Aminolevulinic acid

Name: Aminolevulinic acid

Warnings

The LEVULAN KERASTICK (aminolevulinic acid) for Topical Solution contains alcohol and is intended for topical use only. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion.

Side Effects of Aminolevulinic Acid

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.

Aminolevulinic Acid Precautions

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

 

What happens if I miss a dose?

Call your doctor for instructions if you cannot return for the blue light treatment within the recommended 14 to 18 hours after aminolevulinic acid was applied. The timing of this medicine and light treatment is extremely important to the success of your treatment.

You may need to reschedule your light treatment appointment if you cannot receive it at the correct time after aminolevulinic acid was applied.

What happens if I overdose?

Since this medicine is applied by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while using aminolevulinic acid?

Avoid exposure to sunlight or bright indoor light for at least 40 hours after aminolevulinic acid is applied to your skin or scalp. Wear a hat and clothing that covers your skin. Even if you miss your blue light treatment appointment, you must continue to avoid bright light for 40 hours.

Avoid using other medications on the areas treated with aminolevulinic acid unless your doctor tells you to.

Aminolevulinic acid dosing information

Usual Adult Dose for Actinic Keratosis:

One application and one dose of illumination per treatment site per 8 week treatment session
Duration of therapy: Treated lesions that have not completely resolved after 8 weeks may be treated a second time.

Comments:
-Each individual aminolevulinic acid topical solution should be used for only one patient.
-Photodynamic therapy is a two stage process involving application of the product followed 14 to 18 hours later by illumination with blue light using the BLU-U Blue Light Photodynamic Therapy Illuminator.

Use: Treatment of minimally to moderately thick actinic keratoses of the face or scalp

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