, swell, and may scale over. These effects should improve within 4 weeks of the treatment.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blisters, redness, swelling of skin similar to severe sunburn

Side effects that usually do not require medical attention (report to your doctor if they continue or are bothersome):

• burning or stinging

• crusting or scaling of lesions

• sensitivity to the sun and other lights

• swelling of lesions

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 medicine?

This drug is given in a hospital or clinic and will not be stored at home.