Ameluz
(Aminolevulinic Acid Hydrochloride)Dosage & Administration
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Ameluz Prescribing Information
AMELUZ, in combination with photodynamic therapy (PDT) using BF-RhodoLED® or RhodoLED® XL lamp, a narrowband, red light illumination source, is indicated for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.
- Administer AMELUZ only by a health care provider ().
2.1 Important Administration InformationAMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider.
AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use.
Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED or RhodoLED XL light.
Refer to BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions. Adhere to all safety instructions for both patient and medical personnel while conducting the PDT.
- AMELUZ is for topical use only ().
2.1 Important Administration InformationAMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider.
AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use.
Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED or RhodoLED XL light.
Refer to BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions. Adhere to all safety instructions for both patient and medical personnel while conducting the PDT.
- Use AMELUZ in combination with red light photodynamic therapy (PDT). See BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions ().
2.1 Important Administration InformationAMELUZ, in conjunction with lesion preparation, is only to be administered by a health care provider.
AMELUZ is for topical use only. Not for ophthalmic, oral, or intravaginal use.
Treat single lesions or an entire field affected by multiple lesions with AMELUZ, in combination with red light photodynamic therapy (PDT). PDT requires administration of both AMELUZ and BF-RhodoLED or RhodoLED XL light.
Refer to BF-RhodoLED or RhodoLED XL user manual for detailed lamp safety and operating instructions. Adhere to all safety instructions for both patient and medical personnel while conducting the PDT.
- Photodynamic therapy with AMELUZ involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED or RhodoLED XL lamp ().
2.3 Administration InstructionsPDT is a multi-stage process:
Step 1. Preparation of LesionsBefore applying AMELUZ, carefully wipe all lesions with an ethanol or isopropanol-soaked cotton pad to ensure degreasing of the skin.
Figure 1A: Degreasing the skinThereafter, remove any scaling and crusts and gently roughen all lesion surfaces, taking care to avoid bleeding.
Figure 1B: Removal of scales and crustsStep 2. Application of AMELUZApply AMELUZ using glove protected fingertips or a spatula. Use sufficient amount of gel to cover individual lesions or the entire field:
- Lesion-directed treatment: Apply gel approximately 1 mm thick to one or more individual AK lesions and include approximately 5 mm of the surrounding healthy skin.
- Field-directed treatment: Apply gel approximately 1 mm thick to the treatment field. Apply gel to the lesions and the skin in-between the lesions. Additionally, cover approximately 5 mm of the surrounding healthy area.
Do not exceed an application area of 60 cm2
and do not use more than 6 grams of AMELUZ (3 tubes) at one time. The gel can be applied to healthy skin around the lesions. Avoid application near mucous membranes such as the eyes, nostrils, mouth, and ears (keep a distance of 1 cm from these areas). In case of accidental contact with mucous membranes, thoroughly rinse with water [see Warnings and Precautions (5.7)].Allow the gel to dry for approximately 10 minutes before applying occlusive dressing.
Figure 2: Drug applicationStep 3. Occlusion for 3 HoursCover the area where the gel has been applied with a light-blocking, occlusive dressing. Following 3 hours of occlusion, remove the dressing and wipe off any remaining gel.
Figure 3: OcclusionStep 4. Illumination with Red LightFor patient and medical personnel, wear suitable protective eyewear during illumination. Avoid staring directly into the light source [
see Warnings and Precautions (5.3)].Illuminate the treatment area with the BF-RhodoLED or RhodoLED XL lamp immediately after removing occlusion and any remaining gel. BF-RhodoLED and RhodoLED XL lamps are red light sources with a narrow spectrum around 635 nm that deliver a light dose of approximately 37 J/cm2. Calibration by the operator is not needed; the illumination time is calculated automatically. Physical measures such as cooling with an air stream or nebulized water may help reduce pain during illumination.
Either the BF-RhodoLED or RhodoLED XL lamp can be used:
- BF-RhodoLED has an effective treatment area of 6 x 16 cm when an area of 8 x 18 cm is illuminated. Position the lamp head 5-8 cm from the skin’s surface. Larger areas can be illuminated in several steps.
- RhodoLED XL has a curved configuration with an effective treatment area up to 23 x 29 cm. Position the lamp head of the RhodoLED XL 11-14 cm from the skin’s surface. This usually allows a full-face illumination with the use of 5 panels. The smallest recommended number of panels to be used are 3 adjacent panels (see chapter 8.4.6 of RhodoLED XL user manual).
Healthy untreated skin surrounding the AK lesions does not need protection during illumination.
