Levulan Kerastick (topical)

Levulan Kerastick (topical)

Levulan Kerastick (topical)

What is Levulan Kerastick?

Levulan Kerastick is used to treat actinic keratosis (warty growths on the skin) on the face and scalp. Levulan Kerastick is used together with a special light treatment, also called photodynamic therapy.

Levulan Kerastick may also be used for purposes not listed in this medication guide.

Side effects of Levulan Kerastick

If necessary, get emergency medical helpSigns of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you experience severe stinging or burning that lasts longer than 4 weeks.

Common side effects of Levulan Kerastick may include:

• pain, burning, redness or swelling of the treated skin;

• itching, stinging, tingling, or tingling sensation;

• flaking or crusting of the skin;

• Headache;

• Chills; or

• swollen eyelids.

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

Warnings

Avoid exposure to sunlight or bright indoor light for up to 48 hours after applying Levulan Kerastick to your skin or scalp.

Before you take this medicine

You should not be treated with Levulan Kerastick if you are allergic to it.

Tell your doctor if you have ever had:

• a soybean allergy; or

• Porphyria (a genetic enzyme disorder causing symptoms affecting the skin or nervous system).

Tell your doctor if you are pregnant or breastfeeding.

How is Levulan Kerastick administered?

A doctor will apply Levulan Kerastick directly to your skin lesions to prepare you for light treatment.

If you have actinic keratosis in both areas, your face and scalp may need to be treated in separate sessions.

If you are treated with Ameluz Gel:

• The treated skin is covered with an opaque bandage.

• After 3 hours, the dressing is removed and the lesions are subjected to light treatment.

If you are treated with Levulan Kerastick solution:

• You will need to return to your doctor's office within 14 to 18 hours afterward to receive light treatment.

• After applying the solution, keep the treated skin dry.

• Do not wash skin while waiting for your light treatment.

The photodynamic light is low intensity and does not heat your skin. However, you may experience a tingling, stinging, tingling or burning sensation where Levulan Kerastick was applied. This discomfort is usually temporary.

You need to protect your skin from bright light for up to 48 hours.Sunscreens are not effective enough to protect you while this medicine is on your skin or scalp. Avoid exposure to sunlight and bright indoor light. Wear protective clothing and a wide-brimmed hat when outdoors. If you feel stinging or burning on treated skin, reduce exposure to light.

You may experience redness, swelling, and scaling of your lesions and surrounding skin. These symptoms should disappear completely within 4 weeks.

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

If your actinic keratosis lesions do not disappear completely, a second treatment may be necessary. The Levulan Kerastick and light treatment can be repeated after 8 weeks. The Ameluz and light treatment can be repeated after 3 months.

What happens if I miss a dose?

Call your doctor for instructions if you cannot return to your light treatment within the recommended 14 to 18 hoursLevulan Kerastickwas applied. The timing of using this medicine and light treatment is extremely important to the success of your treatment.

What happens if I overdose?

Because Levulan Kerastick is used by healthcare professionals in a medical setting, overdose is unlikely.

What should I avoid after taking Levulan Kerastick?

Avoid exposure to sunlight or bright indoor light for up to 48 hours. Wear a hat and clothing that covers your skin. Even if you miss your light treatment appointment, continue to avoid bright light for up to 48 hours.

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

What other drugs will affect Levulan Kerastick?

Tell your doctor about all other medicines you are taking. Some medications can increase sensitivity to sunlight, particularly:

• an antibiotic or sulfa drugs;

• a diuretic or “water pill”;

• medicines to treat nausea or vomiting;

• antipsychotic medications; or

• an oral diabetes medication.

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

More information

• Ihr Arzt kann Ihnen weitere Informationen zu Levulan Kerastick geben.

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.