In the U.S.—

• Photosensitizer
• Photodynamic therapy

Aminolevulinic acid (a-mee-noh–LEV–U–lin–ik AS-id) application followed by exposure to a certain type of light (blue light using the BLU–U Blue Light Photodynamic Therapy Illuminator) treats the skin condition called actinic keratoses.

This medicine is available only with your doctor's prescription, in the following dosage form:

Topical
• Solution (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For aminolevulinic acid the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to aminolevulinic acid or porphyrins.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether aminolevulinic acid passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast–feeding. Mothers who are taking this medicine and who wish to breast–feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of aminolevulinic acid in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of aminolevulinic acid in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking aminolevulinic acid, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antidiabetics, oral (diabetes medicine you take by mouth) or
• Antipsychotics (medicine for mental illness) or
• Griseofulvin (e.g., Fulvicin U/F, Grifulvin V) or
• Sulfonamides (sulfa medicine) or
• Tetracyclines (medicine for infection) or
• Thiazide diuretics (water pills)—May increase your skin's sensitivity to sunlight or bright indoor lights

• Skin sensitivity to light or
• Porphyria—May be worsened by aminolevulinic acid

Dosing—

Aminolevulinic acid is applied to your skin in your doctor's office. Blue light illumination treatment must be followed with BLU–U Blue Light Photodynamic Therapy Illuminator in your doctor's office 14 to 18 hours after the application . The blue light treatment lasts approximately 17 minutes. Your doctor may want to re-treat you after 8 weeks if your skin condition did not completely resolve.

Call your doctor if you cannot return for the blue light illumination treatment after the aminolevulinic acid application. You should then protect the treated skin from sunlight and prolonged or intense light for at least 40 hours.

After aminolevulinic acid application you should avoid exposure to sunlight or bright indoor light (e.g., from examination lamps, operating room lamps, tanning beds, or being close to lights) up until the time of the blue light treatment.Wide-brimmed hats or similar head covering can help protect you from sunlight or sources of light.

Sunscreens will not protect you from sunlight or sources of light.

Reduce your exposure to light if you experience stinging or burning on the treated areas before blue light treatment.

Do not wash the treated areas before the blue light treatment.

You and the doctor will wear eye protection during the blue light treatment.

During the blue light treatment you will experience sensations of tingling, stinging, prickling or burning of the treated skin. These feelings of discomfort should improve at the end of the light treatment.

Following treatment, the actinic keratoses and possibly the surrounding skin will redden and swelling and scaling may also occur. These changes are temporary and should completely resolve by 4 weeks after treatment.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Less common
  • Bleeding 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Burning, crawling, itching, numbness, prickling, “pins and needles,” stinging, or tingling feelings;  darkening of treated skin;  lightening of treated skin;  scaling or crusting;  skin sore;  small red raised itchy bumps;  swelling of skin 
  
  

• Less common
  • Blister;  oozing;  open sore on skin ;  pain;  pus filled blister or pimple;  raw skin;  scabbing;  tenderness. 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.