Figure 4A: Illumination with BF-RhodoLED
Figure 4B: Illumination with RhodoLED XLIf for any reason, the lesions cannot be illuminated within 3 hours after AMELUZ application, rinse off the gel with saline and water. For 2 days, protect the lesion sites and surrounding skin from sunlight or prolonged or intense light (e.g., tanning beds, sun lamps).
Figure 1A: Degreasing of the skin Figure 1B: Figure 1B: Removal of scales and crusts Figure 2: Drug application Figure 3: Occlusion Figure 4A: Illumination Figure 4B: Illumination - Apply an approximately 1 mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin. Do not exceed an application area of 60 cm2. Do not use more than 6 grams of AMELUZ (3 tubes) at one time ().
2.2 Recommended DosageApply an approximately 1-mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin. Do not exceed an application area of 60 cm2. Do not use more than 6 grams of AMELUZ (3 tubes) at one time.
Retreat lesions that have not completely resolved after 3 months after the initial treatment. - Retreat lesions that have not completely resolved 3 months after the initial treatment ().
2.2 Recommended DosageApply an approximately 1-mm thick layer of AMELUZ to skin lesion(s). Cover individual lesions or the entire AK-field with AMELUZ. Include approximately 5 mm of the surrounding skin. Do not exceed an application area of 60 cm2. Do not use more than 6 grams of AMELUZ (3 tubes) at one time.
Retreat lesions that have not completely resolved after 3 months after the initial treatment.
Topical gel: 10% aminolevulinic acid hydrochloride as a white-to-yellowish gel in 2-gram tubes.
There are no available data on AMELUZ use in pregnant women to inform a drug associated risk. Animal reproduction studies were not conducted with aminolevulinic acid. Systemic absorption of aminolevulinic acid in humans is negligible following topical administration of AMELUZ under maximal clinical use conditions
Aminolevulinic acid acts as a prodrug to the photoactive metabolite protoporphyrin IX (PpIX).
Pharmacokinetics (PK) of aminolevulinic acid and PpIX were evaluated in two trials:
In the first trial, a single dose of one entire tube of AMELUZ (2 grams) was applied under occlusion for 3 hours followed by PDT to a total area of 20 cm2in 12 adult subjects with mild to moderate AK with at least 10 AK lesions on the face or forehead. The mean ± SD baseline plasma aminolevulinic acid concentration was 20.16 ± 16.53 ng/mL. In most subjects, an up to 2.5-fold increase of aminolevulinic acid plasma concentrations was observed during the first 3 hours after AMELUZ application. The mean ± SD area under the concentration time curve (AUC0-t) and maximum concentration (Cmax) for baseline corrected aminolevulinic acid (n=12) were 142.83 ± 75.50 ng·h/mL and 27.19 ± 20.02 ng/mL, respectively. The median Tmax(time at which Cmaxoccurred) was 3 hours.
The mean ± SD baseline plasma PpIX concentration was 3.27 ± 2.40 ng/mL (n=12). The majority (about 55%) of the PpIX concentrations were below the limit of quantification (LOQ = 1 ng/mL) and baseline corrected values were negative in all subjects except for one. The baseline corrected AUC0-tand Cmaxin the single subject was 0.07 ng·h/mL and 0.29 ng/mL, respectively.
In the second trial, a single dose of three entire tubes of AMELUZ (6 grams) was applied under occlusion for 3 hours followed by PDT to a total area of 60 cm2in 16 adult subjects with mild to severe AK with at least 12 AK lesions on the face and scalp. The mean ± SD baseline plasma aminolevulinic acid concentration was 13.53 ± 1.58 ng/mL. In most subjects, an up to 2.5-fold increase of aminolevulinic acid plasma concentrations was observed during the first 3 hours after AMELUZ application. The mean ± SD area under the concentration time curve (AUC0-t) and maximum concentration (Cmax) for baseline corrected aminolevulinic acid (n=16) were 134.24 ± 87.97 ng·h/mL and 33.85 ± 21.85 ng/mL, respectively. The median Tmax(time at which Cmaxoccurred) was 3 hours.
The mean ± SD baseline plasma PpIX concentration was 1.93 ± 0.42 ng/mL (n=15). The mean ± SD baseline corrected Cmaxof PpIX was 0.67 ± 0.78 ng/mL (n=13) with a median Tmaxof 4 hours. The baseline corrected PpIX concentrations in 14 of 15 subjects were < 1 ng/mL.
The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
AMELUZ is contraindicated in patients with:
- Known hypersensitivity to porphyrins.
- Known hypersensitivity to any of the components of AMELUZ, which includes soybean phosphatidylcholine [see.]
