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|Aminolevulinic Acid Solution

Aminolevulinic Acid Solution

Aminolevulinic Acid Solution is used for:

Treating skin lesions called actinic keratoses on the face or scalp. It is used along with blue light treatment.

Aminolevulinic Acid Solution is a photosensitizing agent. It works by slowing the growth of skin cells in the areas exposed to blue light, which helps the skin to become less scaly and thick.

Do NOT use Aminolevulinic Acid Solution if:

• you are allergic to any ingredient in Aminolevulinic Acid Solution
• you have a history of sensitivity to sunlight
• you have the blood disorder porphyria or you are allergic to porphyrins

Contact your doctor or health care provider right away if any of these apply to you.

Before using Aminolevulinic Acid Solution:

Some medical conditions may interact with Aminolevulinic Acid Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a blood clotting disorder

Some MEDICINES MAY INTERACT with Aminolevulinic Acid Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Griseofulvin, phenothiazines (eg, chlorpromazine), sulfonylureas (eg, glyburide), sulfonamides (eg, sulfamethoxazole), tetracyclines (eg, doxycycline), or thiazide diuretics (eg, hydrochlorothiazide) because actions and side effects of Aminolevulinic Acid Solution may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aminolevulinic Acid Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aminolevulinic Acid Solution:

Use Aminolevulinic Acid Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aminolevulinic Acid Solution will be applied by a qualified health care provider.
• This is a two-part procedure. You will receive a blue light treatment the day after Aminolevulinic Acid Solution is applied.
• Once Aminolevulinic Acid Solution is applied, do not wash the treated lesions. Keep the lesions dry and avoid exposure of treated areas to sunlight and bright indoor light. You should return to your health care provider the next day to receive the blue light treatment. This is the second and final treatment step.
• Before receiving the blue light treatment, Aminolevulinic Acid Solution will be rinsed off of your skin with tap water, and you will be given goggles to protect your eyes. The blue light will not heat your skin.
• During the blue light treatment, you will experience tingling, stinging, prickling, or burning of the treated area. These effects stop at the end of treatment, which lasts for about 17 minutes.
• After the blue light treatment, the treated area and surrounding skin will redden, and swelling or scaling may also occur. This is temporary and should completely resolve 4 weeks after this treatment.
• Do not directly cover the treated area(s) unless advised to do so by your health care provider. Excessive irritation may occur.
• If for any reason you cannot return to your health care provider within 14 to 18 hours after Aminolevulinic Acid Solution is applied, call your health care provider. Continue to avoid bright light for at least 40 hours.
• If you miss a dose of Aminolevulinic Acid Solution, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Aminolevulinic Acid Solution.

Important safety information:

• The treated area will be sensitive to light. Avoid exposing the treated area to sunlight and bright indoor light (eg, lamps, tanning beds, nearby lights) during the treatment period before the blue light treatment and at least 40 hours after the blue light treatment. Stinging, burning, flushing, and swelling may occur if the lesions are exposed to bright light.
• If you feel stinging or burning on the treated skin lesions, further reduce your exposure to light.
• Wear a wide-brimmed hat or similar head covering of light, opaque material when exposed to sunlight or sources of bright light.
• Sunscreens will not protect you from light sensitivity reactions. Do not use sunscreens on the treated lesions.
• Do not apply any other medicine, creams, or lotions to the treated lesions unless instructed otherwise by your doctor.
• Aminolevulinic Acid Solution is for topical application to actinic keratoses on the face or scalp only. Avoid getting Aminolevulinic Acid Solution in your eyes, on skin near your eyes, or on the mucous membranes of the mouth or nose.
• Aminolevulinic Acid Solution may be harmful if swallowed. If you or someone you know may have taken Aminolevulinic Acid Solution by mouth, contact your local poison control center or emergency room immediately.
• Redness and swelling of the treated skin should be gone in 4 weeks. If treated skin lesions get worse or if they do not completely resolve after 8 weeks, check with your doctor.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Aminolevulinic Acid Solution during pregnancy. It is unknown if Aminolevulinic Acid Solution is excreted in breast milk. Do not breast-feed during treatment with Aminolevulinic Acid Solution.

Possible side effects of Aminolevulinic Acid Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning; crusting; flushing; itching; loss of skin color; redness; scabbing; scaling; skin blisters; skin wasting; stinging; swelling; tenderness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding; oozing; pustules; signs of infection in the treated skin; ulceration.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm ), or emergency room immediately. Aminolevulinic Acid Solution may be harmful if swallowed.

Store Aminolevulinic Acid Solution at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief excursions at temperatures between 59 and 86 degrees F (15 and 30 degrees C) are permitted. Keep Aminolevulinic Acid Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Aminolevulinic Acid Solution, please talk with your doctor, pharmacist, or other health care provider.
• Aminolevulinic Acid Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Aminolevulinic Acid Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.