Actinic Keratoses

Levulan® Kerastick®

(aminolevulinic acid HCl) for Topical Solution, 20%

Prescribing Information

Levulan® Kerastick®
(aminolevulinic acid HCl) for Topical Solution, 20%

PATIENT Insert

DUSA Pharmaceuticals, Inc.® 

PHOTODYNAMIC THERAPY (PDT) using the LEVULAN® KERASTICK® for Topical Solution, 20% (generic name = aminolevulinic acid HCl) & the BLU-U® Blue Light Photodynamic Therapy Illuminator for Topical Use on the Face or Scalp.

What is LEVULAN® KERASTICK® for Topical Solution + Blue Light PDT?

This is a two-step (drug + blue light) treatment designed to treat actinic keratoses (AK) lesions on the face or scalp. AKs are precancerous skin changes caused by chronic sun exposure. If untreated, AKs may develop into skin cancer.

In the first part of the treatment, your doctor or other health care provider applies LEVULAN KERASTICK Topical Solution, using the LEVULAN KERASTICK Topical Solution applicator, to individual AK lesions of the face or scalp. Your treatment is completed the next day when you return to your doctor’s office to receive BLU-U® treatment.

Clinical studies have shown that 8 weeks after LEVULAN KERASTICK for Topical Solution + BLU-U treatment, about 80% of patients had 75% or more of their treated AKs completely clear (could not be identified by sight or touch). About 65% of patients had complete clearing of all their treated AK lesions.

Eight weeks after the first treatment, those AK lesions which do not completely clear may be treated a second time. In clinical studies, at 12 weeks after the first treatment or four weeks after the second treatment, about 90% of the patients had 75% or more of their treated AKs completely clear. About 72% of patients had complete clearing of all their treated AK lesions.

LEVULAN KERASTICK for Topical Solution + BLU-U treatment works better for patients with lesions on the face than for patients with lesions on the scalp. In clinical studies, about 10% of the patients who had completely cleared all their treated AK lesions had an AK lesion come back within 12 weeks after treatment. Clinical studies did not examine what happened to completely cleared lesions more than 12 weeks after treatment.

Who should not have LEVULAN KERASTICK for Topical Solution + Blue Light PDT?

You should not have LEVULAN KERASTICK for Topical Solution + Blue Light treatment if you have:

• skin sensitivity to blue light
• porphyrias
• allergies to chemicals called porphyrins

Tell your doctor if you are pregnant or nursing. It is not known if LEVULAN KERASTICK for Topical Solution can cause harm to an unborn child when administered to a pregnant woman or if it can affect the capacity to conceive a child. It is not known whether its use by a nursing mother can affect her baby. If you are pregnant, plan to become pregnant, or are nursing a baby, talk to your doctor about whether you should have LEVULAN KERASTICK for Topical Solution + BLU-U Treatment.

LEVULAN KERASTICK Topical Solution has not been tested on patients with inherited or acquired bloodclotting defects.

If any of these conditions apply to you, inform your doctor immediately.

Tell your doctor if you are using other medicines, especially if they increase sensitivity to light. These medicines include thiazides (used to treat high blood pressure), tetracyclines, fluoroquinolones, griseofulvin, or sulfonamides (used to treat infection), sulfonylureas (used to treat diabetes), and phenothiazines (used to treat serious emotional problems).

There are other medicines that may increase sensitivity to light. Therefore, if you are taking any prescription medicines, non-prescription medicines, herbal remedies (such as St. John’s Wort) or are using any medicines or creams that you put directly on your face or scalp, check with your doctor to make sure they do not interact with LEVULAN KERASTICK for Topical Solution + BLU-U Treatment.

How are actinic keratoses treated with LEVULAN KERASTICK for Topical Solution + Blue Light PDT?

After LEVULAN KERASTICK Topical Solution is applied to your AKs in the doctor’s office, you will be told to return the next day. Keep the treated areas dry and protected from bright light. Fourteen to eighteen hours after LEVULAN KERASTICK Topical Solution is applied, you will return to your doctor’s office to receive BLU-U treatment. Before BLU-U treatment, the areas which LEVULAN KERASTICK Topical Solution was applied will be rinsed with tap water. You will wear goggles to protect your eyes during the BLU-U treatment. The light is low intensity and will not heat your skin.

If for any reason you cannot return to your doctor for BLU-U treatment during the prescribed period after application of LEVULAN KERASTICK Topical Solution (14 to 18 hours), you should call your doctor. You should also continue to avoid exposure of the photosensitized areas to sunlight or to bright light for at least 40 hours after application of the LEVULAN KERASTICK Topical Solution.

What should I avoid after LEVULAN KERASTICK Topical Solution is applied?

Between the time of the application of LEVULAN KERASTICK Topical Solution and BLU-U treatment your AK lesions will become photosensitive (sensitive to light). Care should be taken to keep the areas to which LEVULAN KERASTICK Topical Solution has been applied protected from bright light during this time.

Light-protective headgear, such as a wide-brimmed hat of sufficient size to provide shade to areas to which LEVULAN KERASTICK Topical Solution has been applied, should be worn during this time if you are exposed to sunlight or sources of bright indoor light such as lights at close range, examination lamps or tanning beds.

If you feel burning and/or stinging of the areas to which LEVULAN KERASTICK Topical Solution has been applied, light exposure should be reduced by wearing protective headgear or by reducing the light intensity.

Sunscreens will not protect the areas to which LEVULAN KERASTICK Topical Solution has been applied against sensitivity to light. You must cover or shade these areas from sunlight or sources of bright indoor light.

What are the possible side effects of LEVULAN KERASTICK Topical Solution + Blue Light PDT?

During BLU-U treatment, you will feel tingling, stinging, prickling, or burning of the treated areas. These feelings should improve at the end of BLU-U treatment and should end within 24 hours.

Following BLU-U 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 resolved by 4 weeks after treatment. Other side effects at the treatment sites may include scaling, itching, and changes in skin color.

Other Information

This patient information summarizes the most important information about LEVULAN KERASTICK for Topical Solution + Blue Light PDT. If you would like more information, talk to your doctor or other health care provider. There is also a document prepared specifically for health professionals that your doctor or other health professional can give to you.

LEVULAN®, KERASTICK®, BLU-U®, DUSA Pharmaceuticals, Inc.® and DUSA® are registered trademarks of DUSA Pharmaceuticals, Inc.®

US Patents: 5,079,262; 5,211,938; 5,954,703

 

Manufactured for:

DUSA Pharmaceuticals, Inc.®,
a Sun Pharma company
25 Upton Drive
Wilmington, MA 01887

LAB-0529AW Revision: C

 

For more information please contact:

1-877-533-3872

or

1-978-657-7500

www.dusapharma.com

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

WEB 1459 Rev F