5.1 HypersensitivitySeveral cases of hypersensitivity were reported during postmarketing use of AMELUZ prior to PDT illumination [see Adverse Reactions (6.2)]. If allergic reactions occur, clean the area of skin where the product was applied and institute appropriate therapy. Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe courses (anaphylaxis). - Porphyria. AMELUZ use may cause uncontrolled phototoxic effects [see.]
5.5 Increased PhotosensitivityAMELUZ increases photosensitivity. Avoid sunlight, prolonged or intense light (e.g., tanning beds, sun lamps) on lesions and surrounding skin treated with AMELUZ for approximately 48 hours following treatment, whether exposed to illumination or not. Concomitant use of AMELUZ with other known photosensitizing agents may increase the risk of phototoxic reaction to PDT
[see Drug Interactions (7)]. - Photodermatoses. PDT may worsen the phototoxic or photoallergic reactions [see.]
5.5 Increased PhotosensitivityAMELUZ increases photosensitivity. Avoid sunlight, prolonged or intense light (e.g., tanning beds, sun lamps) on lesions and surrounding skin treated with AMELUZ for approximately 48 hours following treatment, whether exposed to illumination or not. Concomitant use of AMELUZ with other known photosensitizing agents may increase the risk of phototoxic reaction to PDT
[see Drug Interactions (7)].
- Hypersensitivity:Hypersensitivityreactionshave been reported with the use of AMELUZ prior to photodynamic therapy (PDT). If allergic reaction occurs, wash off AMELUZ and institute appropriate therapy ().
5.1 HypersensitivitySeveral cases of hypersensitivity were reported during postmarketing use of AMELUZ prior to PDT illumination [see Adverse Reactions (6.2)]. If allergic reactions occur, clean the area of skin where the product was applied and institute appropriate therapy. Inform patients and their caregivers that AMELUZ may cause hypersensitivity, potentially including severe courses (anaphylaxis). - Transient Amnestic Episodes:Transient amnestic episodes have been reported with use of AMELUZ in combination with PDT. Advise patients to contact their healthcare provider if amnesia or confusion occurs after treatment ().
5.2 Transient Amnestic EpisodesTransient amnestic episodes have been reported during postmarketing use of AMELUZ in combination with photodynamic therapy. Inform patients and their caregivers that AMELUZ in combination with photodynamic therapy may cause transient amnestic episodes. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.
- Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye Injury:Patients and healthcare providers must wear protective eyewear before operating BF-RhodoLED or RhodoLED XL lamp ().
5.3 Risk of BF-RhodoLED or RhodoLED XL Lamp Induced Eye InjuryBF-RhodoLED or RhodoLED XL lamp may cause eye irritation, glare, or injury. Before operating the lamp, personnel must refer to the user manual for specific warnings, cautions, and instructions. Eye exposure to the BF-RhodoLED or RhodoLED XL light must be prevented. Protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period. Avoid staring directly into the light source.
- Ophthalmic Adverse Reactions:Avoid direct contact of AMELUZ with the eyes ().
5.4 Ophthalmic Adverse ReactionsEyelid edema and dry eyes have occurred after PDT with AMELUZ. PDT with AMELUZ can cause ophthalmic adverse reactions. Avoid direct contact of AMELUZ with the eyes. Rinse eyes with water in case of accidental contact.
- Increased Photosensitivity:Protect treated lesions from sunlight exposure for 48 hours post treatment ().
5.5 Increased PhotosensitivityAMELUZ increases photosensitivity. Avoid sunlight, prolonged or intense light (e.g., tanning beds, sun lamps) on lesions and surrounding skin treated with AMELUZ for approximately 48 hours following treatment, whether exposed to illumination or not. Concomitant use of AMELUZ with other known photosensitizing agents may increase the risk of phototoxic reaction to PDT
[see Drug Interactions (7)]. - Risk of Bleedingin Patients with Coagulation Disorders:Take special care to avoid bleeding during lesion preparation in patients with inherited or acquired coagulation disorders ().
5.6 Risk of Bleeding in Patients with Coagulation DisordersAMELUZ has not been tested on patients with inherited or acquired coagulation disorders.
Take special care to avoid bleeding during lesion preparation in such patients
[ see Dosage and Administration (2.3)]. Any bleeding must be stopped before application of the gel. - Mucous Membrane Irritation:Avoid direct contact of AMELUZ with the mucous membranes ().
5.7 Risk of Mucous Membrane IrritationAMELUZ can cause mucous membrane irritation. AMELUZ is intended for topical use only. Avoid direct contact of AMELUZ to the mucous membranes. Rinse with water in case of accidental contact.