Levulan Kerastick

Levulan Kerastick 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. Levulan Kerastick belongs to a group of drugs called photosensitizing agents. When activated by light, Levulan Kerastick 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.

Levulan Kerastick 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.
 

• DUSA Pharmaceuticals, Inc.

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 Levulan Kerastick drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Levulan Kerastick, there are no specific foods that you must exclude from your diet.

Before using Levulan Kerastick,

• tell your doctor and pharmacist if you are allergic to Levulan Kerastick, porphyrins, or any other medications
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take
• tell your doctor if you have porphyria (a condition that causes sensitivity to light). Your doctor will probably tell you not to use Levulan Kerastick.
• tell your doctor if you have or have ever had any other medical conditions
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant during treatment with Levulan Kerastick, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using Levulan Kerastick.
• you should know that Levulan Kerastick 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.

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 Levulan Kerastick 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 Levulan Kerastick 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 Levulan Kerastick.

• Levulan Kerastick contains alcohol and is intended for topical (on the skin) use only.
• Levulan Kerastick comes in a special applicator to be made into a solution and applied to the affected skin area by a doctor.
• You must return to the doctor 14 to 18 hours after Levulan Kerastick application to be treated by blue light PDT. For example, if you have Levulan Kerastick applied in the late afternoon, you will need to have the blue light treatment the next morning.
• You will be given special goggles to protect your eyes during blue light treatment.
• Do not put a dressing or bandage on the area treated with Levulan Kerastick. Keep the treated area dry until you go back to the doctor for blue light treatment.
• Your doctor will examine you 8 weeks after Levulan Kerastick and PDT treatment to decide whether you need retreatment of the same skin area.

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.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

If you cannot return to the doctor for blue light treatment 14 to 18 hours after Levulan Kerastick application, call your doctor. Continue to protect treated skin from sunlight or other strong light for at least 40 hours.