Description
Aminolevulinic acid gel is used in combination with photodynamic therapy (PDT) using the medical device, BF-RhodoLED® for the treatment of mild to moderate actinic keratoses on the face and scalp.
Aminolevulinic acid solution followed by exposure to a certain type of light (blue light using the BLU–U Blue Light Photodynamic Therapy Illuminator) is used to treat minimally to moderately thick actinic keratoses of the face, scalp, or arms.
This medicine is to be given only by or under the direct supervision of a health care provider.
This product is available in the following dosage forms:
- Gel/Jelly
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of aminolevulinic acid in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aminolevulinic acid in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to porphyrins or
- Allergy to soybean phosphatidylcholine or
- Porphyria (enzyme problem) or
- Skin sensitivity to sunlight—Should not be used in patients with these conditions.
- Bleeding or blood clotting problems, inherited or acquired—Use with caution. May increase risk of bleeding in patients using Ameluz®.
Proper Use
You will receive this medicine in a clinic or doctor's office. A nurse or other trained health professional will apply the medicine.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any concerns.
If you are using the aminolevulinic acid solution:
- This medicine is applied on your lesions. Do not get any of the solution into your eyes, nose, mouth, or ears.
- After application of the solution to the arms, cover the treated area with a low density polyethylene plastic wrap held in place with an elastic net dressing.
- Application of the solution to target lesions must be followed by blue light illumination treatment using BLU–U Blue Light Photodynamic Therapy Illuminator in your doctor's office after 3 hours for upper arm lesions or after 14 to 18 hours for face or scalp lesions.
- Your doctor may want to retreat you after 8 weeks if your skin condition did not completely resolve.
- Call your doctor if you cannot return for the blue light illumination treatment after the aminolevulinic acid solution application. You should then protect the treated skin from sunlight and prolonged or intense light for at least 40 hours.
If you are using the aminolevulinic acidgel:
- This medicine is applied on your lesions or to the skin around the lesions. Do not get any of the gel into your eyes, nose, mouth, or ears. Rinse it off right away if it does get on these areas.
- After gel application, the area where the gel has been applied will be covered with a light-blocking, occlusive dressing for 3 hours.
- Immediately after removing the dressing and any remaining gel, you will be treated with a red light using the BF-RhodoLED® lamp.
- If the lesions cannot be treated with the BF-RhodoLED® lamp within 3 hours after the gel has been applied, rinse off the gel with saline and water and protect the lesion sites from sunlight or prolonged or intense light for 2 days.
- Your doctor may want to retreat you after 3 months if your skin condition did not completely resolve.
Precautions
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine can cause episodes of temporary memory loss. Check with your doctor right away if you have problems with your memory, confusion, or disorientation.
For Ameluz® topical gel:
- If your condition does not improve within 3 months, or if it becomes worse, check with your doctor.
- Using Ameluz® with BF-RhodoLED® lamp may cause eye irritation or injury. It may also cause swelling of the eyelids. Tell your doctor right away if you have blurred vision, changes in vision, or red, sore eyes after receiving this medicine.
For Levulan® Kerastick® topical solution:
- Avoid exposure to light if you experience stinging or burning on the treated areas before blue light treatment.
- During the blue light treatment you will experience sensations of tingling, stinging, prickling or burning of the treated skin. These feelings of discomfort should improve at the end of the light treatment.
- Following treatment, the actinic keratoses and possibly the surrounding skin will redden and swelling and scaling may also occur. These changes are temporary and should completely resolve after 4 weeks of treatment.
After aminolevulinic acid application, avoid exposure to sunlight or bright indoor light (eg, from examination lamps, operating room lamps, tanning beds, or being close to lights) up until the time of the blue or red light treatment. Wear long-sleeved shirts, gloves, or other protective clothing to shade the treated skin before blue light treatment. Wide-brimmed hats or similar head covering can help protect you from sunlight or sources of light. Sunscreens will not protect you from sunlight or sources of light.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bleeding
- hives
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- scabbing
- shiny bump
- spots on your skin resembling a blister or pimple
- stinging, burning, pain, redness, swelling, scaling, crusting, lightening or darkening of the skin, itching, cracking, crusting, or dryness of the skin at the application site
- tenderness
- white, yellow or waxy scar-like area
Less common
- Bleeding during lesion preparation
- blistering or irritation of the skin
- flaking, pain, peeling, itching rash, breaking down of the skin
Incidence not known
- Difficulty seeing at night
- double vision
- increased sensitivity of the eyes to sunlight
- loss of memory
- problems with memory
- red, sore eyes
- seeing double
- swelling of the eyelids
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Burning, crawling, itching, numbness, prickling, “pins and needles,” stinging, or tingling feelings
- darkening or lightening of the treated skin
- skin sore
- small, red, raised, itchy bumps
- swelling of the skin
Less common
- Cough
- fever
- headache
- oozing
- open sore on the skin
- pain
- pain or tenderness around the eyes and cheekbones
- pus filled blister or pimple
- raw skin
- stuffy or runny nose
- tenderness
- tightness of the chest
- troubled breathing
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
