`PATIENT INFORMATION
`LEVULAN® KERASTICK® (LEV-you-lan KER-rah-stick)
`(aminolevulinic acid HCl)
`for topical solution, 20%
`Important: LEVULAN KERASTICK is for use as an in-office treatment. LEVULAN KERASTICK treatment is given by a
`healthcare provider only and is not for use at home.
`What is LEVULAN KERASTICK?
`LEVULAN KERASTICK is a prescription medicine used on the skin (topical) with blue light treatment (BLU-U Blue Light
`Photodynamic Therapy or PDT) for the treatment of minimally to moderately thick actinic keratoses (AK’s) of the face,
`scalp, or upper arms.
`It is not known if LEVULAN KERASTICK is safe and effective in children under 18 years of age.
`Who should not receive LEVULAN KERASTICK treatment?
`Do not receive LEVULAN KERASTICK treatment if you:
`• are allergic to aminolevulinic acid HCl or to any of the ingredients in LEVULAN KERASTICK. See the end of this
`leaflet for a complete list of ingredients in LEVULAN KERASTICK.
`• have porphyria or are allergic to porphyrins
`• have a skin sensitivity to blue light
`Before receiving LEVULAN KERASTICK treatment, tell your healthcare provider about all of your medical
`conditions, including if you:
`• have blood clotting problems
`• are pregnant or plan to become pregnant. It is not known if LEVULAN KERASTICK will harm your unborn baby.
`• are breastfeeding or plan to breastfeed. It is not known if LEVULAN KERASTICK passes into your breast milk. Talk
`to your healthcare provider about the best way to feed your baby during LEVULAN KERASTICK treatment.
`Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter
`medicines, vitamins, and herbal supplements. LEVULAN KERASTICK and other medicines may affect each other
`causing side effects.
`How will I receive LEVULAN KERASTICK treatment?
`• LEVULAN KERASTICK treatment is received in 2 parts:
`o Your healthcare provider will apply LEVULAN KERASTICK topical solution to your skin lesions. You should not
`wash the treated areas before you return to your healthcare provider for blue light treatment.
`o After the prescribed amount of time you will return to your healthcare provider for blue light treatment. Call your
`healthcare provider if you cannot return for blue light treatment during the prescribed time after LEVULAN
`KERASTICK topical solution has been applied. If you cannot return for blue light treatment, avoid sunlight and
`bright indoor light for at least 40 hours after LEVULAN KERASTICK topical solution has been applied.
`• During blue light treatment, you will likely feel tingling, stinging, prickling, or burning of the treated areas.
`What should I avoid during LEVULAN KERASTICK treatment?
`After LEVULAN KERASTICK topical solution is applied to your skin you should avoid sunlight or bright indoor light
`(such as examination lights, operating room lights, tanning beds, or lights that are close to you) for 40 hours. During
`this time, the treated areas of your skin will become sensitive to light (photosensitive).
`Exposure to light during this time may cause you to feel a burning or stinging sensation and may cause your treated
`lesions to become red or swollen. You should wear appropriate protective apparel such as a wide-brimmed hat, long
`sleeve shirt, and gloves to protect your treated skin from sunlight and other bright light.
`Sunscreen will not protect the treated areas of your skin against sensitivity to light.
`What are the possible side effects of LEVULAN KERASTICK?
`LEVULAN KERASTICK may cause serious side effects, including:
`• Temporary memory problems. Temporary memory problems have happened during treatment with LEVULAN
`KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. You or your family members
`or caregiver should call your healthcare provider right away if you develop any problems with memory, confusion,
`or disorientation during treatment.
`• Sensitivity to light (photosensitivity). See, “What should I avoid during LEVULAN KERASTICK treatment?”
`• Skin irritation. LEVULAN KERASTICK topical solution contains alcohol and may cause skin irritation if covered or
`bandaged for longer than 3 hours.
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`Reference ID: 4980021
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`The common side effects of LEVULAN KERASTICK include:
`• Local skin reactions including redness, swelling, stinging and burning, scaling, crusting, oozing, pustules, welts,
`scabbing, itching, erosion, changes in skin color, bleeding, tenderness, changes in the sense of touch, and
`dryness.
`These are not all the possible side effects of LEVULAN KERASTICK.
`Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
`General Information about LEVULAN KERASTICK
`Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask
`your pharmacist and healthcare provider for information about LEVULAN KERASTICK that is written for health
`professionals.
` What are the Ingredients in LEVULAN KERASTICK?
`Active ingredient: aminolevulinic acid HCl
`Inactive ingredients: alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, polyethylene glycol
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`Manufactured by:
`Pharmalucence, Inc., a Sun Pharma company Billerica, MA 01821
`For more information call 1-877-533-3872
`www.levulan.com
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`This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 5/2022
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`Reference ID: 4980021
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