Aminolevulinic Acid

Aminolevulinic acid is a prescription medication used to treat to actinic keratoses of the face or scalp. This is a condition of small crusty or scaly bumps or horns on or under the skin that result from exposure to sunlight and can develop into skin cancer. Aminolevulinic acid belongs to a group of drugs called photosensitizing agents. When activated by light, aminolevulinic acid damages the cells of lesions and bumps. This medication comes in a topical solution form and applied to the affected skin area by a doctor. You must return to the doctor 14 to 18 hours after application to be treated by blue light PDT (photodynamic therapy). Common side effects include blistering, itching, and bleeding of skin at site of application. During PDT (lasts for approximately 17 minutes), you may experience sensations of tingling, stinging, prickling or burning of the treated lesions. These feelings of discomfort should improve at the end of the light treatment.

Aminolevulinic acid is a prescription medication used to treat to actinic keratoses of the face or scalp. This is a condition of small crusty or scaly bumps or horns on or under the skin that result from exposure to sunlight and can develop into skin cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended treatment frequency is one application of the and one dose of illumination (blue light PDT) per treatment site per 8-week treatment session.

Serious side effects have been reported with aminolevulinic acid.

• During the time period between the application and exposure to blue light PDT, the treatment site will become sensitive to light (photosensitive).
  • You should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to blue light treatment.
  • Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against reactions caused by visible light. It has not been determined if perspiration can spread aminolevulinic acid outside the treatment site to the eyes or surrounding skin.
• Application to areas around lesions of damaged skin (perilesional) may result in photosensitization. Upon exposure to light from the blue light PDT, you may experience a stinging and/or burning sensation and may become red and/or may swell in a manner similar to that of actinic keratoses.
• Because of the potential for skin to become photosensitized, this medication should be used by a health professional.

Do not use this medication if

• are allergic to aminolevulinic acid
• you are photosensitive at wavelengths of 400-450 nm
• have a history of porphyria
• have allergies to porphyrins
• are sensitive to any of the components of this medication

Common side effects include:

• tingling, stinging, prickling, or burning of lesions during blue light treatment (should get better within 24 hours)
• redness, swelling, and scaling of treated lesions and surrounding skin (should get better within 4 weeks)
• discoloration of the skin
• itching
• bleeding
• blistering
• pus under the skin
• hives

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antihistamines
• diuretics ('water pills')
• griseofulvin (Fulvicin-U/F, Grifulvin V, Gris-PEG)
• medications for diabetes
• medications for mental illness
• medications for nausea
• sulfa antibiotics
• tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin)

This is not a complete list of aminolevulinic acid drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Animal studies have not been done with this medication. It is also not known whether aminolevulinic acid can cause harm to an unborn baby when given to a pregnant woman. This medication should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if aminolevulinic acid crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using aminolevulinic acid.

You must return to the doctor 14 to 18 hours after application to be treated by blue light PDT (photodynamic therapy).

• During PDT (lasts for approximately 17 minutes), you may experience sensations of tingling, stinging, prickling or burning of the treated lesions. These feelings of discomfort should improve at the end of the light treatment.

Aminolevulinic acid will make your skin very sensitive to sunlight (likely to get sunburn).

• Avoid exposure of treated skin to direct sunlight or bright indoor light (e.g. tanning salons, bright halogen lighting, close task lighting, and high power lighting used in operating rooms or dental offices) before exposure to blue light treatment.
• Before going outdoors in the sunlight, protect treated skin from the sun by wearing a wide-brimmed hat or other head covering that will shade the treated area or block the sun.
• Sunscreen will not protect you from sensitivity to sunlight.
• If you feel burning or stinging of the treated areas or see that they have become red or swollen, be sure that you are keeping the area protected from sunlight or bright light.