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warnings and cautions
5 WARNINGS 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.
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 local symptoms of stinging and/or burning, itching, erythema and edema as a result of LEVULAN KERASTICK photodynamic therapy (PDT) was observed in all clinical trials 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. Local skin reactions at the application site were observed in 99% of subjects treated with LEVULAN KERASTICK topical solution and BLU-U Blue Light Photodynamic Therapy Illuminator. The most common local adverse reactions (incidence ≥ 10%) were application site stinging/burning, erythema, edema, scaling/crusting, hypo/hyperpigmentation, itching, erosion, oozing/vesiculation/crusting, dryness. In the trials for face and scalp lesions, severe stinging and/or burning at one or more lesions during light treatment was reported by at least 50% of subjects. Severe stinging and/or burning also occurred during light treatment in 9% of subjects receiving treatment for upper extremity lesions. The majority of subjects reported that all lesions treated exhibited at least slight stinging and/or burning. In trials of the face and scalp, the sensation of stinging/burning appeared to reach a plateau at 6 minutes into the treatment. Less than 3% of subjects receiving treatment for face or scalp lesions discontinued light treatment because of stinging/burning. No subjects discontinued light treatment in the trial for upper extremity lesions. In trials for the face or scalp lesions, 99% of the active treatment group and 79% of the vehicle group experienced erythema shortly after treatment. In the trial for the upper extremity lesions, 99% of LEVULAN KERASTICK topical solution treatment group and 52% of the vehicle group experienced erythema on visit Days 2-3. Approximately 35% of LEVULAN KERASTICK topical solution group had edema, while edema occurred in < 1% of the vehicle group. Both erythema and edema resolved to baseline or improved by 4 weeks after therapy for face or scalp. Edema resolved by 4 weeks and erythema resolved to baseline by 8 weeks for upper extremities. The application of LEVULAN KERASTICK topical solution to perilesional skin resulted in stinging, burning, erythema and edema similar to treated actinic keratoses [see Warnings and Precautions (5.2) ] . Other Localized Cutaneous Adverse Experiences: Table 2 depicts the incidence and severity of cutaneous adverse events in trials for the face and scalp. TABLE 2 Post-PDT Cutaneous Adverse Events – ALA-018/ALA-019 For the Face and Scalp FACE SCALP LEVULAN KERASTICK Topical Solution + PDT (n=139) Vehicle + PDT (n=41) LEVULAN KERASTICK Topical Solution + PDT (n=42) Vehicle + PDT (n=21) Degree of Severity Mild/ Moderate Severe Mild/ Moderate Severe Mild/ Moderate Severe Mild/ Moderate Severe Scaling/Crusting 71% 1% 12% 0% 64% 2% 19% 0% Pain 1% 0% 0% 0% 0% 0% 0% 0% Tenderness 1% 0% 0% 0% 2% 0% 0% 0% Itching 25% 1% 7% 0% 14% 7% 19% 0% Edema 1% 0% 0% 0% 0% 0% 0% 0% Ulceration 4% 0% 0% 0% 2% 0% 0% 0% Bleeding/Hemorrhage 4% 0% 0% 0% 2% 0% 0% 0% Hypo/hyper-pigmentation 22% 20% 36% 33% Vesiculation 4% 0% 0% 0% 5% 0% 0% 0% Pustules 4% 0% 0% 0% 0% 0% 0% 0% Oozing 1% 0% 0% 0% 0% 0% 0% 0% Dysesthesia 2% 0% 0% 0% 0% 0% 0% 0% Scabbing 2% 1% 0% 0% 0% 0% 0% 0% Erosion 14% 1% 0% 0% 2% 0% 0% 0% Excoriation 1% 0% 0% 0% 0% 0% 0% 0% Wheal/Flare 7% 1% 0% 0% 2% 0% 0% 0% Skin disorder NOS 5% 0% 0% 0% 12% 0% 5% 0% Table 3 depicts the incidence of other cutaneous adverse events in Phase 3 studies for the upper extremities. TABLE 3 Percentage of Subjects with Cutaneous Adverse Reactions by the Most Severe Grade Reported Post-Baseline – CP0108 For Upper Extremities LEVULAN KERASTICK Topical Solution + PDT (N=135) Vehicle + PDT (N=134) Degree of Severity Minimal/ Mild Moderate/ Severe Total Minimal/ Mild Moderate/ Severe Total Edema 51% 4% 56% 7% 1% 8% Erythema 35% 65% 100% 63% 12% 75% Hyper-pigmentation 64% 9% 73% 57% 10% 66% Hypo-pigmentation 46% 4% 50% 50% 5% 55% Oozing/Vesiculation/ Crusting 36% 5% 41% 8% 2% 10% Scaling and Dryness 65% 22% 87% 58% 7% 64% Stinging/Burning 23% 73% 96% 23% 0% 23% In the trial for upper extremity lesions, itching and scabbing occurred in 8% and 4%, respectively, of the subjects in the LEVULAN KERASTICK photodynamic therapy group. No subjects in the vehicle group reported itching or scabbing. Common ( > 2%, <10%) local cutaneous adverse reactions for face, scalp and upper extremities in the LEVULAN KERASTICK topical solution group included wheal, scabbing, pustules, ulceration, bleeding, tenderness and dysesthesia. Uncommon (<2%) local cutaneous adverse reactions for face, scalp and upper extremities in the LEVULAN KERASTICK topical solution group were flaking, pain, peeling, perilesional pruritic rash, excoriation and blistering. Common ( > 2%, <10%) adverse reactions not limited to the application site for upper extremities and occurring more frequently in the LEVULAN KERASTICK topical solution group than in the vehicle group were sinusitis, squamous cell carcinoma, and squamous cell carcinoma of skin. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of LEVULAN KERASTICK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nervous system disorders : transient amnestic episodes