AMINOLEVULINIC ACID Drug Interactions: What You Need to Know

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 )

4. CONTRAINDICATIONS AMELUZ is contraindicated in patients with: Known hypersensitivity to porphyrins. Known hypersensitivity to any of the components of AMELUZ, which includes soybean phosphatidylcholine [see Warnings and Precautions (5.1) ] . Porphyria. AMELUZ use may cause uncontrolled phototoxic effects [see Warnings and Precautions (5.5) ] . Photodermatoses. PDT may worsen the phototoxic or photoallergic reactions [see Warnings and Precautions (5.5) ] . Known hypersensitivity to porphyrins ( 4 ). Known hypersensitivity to any component of AMELUZ, which includes soybean phosphatidylcholine ( 4 ). Porphyria ( 4 ). Photodermatoses ( 4 ).

AND PRECAUTIONS Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment. ( 5.1 ) Avoid exposure of the photosensitive actinic keratoses to sunlight or bright indoor light prior to blue light treatment. Protect treated lesions from sunlight exposure. Sunscreens will not protect the patient against photosensitivity reactions. ( 5.2 ) The LEVULAN KERASTICK for topical solution should be used by a qualified health professional. To avoid unintended photosensitivity, LEVULAN KERASTICK topical solution should be applied to no more than 5 mm of perilesional skin surrounding each target actinic keratosis lesion. ( 5.2 ) Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours. ( 5.3 )

5.1 Transient Amnestic Episodes Transient amnestic episodes have been reported during postmarketing use of LEVULAN KERASTICK in combination with BLU-U Blue Light Photodynamic Therapy Illuminator. Inform patients and their caregivers that LEVULAN KERASTICK in combination with PDT may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.

5.2 Photosensitivity After LEVULAN KERASTICK topical solution has been applied, the treatment site will become photosensitive and patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) for 40 hours. Exposure may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Therefore, before exposure to sunlight, patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material, and/or a long-sleeved shirt and/or gloves. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the LEVULAN KERASTICK topical solution outside the treatment site to the eye or surrounding skin. Application of LEVULAN KERASTICK topical solution to perilesional areas of photodamaged skin of the face, scalp or upper extremities may result in photosensitization. Upon exposure to activating light from the BLU-U, such photosensitized skin may produce a stinging and/or burning sensation and may become erythematous and/or edematous in a manner similar to that of actinic keratoses treated with LEVULAN KERASTICK Photodynamic Therapy. Because of the potential for skin to become photosensitized, the LEVULAN KERASTICK topical solution should be used by a qualified health professional to apply drug to no more than 5mm of perilesional skin surrounding the target actinic keratosis lesions. If for any reason the patient cannot return for blue light treatment during the prescribed period after applying LEVULAN KERASTICK topical solution, the patient should call the doctor. The patient should also continue to avoid exposure of the photosensitized lesions to sunlight or prolonged or intense light for at least 40 hours. If stinging and/or burning is noted, exposure to light should be reduced.

5.3 Irritation The LEVULAN KERASTICK topical solution contains alcohol and is intended for topical use only. Irritation may be experienced if this product is applied to eyes or mucous membranes. Do not apply to the eyes or to mucous membranes. Excessive irritation may be experienced if this product is applied under occlusion longer than 3 hours.

5.4 Coagulation Defects The LEVULAN KERASTICK for topical solution has not been tested on patients with inherited or acquired coagulation defects.