Levulan Kerastick

• Picato

© Levulan Kerastick Patient Information is supplied by Cerner Multum, Inc. and Levulan Kerastick Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Levulan Kerastick is part of the drug class:

• Sensitizers used in photodynamic/radiation therapy

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.

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.

Aminolevulinic acid causes skin cells to become more sensitive to certain types of light. Skin cells treated with aminolevulinic acid will die and slough off after being exposed to a special light treatment.

Aminolevulinic acid is used to treat actinic keratosis (warty overgrowths of skin) on the face and scalp. This medicine is used together with a special light treatment, also called photodynamic therapy.

Aminolevulinic acid may also be used for purposes not listed in this medication guide.

• If you need to store Levulan Kerastick at home, talk with your doctor, nurse, or pharmacist about how to store it.

The Levulan Kerastick for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy (PDT) Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp.

In Phase 3 studies, no non-cutaneous adverse events were found to be consistently associated with Levulan Kerastick Topical Solution application followed by blue light exposure.

Photodynamic Therapy Response: The constellation of transient local symptoms of stinging and/or burning, itching, erythema and edema as a result of Levulan Kerastick Topical Solution plus BLU-U treatment was observed in all clinical studies of Levulan Kerastick for Topical Solution Photodynamic Therapy for actinic keratoses treatment. Stinging and/or burning subsided between 1 minute and 24 hours after the BLU-U Blue Light Photodynamic Therapy Illuminator was turned off, and appeared qualitatively similar to that perceived by patients with erythropoietic protoporphyria upon exposure to sunlight. There was no clear drug dose or light dose dependent change in the incidence or severity of stinging and/or burning.

In two Phase 3 trials, the sensation of stinging and/or burning appeared to reach a plateau at 6 minutes into the treatment. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of the patients at some time during treatment. The majority of patients reported that all lesions treated exhibited at least slight stinging and/or burning. Less than 3% of patients discontinued light treatment due to stinging and/or burning.

In the Phase 3 trials, the most common changes in lesion appearance after Levulan Kerastick for Topical Solution Photodynamic Therapy were erythema and edema. In 99% of active treatment patients, some or all lesions were erythematous shortly after treatment, while in 79% of vehicle treatment patients, some or all lesions were erythematous. In 35% of active treatment patients, some or all lesions were edematous, while no vehicle-treated patients had edematous lesions. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy. Levulan Kerastick Topical Solution application to photodamaged perilesional skin resulted in photosensitization of photodamaged skin and in a photodynamic response (see Warnings and Precautions (5.2)).

Other Localized Cutaneous Adverse Experiences: Table 2 depicts the incidence and severity of cutaneous adverse events in Phase 3 studies, stratified by anatomic site treated.

Adverse Experiences Reported by Body System: In the Phase 3 studies, 7 patients experienced a serious adverse event. All were deemed remotely or not related to treatment. No clinically significant patterns of clinical laboratory changes were observed for standard serum chemical or hematologic parameters in any of the controlled clinical trials.

Levulan Kerastick Topical Solution Overdose

Levulan Kerastick Topical Solution overdose has not been reported. In the unlikely event that the drug is ingested, monitoring and supportive care are recommended. The patient should be advised to avoid incidental exposure to intense light sources for at least 40 hours after ingestion. The consequences of exceeding the recommended topical dosage are unknown.

BLU-U Light Overdose

There is no information on overdose of blue light from the BLU-U Blue Light Photodynamic Therapy Illuminator following Levulan Kerastick Topical Solution application.

LEVULAN® KERASTICK® (aminolevulinic acid HCl) for Topical Solution, 20%, a porphyrin precursor, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone.

ALA HCl is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil.

The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride (MW = 167.59). The structural formula is represented below:

The Levulan Kerastick for Topical Solution applicator is a two component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of ALA HCl as a dry solid. The applicator tube is enclosed in a protective cardboard sleeve and cap. The 20% topical solution is prepared just prior to the time of use by breaking the ampules and mixing the contents by shaking the Levulan Kerastick applicator. The term “ALA HCl” refers to unformulated active ingredient, “Levulan Kerastick for Topical Solution” refers to the drug product in its unmixed state, “Levulan Kerastick Topical Solution” refers to the mixed drug product (in the applicator tube or after application), and “Levulan Kerastick” refers to the applicator only.