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Levulan®

Brand Name: Levulan® Kerastick
Active Ingredient:   aminolevulinic acid HCl
Strength(s): 20%
Dosage Form(s):   Topical Solution
Company Name:    Guidelines, Incorporated
Availability:         Prescription only
*Date Approved by the FDA:   December 3, 1999
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Levulan used for?

The Levulan Kerastick for Topical Solution plus blue light illumination using BLU-U Blue Light Photodynamic Therapy Illuminator is a two-step (drug plus blue light) treatment used to treat pre-cancerous skin lesions of the face or scalp called actinic keratoses (AK).

Who should not be treated with Levulan?

You should not be treated with Levulan if you have:

  • Skin sensitivity to blue light
  • Porphyria (a disorder of the metabolism that can lead to sensitivity to light)
  • allergies to chemicals called porphyrins

General Precautions with Levulan:

The treated lesions are sensitive to light therefore, people being treated will need to avoid sunlight and sources of bright light for at least 40 hours after Levulan is applied.

What should I tell my doctor or health care provider?

There are other medications that increase sensitivity to light. Tell your doctor or health care provider if you are using any other medicines. These medicines include:

  • thiazides (used to treat high blood pressure)
  • tetracyclines, fluoroquinolones, griseofulvin, or sulfonamides (used to treat infection)
  • sulfonylureas (used to treat diabetes)
  • phenothiazines (used to treat serious emotional problems)

What are some possible side effects of Levulan? (This is NOT a complete list of side effects reported with Levulan. Your health care provider can discuss with you a more complete list of side effects.)  

Blue light treatment may cause tingling, stinging, prickling, or burning feeling of the treated areas. These feelings should improve at the end of the blue light treatment and should end within 24 hours.

Following blue light treatment, the AKs and, to some degree, the surrounding skin, will redden. Swelling may also occur. These changes should reach a maximum the day after BLU-U treatment. However, these changes are temporary, should improve markedly by the end of the first week, and should be completely gone by 4 weeks after treatment. Other side effects at the treatment sites may include:

  • Scaling
  • Itching
  • Changes in skin color

For more detailed information about Levulan, ask your health care provider.

http://www.fda.gov/cder/foi/label/1999/20965lbl.pdf    Link to Levulan's Labeling

Posted 12/8/00

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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