LEVULAN KERASTICK
aminolevulinic acid hydrochloride · KIT · Sun Pharmaceutical Industries, Inc
Levulan Kerastick is a prescription medication containing aminolevulinic acid that is applied topically to the skin and used with a specific light treatment to address certain precancerous skin lesions and acne. It works by making abnormal cells more sensitive to light energy, which then destroys those cells.
Key Facts
- Brand Name
- LEVULAN KERASTICK
- Generic Name
- aminolevulinic acid hydrochloride
- NDC Code (Product)
67308-101- Manufacturer
- Sun Pharmaceutical Industries, Inc
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA020965
- Marketing Start
- 09/04/2000
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION LEVULAN KERASTICK photodynamic therapy is a two-stage process for administration by a health care provider.( 2.1 ) Apply the drug product to the target lesions. ( 2.1 ) Illuminate with blue light using the BLU-U ® Blue Light Photodynamic Therapy Illuminator after the incubation time of( 2.2 ): 14 to 18 hours for scalp or face 3 hours for upper extremities, with occlusion LEVULAN KERASTICK photodynamic therapy may be repeated a second time for lesions that have not completely resolved after 8 weeks ( 2.1 ) For topical use only. ( 2.1) See full prescribing information for complete dosage and administration instruction. ( 2 ) See BLU-U user manual for detailed lamp safety and operating instructions. ( 2.2 ) 2.1 Preparation and Administration Overview After mixing, the LEVULAN KERASTICK topical solution 20% is intended for direct application to individual lesions diagnosed as actinic keratoses and not to perilesional skin. This product is not intended for application by patients or unqualified medical personnel. Application should involve lesions on the scalp, face or upper extremities; multiple lesions can be treated within a treatment region, but multiple …
Contraindications
4 CONTRAINDICATIONS The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with: Cutaneous photosensitivity at wavelengths of 400-450 nm [see Warnings and Precautions (5.2) ] Porphyria or known allergies to porphyrins [see Warnings and Precautions (5.2) ] Known sensitivity to any of the components of the LEVULAN KERASTICK. Cutaneous photosensitivity at wavelengths of 400-450 nm. ( 4 ) Porphyria or known allergies to porphyrins. ( 4 ) Sensitivity to any of the components of the LEVULAN KERASTICK. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS There have been no formal studies of the interaction of LEVULAN KERASTICK topical solution with any other drugs, and no drug-specific interactions were noted during any of the controlled clinical trials. It is, however, possible that concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction of actinic keratoses treated with LEVULAN KERASTICK topical solution [see Warnings and Precautions (5.2) ] . Concomitant use of other known photosensitizing agents such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines might increase the photosensitivity reaction. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the other sections of the labeling: Transient Amnestic Episodes [see Warnings and Precautions (5.1) ] Increased Photosensitivity [see Warnings and Precautions (5.2) ] Irritation [see Warnings and Precautions (5.3) ] Coagulation defects [see Warnings and Precautions (5.4) ] The most common local adverse reactions (incidence ≥ 10%) were erythema, edema, stinging/burning, scaling/crusting, itching, erosion, hypo/hyperpigmentation, oozing/vesiculation/crusting, scaling and dryness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Dermatology at 877-533-3872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, no non-cutaneous adverse events were found to be consistently associated with LEVULAN KERASTICK photodynamic therapy. Photodynamic Therapy Response: The constellation of transient …
Frequently Asked Questions
What is LEVULAN KERASTICK used for?
Levulan Kerastick is a prescription medication containing aminolevulinic acid that is applied topically to the skin and used with a specific light treatment to address certain precancerous skin lesions and acne. It works by making abnormal cells more sensitive to light energy, which then destroys those cells.
Is LEVULAN KERASTICK a controlled substance?
LEVULAN KERASTICK is not classified as a controlled substance by the DEA.
What is the generic name for LEVULAN KERASTICK?
The generic name for LEVULAN KERASTICK is aminolevulinic acid hydrochloride. There are 3 other brand versions of aminolevulinic acid hydrochloride.
What is the NDC code for LEVULAN KERASTICK ?
The NDC (National Drug Code) for LEVULAN KERASTICK is 67308-101, listed by Sun Pharmaceutical Industries, Inc.