Ameluz is a prescription medication used to treat mild to moderate actinic keratoses on the face and scalp. Ameluz is used in combination with photodynamic therapy (PDT) using BF-RhodoLED. BF-RhodoLED, considered a medical device, is a lamp that produces red light and activates the medication.
Ameluz belongs to a group of drugs called a porphyrin precursor. After being activated by BF-RhodoLED, Ameluz destroys the target cells.
This medication is available as a gel and is administered by a health care provider.
Common side effects include applicate site side effects such as pain/burning, irritation, and itching.
What should I discuss with my healthcare provider before using Ameluz (aminolevulinic acid)?
You should not use aminolevulinic acid if you are allergic to it.
To make sure aminolevulinic acid is safe for you, tell your doctor if you have:
a bleeding or blood clotting disorder such as hemophilia; or
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.
Do not breast-feed within 12 hours after you are treated with aminolevulinic acid. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.
What do I need to tell my doctor BEFORE I take Ameluz?
- If you have an allergy to aminolevulinic acid or any other part of Ameluz (aminolevulinic acid gel).
- If you are allergic to porphyrins.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your skin is sensitive to light.
- If you have porphyria.
- If you are taking any drugs that may make your skin more sensitive to light. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Ameluz with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some other side effects of Ameluz?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Adverse effects are for all grades unless otherwise specified
- Erythema (92%)
- Pain/burning (92%)
- Irritation (72%)
- Edema (35%)
- Pruritus (34%)
- Exfoliation (19%)
- Scab (19%)
- Induration (12%)
- Vesicles (12%)
- Scaling/crusting (1-71%)
- Itching (1-25%)
- Hypo/hyperpigmentation (22%)
- Erosion (1-14%)
- Scaling/crusting (2-64%)
- Hypo/hyperpigmentation (36%)
- Itching (7-14%)
- Skin disorder NOS (12%)
- Upper extremities
- Erythema (100%)
- Stinging/burning (96%)
- Scaling and dryness (87%)
- Hyperpigmentation (73%)
- Edema (56%)
- Hypopigmentation (50%)
- Oozing/vesiculation/crusting (41%)
- Paresthesia (9%)
- Hyperalgesia (5%)
- Discomfort (3%)
- Erosion (3%)
- Discharge (2%)
- Bleeding (1%)
- Pustules (1%)
- Wheal/flare (1-7%)
- Skin disorder NOS (5%)
- Ulceration (4%)
- Bleeding/hemorrhage (4%)
- Vesiculation (4%)
- Pustules (4%)
- Dysesthesia (2%)
- Scabbing (1-2%)
- Excoriation (1%)
- Oozing (1%)
- Pain (1%)
- Tenderness (1%)
- Edema (1%)
- Vesiculation (5%)
- Tenderness (2%)
- Ulceration (2%)
- Bleeding/hemorrhage (2%)
- Erosion (2%)
- Wheal/flare (2%)
Skin and subcutaneous tissue disorders: Erythema, swelling, application site inflammation, skin discoloration; increased photosensitivity
Eye disorders: Eye irritation, diplopia, ocular hyperemia, photophobia, and blurred vision
Transient amnestic episodes