The BF-RhodoLED® has been developed for use in photodynamic therapy in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for topical use. There is no approval for any other use or combination of use.
On the profile screen, press “Start” to begin treatment. You can interrupt the treatment at any time by pressing the “Break” button. Press the “Start” button to resume the treatment. Abort the current treatment by pressing the “Stop” button.
In order to avoid eye irritation, glare or injury, protective eye equipment must be used by patient, healthcare providers and any person present during the illumination period. Healthcare personnel and other persons present must wear protective glasses with a visible light transmission (VLT) of approximately 10%. Patients must wear eye protection with an optical density for visible light of 6 or higher.
Note: Eyewear is not part of the medical device. Please carefully read any accompanying usage information before using any eye protection.
BF-RhodoLED® PDT Step-by-Step
These instructions should be used in conjunction with detailed operating instructions (see user manual). The section titles and numbers listed next to the instruction refer to the detailed instructions and/or descriptions that correspond with each step.
- Plug in lamp.
- Turn on the lamp and wait for home screen to appear (see chapter 7.1).
- Position patient comfortably and prepare skin area to be treated following the USPI of Ameluz®.
- Ensure patient is wearing protective eyewear (see chapter 5).
- Position the lamp and adjust the lamp head over the skin area to be treated (distance 2-3 inches) (see chapter 7.3.1).
- Put on protective eyewear and make sure anyone remaining in the treatment room also wears protective eyewear.
- Start treatment by pressing “Treatment” on the home screen, press “Start” on the treatment screen, and press “Start” once again in the profile screen. The illumination period of 10 minutes begins (see chapter 7.3.2).
- Remind the patient to remain still throughout the illumination period.
- If the patient needs a break, press “Break” on the profile screen. To resume treatment, press “Start” on the profile screen (see chapter 7.3.2).
- To abort the illumination, press “Stop” on the profile screen.
- Adjust fan speed to patient’s needs by pressing plus or minus 1% or 10% on the profile screen.
The BF-RhodoLED® may only be used by healthcare providers who have received adequate training in its use. In order to avoid the risk of electrical shock, the device may only be connected to a power supply with a grounded connection.
Neither the BF-RhodoLED® nor its touchscreen monitor may come into contact with water as this may lead to severe damage or electrical shock (exception: cleaning with a damp cloth).
For Ameluz® full prescribing information and BF-RhodoLED® user manual please refer to: www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=650daa9f-aeec-49ce-95b9-5fa20b988afd
Important Safety Information
AMELUZ® (aminolevulinic acid hydrochloride) gel, 10% with BF-RhodoLED® lamp
AMELUZ®, containing 10% aminolevulinic acid hydrochloride, is a non-sterile gel formulation for topical use only. Not for ophthalmic, oral, or intravaginal use.
AMELUZ®, in conjunction with lesion preparation, is only to be administered by a health care provider. Photodynamic therapy with AMELUZ® involves preparation of lesions, application of the product, occlusion and illumination with BF-RhodoLED®. The application area should not exceed 20 cm2 and no more than 2 grams of AMELUZ® (one tube) should be used at one time. Lesions that have not completely resolved shall be retreated 3 months after the initial treatment. Refer to BF-RhodoLED® user manual for detailed lamp safety and operating instructions. Both patient and medical personnel conducting the PDT should adhere to all safety instructions.
Ameluz® shall not be used by persons who have known hypersensitivity to porphyrins or any of the components of AMELUZ®, which includes soybean phosphatidylcholine. Ameluz® should also not be used for patients who have porphyria or photodermatoses.
Transient Amnestic Episodes have been reported during postmarketing use of AMELUZ® in combination with photodynamic therapy (PDT). If patients experience amnesia or confusion, discontinue treatment. Advise them to contact the healthcare provider if the patient develops amnesia after treatment.
Eye exposure to the red light of the BF-RhodoLED® lamp during PDT must be prevented by protective eyewear. Direct staring into the light source must be avoided. AMELUZ® increases photosensitivity. Patients should 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.
AMELUZ® has not been tested on patients with inherited or acquired coagulation disorders. Special care should be taken to avoid bleeding during lesion preparation in such patients. Any bleeding must be stopped before application of the gel. AMELUZ® should not be used on mucous membranes or in the eyes.
Local skin reactions at the application site were observed in about 99.5% of subjects treated with AMELUZ® and narrow spectrum lamps. The very common adverse reactions (≥10%) during and after PDT were application site erythema, pain/burning, irritation, edema, pruritus, exfoliation, scab, induration, and vesicles. Most adverse reactions occurred during illumination or shortly afterwards, were generally of mild or moderate intensity, and lasted for 1 to 4 days in most cases; in some cases, however, they persisted for 1 to 2 weeks or even longer. Severe pain/burning occurred in up to 30% of treatments.
There have been no formal studies of the interaction of AMELUZ® with other drugs. Concomitant use of the following photosensitizing medications may increase the phototoxic reactions after PDT: St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones, and tetracyclines.
There are no available data on AMELUZ® use in pregnant women to inform a drug associated risk. No data are available regarding the presence of aminolevulinic acid in human milk, the effects of aminolevulinic acid on the breastfed infant or on milk production. Safety and effectiveness in pediatric patients below the age of 18 have not been established as AK is not a condition generally seen in the pediatric population. No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Please read the US Full Prescribing Information for Ameluz® and/or US User Manual of BF-RhodoLED® lamp available together at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=650daa9f-aeec-49ce-95b9-5fa20b988afd.
You are encouraged to report side effects of Ameluz®. Please contact Biofrontera Inc. at 1-844-829-7434 or FDA at 1-800-332-1088 or www.fda.gov/medwatch.