Levulan Kerastick

Levulan Kerastick (Aminolevulinic-acid-topical) should be applied by a health care professional who has experience with this product.

Levulan Kerastick (Aminolevulinic-acid-topical) is used in 2 steps. In the first step, your doctor or qualified health care professional will apply aminolevulinic acid directly to the actinic keratoses lesions on your face and scalp. You will then go home and return to the doctor's office 14 to 18 hours after the application of the medication. During this time, while your skin is absorbing the medication, you should keep the affected areas dry and out of direct bright light. That means avoiding sunlight, examination lamps, and unshaded light bulbs at close distances. Before going outside in bright sunlight, you should cover up by wearing a wide-brimmed hat.

In the second step, you return to the doctor's office 14 to 18 hours later. Your health care professional will rinse the actinic keratoses lesions with water and then perform light therapy by applying blue light to the areas where the aminolevulinic acid was applied. You will wear protective goggles during the blue light treatment.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that Levulan Kerastick (Aminolevulinic-acid-topical) be used exactly as recommended by your doctor. If you miss an appointment to receive blue light treatment after having applied aminolevulinic acid, you should continue to avoid exposing the affected areas to sunlight or excessive bright light for at least 40 hours. Contact your doctor as soon as possible.

Levulan Kerastick (Aminolevulinic-acid-topical) is stored at room temperature.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. The tube is covered with a protective cardboard sleeve. One ampule contains 1.5 mL of solution vehicle which contains alcohol, water, lareth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains aminolevulinic acid 354 mg. The applicator is a two-component system in which the topical solution is admixed to produce a 20% solution just prior to use.

Do not use aminulevulinic acid if you:

• are allergic to aminolevulinic acid, porphyrins, or any ingredients of the medication
• have porphyria (a group of conditions that result in the accumulation of porphyrins)
• your skin is sensitive to light at wavelengths of 400 nm to 450 nm

There may be an interaction between aminolevulinic acid and any of the following:

• other medications that make the skin more sensitive to sunlight
  • griseofulvin
  • phenothiazines (e.g., Chlorpromazine, Perphenazine)
  • sulfonamides (e.g., Celecoxib, sulfamethoxazole)
  • sulfonylureas (e.g., Gliclazide, Glyburide)
  • tetracyclines
  • thiazide diuretics (e.g., Hydrochlorothiazide)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Levulan Kerastick (Aminolevulinic-acid-topical). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Levulan Kerastick (Aminolevulinic-acid-topical).

Application: Because Levulan Kerastick (Aminolevulinic-acid-topical) contains alcohol, it should not be applied to the eyes or mouth.

Sensitivity to light: Between the time aminolevulinic acid has been applied to the skin and blue light treatment, your affected areas of skin will become more sensitive to light. During this time, you should avoid exposing the areas where the medication was applied to sunlight or any bright indoor light (e.g., examination lamps, unshaded light bulbs) at close distances.

Exposure to light might cause burning or stinging and cause redness and swelling of the affected areas. Before going outside, wear protective clothing. Sunscreens with ultraviolet protection will not protect against this type of light sensitivity.

Pregnancy: Levulan Kerastick (Aminolevulinic-acid-topical) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Levulan Kerastick (Aminolevulinic-acid-topical), contact your doctor immediately.

Breast-feeding: It is not known if aminolevulinic acid passes into breast milk. If you are a breast-feeding mother and are using Levulan Kerastick (Aminolevulinic-acid-topical), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Levulan Kerastick (Aminolevulinic-acid-topical) have not been established for children and adolescents less than 18 years old.