Levulan Kerastick (topical)

Levulan Kerastick (for the skin) is used together with light therapy to treat a skin condition called actinic keratosis (warty overgrowths of skin).

Levulan Kerastick may also be used for reasons not mentioned in this medication guide.

Stay away from direct sunlight and avoid strong or prolonged light exposure before and for 48 hours after Levulan Kerastick is applied to the affected skin.

You should not use this medicine if you are allergic to Levulan Kerastick or any of its ingredients, including soybean and phosphatidylcholine, or if you have:

• an allergy to porphyrins;
• porphyria (a genetic enzyme disorder that affects the skin or nervous system); or
• skin that is especially sensitive to light.

Inform your doctor if you have or have ever had:

• a blood clotting problem; or
• are taking certain medications that increase your skin's sensitivity to light.

It is not known if Levulan Kerastick will harm an unborn baby. Let your doctor know if you are pregnant or plan to become pregnant.

Check with a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Levulan Kerastick may cause serious side effects. Call your doctor right away if you have:

• eye problems such as eyelid swelling;
• skin irritation; or
• problems with memory, confusion, or disorientation.

Common side effects of Levulan Kerastick may include:

• pain, stinging, burning, induration, redness, or swelling;
• itching, hives, blisters, dryness, tenderness;
• scaling, oozing, bleeding, crusting, or breakdown of the skin; or
• changes in skin color or your sense of touch.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Levulan Kerastick is applied to your skin lesions before you receive light treatment. A healthcare provider will apply Levulan Kerastick in a clinical setting.

Your treatment may require you to return to your healthcare provider for light therapy after Levulan Kerastick is applied.

Your may need to be treated in separate sessions if you have actinic keratosis in more than one area.

You will be provided eye protection before starting light therapy. Follow your doctor's instructions.

The light therapy has a low intensity and will not heat your skin. However, you may feel tingling, stinging, prickling, or burning where Levulan Kerastick was applied. This discomfort is usually temporary.

Call your doctor if you have severe skin discomfort, or if you have new or worsening skin problems.

If your actinic keratosis lesions do not clear up completely, you may need another treatment. Your doctor will determine if you need additional treatment with Levulan Kerastick.

In a medical setting, it is unlikely that you will miss a dose.

If you miss an appointment for your light treatment within the recommended time frame, call your doctor for instructions.

In a medical setting, an overdose will be treated quickly.

Levulan Kerastick could make you more sensitive to light. Stay out of direct sunlight and avoid strong or extended light exposure for 48 hours before and after Levulan Kerastick is applied to the affected skin. Sunscreens will not protect you against a reaction. Wear a hat and clothing that covers your skin.

Do not get this medicine in your eyes, nose, mouth, or ears. If contact does occur, rinse with water.

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

Tell your doctor about all the other medicines you are taking. Some drugs can make you more sensitive to sunlight, especially:

• an antibiotic or sulfa drugs;
• griseofulvin;
• a diuretic or "water pill";
• St. John's wort;
• medicine to treat nausea or vomiting;
• medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia; or
• an oral diabetes medicine.

This list is not complete. Other drugs may also affect Levulan Kerastick, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.